Diabetes Mellitus, Type 2, Hypertension
Conditions
Brief summary
To evaluate the impact of escalating doses of IW-1973 on endothelial function \[using EndoPAT to measure fingertip small vessel pulse volume\], blood pressure (BP), and heart rate.
Interventions
DRUGMatching Placebo
DRUGIW-1973
Sponsors
Cyclerion Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patient is ambulatory male or female * Patient's body mass index score is \>20 and \<40 kg/m2 at the Screening Visit * Women of childbearing potential must have a negative pregnancy test at the time of check-in and must agree to use double-barrier contraception throughout the duration of the study * Patient's health is stable with no clinically significant findings on a physical examination * Patient has type 2 (ie adult onset) diabetes mellitus diagnosed by a physician or nurse practitioner \> 6 months before the Screening Visit, and an entry HbA1c that does not mandate prompt intervention for improved control * Patient has hypertension diagnosed by a physician or nurse practitioner \> 6 months before the Screening Visit and BP within the protocol's acceptable range * Patients must be on a stable regimen for glycemic control, and a stable regimen for hypertension control that includes an angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) * Patient has abnormal endothelial function measured by the EndoPAT * Other inclusion criteria per protocol
Exclusion criteria
* Patient has a clinically significant active or unstable medical condition that, in the opinion of the Investigator, would preclude trial participation * Patient is on medication(s) that when co-administered with a soluble guanylate cyclase (sGC) stimulator, could increase the risk of hypotension * Patient has evidence of severe or active end-organ damage attributable to diabetes * Patient has severe renal insufficiency, has undergone renal transplantation, or has planned renal transplantation * Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Pre- to Post-Nitroglycerin Dose Assessment in Supine Pulse | Follow-up Visit Day 32 (± 2 days) | — |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to TEAEs | From first dose of study drug through end of trial (Day 46 [±3 days]) | An adverse event (AE) is any untoward medical occurrence, which does not necessarily have to have a causal relationship with study treatment. An SAE is defined as any AE occurring at any dose that results in any of the following outcomes: death; life-threatening; hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; important medical events. TEAEs are defined as those AEs that started or worsened in severity after the initiation of study drug administration. |
| Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Cholesterol, Glucose, HDL-C, LDL-C, and Triglycerides at Discharge Day (Day 19) | Baseline, Day 19 | Study baseline is defined as the Day -1 assessment. |
| Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Cholesterol, Glucose, HDL-C, LDL-C, and Triglycerides at Follow-Up (Day 32) | Baseline, Day 32 | Study baseline is defined as the Day -1 assessment. |
| Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase at Discharge Day (Day 19) | Baseline, Day 19 | Study baseline is defined as the Day -1 assessment. |
| Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in GGT and Lactate Dehydrogenase at Follow-Up (Day 32) | Baseline, Day 32 | Study baseline is defined as the Day -1 assessment. |
| Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Hemoglobin A1c at Discharge Day (Day 19) | Baseline, Day 19 | Study baseline is defined as the Day -1 assessment. |
| Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Hemoglobin A1c at Follow-Up (Day 32) | Baseline, Day 32 | Study baseline is defined as the Day -1 assessment. |
| Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Insulin at Discharge Day (Day 19) | Baseline, Day 19 | Study baseline is defined as the Day -1 assessment. |
| Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Insulin at Follow-Up (Day 32) | Baseline, Day 32 | Study baseline is defined as the Day -1 assessment. |
| Change From Time-Matched Baseline in Fasting Blood Glucose on Day 2 of Each Dose Cycle | Time-Matched Baseline (Day 2 Placebo Cycle), Day 2 of Each Dose Cycle (Days 5, 8, 11, 14, 17) | Time-matched baseline is defined as the corresponding assessment on Day 2 of the placebo cycle. Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment). To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose are presented as the second row of data. |
| Change From Time-Matched Baseline in Serum Insulin on Day 2 of Each Dose Cycle | Time-Matched Baseline (Day 2 Placebo Cycle), Day 2 of Each Dose Cycle (Days 5, 8, 11, 14, 17) | Time-matched baseline is defined as the corresponding assessment on Day 2 of the placebo cycle. Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment). To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose are presented as the second row of data. |
| Number of Participants With Notable Changes in Post Baseline Vital Signs Values | Up to Day 32 | Supine systolic blood pressure (SSBP): ≥ 180 mmHg and increase (↑) from baseline (BL) ≥ 30 mmHg; ≤ 90 mmHg and decrease (↓) from BL ≥ 30 mmHg. Supine Diastolic Blood Pressure (SDBP): ≥ 105 mmHg and ↑ from BL ≥ 20 mmHg; ≤ 50 mmHg and ↓ from BL ≥ 20 mmHg. Supine pulse rate (SPR): ≥ 110 beats per minute (bpm) and ↑ from BL ≥ 20 bpm; ≤ 50 bpm and ↓ from BL ≥ 20 bpm. Standing systolic blood pressure (StSBP): ≥ 180 mmHg and increase (↑) from baseline (BL) ≥ 30 mmHg; ≤ 90 mmHg and decrease (↓) from BL ≥ 30 mmHg. Standing Diastolic Blood Pressure (StDBP): ≥ 105 mmHg and ↑ from BL ≥ 20 mmHg; ≤ 50 mmHg and ↓ from BL ≥ 20 mmHg. Standing pulse rate (StPR): ≥ 110 beats per minute (bpm) and ↑ from BL ≥ 20 bpm; ≤ 50 bpm and ↓ from BL ≥ 20 bpm. |
| Number of Participants With Notable Post Baseline Orthostatic Vital Signs Values | Up to Day 32 | Systolic blood pressure (SBP): Decrease of \> 20 mmHg from supine to standing Diastolic blood pressure (DBP): Decrease of \> 10 mmHg from supine to standing Pulse rate (PR): Increase of \> 20 bpm from supine to standing. |
| Change From Baseline Over Time in Respiratory Rate | Baseline, Day 19, Day 32 | — |
| Change From Baseline Over Time in Temperature | Baseline, Day 19, Day 32 | — |
| Change From Baseline Over Time in Weight | Baseline, Day 19, Day 32 | — |
| Number of Participants With Clinically Significant Findings or Shifts in Baseline in Electrocardiograms (ECGs) | Study Baseline, Cycle Day 1: 0 (≤ 15m) predose; 1h, 4h (± 15m) postdose; Day 19 | — |
| Number of Participants With Clinically Significant Findings or Shifts in Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) | Study Baseline, Cycle Day 1: 0 (≤ 15m) predose; 1h, 4h (± 15m) postdose; Day 19 | — |
| Change From Study Baseline Over Time in Supine Pulse | Study Baseline; Cycle Day 1, 0 h; Cycle Day 1, 1 h; Cycle Day 1, 2 h; Cycle Day 1, 4 h; Cycle Day 1, 8 h; Cycle Day 1, 12 h; Cycle Day 3, 0 h; Cycle Day 3, 1 h; Cycle Day 3, 2 h; Cycle Day 3, 8 h | Study baseline is defined as the Day -1 assessment. |
| Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time-Matched Baseline (Placebo Cycle); Cycle Day 1, 0 h; Cycle Day 1, 1 h; Cycle Day 1, 2 h; Cycle Day 1, 4 h; Cycle Day 1, 8 h; Cycle Day 1, 12 h; Cycle Day 3, 0 h; Cycle Day 3, 1 h; Cycle Day 3, 2 h; Cycle Day 3, 8 h | Time-matched baseline for each timepoint is defined as the corresponding assessment during the placebo cycle. Baseline is designated per protocol as Day 1 or 3 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 1 or 3 of each IW-1973 dose at given time point are presented as the second row of data. |
| Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Study Baseline; Cycle Day 1, 0 h; Cycle Day 1, 1 h; Cycle Day 1, 2 h; Cycle Day 1, 4 h; Cycle Day 1, 8 h; Cycle Day 1, 12 h; Cycle Day 3, 0 h; Cycle Day 3, 1 h; Cycle Day 3, 2 h; Cycle Day 3, 8 h | Study baseline is defined as the Day -1 assessment. |
| Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time-Matched Baseline (Placebo Cycle); Cycle Day 1, 0 h; Cycle Day 1, 1 h; Cycle Day 1, 2 h; Cycle Day 1, 4 h; Cycle Day 1, 8 h; Cycle Day 1, 12 h; Cycle Day 3, 0 h; Cycle Day 3, 1 h; Cycle Day 3, 2 h; Cycle Day 3, 8 h | Time-matched baseline for each timepoint is defined as the corresponding assessment during the placebo cycle. Baseline is designated per protocol as Day 1 or 3 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 1 or 3 of each IW-1973 dose at given time point are presented as the second row of data. |
| Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Study Baseline; Cycle Day 1, 0 h; Cycle Day 1, 1 h; Cycle Day 1, 2 h; Cycle Day 1, 4 h; Cycle Day 1, 8 h; Cycle Day 1, 12 h; Cycle Day 3, 0 h; Cycle Day 3, 1 h; Cycle Day 3, 2 h; Cycle Day 3, 8 h | Study baseline is defined as the Day -1 assessment. |
| Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time-Matched Baseline (Placebo Cycle); Cycle Day 1, 0 h; Cycle Day 1, 1 h; Cycle Day 1, 2 h; Cycle Day 1, 4 h; Cycle Day 1, 8 h; Cycle Day 1, 12 h; Cycle Day 3, 0 h; Cycle Day 3, 1 h; Cycle Day 3, 2 h; Cycle Day 3, 8 h | Time-matched baseline for each timepoint is defined as the corresponding assessment during the placebo cycle. Baseline is designated per protocol as Day 1 or 3 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 1 or 3 of each IW-1973 dose at given time point are presented as the second row of data. |
| Orthostatic Pulse Over Time | Cycle Day 1, Predose; Cycle Day 1, 1 h; Cycle Day 1, 2 h; Cycle Day 1, 4 h; Cycle Day 1, 8 h; Cycle Day 1, 12 h | An orthostatic measurement is obtained by subtracting the supine measurement from the standing measurement. |
| Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, Predose; Cycle Day 1, 1 h; Cycle Day 1, 2 h; Cycle Day 1, 4 h; Cycle Day 1, 8 h; Cycle Day 1, 12 h | An orthostatic measurement is obtained by subtracting the supine measurement from the standing measurement. |
| Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, Predose; Cycle Day 1, 1 h; Cycle Day 1, 2 h; Cycle Day 1, 4 h; Cycle Day 1, 8 h; Cycle Day 1, 12 h | An orthostatic measurement is obtained by subtracting the supine measurement from the standing measurement. |
| Change From Time-Matched Baseline (Placebo Cycle) Over Time in Ambulatory Blood Pressure Monitoring (ABPM) 4-Hour Averages of Systolic Blood Pressure | Time-Matched Baseline (Placebo Cycle); Cycle Day 2: 0-4 hrs, 4-8 hrs, 8-12 hrs | Four-hour average is the average of ABPM assessments over 4 hours intervals from the time of dosing. Time-matched baseline is the 4 hours average during the placebo cycle (Day 2). Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose at given time point are presented as the second row of data. |
| Change From Pre- to Post-Nitroglycerin Dose Assessment in Supine Systolic Blood Pressure | Follow-up Visit Day 32 (± 2 days) | — |
| Change From Pre- to Post-Nitroglycerin Dose Assessment in Supine Diastolic Blood Pressure | Follow-up Visit Day 32 (± 2 days) | — |
| Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | Time-Matched Baseline (Placebo Cycle); Cycle Day 2: 0.5 hr, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, 10 hrs, 10.5 hrs, 11 hrs, 11.5 hrs, 12 hrs | Thirty-minute average is the average of ABPM assessments over 30 minutes intervals from the time of dosing. Time-matched baseline is the 30 minutes average during the placebo cycle (Day 2). Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose at given time point are presented as the second row of data. |
| Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Systolic Blood Pressure | Time-Matched Baseline (Placebo Cycle); Cycle Day 2 | Daytime average is the average of ABPM assessments over 12 hours from the time of dosing. Time-matched baseline is the daytime average during the placebo cycle (Day 2). Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose at given time point are presented as the second row of data. |
| Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Diastolic Blood Pressure | Time-Matched Baseline (Placebo Cycle); Cycle Day 2: 0-4 hrs, 4-8 hrs, 8-12 hrs | Four-hour average is the average of ABPM assessments over 4 hours intervals from the time of dosing. Time-matched baseline is the 4 hours average during the placebo cycle (Day 2). Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose at given time point are presented as the second row of data. |
| Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | Time-Matched Baseline (Placebo Cycle); Cycle Day 2: 0.5 hr, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, 10 hrs, 10.5 hrs, 11 hrs, 11.5 hrs, 12 hrs | Thirty-minute average is the average of ABPM assessments over 30 minutes intervals from the time of dosing. Time-matched baseline is the 30 minutes average during the placebo cycle (Day 2). Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose at given time point are presented as the second row of data. |
| Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Diastolic Blood Pressure | Time-Matched Baseline (Placebo Cycle); Cycle Day 2 | Daytime average is the average of ABPM assessments over 12 hours from the time of dosing. Time-matched baseline is the daytime average during the placebo cycle (Day 2). Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment). To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose are presented as the second row of data. |
| Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Mean Arterial Pressure | Time-Matched Baseline (Placebo Cycle); Cycle Day 2: 0-4 hrs, 4-8 hrs, 8-12 hrs | Four-hour average is the average of ABPM assessments over 4 hours intervals from the time of dosing. Time-matched baseline is the 4 hours average during the placebo cycle (Day 2). Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose at given time point are presented as the second row of data. |
| Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | Time-Matched Baseline (Placebo Cycle); Cycle Day 2: 0.5 hr, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, 10 hrs, 10.5 hrs, 11 hrs, 11.5 hrs, 12 hrs | Thirty-minute average is the average of ABPM assessments over 30 minutes intervals from the time of dosing. Time-matched baseline is the 30 minutes average during the placebo cycle (Day 2). Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose at given time point are presented as the second row of data. |
| Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Mean Arterial Pressure | Time-Matched Baseline (Placebo Cycle); Cycle Day 2 | Daytime average is the average of ABPM assessments over 12 hours from the time of dosing. Time-matched baseline is the daytime average during the placebo cycle (Day 2). Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment). To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose are presented as the second row of data. |
| Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Pulse | Time-Matched Baseline (Placebo Cycle); Cycle Day 2: 0-4 hrs, 4-8 hrs, 8-12 hrs | Four-hour average is the average of ABPM assessments over 4 hours intervals from the time of dosing. Time-matched baseline is the 4 hours average during the placebo cycle (Day 2). Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose at given time point are presented as the second row of data. |
| Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | Time-Matched Baseline (Placebo Cycle); Cycle Day 2: 0.5 hr, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, 10 hrs, 10.5 hrs, 11 hrs, 11.5 hrs, 12 hrs | Thirty-minute average is the average of ABPM assessments over 30 minutes intervals from the time of dosing. Time-matched baseline is the 30 minutes average during the placebo cycle (Day 2). Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose at given time point are presented as the second row of data. |
| Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Pulse | Time-Matched Baseline (Placebo Cycle); Cycle Day 2 | Daytime average is the average of ABPM assessments over 12 hours from the time of dosing. Time-matched baseline is the daytime average during the placebo cycle (Day 2). Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment). To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose are presented as the second row of data. |
| Change From Study Baseline Over Time in Endothelial Function: Reactive Hyperemia Index (RHI) | Study Baseline; Cycle Day 3: 0 h, 4 h, 12 h | Study baseline is defined as the Day -1 assessment. Endothelial function was assessed by RHI value determined using the noninvasive EndoPAT™ (Itamar Medical; Caesarea, Israel) device. RHI is a validated measure of endothelial function, with a higher RHI indicating better endothelial function compared to a lower value. The full EndoPAT 2000 user manual (software version 3.7.x) recommends using RHI values \>1.67 as a cutoff for normal endothelial function, with values ≤1.67 indicating endothelial dysfunction. |
| Change From Time-Matched Baseline (Placebo Cycle) Over Time in Endothelial Function: RHI | Time-matched Baseline (Placebo Cycle); Cycle Day 3: 0 h, 4 h, 12 h | Time-matched baseline for each timepoint is defined as the corresponding assessment during the placebo cycle. Endothelial function was assessed by RHI value determined using the noninvasive EndoPAT™ (Itamar Medical; Caesarea, Israel) device. RHI is a validated measure of endothelial function, with a higher RHI indicating better endothelial function compared to a lower value. The full EndoPAT 2000 user manual (software version 3.7.x) recommends using RHI values \>1.67 as a cutoff for normal endothelial function, with values ≤1.67 indicating endothelial dysfunction. Baseline is designated per protocol as Day 3 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 3 of each IW-1973 dose at given time point are presented as the second row of data. |
| Change From Pre- to Post-Nitroglycerin Dose Assessment in Endothelial Function: RHI | Follow-up Visit Day 32 (± 2 days) | Endothelial function was assessed by RHI value determined using the noninvasive EndoPAT™ (Itamar Medical; Caesarea, Israel) device. RHI is a validated measure of endothelial function, with a higher RHI indicating better endothelial function compared to a lower value. The full EndoPAT 2000 user manual (software version 3.7.x) recommends using RHI values \>1.67 as a cutoff for normal endothelial function, with values ≤1.67 indicating endothelial dysfunction. |
| Change From Time-Matched Baseline (Placebo Cycle) in Platelet Function Assessments: Collagen/Epinephrine Time to Aggregation | Time-Matched Baseline (Placebo Cycle), Cycle Day 1, 0 h, Cycle Day 1, 4 h | Time-matched baseline is defined as the corresponding assessment on Day 1 of the placebo cycle. Platelet function assessment used the PFA-100® instrument to evaluate collagen/epinephrine time to aggregation. Baseline is designated per protocol as Day 1 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 1 of each IW-1973 dose at given time point are presented as the second row of data. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Once-daily study drug for 18 days: placebo for 3 days and escalating doses of IW-1973 for 15 days (10 mg, 20 mg, 30 mg, 40 mg, 50 mg for 3 days each). | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 56.6 years STANDARD_DEVIATION 6.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 5 Participants |
| Race/Ethnicity, Customized White | 6 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 7 Participants |
| Study Baseline: Cholesterol, Glucose, HDL-C, LDL-C, Triglycerides Cholesterol | 185.0 mg/dL STANDARD_DEVIATION 44.9 |
| Study Baseline: Cholesterol, Glucose, HDL-C, LDL-C, Triglycerides Glucose | 143.27 mg/dL STANDARD_DEVIATION 34.34 |
| Study Baseline: Cholesterol, Glucose, HDL-C, LDL-C, Triglycerides High-density lipoprotein cholesterol (HDL-C) | 50.27 mg/dL STANDARD_DEVIATION 14.11 |
| Study Baseline: Cholesterol, Glucose, HDL-C, LDL-C, Triglycerides Low-density lipoprotein cholesterol (LDL-C) | 107.45 mg/dL STANDARD_DEVIATION 36.74 |
| Study Baseline: Cholesterol, Glucose, HDL-C, LDL-C, Triglycerides Triglycerides | 137.73 mg/dL STANDARD_DEVIATION 54.23 |
| Study Baseline: Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase GGT | 36.2 U/L STANDARD_DEVIATION 28.4 |
| Study Baseline: Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase Lactate Dehydrogenase | 163.1 U/L STANDARD_DEVIATION 30.7 |
| Study Baseline: Hemoglobin A1c | 7.67 percent STANDARD_DEVIATION 1.33 |
| Study Baseline: Insulin | 17.50 μIU/mL STANDARD_DEVIATION 12.17 |
| Study Baseline: Pulse | 72.0 beats per minute STANDARD_DEVIATION 15.9 |
| Study Baseline: Respiratory Rate | 16.4 breaths/min STANDARD_DEVIATION 2.2 |
| Study Baseline: Supine diastolic blood pressure | 80.4 mmHg STANDARD_DEVIATION 5.9 |
| Study Baseline: Supine systolic blood pressure | 136.3 mmHg STANDARD_DEVIATION 12.9 |
| Study Baseline: Temperature | 36.68 degrees celcius STANDARD_DEVIATION 0.21 |
| Study Baseline: Weight | 91.08 kg STANDARD_DEVIATION 11.58 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 10 | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 3 / 11 | 3 / 11 | 2 / 11 | 4 / 10 | 3 / 9 | 2 / 9 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 10 | 0 / 9 | 0 / 9 |
Outcome results
Primary
Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Cholesterol, Glucose, HDL-C, LDL-C, and Triglycerides at Discharge Day (Day 19)
Study baseline is defined as the Day -1 assessment.
Time frame: Baseline, Day 19
Population: Safety Population: all participants who received ≥1 dose of study drug, grouped according to actual study drug taken.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Cholesterol, Glucose, HDL-C, LDL-C, and Triglycerides at Discharge Day (Day 19) | Cholesterol: Day 19/Discharge | 141.7 mg/dL | Standard Deviation 39.6 |
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Cholesterol, Glucose, HDL-C, LDL-C, and Triglycerides at Discharge Day (Day 19) | Cholesterol: Change at Day 19/Discharge | -43.3 mg/dL | Standard Deviation 35.1 |
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Cholesterol, Glucose, HDL-C, LDL-C, and Triglycerides at Discharge Day (Day 19) | Glucose: Day 19/Discharge | 116.82 mg/dL | Standard Deviation 25.43 |
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Cholesterol, Glucose, HDL-C, LDL-C, and Triglycerides at Discharge Day (Day 19) | Glucose: Change at Day 19/Discharge | -26.45 mg/dL | Standard Deviation 25.25 |
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Cholesterol, Glucose, HDL-C, LDL-C, and Triglycerides at Discharge Day (Day 19) | HDL-C: Day 19/Discharge | 44.36 mg/dL | Standard Deviation 10.74 |
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Cholesterol, Glucose, HDL-C, LDL-C, and Triglycerides at Discharge Day (Day 19) | HDL-C: Change at Day 19/Discharge | -5.91 mg/dL | Standard Deviation 7.73 |
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Cholesterol, Glucose, HDL-C, LDL-C, and Triglycerides at Discharge Day (Day 19) | LDL-C: Day 19/Discharge | 73.09 mg/dL | Standard Deviation 34.69 |
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Cholesterol, Glucose, HDL-C, LDL-C, and Triglycerides at Discharge Day (Day 19) | LDL-C: Change at Day 19/Discharge | -34.36 mg/dL | Standard Deviation 28.88 |
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Cholesterol, Glucose, HDL-C, LDL-C, and Triglycerides at Discharge Day (Day 19) | Triglycerides: Day 19/Discharge | 121.73 mg/dL | Standard Deviation 46.1 |
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Cholesterol, Glucose, HDL-C, LDL-C, and Triglycerides at Discharge Day (Day 19) | Triglycerides: Change at Day 19/Discharge | -16.00 mg/dL | Standard Deviation 42.45 |
Primary
Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Cholesterol, Glucose, HDL-C, LDL-C, and Triglycerides at Follow-Up (Day 32)
Study baseline is defined as the Day -1 assessment.
Time frame: Baseline, Day 32
Population: Safety Population: all participants who received ≥1 dose of study drug, grouped according to actual study drug taken.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Cholesterol, Glucose, HDL-C, LDL-C, and Triglycerides at Follow-Up (Day 32) | Cholesterol: Day 32/Follow-Up | 183.1 mg/dL | Standard Deviation 48.6 |
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Cholesterol, Glucose, HDL-C, LDL-C, and Triglycerides at Follow-Up (Day 32) | Cholesterol: Change at Day 32/Follow-Up | -1.9 mg/dL | Standard Deviation 27.1 |
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Cholesterol, Glucose, HDL-C, LDL-C, and Triglycerides at Follow-Up (Day 32) | Glucose: Day 32/Follow-Up | 154.27 mg/dL | Standard Deviation 48.54 |
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Cholesterol, Glucose, HDL-C, LDL-C, and Triglycerides at Follow-Up (Day 32) | Glucose: Change at Day 32/Follow-Up | 11.00 mg/dL | Standard Deviation 41.47 |
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Cholesterol, Glucose, HDL-C, LDL-C, and Triglycerides at Follow-Up (Day 32) | HDL-C: Day 32/Follow-Up | 48.18 mg/dL | Standard Deviation 10.32 |
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Cholesterol, Glucose, HDL-C, LDL-C, and Triglycerides at Follow-Up (Day 32) | HDL-C: Change at Day 32/Follow-Up | -2.09 mg/dL | Standard Deviation 6.88 |
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Cholesterol, Glucose, HDL-C, LDL-C, and Triglycerides at Follow-Up (Day 32) | LDL-C: Day 32/Follow-Up | 107.27 mg/dL | Standard Deviation 42.11 |
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Cholesterol, Glucose, HDL-C, LDL-C, and Triglycerides at Follow-Up (Day 32) | LDL-C: Change at Day 32/Follow-Up | -0.18 mg/dL | Standard Deviation 23.84 |
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Cholesterol, Glucose, HDL-C, LDL-C, and Triglycerides at Follow-Up (Day 32) | Triglycerides: Day 32/Follow-Up | 138.09 mg/dL | Standard Deviation 46.26 |
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Cholesterol, Glucose, HDL-C, LDL-C, and Triglycerides at Follow-Up (Day 32) | Triglycerides: Change at Day 32/Follow-Up | 0.36 mg/dL | Standard Deviation 52.94 |
Primary
Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase at Discharge Day (Day 19)
Study baseline is defined as the Day -1 assessment.
Time frame: Baseline, Day 19
Population: Safety Population: all participants who received ≥1 dose of study drug, grouped according to actual study drug taken.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase at Discharge Day (Day 19) | GGT: Day 19/Discharge | 28.3 U/L | Standard Deviation 17.2 |
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase at Discharge Day (Day 19) | GGT: Change at Day 19/Discharge | -7.9 U/L | Standard Deviation 15.9 |
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase at Discharge Day (Day 19) | Lactate Dehydrogenase: Day 19/Discharge | 135.7 U/L | Standard Deviation 18.2 |
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase at Discharge Day (Day 19) | Lactate Dehydrogenase: Change at Day 19/Discharge | -27.4 U/L | Standard Deviation 21.2 |
Primary
Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in GGT and Lactate Dehydrogenase at Follow-Up (Day 32)
Study baseline is defined as the Day -1 assessment.
Time frame: Baseline, Day 32
Population: Safety Population: all participants who received ≥1 dose of study drug, grouped according to actual study drug taken.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in GGT and Lactate Dehydrogenase at Follow-Up (Day 32) | GGT: Day 32/Follow-Up | 53.6 U/L | Standard Deviation 83.9 |
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in GGT and Lactate Dehydrogenase at Follow-Up (Day 32) | GGT: Change at Day 32/Follow-Up | 17.5 U/L | Standard Deviation 67.8 |
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in GGT and Lactate Dehydrogenase at Follow-Up (Day 32) | Lactate Dehydrogenase: Day 32/Follow-Up | 171.6 U/L | Standard Deviation 55.2 |
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in GGT and Lactate Dehydrogenase at Follow-Up (Day 32) | Lactate Dehydrogenase: Change at Day 32/Follow-Up | 8.5 U/L | Standard Deviation 46.4 |
Primary
Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Hemoglobin A1c at Discharge Day (Day 19)
Study baseline is defined as the Day -1 assessment.
Time frame: Baseline, Day 19
Population: Safety Population: all participants who received ≥1 dose of study drug, grouped according to actual study drug taken.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Hemoglobin A1c at Discharge Day (Day 19) | Discharge Day (Day 19) | 7.27 percent | Standard Deviation 1.53 |
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Hemoglobin A1c at Discharge Day (Day 19) | Change at Discharge Day (Day 19) | -0.40 percent | Standard Deviation 0.54 |
Primary
Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Hemoglobin A1c at Follow-Up (Day 32)
Study baseline is defined as the Day -1 assessment.
Time frame: Baseline, Day 32
Population: Safety Population: all participants who received ≥1 dose of study drug, grouped according to actual study drug taken.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Hemoglobin A1c at Follow-Up (Day 32) | Follow-Up (Day 32) | 7.54 percent | Standard Deviation 1.49 |
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Hemoglobin A1c at Follow-Up (Day 32) | Change at Follow-Up (Day 32) | -0.14 percent | Standard Deviation 0.49 |
Primary
Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Insulin at Discharge Day (Day 19)
Study baseline is defined as the Day -1 assessment.
Time frame: Baseline, Day 19
Population: Safety Population: all participants who received ≥1 dose of study drug, grouped according to actual study drug taken.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Insulin at Discharge Day (Day 19) | Discharge Day (Day 19) | 17.45 µIU/mL | Standard Deviation 14.2 |
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Insulin at Discharge Day (Day 19) | Change at Discharge Day (Day 19) | -0.05 µIU/mL | Standard Deviation 5.31 |
Primary
Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Insulin at Follow-Up (Day 32)
Study baseline is defined as the Day -1 assessment.
Time frame: Baseline, Day 32
Population: Safety Population: all participants who received ≥1 dose of study drug, grouped according to actual study drug taken.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Insulin at Follow-Up (Day 32) | Follow-Up (Day 32) | 23.81 µIU/mL | Standard Deviation 18.81 |
| Control | Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Insulin at Follow-Up (Day 32) | Change at Follow-Up (Day 32) | 6.31 µIU/mL | Standard Deviation 11.18 |
Primary
Change From Baseline Over Time in Respiratory Rate
Time frame: Baseline, Day 19, Day 32
Population: Safety Population: all participants who received ≥1 dose of study drug, grouped according to actual study drug taken.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change From Baseline Over Time in Respiratory Rate | Change at Day 19/Discharge | -0.7 breaths/min | Standard Deviation 1.8 |
| Control | Change From Baseline Over Time in Respiratory Rate | Change at Day 32/Follow-Up | -1.5 breaths/min | Standard Deviation 2.7 |
Primary
Change From Baseline Over Time in Temperature
Time frame: Baseline, Day 19, Day 32
Population: Safety Population: all participants who received ≥1 dose of study drug, grouped according to actual study drug taken.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change From Baseline Over Time in Temperature | Change at Day 19/Discharge | 0.12 degrees celcius | Standard Deviation 0.19 |
| Control | Change From Baseline Over Time in Temperature | Change at Day 32/Follow-Up | -0.03 degrees celcius | Standard Deviation 0.2 |
Primary
Change From Baseline Over Time in Weight
Time frame: Baseline, Day 19, Day 32
Population: Safety Population: all participants who received ≥1 dose of study drug, grouped according to actual study drug taken.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change From Baseline Over Time in Weight | Change at Day 19/Discharge | -3.47 kg | Standard Deviation 2.16 |
| Control | Change From Baseline Over Time in Weight | Change at Day 32/Follow-Up | -1.40 kg | Standard Deviation 1.61 |
Primary
Change From Pre- to Post-Nitroglycerin Dose Assessment in Endothelial Function: RHI
Endothelial function was assessed by RHI value determined using the noninvasive EndoPAT™ (Itamar Medical; Caesarea, Israel) device. RHI is a validated measure of endothelial function, with a higher RHI indicating better endothelial function compared to a lower value. The full EndoPAT 2000 user manual (software version 3.7.x) recommends using RHI values \>1.67 as a cutoff for normal endothelial function, with values ≤1.67 indicating endothelial dysfunction.
Time frame: Follow-up Visit Day 32 (± 2 days)
Population: PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Change From Pre- to Post-Nitroglycerin Dose Assessment in Endothelial Function: RHI | -0.05 units on a scale | Standard Deviation 0.37 |
Primary
Change From Pre- to Post-Nitroglycerin Dose Assessment in Supine Diastolic Blood Pressure
Time frame: Follow-up Visit Day 32 (± 2 days)
Population: PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Change From Pre- to Post-Nitroglycerin Dose Assessment in Supine Diastolic Blood Pressure | -0.5 mmHg | Standard Deviation 3.8 |
Primary
Change From Pre- to Post-Nitroglycerin Dose Assessment in Supine Pulse
Time frame: Follow-up Visit Day 32 (± 2 days)
Population: PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Change From Pre- to Post-Nitroglycerin Dose Assessment in Supine Pulse | -2.5 bpm | Standard Deviation 5.4 |
Primary
Change From Pre- to Post-Nitroglycerin Dose Assessment in Supine Systolic Blood Pressure
Time frame: Follow-up Visit Day 32 (± 2 days)
Population: PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Change From Pre- to Post-Nitroglycerin Dose Assessment in Supine Systolic Blood Pressure | 3.5 mmHg | Standard Deviation 7.3 |
Primary
Change From Study Baseline Over Time in Endothelial Function: Reactive Hyperemia Index (RHI)
Study baseline is defined as the Day -1 assessment. Endothelial function was assessed by RHI value determined using the noninvasive EndoPAT™ (Itamar Medical; Caesarea, Israel) device. RHI is a validated measure of endothelial function, with a higher RHI indicating better endothelial function compared to a lower value. The full EndoPAT 2000 user manual (software version 3.7.x) recommends using RHI values \>1.67 as a cutoff for normal endothelial function, with values ≤1.67 indicating endothelial dysfunction.
Time frame: Study Baseline; Cycle Day 3: 0 h, 4 h, 12 h
Population: PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change From Study Baseline Over Time in Endothelial Function: Reactive Hyperemia Index (RHI) | Study Baseline | 2.21 units on a scale | Standard Deviation 0.62 |
| Control | Change From Study Baseline Over Time in Endothelial Function: Reactive Hyperemia Index (RHI) | Change at Cycle Day 3, 0 h | -0.08 units on a scale | Standard Deviation 0.74 |
| Control | Change From Study Baseline Over Time in Endothelial Function: Reactive Hyperemia Index (RHI) | Change at Cycle Day 3, 4 h | -0.39 units on a scale | Standard Deviation 0.65 |
| Control | Change From Study Baseline Over Time in Endothelial Function: Reactive Hyperemia Index (RHI) | Change at Cycle Day 3, 12 h | -0.03 units on a scale | Standard Deviation 0.64 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Endothelial Function: Reactive Hyperemia Index (RHI) | Change at Cycle Day 3, 4 h | 0.08 units on a scale | Standard Deviation 0.99 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Endothelial Function: Reactive Hyperemia Index (RHI) | Change at Cycle Day 3, 0 h | -0.14 units on a scale | Standard Deviation 0.91 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Endothelial Function: Reactive Hyperemia Index (RHI) | Study Baseline | 2.21 units on a scale | Standard Deviation 0.62 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Endothelial Function: Reactive Hyperemia Index (RHI) | Change at Cycle Day 3, 12 h | 0.33 units on a scale | Standard Deviation 1.07 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Endothelial Function: Reactive Hyperemia Index (RHI) | Change at Cycle Day 3, 12 h | 0.29 units on a scale | Standard Deviation 0.68 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Endothelial Function: Reactive Hyperemia Index (RHI) | Change at Cycle Day 3, 4 h | 0.01 units on a scale | Standard Deviation 0.75 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Endothelial Function: Reactive Hyperemia Index (RHI) | Change at Cycle Day 3, 0 h | -0.13 units on a scale | Standard Deviation 0.69 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Endothelial Function: Reactive Hyperemia Index (RHI) | Study Baseline | 2.28 units on a scale | Standard Deviation 0.61 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Endothelial Function: Reactive Hyperemia Index (RHI) | Study Baseline | 2.21 units on a scale | Standard Deviation 0.66 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Endothelial Function: Reactive Hyperemia Index (RHI) | Change at Cycle Day 3, 12 h | 0.07 units on a scale | Standard Deviation 0.91 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Endothelial Function: Reactive Hyperemia Index (RHI) | Change at Cycle Day 3, 0 h | 0.31 units on a scale | Standard Deviation 1.08 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Endothelial Function: Reactive Hyperemia Index (RHI) | Change at Cycle Day 3, 4 h | -0.15 units on a scale | Standard Deviation 0.8 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Endothelial Function: Reactive Hyperemia Index (RHI) | Change at Cycle Day 3, 4 h | -0.17 units on a scale | Standard Deviation 0.98 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Endothelial Function: Reactive Hyperemia Index (RHI) | Change at Cycle Day 3, 12 h | 0.17 units on a scale | Standard Deviation 1.06 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Endothelial Function: Reactive Hyperemia Index (RHI) | Change at Cycle Day 3, 0 h | 0.20 units on a scale | Standard Deviation 0.87 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Endothelial Function: Reactive Hyperemia Index (RHI) | Study Baseline | 2.28 units on a scale | Standard Deviation 0.66 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Endothelial Function: Reactive Hyperemia Index (RHI) | Change at Cycle Day 3, 0 h | -0.09 units on a scale | Standard Deviation 0.87 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Endothelial Function: Reactive Hyperemia Index (RHI) | Change at Cycle Day 3, 4 h | -0.06 units on a scale | Standard Deviation 0.78 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Endothelial Function: Reactive Hyperemia Index (RHI) | Change at Cycle Day 3, 12 h | 0.37 units on a scale | Standard Deviation 1.14 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Endothelial Function: Reactive Hyperemia Index (RHI) | Study Baseline | 2.28 units on a scale | Standard Deviation 0.66 |
Primary
Change From Study Baseline Over Time in Supine Diastolic Blood Pressure
Study baseline is defined as the Day -1 assessment.
Time frame: Study Baseline; Cycle Day 1, 0 h; Cycle Day 1, 1 h; Cycle Day 1, 2 h; Cycle Day 1, 4 h; Cycle Day 1, 8 h; Cycle Day 1, 12 h; Cycle Day 3, 0 h; Cycle Day 3, 1 h; Cycle Day 3, 2 h; Cycle Day 3, 8 h
Population: PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 4 h | -8.2 mmHg | Standard Deviation 4.9 |
| Control | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Study Baseline | 80.4 mmHg | Standard Deviation 5.9 |
| Control | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 2 h | -8.4 mmHg | Standard Deviation 7.4 |
| Control | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 1 h | -6.8 mmHg | Standard Deviation 6.8 |
| Control | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 12 h | -6.5 mmHg | Standard Deviation 6.6 |
| Control | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 2 h | -4.8 mmHg | Standard Deviation 8.6 |
| Control | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 0 h | -4.6 mmHg | Standard Deviation 6.7 |
| Control | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 8 h | -7.2 mmHg | Standard Deviation 7.5 |
| Control | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 8 h | -7.5 mmHg | Standard Deviation 7.8 |
| Control | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 0 h | -3.3 mmHg | Standard Deviation 5.1 |
| Control | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 1 h | -7.6 mmHg | Standard Deviation 7.9 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 8 h | -6.7 mmHg | Standard Deviation 8.7 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 0 h | -2.6 mmHg | Standard Deviation 6.9 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 12 h | -8.6 mmHg | Standard Deviation 8.7 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 8 h | -9.1 mmHg | Standard Deviation 8.5 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 0 h | -4.4 mmHg | Standard Deviation 9.2 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 1 h | -7.9 mmHg | Standard Deviation 8.4 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 2 h | -10.5 mmHg | Standard Deviation 8.9 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 2 h | -10.9 mmHg | Standard Deviation 9.4 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Study Baseline | 80.4 mmHg | Standard Deviation 5.9 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 1 h | -10.9 mmHg | Standard Deviation 9.1 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 4 h | -8.2 mmHg | Standard Deviation 7.3 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 2 h | -12.9 mmHg | Standard Deviation 7.5 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 12 h | -9.7 mmHg | Standard Deviation 10.6 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 1 h | -14.1 mmHg | Standard Deviation 9.6 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 0 h | -5.6 mmHg | Standard Deviation 7.1 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 0 h | -6.9 mmHg | Standard Deviation 6.9 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 8 h | -11.5 mmHg | Standard Deviation 6.3 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 8 h | -11.2 mmHg | Standard Deviation 6.2 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 4 h | -10.1 mmHg | Standard Deviation 5.8 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 1 h | -12.5 mmHg | Standard Deviation 8.2 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 2 h | -13.5 mmHg | Standard Deviation 8.4 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Study Baseline | 80.4 mmHg | Standard Deviation 5.9 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 2 h | -12.3 mmHg | Standard Deviation 10.7 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Study Baseline | 79.9 mmHg | Standard Deviation 6 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 0 h | -6.4 mmHg | Standard Deviation 6.8 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 1 h | -13.3 mmHg | Standard Deviation 7 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 2 h | -16.3 mmHg | Standard Deviation 8.2 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 4 h | -11.7 mmHg | Standard Deviation 6.6 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 8 h | -10.1 mmHg | Standard Deviation 8.8 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 12 h | -10.3 mmHg | Standard Deviation 9.7 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 0 h | -7.0 mmHg | Standard Deviation 6.5 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 1 h | -13.6 mmHg | Standard Deviation 8.8 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 8 h | -12.1 mmHg | Standard Deviation 8.3 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 8 h | -8.4 mmHg | Standard Deviation 7.7 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 0 h | -7.4 mmHg | Standard Deviation 5.4 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 4 h | -12.0 mmHg | Standard Deviation 4.9 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 2 h | -11.7 mmHg | Standard Deviation 6.6 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 8 h | -10.9 mmHg | Standard Deviation 5.3 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 1 h | -13.3 mmHg | Standard Deviation 6.3 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 1 h | -11.3 mmHg | Standard Deviation 5.5 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 0 h | -6.3 mmHg | Standard Deviation 5.6 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 2 h | -12.2 mmHg | Standard Deviation 5.6 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Study Baseline | 78.2 mmHg | Standard Deviation 2.9 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 12 h | -9.9 mmHg | Standard Deviation 6.8 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 4 h | -10.8 mmHg | Standard Deviation 5.5 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 8 h | -9.4 mmHg | Standard Deviation 5.6 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 8 h | -13.3 mmHg | Standard Deviation 6.8 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 0 h | -5.3 mmHg | Standard Deviation 6.8 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 12 h | -11.0 mmHg | Standard Deviation 9.4 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 2 h | -13.3 mmHg | Standard Deviation 5.9 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 0 h | -5.9 mmHg | Standard Deviation 6.1 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 2 h | -16.3 mmHg | Standard Deviation 5.3 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Study Baseline | 78.2 mmHg | Standard Deviation 2.9 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 1 h | -13.2 mmHg | Standard Deviation 6.3 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 1 h | -13.7 mmHg | Standard Deviation 6 |
Primary
Change From Study Baseline Over Time in Supine Pulse
Study baseline is defined as the Day -1 assessment.
Time frame: Study Baseline; Cycle Day 1, 0 h; Cycle Day 1, 1 h; Cycle Day 1, 2 h; Cycle Day 1, 4 h; Cycle Day 1, 8 h; Cycle Day 1, 12 h; Cycle Day 3, 0 h; Cycle Day 3, 1 h; Cycle Day 3, 2 h; Cycle Day 3, 8 h
Population: PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change From Study Baseline Over Time in Supine Pulse | Study Baseline | 72.0 bpm | Standard Deviation 15.9 |
| Control | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 8 h | -3.2 bpm | Standard Deviation 9.7 |
| Control | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 4 h | -3.5 bpm | Standard Deviation 9.4 |
| Control | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 3, 2 h | 2.0 bpm | Standard Deviation 9.1 |
| Control | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 0 h | -5.5 bpm | Standard Deviation 7.6 |
| Control | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 3, 8 h | -1.0 bpm | Standard Deviation 11.2 |
| Control | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 3, 1 h | -1.8 bpm | Standard Deviation 9.3 |
| Control | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 1 h | -0.1 bpm | Standard Deviation 8.7 |
| Control | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 3, 0 h | -4.1 bpm | Standard Deviation 11.7 |
| Control | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 12 h | -2.3 bpm | Standard Deviation 8.4 |
| Control | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 2 h | -1.8 bpm | Standard Deviation 7.6 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 12 h | 4.1 bpm | Standard Deviation 10.4 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 3, 0 h | -6.2 bpm | Standard Deviation 10.7 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 4 h | -2.2 bpm | Standard Deviation 10.7 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 2 h | 3.4 bpm | Standard Deviation 8.9 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Study Baseline | 72.0 bpm | Standard Deviation 15.9 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 3, 2 h | 4.5 bpm | Standard Deviation 11.3 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 1 h | -1.9 bpm | Standard Deviation 9.8 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 3, 8 h | 0.6 bpm | Standard Deviation 9.3 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 0 h | -6.5 bpm | Standard Deviation 11.6 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 8 h | 2.1 bpm | Standard Deviation 12.3 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 3, 1 h | 3.9 bpm | Standard Deviation 11.9 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 3, 2 h | 7.2 bpm | Standard Deviation 8.9 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 0 h | -5.8 bpm | Standard Deviation 11.1 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 1 h | 1.7 bpm | Standard Deviation 12.7 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 2 h | 6.3 bpm | Standard Deviation 11.7 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 4 h | 1.7 bpm | Standard Deviation 9.5 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 8 h | 0.8 bpm | Standard Deviation 10.2 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 12 h | 2.9 bpm | Standard Deviation 9.6 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 3, 0 h | -5.1 bpm | Standard Deviation 11.2 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 3, 1 h | 5.5 bpm | Standard Deviation 11.7 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Study Baseline | 72.0 bpm | Standard Deviation 15.9 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 3, 8 h | -1.6 bpm | Standard Deviation 11.7 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 3, 1 h | 6.1 bpm | Standard Deviation 8.4 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 3, 8 h | -1.2 bpm | Standard Deviation 7.8 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 3, 0 h | -5.4 bpm | Standard Deviation 10.8 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 4 h | 0.7 bpm | Standard Deviation 10.6 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 0 h | -7.2 bpm | Standard Deviation 11 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 8 h | -1.4 bpm | Standard Deviation 9.3 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Study Baseline | 72.7 bpm | Standard Deviation 16.6 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 12 h | 0 bpm | Standard Deviation 9.4 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 2 h | 11.9 bpm | Standard Deviation 14.1 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 3, 2 h | 9.1 bpm | Standard Deviation 10.7 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 1 h | 5.7 bpm | Standard Deviation 12.7 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 0 h | -4.9 bpm | Standard Deviation 12.1 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 8 h | -1.7 bpm | Standard Deviation 11.7 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 1 h | 1.0 bpm | Standard Deviation 9.4 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 12 h | 3.2 bpm | Standard Deviation 12.9 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 3, 0 h | -6.8 bpm | Standard Deviation 12.2 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 3, 1 h | 8.8 bpm | Standard Deviation 15.2 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Study Baseline | 73.2 bpm | Standard Deviation 17.5 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 3, 8 h | -0.3 bpm | Standard Deviation 11.4 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 3, 2 h | 11.1 bpm | Standard Deviation 12.6 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 4 h | 3.7 bpm | Standard Deviation 7.5 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 2 h | 13.9 bpm | Standard Deviation 10.9 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Study Baseline | 73.2 bpm | Standard Deviation 17.5 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 1 h | 4.8 bpm | Standard Deviation 12.1 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 8 h | -0.2 bpm | Standard Deviation 8.9 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 12 h | 0.8 bpm | Standard Deviation 10.2 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 2 h | 9.0 bpm | Standard Deviation 12.1 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 3, 2 h | 11.6 bpm | Standard Deviation 13.1 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 3, 0 h | -6.3 bpm | Standard Deviation 11.4 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 3, 8 h | 4.2 bpm | Standard Deviation 14.8 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 0 h | -6.3 bpm | Standard Deviation 13.7 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 1, 4 h | 0.2 bpm | Standard Deviation 8.8 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Supine Pulse | Change at Cycle Day 3, 1 h | 10.0 bpm | Standard Deviation 13.2 |
Primary
Change From Study Baseline Over Time in Supine Systolic Blood Pressure
Study baseline is defined as the Day -1 assessment.
Time frame: Study Baseline; Cycle Day 1, 0 h; Cycle Day 1, 1 h; Cycle Day 1, 2 h; Cycle Day 1, 4 h; Cycle Day 1, 8 h; Cycle Day 1, 12 h; Cycle Day 3, 0 h; Cycle Day 3, 1 h; Cycle Day 3, 2 h; Cycle Day 3, 8 h
Population: PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Study Baseline | 136.3 mmHg | Standard Deviation 12.9 |
| Control | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 0 h | -8.9 mmHg | Standard Deviation 9.9 |
| Control | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 4 h | -13.5 mmHg | Standard Deviation 10.7 |
| Control | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 1 h | -16.1 mmHg | Standard Deviation 15.6 |
| Control | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 8 h | -16.6 mmHg | Standard Deviation 12 |
| Control | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 8 h | -15.4 mmHg | Standard Deviation 15 |
| Control | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 0 h | -13.3 mmHg | Standard Deviation 15 |
| Control | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 1 h | -14.8 mmHg | Standard Deviation 13 |
| Control | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 12 h | -14.4 mmHg | Standard Deviation 12.7 |
| Control | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 2 h | -16.1 mmHg | Standard Deviation 15.5 |
| Control | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 2 h | -17.3 mmHg | Standard Deviation 11.5 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 12 h | -15.5 mmHg | Standard Deviation 16.8 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 2 h | -23.2 mmHg | Standard Deviation 16.7 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 1 h | -22.1 mmHg | Standard Deviation 17.8 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 2 h | -22.5 mmHg | Standard Deviation 17.8 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 4 h | -18.4 mmHg | Standard Deviation 13 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 0 h | -9.8 mmHg | Standard Deviation 19.6 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 0 h | -13.0 mmHg | Standard Deviation 16.1 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 1 h | -18.1 mmHg | Standard Deviation 18.7 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Study Baseline | 136.3 mmHg | Standard Deviation 12.9 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 8 h | -20.5 mmHg | Standard Deviation 14.6 |
| 10 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 8 h | -17.7 mmHg | Standard Deviation 13.5 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Study Baseline | 136.3 mmHg | Standard Deviation 12.9 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 12 h | -23.8 mmHg | Standard Deviation 13.4 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 0 h | -18.7 mmHg | Standard Deviation 16.4 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 2 h | -27.7 mmHg | Standard Deviation 18.7 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 1 h | -25.6 mmHg | Standard Deviation 16.8 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 8 h | -25.3 mmHg | Standard Deviation 11.5 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 2 h | -27.5 mmHg | Standard Deviation 15.7 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 1 h | -24.9 mmHg | Standard Deviation 21.1 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 4 h | -24.4 mmHg | Standard Deviation 13.4 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 8 h | -23.5 mmHg | Standard Deviation 16.3 |
| 20 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 0 h | -18.3 mmHg | Standard Deviation 16.1 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 2 h | -28.8 mmHg | Standard Deviation 15.7 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Study Baseline | 133.9 mmHg | Standard Deviation 10.8 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 0 h | -16.1 mmHg | Standard Deviation 10.3 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 1 h | -24.0 mmHg | Standard Deviation 13.5 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 2 h | -27.9 mmHg | Standard Deviation 14.5 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 4 h | -23.9 mmHg | Standard Deviation 15.1 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 8 h | -21.7 mmHg | Standard Deviation 13.5 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 12 h | -20.9 mmHg | Standard Deviation 14.2 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 0 h | -18.5 mmHg | Standard Deviation 15.1 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 1 h | -26.3 mmHg | Standard Deviation 15.1 |
| 30 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 8 h | -26.2 mmHg | Standard Deviation 12.5 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 8 h | -24.3 mmHg | Standard Deviation 14.4 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 0 h | -16.9 mmHg | Standard Deviation 11.5 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 4 h | -27.0 mmHg | Standard Deviation 14.7 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 2 h | -26.6 mmHg | Standard Deviation 16.8 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 8 h | -24.9 mmHg | Standard Deviation 14.3 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 1 h | -24.7 mmHg | Standard Deviation 16.3 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 1 h | -22.9 mmHg | Standard Deviation 13.2 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 12 h | -22.3 mmHg | Standard Deviation 15.6 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 2 h | -28.0 mmHg | Standard Deviation 12.8 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 0 h | -15.0 mmHg | Standard Deviation 14.3 |
| 40 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Study Baseline | 132.9 mmHg | Standard Deviation 10.9 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Study Baseline | 132.9 mmHg | Standard Deviation 10.9 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 8 h | -20.6 mmHg | Standard Deviation 13.5 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 0 h | -16.1 mmHg | Standard Deviation 15.7 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 0 h | -18.8 mmHg | Standard Deviation 16.7 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 4 h | -25.3 mmHg | Standard Deviation 16.7 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 2 h | -27.2 mmHg | Standard Deviation 15.1 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 12 h | -23.4 mmHg | Standard Deviation 17.4 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 2 h | -26.6 mmHg | Standard Deviation 12 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 8 h | -30.6 mmHg | Standard Deviation 15.5 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 1 h | -25.7 mmHg | Standard Deviation 13.5 |
| 50 mg IW-1973 | Change From Study Baseline Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 1 h | -27.2 mmHg | Standard Deviation 13.5 |
Primary
Change From Time-Matched Baseline in Fasting Blood Glucose on Day 2 of Each Dose Cycle
Time-matched baseline is defined as the corresponding assessment on Day 2 of the placebo cycle. Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment). To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose are presented as the second row of data.
Time frame: Time-Matched Baseline (Day 2 Placebo Cycle), Day 2 of Each Dose Cycle (Days 5, 8, 11, 14, 17)
Population: Pharmacodynamic (PD) Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change From Time-Matched Baseline in Fasting Blood Glucose on Day 2 of Each Dose Cycle | Time-Matched Baseline | 142.3 mg/dL | Standard Deviation 32.6 |
| Control | Change From Time-Matched Baseline in Fasting Blood Glucose on Day 2 of Each Dose Cycle | Cycle Day 2 Change | -12.0 mg/dL | Standard Deviation 10.3 |
| 10 mg IW-1973 | Change From Time-Matched Baseline in Fasting Blood Glucose on Day 2 of Each Dose Cycle | Time-Matched Baseline | 142.3 mg/dL | Standard Deviation 32.6 |
| 10 mg IW-1973 | Change From Time-Matched Baseline in Fasting Blood Glucose on Day 2 of Each Dose Cycle | Cycle Day 2 Change | -13.4 mg/dL | Standard Deviation 9.9 |
| 20 mg IW-1973 | Change From Time-Matched Baseline in Fasting Blood Glucose on Day 2 of Each Dose Cycle | Time-Matched Baseline | 144.1 mg/dL | Standard Deviation 33.8 |
| 20 mg IW-1973 | Change From Time-Matched Baseline in Fasting Blood Glucose on Day 2 of Each Dose Cycle | Cycle Day 2 Change | -21.1 mg/dL | Standard Deviation 16 |
| 30 mg IW-1973 | Change From Time-Matched Baseline in Fasting Blood Glucose on Day 2 of Each Dose Cycle | Cycle Day 2 Change | -24.3 mg/dL | Standard Deviation 16.9 |
| 30 mg IW-1973 | Change From Time-Matched Baseline in Fasting Blood Glucose on Day 2 of Each Dose Cycle | Time-Matched Baseline | 147.7 mg/dL | Standard Deviation 33.8 |
| 40 mg IW-1973 | Change From Time-Matched Baseline in Fasting Blood Glucose on Day 2 of Each Dose Cycle | Time-Matched Baseline | 147.7 mg/dL | Standard Deviation 33.8 |
| 40 mg IW-1973 | Change From Time-Matched Baseline in Fasting Blood Glucose on Day 2 of Each Dose Cycle | Cycle Day 2 Change | -25.3 mg/dL | Standard Deviation 15.9 |
Primary
Change From Time-Matched Baseline in Serum Insulin on Day 2 of Each Dose Cycle
Time-matched baseline is defined as the corresponding assessment on Day 2 of the placebo cycle. Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment). To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose are presented as the second row of data.
Time frame: Time-Matched Baseline (Day 2 Placebo Cycle), Day 2 of Each Dose Cycle (Days 5, 8, 11, 14, 17)
Population: PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change From Time-Matched Baseline in Serum Insulin on Day 2 of Each Dose Cycle | Time-Matched Baseline | 17.35 µIU/mL | Standard Deviation 10.7 |
| Control | Change From Time-Matched Baseline in Serum Insulin on Day 2 of Each Dose Cycle | Cycle Day 2 Change | 0.20 µIU/mL | Standard Deviation 5.04 |
| 10 mg IW-1973 | Change From Time-Matched Baseline in Serum Insulin on Day 2 of Each Dose Cycle | Time-Matched Baseline | 17.35 µIU/mL | Standard Deviation 10.7 |
| 10 mg IW-1973 | Change From Time-Matched Baseline in Serum Insulin on Day 2 of Each Dose Cycle | Cycle Day 2 Change | -0.40 µIU/mL | Standard Deviation 6.26 |
| 20 mg IW-1973 | Change From Time-Matched Baseline in Serum Insulin on Day 2 of Each Dose Cycle | Time-Matched Baseline | 17.37 µIU/mL | Standard Deviation 11.28 |
| 20 mg IW-1973 | Change From Time-Matched Baseline in Serum Insulin on Day 2 of Each Dose Cycle | Cycle Day 2 Change | -2.61 µIU/mL | Standard Deviation 3.11 |
| 30 mg IW-1973 | Change From Time-Matched Baseline in Serum Insulin on Day 2 of Each Dose Cycle | Cycle Day 2 Change | -2.49 µIU/mL | Standard Deviation 5.65 |
| 30 mg IW-1973 | Change From Time-Matched Baseline in Serum Insulin on Day 2 of Each Dose Cycle | Time-Matched Baseline | 14.32 µIU/mL | Standard Deviation 6.21 |
| 40 mg IW-1973 | Change From Time-Matched Baseline in Serum Insulin on Day 2 of Each Dose Cycle | Time-Matched Baseline | 14.32 µIU/mL | Standard Deviation 6.21 |
| 40 mg IW-1973 | Change From Time-Matched Baseline in Serum Insulin on Day 2 of Each Dose Cycle | Cycle Day 2 Change | -2.70 µIU/mL | Standard Deviation 4.2 |
Primary
Change From Time-Matched Baseline (Placebo Cycle) in Platelet Function Assessments: Collagen/Epinephrine Time to Aggregation
Time-matched baseline is defined as the corresponding assessment on Day 1 of the placebo cycle. Platelet function assessment used the PFA-100® instrument to evaluate collagen/epinephrine time to aggregation. Baseline is designated per protocol as Day 1 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 1 of each IW-1973 dose at given time point are presented as the second row of data.
Time frame: Time-Matched Baseline (Placebo Cycle), Cycle Day 1, 0 h, Cycle Day 1, 4 h
Population: PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change From Time-Matched Baseline (Placebo Cycle) in Platelet Function Assessments: Collagen/Epinephrine Time to Aggregation | Time-Matched Baseline, 4 h | 121.3 secs | Standard Deviation 35 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) in Platelet Function Assessments: Collagen/Epinephrine Time to Aggregation | Time-Matched Baseline, 0 h | 131.8 secs | Standard Deviation 60.6 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) in Platelet Function Assessments: Collagen/Epinephrine Time to Aggregation | Change at Cycle Day 1, 0 h | -21.0 secs | Standard Deviation 54.6 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) in Platelet Function Assessments: Collagen/Epinephrine Time to Aggregation | Change at Cycle Day 1, 4 h | -3.8 secs | Standard Deviation 22.2 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) in Platelet Function Assessments: Collagen/Epinephrine Time to Aggregation | Change at Cycle Day 1, 0 h | -38.7 secs | Standard Deviation 46.5 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) in Platelet Function Assessments: Collagen/Epinephrine Time to Aggregation | Time-Matched Baseline, 0 h | 132.8 secs | Standard Deviation 63.8 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) in Platelet Function Assessments: Collagen/Epinephrine Time to Aggregation | Change at Cycle Day 1, 4 h | -15.5 secs | Standard Deviation 40.2 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) in Platelet Function Assessments: Collagen/Epinephrine Time to Aggregation | Time-Matched Baseline, 4 h | 121.3 secs | Standard Deviation 35 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) in Platelet Function Assessments: Collagen/Epinephrine Time to Aggregation | Time-Matched Baseline, 0 h | 115.5 secs | Standard Deviation 28.7 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) in Platelet Function Assessments: Collagen/Epinephrine Time to Aggregation | Change at Cycle Day 1, 4 h | -7.4 secs | Standard Deviation 23.9 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) in Platelet Function Assessments: Collagen/Epinephrine Time to Aggregation | Change at Cycle Day 1, 0 h | -6.8 secs | Standard Deviation 25 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) in Platelet Function Assessments: Collagen/Epinephrine Time to Aggregation | Time-Matched Baseline, 4 h | 115.0 secs | Standard Deviation 29.6 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) in Platelet Function Assessments: Collagen/Epinephrine Time to Aggregation | Time-Matched Baseline, 0 h | 114.8 secs | Standard Deviation 30.3 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) in Platelet Function Assessments: Collagen/Epinephrine Time to Aggregation | Change at Cycle Day 1, 4 h | 14.2 secs | Standard Deviation 42.7 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) in Platelet Function Assessments: Collagen/Epinephrine Time to Aggregation | Time-Matched Baseline, 4 h | 114.6 secs | Standard Deviation 31.4 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) in Platelet Function Assessments: Collagen/Epinephrine Time to Aggregation | Change at Cycle Day 1, 0 h | 9.9 secs | Standard Deviation 47.4 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) in Platelet Function Assessments: Collagen/Epinephrine Time to Aggregation | Change at Cycle Day 1, 4 h | -4.0 secs | Standard Deviation 32.4 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) in Platelet Function Assessments: Collagen/Epinephrine Time to Aggregation | Time-Matched Baseline, 0 h | 114.8 secs | Standard Deviation 30.3 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) in Platelet Function Assessments: Collagen/Epinephrine Time to Aggregation | Change at Cycle Day 1, 0 h | -4.2 secs | Standard Deviation 28.8 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) in Platelet Function Assessments: Collagen/Epinephrine Time to Aggregation | Time-Matched Baseline, 4 h | 114.6 secs | Standard Deviation 31.4 |
Primary
Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure
Thirty-minute average is the average of ABPM assessments over 30 minutes intervals from the time of dosing. Time-matched baseline is the 30 minutes average during the placebo cycle (Day 2). Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose at given time point are presented as the second row of data.
Time frame: Time-Matched Baseline (Placebo Cycle); Cycle Day 2: 0.5 hr, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, 10 hrs, 10.5 hrs, 11 hrs, 11.5 hrs, 12 hrs
Population: PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 5 hrs: Time Matched Baseline | 70.10 mmHg | Standard Deviation 14.1 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 1 hr: Cycle Day 2 Change | -2.70 mmHg | Standard Deviation 7.29 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 4.5 hrs: Cycle Day 2 Change | -1.60 mmHg | Standard Deviation 11.72 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 3 hrs: Time Matched Baseline | 73.50 mmHg | Standard Deviation 11.83 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 10.5 hrs: Cycle Day 2 Change | -2.80 mmHg | Standard Deviation 9.38 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 0.5 hr: Time Matched Baseline | 87.90 mmHg | Standard Deviation 7.45 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 4.5 hrs: Time Matched Baseline | 79.40 mmHg | Standard Deviation 12.88 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 4 hrs: Cycle Day 2 Change | -1.90 mmHg | Standard Deviation 6.4 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 3 hrs: Cycle Day 2 Change | -5.00 mmHg | Standard Deviation 9.82 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 9.5 hrs: Time Matched Baseline | 80.90 mmHg | Standard Deviation 10.28 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 4 hrs: Time Matched Baseline | 76.60 mmHg | Standard Deviation 6.02 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 3.5 hrs: Cycle Day 2 Change | -1.67 mmHg | Standard Deviation 12.57 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 10 hrs: Cycle Day 2 Change | 0.56 mmHg | Standard Deviation 10.45 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 3.5 hrs: Time Matched Baseline | 70.33 mmHg | Standard Deviation 9.7 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 8.5 hrs: Cycle Day 2 Change | 2.20 mmHg | Standard Deviation 9.85 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 1 hr: Time Matched Baseline | 77.90 mmHg | Standard Deviation 8.58 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 8.5 hrs: Time Matched Baseline | 73.70 mmHg | Standard Deviation 9.26 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 10 hrs: Time Matched Baseline | 79.56 mmHg | Standard Deviation 7.32 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 11 hrs: Time Matched Baseline | 76.22 mmHg | Standard Deviation 8.45 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 2 hrs: Cycle Day 2 Change | -3.10 mmHg | Standard Deviation 8.54 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 8 hrs: Cycle Day 2 Change | -0.40 mmHg | Standard Deviation 15.46 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 2 hrs: Time Matched Baseline | 72.30 mmHg | Standard Deviation 7.59 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 8 hrs: Time Matched Baseline | 73.70 mmHg | Standard Deviation 13.28 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 11 hrs: Cycle Day 2 Change | 0.89 mmHg | Standard Deviation 10.56 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 9 hrs: Cycle Day 2 Change | 3.80 mmHg | Standard Deviation 11.51 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 7.5 hrs: Cycle Day 2 Change | -0.80 mmHg | Standard Deviation 12.65 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 7.5 hrs: Time Matched Baseline | 73.70 mmHg | Standard Deviation 12.29 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 7 hrs: Cycle Day 2 Change | -1.50 mmHg | Standard Deviation 10.56 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 11.5 hrs: Time Matched Baseline | 73.50 mmHg | Standard Deviation 9.96 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 0.5 hr: Cycle Day 2 Change | -2.40 mmHg | Standard Deviation 6.04 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 7 hrs: Time Matched Baseline | 75.70 mmHg | Standard Deviation 7.76 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 6.5 hrs: Cycle Day 2 Change | -3.70 mmHg | Standard Deviation 12.28 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 10.5 hrs: Time Matched Baseline | 83.60 mmHg | Standard Deviation 10.24 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 11.5 hrs: Cycle Day 2 Change | 0.20 mmHg | Standard Deviation 9.5 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 9.5 hrs: Cycle Day 2 Change | 0.60 mmHg | Standard Deviation 13.48 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 6.5 hrs: Time Matched Baseline | 73.60 mmHg | Standard Deviation 7.17 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 6 hrs: Cycle Day 2 Change | -5.70 mmHg | Standard Deviation 16.38 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 2.5 hrs: Cycle Day 2 Change | -3.10 mmHg | Standard Deviation 12.91 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 12 hrs: Time Matched Baseline | 73.20 mmHg | Standard Deviation 6.44 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 1.5 hrs: Cycle Day 2 Change | -4.70 mmHg | Standard Deviation 11.54 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 6 hrs: Time Matched Baseline | 74.80 mmHg | Standard Deviation 7.67 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 1.5 hrs: Time Matched Baselline | 73.70 mmHg | Standard Deviation 11.02 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 9 hrs: Time Matched Baseline | 75.90 mmHg | Standard Deviation 10.34 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 12 hrs: Cycle Day 2 Change | 5.30 mmHg | Standard Deviation 8.21 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 2.5 hrs: Time Matched Baseline | 72.20 mmHg | Standard Deviation 7.93 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 5.5 hrs: Cycle Day 2 Change | -3.30 mmHg | Standard Deviation 9.19 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 5.5 hrs: Time Matched Baseline | 75.30 mmHg | Standard Deviation 7.54 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 5 hrs: Cycle Day 2 Change | -1.20 mmHg | Standard Deviation 14.65 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 8.5 hrs: Cycle Day 2 Change | -3.60 mmHg | Standard Deviation 7.6 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 10 hrs: Cycle Day 2 Change | -3.67 mmHg | Standard Deviation 9.68 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 10.5 hrs: Time Matched Baseline | 84.22 mmHg | Standard Deviation 10.66 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 10.5 hrs: Cycle Day 2 Change | -4.56 mmHg | Standard Deviation 9.15 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 2.5 hrs: Time Matched Baseline | 72.20 mmHg | Standard Deviation 7.93 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 11 hrs: Time Matched Baseline | 77.00 mmHg | Standard Deviation 8.34 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 11 hrs: Cycle Day 2 Change | -5.40 mmHg | Standard Deviation 7.85 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 11.5 hrs: Time Matched Baseline | 73.50 mmHg | Standard Deviation 9.96 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 0.5 hr: Cycle Day 2 Change | -8.70 mmHg | Standard Deviation 11.37 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 11.5 hrs: Cycle Day 2 Change | -0.50 mmHg | Standard Deviation 11.65 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 12 hrs: Time Matched Baseline | 73.20 mmHg | Standard Deviation 6.44 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 2.5 hrs: Cycle Day 2 Change | -9.70 mmHg | Standard Deviation 14.3 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 12 hrs: Cycle Day 2 Change | -0.10 mmHg | Standard Deviation 5.57 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 3 hrs: Time Matched Baseline | 73.50 mmHg | Standard Deviation 11.83 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 3 hrs: Cycle Day 2 Change | -7.90 mmHg | Standard Deviation 15.67 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 3.5 hrs: Time Matched Baseline | 70.33 mmHg | Standard Deviation 9.7 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 3.5 hrs: Cycle Day 2 Change | -6.89 mmHg | Standard Deviation 11.04 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 1 hr: Time Matched Baseline | 77.90 mmHg | Standard Deviation 8.58 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 4 hrs: Time Matched Baseline | 76.60 mmHg | Standard Deviation 6.02 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 4 hrs: Cycle Day 2 Change | -6.10 mmHg | Standard Deviation 6.08 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 4.5 hrs: Time Matched Baseline | 79.40 mmHg | Standard Deviation 12.88 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 4.5 hrs: Cycle Day 2 Change | -5.80 mmHg | Standard Deviation 11.11 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 5 hrs: Time Matched Baseline | 70.10 mmHg | Standard Deviation 14.1 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 1 hr: Cycle Day 2 Change | -10.40 mmHg | Standard Deviation 5.38 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 5 hrs: Cycle Day 2 Change | 1.70 mmHg | Standard Deviation 14.24 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 5.5 hrs: Time Matched Baseline | 75.30 mmHg | Standard Deviation 7.54 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 0.5 hr: Time Matched Baseline | 87.90 mmHg | Standard Deviation 7.45 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 5.5 hrs: Cycle Day 2 Change | -6.00 mmHg | Standard Deviation 8.88 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 6 hrs: Time Matched Baseline | 75.89 mmHg | Standard Deviation 7.27 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 1.5 hrs: Time Matched Baselline | 73.70 mmHg | Standard Deviation 11.02 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 6 hrs: Cycle Day 2 Change | -7.44 mmHg | Standard Deviation 9.86 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 6.5 hrs: Time Matched Baseline | 73.60 mmHg | Standard Deviation 7.17 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 6.5 hrs: Cycle Day 2 Change | -5.30 mmHg | Standard Deviation 6.86 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 7 hrs: Time Matched Baseline | 75.70 mmHg | Standard Deviation 7.76 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 1.5 hrs: Cycle Day 2 Change | -6.30 mmHg | Standard Deviation 17.63 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 7 hrs: Cycle Day 2 Change | -5.60 mmHg | Standard Deviation 10.39 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 7.5 hrs: Time Matched Baseline | 73.70 mmHg | Standard Deviation 12.29 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 7.5 hrs: Cycle Day 2 Change | -3.50 mmHg | Standard Deviation 14.73 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 8 hrs: Time Matched Baseline | 73.70 mmHg | Standard Deviation 13.28 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 8 hrs: Cycle Day 2 Change | -1.80 mmHg | Standard Deviation 12.93 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 2 hrs: Time Matched Baseline | 72.30 mmHg | Standard Deviation 7.59 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 8.5 hrs: Time Matched Baseline | 73.70 mmHg | Standard Deviation 9.26 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 10 hrs: Time Matched Baseline | 79.56 mmHg | Standard Deviation 7.32 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 9 hrs: Time Matched Baseline | 75.90 mmHg | Standard Deviation 10.34 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 9 hrs: Cycle Day 2 Change | -0.90 mmHg | Standard Deviation 13.92 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 9.5 hrs: Time Matched Baseline | 80.90 mmHg | Standard Deviation 10.28 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 2 hrs: Cycle Day 2 Change | -5.60 mmHg | Standard Deviation 10.41 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 9.5 hrs: Cycle Day 2 Change | -12.20 mmHg | Standard Deviation 11.63 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 3 hrs: Cycle Day 2 Change | -8.50 mmHg | Standard Deviation 14.18 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 8.5 hrs: Cycle Day 2 Change | 0.89 mmHg | Standard Deviation 10.48 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 5 hrs: Cycle Day 2 Change | -0.70 mmHg | Standard Deviation 13.49 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 5.5 hrs: Time Matched Baseline | 75.30 mmHg | Standard Deviation 7.54 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 12 hrs: Cycle Day 2 Change | 2.50 mmHg | Standard Deviation 12.06 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 5.5 hrs: Cycle Day 2 Change | -5.00 mmHg | Standard Deviation 7.62 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 12 hrs: Time Matched Baseline | 73.20 mmHg | Standard Deviation 6.44 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 10 hrs: Time Matched Baseline | 79.56 mmHg | Standard Deviation 7.32 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 6 hrs: Time Matched Baseline | 74.80 mmHg | Standard Deviation 7.67 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 9 hrs: Time Matched Baseline | 75.90 mmHg | Standard Deviation 10.34 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 6 hrs: Cycle Day 2 Change | -6.10 mmHg | Standard Deviation 10.87 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 1.5 hrs: Time Matched Baselline | 73.70 mmHg | Standard Deviation 11.02 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 11.5 hrs: Cycle Day 2 Change | -2.80 mmHg | Standard Deviation 8.07 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 10.5 hrs: Time Matched Baseline | 83.60 mmHg | Standard Deviation 10.24 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 6.5 hrs: Time Matched Baseline | 73.60 mmHg | Standard Deviation 7.17 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 6.5 hrs: Cycle Day 2 Change | -3.20 mmHg | Standard Deviation 14.86 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 0.5 hr: Time Matched Baseline | 87.90 mmHg | Standard Deviation 7.45 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 11.5 hrs: Time Matched Baseline | 73.50 mmHg | Standard Deviation 9.96 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 9.5 hrs: Cycle Day 2 Change | -3.60 mmHg | Standard Deviation 15.04 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 7 hrs: Time Matched Baseline | 75.70 mmHg | Standard Deviation 7.76 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 9 hrs: Cycle Day 2 Change | -0.80 mmHg | Standard Deviation 12.86 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 7 hrs: Cycle Day 2 Change | -1.70 mmHg | Standard Deviation 12.46 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 1.5 hrs: Cycle Day 2 Change | -9.20 mmHg | Standard Deviation 10.61 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 10 hrs: Cycle Day 2 Change | -1.78 mmHg | Standard Deviation 4.66 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 7.5 hrs: Time Matched Baseline | 73.70 mmHg | Standard Deviation 12.29 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 11 hrs: Cycle Day 2 Change | -5.56 mmHg | Standard Deviation 8 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 7.5 hrs: Cycle Day 2 Change | -3.20 mmHg | Standard Deviation 16.51 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 2.5 hrs: Time Matched Baseline | 72.20 mmHg | Standard Deviation 7.93 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 8 hrs: Time Matched Baseline | 73.70 mmHg | Standard Deviation 13.28 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 11 hrs: Time Matched Baseline | 76.22 mmHg | Standard Deviation 8.45 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 9.5 hrs: Time Matched Baseline | 80.90 mmHg | Standard Deviation 10.28 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 8 hrs: Cycle Day 2 Change | -0.70 mmHg | Standard Deviation 13.56 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 3.5 hrs: Time Matched Baseline | 70.33 mmHg | Standard Deviation 9.7 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 3.5 hrs: Cycle Day 2 Change | -3.78 mmHg | Standard Deviation 9.19 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 1 hr: Cycle Day 2 Change | -6.30 mmHg | Standard Deviation 10.63 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 2 hrs: Cycle Day 2 Change | -7.40 mmHg | Standard Deviation 8.37 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 4 hrs: Time Matched Baseline | 76.33 mmHg | Standard Deviation 6.32 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 1 hr: Time Matched Baseline | 77.90 mmHg | Standard Deviation 8.58 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 8.5 hrs: Time Matched Baseline | 73.33 mmHg | Standard Deviation 9.75 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 4 hrs: Cycle Day 2 Change | -2.22 mmHg | Standard Deviation 11.02 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 4.5 hrs: Time Matched Baseline | 79.40 mmHg | Standard Deviation 12.88 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 3 hrs: Time Matched Baseline | 73.50 mmHg | Standard Deviation 11.83 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 0.5 hr: Cycle Day 2 Change | -2.60 mmHg | Standard Deviation 6.5 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 2 hrs: Time Matched Baseline | 72.30 mmHg | Standard Deviation 7.59 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 4.5 hrs: Cycle Day 2 Change | -7.30 mmHg | Standard Deviation 9.78 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 2.5 hrs: Cycle Day 2 Change | -5.80 mmHg | Standard Deviation 11.59 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 10.5 hrs: Cycle Day 2 Change | -1.60 mmHg | Standard Deviation 4.88 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 5 hrs: Time Matched Baseline | 70.10 mmHg | Standard Deviation 14.1 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 7.5 hrs: Time Matched Baseline | 71.89 mmHg | Standard Deviation 11.54 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 1.5 hrs: Cycle Day 2 Change | -9.78 mmHg | Standard Deviation 12.36 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 4.5 hrs: Time Matched Baseline | 76.56 mmHg | Standard Deviation 9.77 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 5 hrs: Cycle Day 2 Change | 0.11 mmHg | Standard Deviation 14.17 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 1 hr: Cycle Day 2 Change | -7.56 mmHg | Standard Deviation 6.11 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 12 hrs: Cycle Day 2 Change | 1.89 mmHg | Standard Deviation 9.49 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 8.5 hrs: Cycle Day 2 Change | -2.67 mmHg | Standard Deviation 10.23 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 2 hrs: Cycle Day 2 Change | -5.33 mmHg | Standard Deviation 10.99 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 5.5 hrs: Time Matched Baseline | 74.22 mmHg | Standard Deviation 7.14 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 2 hrs: Time Matched Baseline | 71.00 mmHg | Standard Deviation 6.76 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 4 hrs: Time Matched Baseline | 76.89 mmHg | Standard Deviation 6.31 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 10.5 hrs: Time Matched Baseline | 82.56 mmHg | Standard Deviation 10.28 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 7.5 hrs: Cycle Day 2 Change | -2.78 mmHg | Standard Deviation 15.71 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 5.5 hrs: Cycle Day 2 Change | -14.67 mmHg | Standard Deviation 10.85 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 12 hrs: Time Matched Baseline | 71.56 mmHg | Standard Deviation 4.03 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 0.5 hr: Time Matched Baseline | 86.44 mmHg | Standard Deviation 6.21 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 4.5 hrs: Cycle Day 2 Change | -3.78 mmHg | Standard Deviation 7.29 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 9.5 hrs: Cycle Day 2 Change | -9.78 mmHg | Standard Deviation 11.38 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 6 hrs: Time Matched Baseline | 73.44 mmHg | Standard Deviation 6.75 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 0.5 hr: Cycle Day 2 Change | -7.56 mmHg | Standard Deviation 6.48 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 11.5 hrs: Cycle Day 2 Change | 0.78 mmHg | Standard Deviation 10.37 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 9 hrs: Time Matched Baseline | 74.22 mmHg | Standard Deviation 9.42 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 8 hrs: Time Matched Baseline | 71.78 mmHg | Standard Deviation 12.52 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 6 hrs: Cycle Day 2 Change | -15.22 mmHg | Standard Deviation 10.72 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 11 hrs: Time Matched Baseline | 75.89 mmHg | Standard Deviation 8.02 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 2.5 hrs: Cycle Day 2 Change | -11.11 mmHg | Standard Deviation 8.91 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 10 hrs: Time Matched Baseline | 78.63 mmHg | Standard Deviation 7.23 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 4 hrs: Cycle Day 2 Change | -6.56 mmHg | Standard Deviation 9.58 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 6.5 hrs: Time Matched Baseline | 72.67 mmHg | Standard Deviation 6.93 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 1.5 hrs: Time Matched Baselline | 72.89 mmHg | Standard Deviation 11.36 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 11.5 hrs: Time Matched Baseline | 72.78 mmHg | Standard Deviation 10.28 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 10 hrs: Cycle Day 2 Change | -7.75 mmHg | Standard Deviation 13.04 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 8 hrs: Cycle Day 2 Change | -5.33 mmHg | Standard Deviation 17.05 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 6.5 hrs: Cycle Day 2 Change | -8.00 mmHg | Standard Deviation 10.81 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 3.5 hrs: Time Matched Baseline | 69.50 mmHg | Standard Deviation 10.01 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 1 hr: Time Matched Baseline | 77.11 mmHg | Standard Deviation 8.71 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 3 hrs: Cycle Day 2 Change | -8.44 mmHg | Standard Deviation 9.62 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 9.5 hrs: Time Matched Baseline | 80.00 mmHg | Standard Deviation 10.48 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 7 hrs: Time Matched Baseline | 74.67 mmHg | Standard Deviation 7.47 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 3 hrs: Time Matched Baseline | 73.44 mmHg | Standard Deviation 12.55 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 2.5 hrs: Time Matched Baseline | 71.89 mmHg | Standard Deviation 8.34 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 9 hrs: Cycle Day 2 Change | -6.67 mmHg | Standard Deviation 12.74 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 3.5 hrs: Cycle Day 2 Change | -8.00 mmHg | Standard Deviation 11.83 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 7 hrs: Cycle Day 2 Change | -11.22 mmHg | Standard Deviation 10.11 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 10.5 hrs: Cycle Day 2 Change | -8.11 mmHg | Standard Deviation 11.24 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 11 hrs: Cycle Day 2 Change | -6.44 mmHg | Standard Deviation 9.94 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 8.5 hrs: Time Matched Baseline | 71.33 mmHg | Standard Deviation 5.79 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 5 hrs: Time Matched Baseline | 67.78 mmHg | Standard Deviation 12.76 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 12 hrs: Cycle Day 2 Change | 0.89 mmHg | Standard Deviation 8.37 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 0.5 hr: Time Matched Baseline | 86.44 mmHg | Standard Deviation 6.21 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 0.5 hr: Cycle Day 2 Change | -7.44 mmHg | Standard Deviation 9.81 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 1 hr: Time Matched Baseline | 77.11 mmHg | Standard Deviation 8.71 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 1 hr: Cycle Day 2 Change | -11.33 mmHg | Standard Deviation 8.08 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 1.5 hrs: Time Matched Baselline | 72.89 mmHg | Standard Deviation 11.36 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 1.5 hrs: Cycle Day 2 Change | -10.11 mmHg | Standard Deviation 10.76 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 2 hrs: Time Matched Baseline | 71.00 mmHg | Standard Deviation 6.76 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 2 hrs: Cycle Day 2 Change | -7.89 mmHg | Standard Deviation 9.4 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 2.5 hrs: Time Matched Baseline | 71.89 mmHg | Standard Deviation 8.34 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 2.5 hrs: Cycle Day 2 Change | -6.22 mmHg | Standard Deviation 9.9 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 3 hrs: Time Matched Baseline | 73.44 mmHg | Standard Deviation 12.55 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 3 hrs: Cycle Day 2 Change | -7.78 mmHg | Standard Deviation 17.5 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 3.5 hrs: Time Matched Baseline | 69.50 mmHg | Standard Deviation 10.01 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 3.5 hrs: Cycle Day 2 Change | -5.88 mmHg | Standard Deviation 13.89 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 4 hrs: Time Matched Baseline | 76.89 mmHg | Standard Deviation 6.31 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 4 hrs: Cycle Day 2 Change | -9.67 mmHg | Standard Deviation 9.71 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 4.5 hrs: Time Matched Baseline | 76.56 mmHg | Standard Deviation 9.77 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 4.5 hrs: Cycle Day 2 Change | -6.44 mmHg | Standard Deviation 7.84 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 5 hrs: Time Matched Baseline | 67.78 mmHg | Standard Deviation 12.76 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 5 hrs: Cycle Day 2 Change | -0.67 mmHg | Standard Deviation 14.49 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 5.5 hrs: Time Matched Baseline | 74.22 mmHg | Standard Deviation 7.14 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 5.5 hrs: Cycle Day 2 Change | -9.33 mmHg | Standard Deviation 9.63 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 6 hrs: Time Matched Baseline | 73.44 mmHg | Standard Deviation 6.75 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 6 hrs: Cycle Day 2 Change | -8.11 mmHg | Standard Deviation 10.45 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 6.5 hrs: Time Matched Baseline | 72.67 mmHg | Standard Deviation 6.93 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 6.5 hrs: Cycle Day 2 Change | -8.78 mmHg | Standard Deviation 12.34 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 7 hrs: Time Matched Baseline | 74.67 mmHg | Standard Deviation 7.47 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 7 hrs: Cycle Day 2 Change | -4.78 mmHg | Standard Deviation 11.98 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 7.5 hrs: Time Matched Baseline | 71.89 mmHg | Standard Deviation 11.54 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 7.5 hrs: Cycle Day 2 Change | -4.11 mmHg | Standard Deviation 20.57 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 8 hrs: Time Matched Baseline | 71.78 mmHg | Standard Deviation 12.52 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 8 hrs: Cycle Day 2 Change | -5.11 mmHg | Standard Deviation 18.45 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 8.5 hrs: Time Matched Baseline | 71.33 mmHg | Standard Deviation 5.79 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 8.5 hrs: Cycle Day 2 Change | -2.78 mmHg | Standard Deviation 11.22 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 9 hrs: Time Matched Baseline | 74.22 mmHg | Standard Deviation 9.42 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 9 hrs: Cycle Day 2 Change | -6.67 mmHg | Standard Deviation 12.13 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 9.5 hrs: Time Matched Baseline | 80.00 mmHg | Standard Deviation 10.48 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 9.5 hrs: Cycle Day 2 Change | -7.11 mmHg | Standard Deviation 13.36 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 10 hrs: Time Matched Baseline | 78.63 mmHg | Standard Deviation 7.23 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 10 hrs: Cycle Day 2 Change | -3.75 mmHg | Standard Deviation 12.69 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 10.5 hrs: Time Matched Baseline | 82.56 mmHg | Standard Deviation 10.28 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 10.5 hrs: Cycle Day 2 Change | -9.22 mmHg | Standard Deviation 10.1 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 11 hrs: Time Matched Baseline | 75.89 mmHg | Standard Deviation 8.02 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 11 hrs: Cycle Day 2 Change | -8.22 mmHg | Standard Deviation 12.08 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 11.5 hrs: Time Matched Baseline | 72.78 mmHg | Standard Deviation 10.28 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 11.5 hrs: Cycle Day 2 Change | -2.78 mmHg | Standard Deviation 10.29 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure | 12 hrs: Time Matched Baseline | 71.56 mmHg | Standard Deviation 4.03 |
Primary
Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure
Thirty-minute average is the average of ABPM assessments over 30 minutes intervals from the time of dosing. Time-matched baseline is the 30 minutes average during the placebo cycle (Day 2). Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose at given time point are presented as the second row of data.
Time frame: Time-Matched Baseline (Placebo Cycle); Cycle Day 2: 0.5 hr, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, 10 hrs, 10.5 hrs, 11 hrs, 11.5 hrs, 12 hrs
Population: PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 5.5 hrs: Time Matched Baseline | 92.00 mmHg | Standard Deviation 7.21 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 5 hrs: Cycle Day 2 Change | -1.30 mmHg | Standard Deviation 14.03 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 5 hrs: Time Matched Baseline | 86.60 mmHg | Standard Deviation 12.47 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 4.5 hrs: Cycle Day 2 Change | -4.30 mmHg | Standard Deviation 7.75 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 10.5 hrs: Cycle Day 2 Change | -2.70 mmHg | Standard Deviation 13.15 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 1 hr: Cycle Day 2 Change | -7.00 mmHg | Standard Deviation 7.73 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 4.5 hrs: Time Matched Baseline | 97.30 mmHg | Standard Deviation 10.92 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 3 hrs: Time Matched Baseline | 88.10 mmHg | Standard Deviation 11.24 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 3 hrs: Cycle Day 2 Change | -4.20 mmHg | Standard Deviation 10.54 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 10 hrs: Time Matched Baseline | 95.11 mmHg | Standard Deviation 9.68 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 4 hrs: Cycle Day 2 Change | -4.00 mmHg | Standard Deviation 8.46 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 4 hrs: Time Matched Baseline | 94.10 mmHg | Standard Deviation 7.34 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 1 hr: Time Matched Baseline | 96.80 mmHg | Standard Deviation 7.73 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 3.5 hrs: Time Matched Baseline | 87.44 mmHg | Standard Deviation 10.08 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 8.5 hrs: Cycle Day 2 Change | -0.80 mmHg | Standard Deviation 11.21 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 3.5 hrs: Cycle Day 2 Change | -3.89 mmHg | Standard Deviation 13.4 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 8.5 hrs: Time Matched Baseline | 91.80 mmHg | Standard Deviation 10.08 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 2.5 hrs: Time Matched Baseline | 88.80 mmHg | Standard Deviation 6.7 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 11 hrs: Time Matched Baseline | 95.00 mmHg | Standard Deviation 10.28 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 2 hrs: Cycle Day 2 Change | -1.70 mmHg | Standard Deviation 11.16 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 2 hrs: Time Matched Baseline | 89.20 mmHg | Standard Deviation 6.58 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 8 hrs: Cycle Day 2 Change | -3.10 mmHg | Standard Deviation 17.12 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 9.5 hrs: Time Matched Baseline | 96.40 mmHg | Standard Deviation 11.75 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 11 hrs: Cycle Day 2 Change | -0.56 mmHg | Standard Deviation 11.17 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 0.5 hr: Cycle Day 2 Change | -3.70 mmHg | Standard Deviation 7.21 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 8 hrs: Time Matched Baseline | 91.20 mmHg | Standard Deviation 13 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 7.5 hrs: Cycle Day 2 Change | -2.70 mmHg | Standard Deviation 15.6 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 7.5 hrs: Time Matched Baseline | 90.50 mmHg | Standard Deviation 11.72 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 11.5 hrs: Time Matched Baseline | 90.10 mmHg | Standard Deviation 8.45 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 10.5 hrs: Time Matched Baseline | 101.00 mmHg | Standard Deviation 10.84 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 7 hrs: Cycle Day 2 Change | -3.90 mmHg | Standard Deviation 12.06 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 1.5 hrs: Cycle Day 2 Change | -5.20 mmHg | Standard Deviation 11.39 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 7 hrs: Time Matched Baseline | 92.90 mmHg | Standard Deviation 7.92 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 11.5 hrs: Cycle Day 2 Change | -1.40 mmHg | Standard Deviation 7.66 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 9.5 hrs: Cycle Day 2 Change | 1.50 mmHg | Standard Deviation 20.74 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 6.5 hrs: Cycle Day 2 Change | -3.50 mmHg | Standard Deviation 12.09 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 6.5 hrs: Time Matched Baseline | 89.80 mmHg | Standard Deviation 6.41 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 6 hrs: Cycle Day 2 Change | -5.80 mmHg | Standard Deviation 14.99 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 12 hrs: Time Matched Baseline | 90.45 mmHg | Standard Deviation 6.3 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 9 hrs: Cycle Day 2 Change | 3.30 mmHg | Standard Deviation 12 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 6 hrs: Time Matched Baseline | 90.70 mmHg | Standard Deviation 7.18 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 1.5 hrs: Time Matched Baseline | 91.30 mmHg | Standard Deviation 13.02 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 2.5 hrs: Cycle Day 2 Change | -2.40 mmHg | Standard Deviation 12.75 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 12 hrs: Cycle Day 2 Change | 3.80 mmHg | Standard Deviation 7.63 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 9 hrs: Time Matched Baseline | 92.00 mmHg | Standard Deviation 8.5 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 5.5 hrs: Cycle Day 2 Change | -3.40 mmHg | Standard Deviation 10.95 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 0.5 hr: Time Matched Baseline | 104.50 mmHg | Standard Deviation 9.96 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 10 hrs: Cycle Day 2 Change | -0.44 mmHg | Standard Deviation 14.79 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 2.5 hrs: Cycle Day 2 Change | -11.40 mmHg | Standard Deviation 15.25 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 10 hrs: Cycle Day 2 Change | -4.89 mmHg | Standard Deviation 10.73 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 10.5 hrs: Time Matched Baseline | 101.78 mmHg | Standard Deviation 11.2 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 0.5 hr: Cycle Day 2 Change | -9.20 mmHg | Standard Deviation 10.99 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 10.5 hrs: Cycle Day 2 Change | -3.67 mmHg | Standard Deviation 10.95 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 11 hrs: Time Matched Baseline | 95.50 mmHg | Standard Deviation 9.82 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 2.5 hrs: Time Matched Baseline | 88.80 mmHg | Standard Deviation 6.7 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 11 hrs: Cycle Day 2 Change | -7.10 mmHg | Standard Deviation 11.26 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 11.5 hrs: Time Matched Baseline | 90.10 mmHg | Standard Deviation 8.45 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 11.5 hrs: Cycle Day 2 Change | 0.60 mmHg | Standard Deviation 10.62 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 12 hrs: Time Matched Baseline | 90.45 mmHg | Standard Deviation 6.3 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 12 hrs: Cycle Day 2 Change | -0.25 mmHg | Standard Deviation 7.67 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 0.5 hr: Time Matched Baseline | 104.50 mmHg | Standard Deviation 9.96 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 3 hrs: Time Matched Baseline | 88.10 mmHg | Standard Deviation 11.24 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 3 hrs: Cycle Day 2 Change | -6.90 mmHg | Standard Deviation 14.26 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 3.5 hrs: Time Matched Baseline | 87.44 mmHg | Standard Deviation 10.08 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 1 hr: Time Matched Baseline | 96.80 mmHg | Standard Deviation 7.73 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 3.5 hrs: Cycle Day 2 Change | -9.00 mmHg | Standard Deviation 11.24 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 4 hrs: Time Matched Baseline | 94.10 mmHg | Standard Deviation 7.34 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 4 hrs: Cycle Day 2 Change | -7.90 mmHg | Standard Deviation 7.29 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 6.5 hrs: Time Matched Baseline | 89.80 mmHg | Standard Deviation 6.41 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 4.5 hrs: Time Matched Baseline | 97.30 mmHg | Standard Deviation 10.92 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 4.5 hrs: Cycle Day 2 Change | -7.40 mmHg | Standard Deviation 10.16 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 1 hr: Cycle Day 2 Change | -12.70 mmHg | Standard Deviation 6.8 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 5 hrs: Time Matched Baseline | 86.60 mmHg | Standard Deviation 12.47 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 5 hrs: Cycle Day 2 Change | -0.80 mmHg | Standard Deviation 11.52 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 5.5 hrs: Time Matched Baseline | 92.00 mmHg | Standard Deviation 7.21 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 5.5 hrs: Cycle Day 2 Change | -8.70 mmHg | Standard Deviation 8.38 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 6 hrs: Time Matched Baseline | 92.33 mmHg | Standard Deviation 5.29 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 1.5 hrs: Time Matched Baseline | 91.30 mmHg | Standard Deviation 13.02 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 6 hrs: Cycle Day 2 Change | -9.00 mmHg | Standard Deviation 9.54 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 6.5 hrs: Cycle Day 2 Change | -6.10 mmHg | Standard Deviation 9.18 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 7 hrs: Time Matched Baseline | 92.90 mmHg | Standard Deviation 7.92 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 7 hrs: Cycle Day 2 Change | -8.50 mmHg | Standard Deviation 12.43 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 1.5 hrs: Cycle Day 2 Change | -8.80 mmHg | Standard Deviation 17.82 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 7.5 hrs: Time Matched Baseline | 90.50 mmHg | Standard Deviation 11.72 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 7.5 hrs: Cycle Day 2 Change | -3.90 mmHg | Standard Deviation 15.15 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 8 hrs: Time Matched Baseline | 91.20 mmHg | Standard Deviation 13 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 8 hrs: Cycle Day 2 Change | -3.90 mmHg | Standard Deviation 12.57 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 8.5 hrs: Time Matched Baseline | 91.80 mmHg | Standard Deviation 10.08 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 2 hrs: Time Matched Baseline | 89.20 mmHg | Standard Deviation 6.58 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 8.5 hrs: Cycle Day 2 Change | -6.30 mmHg | Standard Deviation 9.26 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 9 hrs: Time Matched Baseline | 92.00 mmHg | Standard Deviation 8.5 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 9 hrs: Cycle Day 2 Change | -1.80 mmHg | Standard Deviation 14.61 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 9.5 hrs: Time Matched Baseline | 96.40 mmHg | Standard Deviation 11.75 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 9.5 hrs: Cycle Day 2 Change | -11.90 mmHg | Standard Deviation 14.81 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 2 hrs: Cycle Day 2 Change | -6.10 mmHg | Standard Deviation 8.92 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 10 hrs: Time Matched Baseline | 95.11 mmHg | Standard Deviation 9.68 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 1 hr: Cycle Day 2 Change | -10.60 mmHg | Standard Deviation 11.05 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 2 hrs: Time Matched Baseline | 89.20 mmHg | Standard Deviation 6.58 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 5 hrs: Cycle Day 2 Change | -2.80 mmHg | Standard Deviation 15.51 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 10 hrs: Time Matched Baseline | 95.11 mmHg | Standard Deviation 9.68 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 5.5 hrs: Time Matched Baseline | 92.00 mmHg | Standard Deviation 7.21 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 12 hrs: Cycle Day 2 Change | 0.95 mmHg | Standard Deviation 10.96 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 5.5 hrs: Cycle Day 2 Change | -7.10 mmHg | Standard Deviation 8.12 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 12 hrs: Time Matched Baseline | 90.45 mmHg | Standard Deviation 6.3 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 9 hrs: Time Matched Baseline | 92.00 mmHg | Standard Deviation 8.5 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 6 hrs: Time Matched Baseline | 90.70 mmHg | Standard Deviation 7.18 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 0.5 hr: Cycle Day 2 Change | -3.90 mmHg | Standard Deviation 8.5 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 6 hrs: Cycle Day 2 Change | -7.20 mmHg | Standard Deviation 11.06 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 1.5 hrs: Time Matched Baseline | 91.30 mmHg | Standard Deviation 13.02 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 6.5 hrs: Time Matched Baseline | 89.80 mmHg | Standard Deviation 6.41 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 11.5 hrs: Cycle Day 2 Change | -5.20 mmHg | Standard Deviation 5.39 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 10.5 hrs: Time Matched Baseline | 101.00 mmHg | Standard Deviation 10.84 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 6.5 hrs: Cycle Day 2 Change | -4.40 mmHg | Standard Deviation 12.82 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 0.5 hr: Time Matched Baseline | 104.50 mmHg | Standard Deviation 9.96 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 9.5 hrs: Cycle Day 2 Change | -3.40 mmHg | Standard Deviation 16.81 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 7 hrs: Time Matched Baseline | 92.90 mmHg | Standard Deviation 7.92 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 11.5 hrs: Time Matched Baseline | 90.10 mmHg | Standard Deviation 8.45 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 9 hrs: Cycle Day 2 Change | -1.30 mmHg | Standard Deviation 14.25 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 7 hrs: Cycle Day 2 Change | -5.60 mmHg | Standard Deviation 12.73 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 2.5 hrs: Time Matched Baseline | 88.80 mmHg | Standard Deviation 6.7 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 7.5 hrs: Time Matched Baseline | 90.50 mmHg | Standard Deviation 11.72 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 1.5 hrs: Cycle Day 2 Change | -10.00 mmHg | Standard Deviation 11.55 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 7.5 hrs: Cycle Day 2 Change | -3.70 mmHg | Standard Deviation 17.84 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 11 hrs: Cycle Day 2 Change | -8.22 mmHg | Standard Deviation 9.92 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 8 hrs: Time Matched Baseline | 91.20 mmHg | Standard Deviation 13 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 9.5 hrs: Time Matched Baseline | 96.40 mmHg | Standard Deviation 11.75 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 8 hrs: Cycle Day 2 Change | -2.30 mmHg | Standard Deviation 15.82 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 11 hrs: Time Matched Baseline | 95.00 mmHg | Standard Deviation 10.28 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 3.5 hrs: Time Matched Baseline | 87.44 mmHg | Standard Deviation 10.08 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 3.5 hrs: Cycle Day 2 Change | -6.56 mmHg | Standard Deviation 8.8 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 1 hr: Time Matched Baseline | 96.80 mmHg | Standard Deviation 7.73 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 8.5 hrs: Time Matched Baseline | 91.00 mmHg | Standard Deviation 10.34 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 4 hrs: Time Matched Baseline | 92.78 mmHg | Standard Deviation 6.4 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 3 hrs: Cycle Day 2 Change | -5.50 mmHg | Standard Deviation 15.17 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 4 hrs: Cycle Day 2 Change | -5.78 mmHg | Standard Deviation 10.33 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 10 hrs: Cycle Day 2 Change | -2.56 mmHg | Standard Deviation 7.99 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 10.5 hrs: Cycle Day 2 Change | -3.50 mmHg | Standard Deviation 6.52 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 4.5 hrs: Time Matched Baseline | 97.30 mmHg | Standard Deviation 10.92 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 3 hrs: Time Matched Baseline | 88.10 mmHg | Standard Deviation 11.24 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 2 hrs: Cycle Day 2 Change | -9.10 mmHg | Standard Deviation 8.52 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 4.5 hrs: Cycle Day 2 Change | -11.30 mmHg | Standard Deviation 8.14 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 8.5 hrs: Cycle Day 2 Change | -0.89 mmHg | Standard Deviation 10.29 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 5 hrs: Time Matched Baseline | 86.60 mmHg | Standard Deviation 12.47 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 2.5 hrs: Cycle Day 2 Change | -7.20 mmHg | Standard Deviation 10.94 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 4.5 hrs: Time Matched Baseline | 94.67 mmHg | Standard Deviation 7.5 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 11 hrs: Cycle Day 2 Change | -10.00 mmHg | Standard Deviation 14.24 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 10 hrs: Cycle Day 2 Change | -9.75 mmHg | Standard Deviation 14.32 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 5 hrs: Cycle Day 2 Change | -3.00 mmHg | Standard Deviation 12.61 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 1 hr: Cycle Day 2 Change | -10.11 mmHg | Standard Deviation 9.24 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 4 hrs: Time Matched Baseline | 94.78 mmHg | Standard Deviation 7.45 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 10.5 hrs: Time Matched Baseline | 98.89 mmHg | Standard Deviation 9.06 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 7.5 hrs: Cycle Day 2 Change | -6.33 mmHg | Standard Deviation 16.67 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 5.5 hrs: Time Matched Baseline | 91.11 mmHg | Standard Deviation 7.04 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 12 hrs: Cycle Day 2 Change | -0.72 mmHg | Standard Deviation 6.64 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 1.5 hrs: Cycle Day 2 Change | -11.67 mmHg | Standard Deviation 14.97 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 10 hrs: Time Matched Baseline | 93.63 mmHg | Standard Deviation 9.18 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 1 hr: Time Matched Baseline | 96.33 mmHg | Standard Deviation 8.05 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 5.5 hrs: Cycle Day 2 Change | -18.44 mmHg | Standard Deviation 10.03 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 12 hrs: Time Matched Baseline | 88.94 mmHg | Standard Deviation 4.37 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 9.5 hrs: Cycle Day 2 Change | -11.11 mmHg | Standard Deviation 15.32 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 5 hrs: Time Matched Baseline | 84.56 mmHg | Standard Deviation 11.3 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 8 hrs: Time Matched Baseline | 89.11 mmHg | Standard Deviation 11.88 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 6 hrs: Time Matched Baseline | 89.78 mmHg | Standard Deviation 6.96 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 9 hrs: Time Matched Baseline | 90.44 mmHg | Standard Deviation 7.35 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 0.5 hr: Time Matched Baseline | 102.00 mmHg | Standard Deviation 6.42 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 2 hrs: Time Matched Baseline | 88.44 mmHg | Standard Deviation 6.5 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 11 hrs: Time Matched Baseline | 94.33 mmHg | Standard Deviation 9.66 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 6 hrs: Cycle Day 2 Change | -15.56 mmHg | Standard Deviation 10.5 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 8.5 hrs: Time Matched Baseline | 89.44 mmHg | Standard Deviation 7.2 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 11.5 hrs: Cycle Day 2 Change | -0.78 mmHg | Standard Deviation 8.35 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 0.5 hr: Cycle Day 2 Change | -5.33 mmHg | Standard Deviation 6.06 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 6.5 hrs: Time Matched Baseline | 89.44 mmHg | Standard Deviation 6.69 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 1.5 hrs: Time Matched Baseline | 91.22 mmHg | Standard Deviation 13.81 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 8 hrs: Cycle Day 2 Change | -7.56 mmHg | Standard Deviation 17.98 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 4 hrs: Cycle Day 2 Change | -8.78 mmHg | Standard Deviation 9.02 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 3.5 hrs: Time Matched Baseline | 87.25 mmHg | Standard Deviation 10.75 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 6.5 hrs: Cycle Day 2 Change | -11.44 mmHg | Standard Deviation 11.07 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 10.5 hrs: Cycle Day 2 Change | -10.11 mmHg | Standard Deviation 7.69 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 2.5 hrs: Time Matched Baseline | 88.67 mmHg | Standard Deviation 7.09 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 2.5 hrs: Cycle Day 2 Change | -12.22 mmHg | Standard Deviation 9.86 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 9.5 hrs: Time Matched Baseline | 95.22 mmHg | Standard Deviation 11.82 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 7 hrs: Time Matched Baseline | 92.44 mmHg | Standard Deviation 8.26 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 11.5 hrs: Time Matched Baseline | 89.56 mmHg | Standard Deviation 8.78 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 3 hrs: Time Matched Baseline | 88.22 mmHg | Standard Deviation 11.91 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 3.5 hrs: Cycle Day 2 Change | -8.63 mmHg | Standard Deviation 13.16 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 8.5 hrs: Cycle Day 2 Change | -6.11 mmHg | Standard Deviation 12.73 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 7 hrs: Cycle Day 2 Change | -14.11 mmHg | Standard Deviation 10.81 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 9 hrs: Cycle Day 2 Change | -7.44 mmHg | Standard Deviation 12.41 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 3 hrs: Cycle Day 2 Change | -8.78 mmHg | Standard Deviation 9.43 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 2 hrs: Cycle Day 2 Change | -8.11 mmHg | Standard Deviation 10.17 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 4.5 hrs: Cycle Day 2 Change | -5.89 mmHg | Standard Deviation 2.93 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 7.5 hrs: Time Matched Baseline | 88.78 mmHg | Standard Deviation 11.01 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 12 hrs: Cycle Day 2 Change | -0.89 mmHg | Standard Deviation 7.88 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 0.5 hr: Time Matched Baseline | 102.00 mmHg | Standard Deviation 6.42 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 0.5 hr: Cycle Day 2 Change | -4.11 mmHg | Standard Deviation 10.41 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 1 hr: Time Matched Baseline | 96.33 mmHg | Standard Deviation 8.05 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 1 hr: Cycle Day 2 Change | -14.89 mmHg | Standard Deviation 9.31 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 1.5 hrs: Time Matched Baseline | 91.22 mmHg | Standard Deviation 13.81 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 1.5 hrs: Cycle Day 2 Change | -12.00 mmHg | Standard Deviation 15.28 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 2 hrs: Time Matched Baseline | 88.44 mmHg | Standard Deviation 6.5 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 2 hrs: Cycle Day 2 Change | -8.67 mmHg | Standard Deviation 16.51 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 2.5 hrs: Time Matched Baseline | 88.67 mmHg | Standard Deviation 7.09 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 2.5 hrs: Cycle Day 2 Change | -10.11 mmHg | Standard Deviation 9.83 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 3 hrs: Time Matched Baseline | 88.22 mmHg | Standard Deviation 11.91 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 3 hrs: Cycle Day 2 Change | -7.44 mmHg | Standard Deviation 17.26 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 3.5 hrs: Time Matched Baseline | 87.25 mmHg | Standard Deviation 10.75 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 3.5 hrs: Cycle Day 2 Change | -7.50 mmHg | Standard Deviation 15.68 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 4 hrs: Time Matched Baseline | 94.78 mmHg | Standard Deviation 7.45 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 4 hrs: Cycle Day 2 Change | -12.11 mmHg | Standard Deviation 13.6 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 4.5 hrs: Time Matched Baseline | 94.67 mmHg | Standard Deviation 7.5 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 4.5 hrs: Cycle Day 2 Change | -9.67 mmHg | Standard Deviation 7.94 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 5 hrs: Time Matched Baseline | 84.56 mmHg | Standard Deviation 11.3 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 5 hrs: Cycle Day 2 Change | -5.11 mmHg | Standard Deviation 12.29 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 5.5 hrs: Time Matched Baseline | 91.11 mmHg | Standard Deviation 7.04 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 5.5 hrs: Cycle Day 2 Change | -13.33 mmHg | Standard Deviation 11.09 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 6 hrs: Time Matched Baseline | 89.78 mmHg | Standard Deviation 6.96 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 6 hrs: Cycle Day 2 Change | -10.67 mmHg | Standard Deviation 11.15 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 6.5 hrs: Time Matched Baseline | 89.44 mmHg | Standard Deviation 6.69 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 6.5 hrs: Cycle Day 2 Change | -11.33 mmHg | Standard Deviation 10.63 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 7 hrs: Time Matched Baseline | 92.44 mmHg | Standard Deviation 8.26 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 7 hrs: Cycle Day 2 Change | -6.44 mmHg | Standard Deviation 11.67 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 7.5 hrs: Time Matched Baseline | 88.78 mmHg | Standard Deviation 11.01 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 7.5 hrs: Cycle Day 2 Change | -5.44 mmHg | Standard Deviation 18.26 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 8 hrs: Time Matched Baseline | 89.11 mmHg | Standard Deviation 11.88 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 8 hrs: Cycle Day 2 Change | -7.22 mmHg | Standard Deviation 13.63 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 8.5 hrs: Time Matched Baseline | 89.44 mmHg | Standard Deviation 7.2 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 8.5 hrs: Cycle Day 2 Change | -6.33 mmHg | Standard Deviation 11.28 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 9 hrs: Time Matched Baseline | 90.44 mmHg | Standard Deviation 7.35 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 9 hrs: Cycle Day 2 Change | -8.11 mmHg | Standard Deviation 11.26 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 9.5 hrs: Time Matched Baseline | 95.22 mmHg | Standard Deviation 11.82 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 9.5 hrs: Cycle Day 2 Change | -8.22 mmHg | Standard Deviation 16.05 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 10 hrs: Time Matched Baseline | 93.63 mmHg | Standard Deviation 9.18 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 10 hrs: Cycle Day 2 Change | -2.50 mmHg | Standard Deviation 18.24 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 10.5 hrs: Time Matched Baseline | 98.89 mmHg | Standard Deviation 9.06 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 10.5 hrs: Cycle Day 2 Change | -10.67 mmHg | Standard Deviation 11.45 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 11 hrs: Time Matched Baseline | 94.33 mmHg | Standard Deviation 9.66 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 11 hrs: Cycle Day 2 Change | -11.78 mmHg | Standard Deviation 14.7 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 11.5 hrs: Time Matched Baseline | 89.56 mmHg | Standard Deviation 8.78 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 11.5 hrs: Cycle Day 2 Change | -3.89 mmHg | Standard Deviation 7.46 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure | 12 hrs: Time Matched Baseline | 88.94 mmHg | Standard Deviation 4.37 |
Primary
Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse
Thirty-minute average is the average of ABPM assessments over 30 minutes intervals from the time of dosing. Time-matched baseline is the 30 minutes average during the placebo cycle (Day 2). Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose at given time point are presented as the second row of data.
Time frame: Time-Matched Baseline (Placebo Cycle); Cycle Day 2: 0.5 hr, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, 10 hrs, 10.5 hrs, 11 hrs, 11.5 hrs, 12 hrs
Population: PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 0.5 hr: Cycle Day 2 Change | -0.60 mmHg | Standard Deviation 4.17 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 1.5 hrs: Time Matched Baseline | 74.80 mmHg | Standard Deviation 12.25 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 9 hrs: Time Matched Baseline | 71.30 mmHg | Standard Deviation 15.1 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 1 hr: Cycle Day 2 Change | 3.00 mmHg | Standard Deviation 6.09 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 11 hrs: Time Matched Baseline | 82.22 mmHg | Standard Deviation 17.1 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 3 hrs: Cycle Day 2 Change | 2.70 mmHg | Standard Deviation 9.01 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 7.5 hrs: Time Matched Baseline | 70.40 mmHg | Standard Deviation 14.42 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 8.5 hrs: Cycle Day 2 Change | 5.80 mmHg | Standard Deviation 9.61 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 6 hrs: Cycle Day 2 Change | 12.60 mmHg | Standard Deviation 15.07 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 11 hrs: Cycle Day 2 Change | -4.33 mmHg | Standard Deviation 14.96 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 5 hrs: Time Matched Baseline | 75.50 mmHg | Standard Deviation 10.21 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 1 hr: Time Matched Baseline | 73.50 mmHg | Standard Deviation 11.69 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 9.5 hrs: Time Matched Baseline | 72.00 mmHg | Standard Deviation 14.83 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 8 hrs: Time Matched Baseline | 71.20 mmHg | Standard Deviation 13.72 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 11.5 hrs: Time Matched Baseline | 81.60 mmHg | Standard Deviation 15.9 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 12 hrs: Cycle Day 2 Change | 2.25 mmHg | Standard Deviation 12.76 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 12 hrs: Time Matched Baseline | 78.45 mmHg | Standard Deviation 12.16 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 10 hrs: Time Matched Baseline | 73.56 mmHg | Standard Deviation 12.82 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 11.5 hrs: Cycle Day 2 Change | -3.10 mmHg | Standard Deviation 8.7 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 8.5 hrs: Time Matched Baseline | 70.40 mmHg | Standard Deviation 13.63 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 3.5 hrs: Time Matched Baseline | 74.33 mmHg | Standard Deviation 15.84 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 3 hrs: Time Matched Baseline | 77.10 mmHg | Standard Deviation 15.53 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 7.5 hrs: Cycle Day 2 Change | 9.70 mmHg | Standard Deviation 9.23 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 5 hrs: Cycle Day 2 Change | 5.50 mmHg | Standard Deviation 11.45 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 4.5 hrs: Time Matched Baseline | 80.80 mmHg | Standard Deviation 13.73 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 2.5 hrs: Cycle Day 2 Change | 3.20 mmHg | Standard Deviation 7.79 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 7 hrs: Time Matched Baseline | 69.10 mmHg | Standard Deviation 13.47 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 6.5 hrs: Time Matched Baseline | 71.40 mmHg | Standard Deviation 11.04 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 5.5 hrs: Time Matched Baseline | 75.50 mmHg | Standard Deviation 10.1 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 6.5 hrs: Cycle Day 2 Change | 13.10 mmHg | Standard Deviation 7.53 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 2.5 hrs: Time Matched Baseline | 76.60 mmHg | Standard Deviation 13.43 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 10 hrs: Cycle Day 2 Change | 4.89 mmHg | Standard Deviation 12.2 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 6 hrs: Time Matched Baseline | 72.00 mmHg | Standard Deviation 11.11 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 5.5 hrs: Cycle Day 2 Change | 7.80 mmHg | Standard Deviation 11.69 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 4 hrs: Cycle Day 2 Change | 2.70 mmHg | Standard Deviation 6.63 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 2 hrs: Cycle Day 2 Change | 0.90 mmHg | Standard Deviation 8.13 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 0.5 hr: Time Matched Baseline | 76.30 mmHg | Standard Deviation 9.89 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 2 hrs: Time Matched Baseline | 78.80 mmHg | Standard Deviation 15.3 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 9 hrs: Cycle Day 2 Change | 5.30 mmHg | Standard Deviation 12.45 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 4 hrs: Time Matched Baseline | 73.70 mmHg | Standard Deviation 15.98 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 7 hrs: Cycle Day 2 Change | 14.00 mmHg | Standard Deviation 6.39 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 4.5 hrs: Cycle Day 2 Change | 4.70 mmHg | Standard Deviation 7.02 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 10.5 hrs: Time Matched Baseline | 81.00 mmHg | Standard Deviation 12.12 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 3.5 hrs: Cycle Day 2 Change | 2.78 mmHg | Standard Deviation 6.85 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 1.5 hrs: Cycle Day 2 Change | 5.60 mmHg | Standard Deviation 4.93 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 9.5 hrs: Cycle Day 2 Change | 3.60 mmHg | Standard Deviation 9.38 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 8 hrs: Cycle Day 2 Change | 6.50 mmHg | Standard Deviation 7.04 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 10.5 hrs: Cycle Day 2 Change | 0.60 mmHg | Standard Deviation 10.84 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 10 hrs: Cycle Day 2 Change | 1.56 mmHg | Standard Deviation 8 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 4 hrs: Cycle Day 2 Change | 3.90 mmHg | Standard Deviation 9.45 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 4.5 hrs: Time Matched Baseline | 80.80 mmHg | Standard Deviation 13.73 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 10 hrs: Time Matched Baseline | 73.56 mmHg | Standard Deviation 12.82 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 6 hrs: Cycle Day 2 Change | 7.89 mmHg | Standard Deviation 9.57 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 4.5 hrs: Cycle Day 2 Change | 2.70 mmHg | Standard Deviation 8.03 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 5 hrs: Time Matched Baseline | 75.50 mmHg | Standard Deviation 10.21 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 8.5 hrs: Cycle Day 2 Change | 3.60 mmHg | Standard Deviation 7.18 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 5 hrs: Cycle Day 2 Change | 7.90 mmHg | Standard Deviation 13.87 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 6 hrs: Time Matched Baseline | 71.44 mmHg | Standard Deviation 11.63 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 5.5 hrs: Time Matched Baseline | 75.50 mmHg | Standard Deviation 10.1 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 5.5 hrs: Cycle Day 2 Change | 5.70 mmHg | Standard Deviation 11.79 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 8 hrs: Cycle Day 2 Change | 3.70 mmHg | Standard Deviation 5.14 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 9 hrs: Cycle Day 2 Change | 1.50 mmHg | Standard Deviation 9.65 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 10.5 hrs: Time Matched Baseline | 81.78 mmHg | Standard Deviation 12.59 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 10.5 hrs: Cycle Day 2 Change | -3.89 mmHg | Standard Deviation 10.17 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 11 hrs: Time Matched Baseline | 81.30 mmHg | Standard Deviation 16.38 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 8 hrs: Time Matched Baseline | 71.20 mmHg | Standard Deviation 13.72 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 11 hrs: Cycle Day 2 Change | -7.30 mmHg | Standard Deviation 14.62 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 12 hrs: Time Matched Baseline | 78.45 mmHg | Standard Deviation 12.16 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 9.5 hrs: Time Matched Baseline | 72.00 mmHg | Standard Deviation 14.83 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 7.5 hrs: Cycle Day 2 Change | 6.40 mmHg | Standard Deviation 8.76 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 11.5 hrs: Time Matched Baseline | 81.60 mmHg | Standard Deviation 15.9 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 12 hrs: Cycle Day 2 Change | 0.65 mmHg | Standard Deviation 9.6 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 11.5 hrs: Cycle Day 2 Change | -5.80 mmHg | Standard Deviation 11.28 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 7.5 hrs: Time Matched Baseline | 70.40 mmHg | Standard Deviation 14.42 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 1 hr: Time Matched Baseline | 73.50 mmHg | Standard Deviation 11.69 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 9 hrs: Time Matched Baseline | 71.30 mmHg | Standard Deviation 15.1 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 1 hr: Cycle Day 2 Change | 7.30 mmHg | Standard Deviation 8.19 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 8.5 hrs: Time Matched Baseline | 70.40 mmHg | Standard Deviation 13.63 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 1.5 hrs: Time Matched Baseline | 74.80 mmHg | Standard Deviation 12.25 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 7 hrs: Cycle Day 2 Change | 14.20 mmHg | Standard Deviation 14.2 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 1.5 hrs: Cycle Day 2 Change | 18.90 mmHg | Standard Deviation 12.72 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 9.5 hrs: Cycle Day 2 Change | 0.80 mmHg | Standard Deviation 9.2 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 2 hrs: Time Matched Baseline | 78.80 mmHg | Standard Deviation 15.3 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 2 hrs: Cycle Day 2 Change | 7.40 mmHg | Standard Deviation 5.91 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 0.5 hr: Time Matched Baseline | 76.30 mmHg | Standard Deviation 9.89 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 7 hrs: Time Matched Baseline | 69.10 mmHg | Standard Deviation 13.47 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 2.5 hrs: Time Matched Baseline | 76.60 mmHg | Standard Deviation 13.43 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 2.5 hrs: Cycle Day 2 Change | 5.20 mmHg | Standard Deviation 6.71 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 3 hrs: Time Matched Baseline | 77.10 mmHg | Standard Deviation 15.53 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 6.5 hrs: Cycle Day 2 Change | 10.30 mmHg | Standard Deviation 10.47 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 3 hrs: Cycle Day 2 Change | 1.20 mmHg | Standard Deviation 10.81 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 3.5 hrs: Time Matched Baseline | 74.33 mmHg | Standard Deviation 15.84 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 0.5 hr: Cycle Day 2 Change | 1.60 mmHg | Standard Deviation 5.23 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 3.5 hrs: Cycle Day 2 Change | 2.44 mmHg | Standard Deviation 5.17 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 6.5 hrs: Time Matched Baseline | 71.40 mmHg | Standard Deviation 11.04 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 4 hrs: Time Matched Baseline | 73.70 mmHg | Standard Deviation 15.98 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 10.5 hrs: Time Matched Baseline | 81.00 mmHg | Standard Deviation 12.12 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 8.5 hrs: Cycle Day 2 Change | 1.33 mmHg | Standard Deviation 8.44 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 1.5 hrs: Cycle Day 2 Change | 14.60 mmHg | Standard Deviation 14.21 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 3 hrs: Cycle Day 2 Change | 12.10 mmHg | Standard Deviation 14.56 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 11.5 hrs: Cycle Day 2 Change | 0.20 mmHg | Standard Deviation 9.44 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 10 hrs: Cycle Day 2 Change | 3.11 mmHg | Standard Deviation 5.88 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 4.5 hrs: Cycle Day 2 Change | 9.60 mmHg | Standard Deviation 15.24 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 2 hrs: Time Matched Baseline | 78.80 mmHg | Standard Deviation 15.3 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 4 hrs: Time Matched Baseline | 74.67 mmHg | Standard Deviation 16.64 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 7 hrs: Time Matched Baseline | 69.10 mmHg | Standard Deviation 13.47 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 5.5 hrs: Cycle Day 2 Change | 6.80 mmHg | Standard Deviation 11.12 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 4.5 hrs: Time Matched Baseline | 80.80 mmHg | Standard Deviation 13.73 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 2 hrs: Cycle Day 2 Change | 6.90 mmHg | Standard Deviation 7.03 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 6 hrs: Cycle Day 2 Change | 7.40 mmHg | Standard Deviation 10.36 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 3.5 hrs: Cycle Day 2 Change | 8.33 mmHg | Standard Deviation 10.1 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 5.5 hrs: Time Matched Baseline | 75.50 mmHg | Standard Deviation 10.1 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 3.5 hrs: Time Matched Baseline | 74.33 mmHg | Standard Deviation 15.84 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 2.5 hrs: Time Matched Baseline | 76.60 mmHg | Standard Deviation 13.43 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 0.5 hr: Time Matched Baseline | 76.30 mmHg | Standard Deviation 9.89 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 8 hrs: Cycle Day 2 Change | 1.90 mmHg | Standard Deviation 6.57 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 5 hrs: Cycle Day 2 Change | 4.00 mmHg | Standard Deviation 10.65 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 0.5 hr: Cycle Day 2 Change | 1.50 mmHg | Standard Deviation 8.34 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 2.5 hrs: Cycle Day 2 Change | 9.30 mmHg | Standard Deviation 12.28 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 8.5 hrs: Time Matched Baseline | 71.33 mmHg | Standard Deviation 14.12 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 11.5 hrs: Time Matched Baseline | 81.60 mmHg | Standard Deviation 15.9 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 12 hrs: Time Matched Baseline | 78.45 mmHg | Standard Deviation 12.16 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 7.5 hrs: Cycle Day 2 Change | 5.70 mmHg | Standard Deviation 7.24 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 9 hrs: Time Matched Baseline | 71.30 mmHg | Standard Deviation 15.1 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 6.5 hrs: Cycle Day 2 Change | 8.30 mmHg | Standard Deviation 11.73 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 12 hrs: Cycle Day 2 Change | 4.40 mmHg | Standard Deviation 7.17 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 9.5 hrs: Time Matched Baseline | 72.00 mmHg | Standard Deviation 14.83 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 7.5 hrs: Time Matched Baseline | 70.40 mmHg | Standard Deviation 14.42 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 9.5 hrs: Cycle Day 2 Change | 3.60 mmHg | Standard Deviation 12.33 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 11 hrs: Cycle Day 2 Change | -2.67 mmHg | Standard Deviation 12.47 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 6 hrs: Time Matched Baseline | 72.00 mmHg | Standard Deviation 11.11 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 1 hr: Time Matched Baseline | 73.50 mmHg | Standard Deviation 11.69 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 6.5 hrs: Time Matched Baseline | 71.40 mmHg | Standard Deviation 11.04 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 11 hrs: Time Matched Baseline | 82.22 mmHg | Standard Deviation 17.1 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 8 hrs: Time Matched Baseline | 71.20 mmHg | Standard Deviation 13.72 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 3 hrs: Time Matched Baseline | 77.10 mmHg | Standard Deviation 15.53 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 1 hr: Cycle Day 2 Change | 11.00 mmHg | Standard Deviation 10.09 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 5 hrs: Time Matched Baseline | 75.50 mmHg | Standard Deviation 10.21 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 7 hrs: Cycle Day 2 Change | 8.30 mmHg | Standard Deviation 7.04 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 10.5 hrs: Cycle Day 2 Change | -1.00 mmHg | Standard Deviation 5.77 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 4 hrs: Cycle Day 2 Change | 8.89 mmHg | Standard Deviation 13.59 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 1.5 hrs: Time Matched Baseline | 74.80 mmHg | Standard Deviation 12.25 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 9 hrs: Cycle Day 2 Change | 1.60 mmHg | Standard Deviation 10.27 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 10 hrs: Time Matched Baseline | 73.56 mmHg | Standard Deviation 12.82 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 11 hrs: Cycle Day 2 Change | -2.22 mmHg | Standard Deviation 15.21 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 8.5 hrs: Cycle Day 2 Change | 6.33 mmHg | Standard Deviation 7.92 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 9 hrs: Time Matched Baseline | 71.89 mmHg | Standard Deviation 15.89 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 9 hrs: Cycle Day 2 Change | 2.22 mmHg | Standard Deviation 13.89 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 9.5 hrs: Time Matched Baseline | 72.67 mmHg | Standard Deviation 15.57 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 0.5 hr: Time Matched Baseline | 75.67 mmHg | Standard Deviation 10.27 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 0.5 hr: Cycle Day 2 Change | 2.67 mmHg | Standard Deviation 9.62 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 10 hrs: Time Matched Baseline | 74.13 mmHg | Standard Deviation 13.58 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 10 hrs: Cycle Day 2 Change | 7.88 mmHg | Standard Deviation 9.6 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 11.5 hrs: Cycle Day 2 Change | -4.89 mmHg | Standard Deviation 9.52 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 10.5 hrs: Time Matched Baseline | 81.33 mmHg | Standard Deviation 12.81 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 10.5 hrs: Cycle Day 2 Change | 3.11 mmHg | Standard Deviation 11.19 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 11 hrs: Time Matched Baseline | 82.56 mmHg | Standard Deviation 16.86 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 9.5 hrs: Cycle Day 2 Change | 6.22 mmHg | Standard Deviation 7.51 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 12 hrs: Time Matched Baseline | 78.94 mmHg | Standard Deviation 12.79 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 11.5 hrs: Time Matched Baseline | 82.78 mmHg | Standard Deviation 16.4 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 12 hrs: Cycle Day 2 Change | 2.44 mmHg | Standard Deviation 6.94 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 1 hr: Time Matched Baseline | 74.44 mmHg | Standard Deviation 11.99 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 1 hr: Cycle Day 2 Change | 8.11 mmHg | Standard Deviation 7.85 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 1.5 hrs: Time Matched Baseline | 75.56 mmHg | Standard Deviation 12.74 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 1.5 hrs: Cycle Day 2 Change | 10.44 mmHg | Standard Deviation 7.75 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 2 hrs: Time Matched Baseline | 80.22 mmHg | Standard Deviation 15.51 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 2 hrs: Cycle Day 2 Change | 14.00 mmHg | Standard Deviation 22.92 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 2.5 hrs: Time Matched Baseline | 77.89 mmHg | Standard Deviation 13.57 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 2.5 hrs: Cycle Day 2 Change | 8.44 mmHg | Standard Deviation 7.7 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 3 hrs: Time Matched Baseline | 78.56 mmHg | Standard Deviation 15.73 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 3 hrs: Cycle Day 2 Change | 2.22 mmHg | Standard Deviation 8.77 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 3.5 hrs: Time Matched Baseline | 75.75 mmHg | Standard Deviation 16.31 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 3.5 hrs: Cycle Day 2 Change | 5.13 mmHg | Standard Deviation 10.52 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 4 hrs: Time Matched Baseline | 75.11 mmHg | Standard Deviation 16.27 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 4 hrs: Cycle Day 2 Change | 5.78 mmHg | Standard Deviation 8.76 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 4.5 hrs: Time Matched Baseline | 81.56 mmHg | Standard Deviation 14.34 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 4.5 hrs: Cycle Day 2 Change | 10.56 mmHg | Standard Deviation 10.86 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 5 hrs: Time Matched Baseline | 76.44 mmHg | Standard Deviation 10.36 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 5 hrs: Cycle Day 2 Change | 17.78 mmHg | Standard Deviation 14.81 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 5.5 hrs: Time Matched Baseline | 76.11 mmHg | Standard Deviation 10.52 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 5.5 hrs: Cycle Day 2 Change | 10.00 mmHg | Standard Deviation 11.22 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 6 hrs: Time Matched Baseline | 72.22 mmHg | Standard Deviation 11.76 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 6 hrs: Cycle Day 2 Change | 16.00 mmHg | Standard Deviation 13.87 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 6.5 hrs: Time Matched Baseline | 71.56 mmHg | Standard Deviation 11.7 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 6.5 hrs: Cycle Day 2 Change | 13.44 mmHg | Standard Deviation 10.57 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 7 hrs: Time Matched Baseline | 69.56 mmHg | Standard Deviation 14.2 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 7 hrs: Cycle Day 2 Change | 12.56 mmHg | Standard Deviation 4.42 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 7.5 hrs: Time Matched Baseline | 70.56 mmHg | Standard Deviation 15.28 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 7.5 hrs: Cycle Day 2 Change | 12.78 mmHg | Standard Deviation 9.76 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 8 hrs: Time Matched Baseline | 72.44 mmHg | Standard Deviation 13.94 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 8 hrs: Cycle Day 2 Change | 9.44 mmHg | Standard Deviation 8.11 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 8.5 hrs: Time Matched Baseline | 71.22 mmHg | Standard Deviation 14.19 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 4 hrs: Time Matched Baseline | 75.11 mmHg | Standard Deviation 16.27 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 3.5 hrs: Cycle Day 2 Change | 5.13 mmHg | Standard Deviation 13.82 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 3.5 hrs: Time Matched Baseline | 75.75 mmHg | Standard Deviation 16.31 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 8 hrs: Cycle Day 2 Change | 5.56 mmHg | Standard Deviation 8.71 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 6.5 hrs: Time Matched Baseline | 71.56 mmHg | Standard Deviation 11.7 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 3 hrs: Cycle Day 2 Change | 7.89 mmHg | Standard Deviation 12.23 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 3 hrs: Time Matched Baseline | 78.56 mmHg | Standard Deviation 15.73 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 2.5 hrs: Cycle Day 2 Change | 6.67 mmHg | Standard Deviation 11.7 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 0.5 hr: Time Matched Baseline | 75.67 mmHg | Standard Deviation 10.27 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 6.5 hrs: Cycle Day 2 Change | 13.00 mmHg | Standard Deviation 15.73 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 2.5 hrs: Time Matched Baseline | 77.89 mmHg | Standard Deviation 13.57 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 2 hrs: Cycle Day 2 Change | 5.33 mmHg | Standard Deviation 9.5 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 2 hrs: Time Matched Baseline | 80.22 mmHg | Standard Deviation 15.51 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 9.5 hrs: Time Matched Baseline | 72.67 mmHg | Standard Deviation 15.57 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 7 hrs: Time Matched Baseline | 69.56 mmHg | Standard Deviation 14.2 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 1.5 hrs: Cycle Day 2 Change | 14.44 mmHg | Standard Deviation 5.39 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 1.5 hrs: Time Matched Baseline | 75.56 mmHg | Standard Deviation 12.74 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 1 hr: Cycle Day 2 Change | 9.89 mmHg | Standard Deviation 9.98 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 9.5 hrs: Cycle Day 2 Change | 8.78 mmHg | Standard Deviation 10.17 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 7 hrs: Cycle Day 2 Change | 13.00 mmHg | Standard Deviation 9.75 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 1 hr: Time Matched Baseline | 74.44 mmHg | Standard Deviation 11.99 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 0.5 hr: Cycle Day 2 Change | 2.11 mmHg | Standard Deviation 5.42 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 12 hrs: Cycle Day 2 Change | 2.78 mmHg | Standard Deviation 10.6 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 8.5 hrs: Cycle Day 2 Change | 8.78 mmHg | Standard Deviation 10.35 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 7.5 hrs: Time Matched Baseline | 70.56 mmHg | Standard Deviation 15.28 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 11.5 hrs: Time Matched Baseline | 82.78 mmHg | Standard Deviation 16.4 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 12 hrs: Time Matched Baseline | 78.94 mmHg | Standard Deviation 12.79 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 11.5 hrs: Cycle Day 2 Change | -3.56 mmHg | Standard Deviation 13.42 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 8.5 hrs: Time Matched Baseline | 71.22 mmHg | Standard Deviation 14.19 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 7.5 hrs: Cycle Day 2 Change | 11.67 mmHg | Standard Deviation 14.98 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 11 hrs: Cycle Day 2 Change | -3.56 mmHg | Standard Deviation 7.49 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 11 hrs: Time Matched Baseline | 82.56 mmHg | Standard Deviation 16.86 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 10.5 hrs: Cycle Day 2 Change | 2.11 mmHg | Standard Deviation 9.51 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 9 hrs: Cycle Day 2 Change | 4.44 mmHg | Standard Deviation 11.26 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 8 hrs: Time Matched Baseline | 72.44 mmHg | Standard Deviation 13.94 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 10.5 hrs: Time Matched Baseline | 81.33 mmHg | Standard Deviation 12.81 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 10 hrs: Cycle Day 2 Change | 5.75 mmHg | Standard Deviation 12.13 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 5.5 hrs: Cycle Day 2 Change | 5.00 mmHg | Standard Deviation 13.22 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 5.5 hrs: Time Matched Baseline | 76.11 mmHg | Standard Deviation 10.52 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 5 hrs: Cycle Day 2 Change | 7.00 mmHg | Standard Deviation 15.26 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 5 hrs: Time Matched Baseline | 76.44 mmHg | Standard Deviation 10.36 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 10 hrs: Time Matched Baseline | 74.13 mmHg | Standard Deviation 13.58 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 6 hrs: Time Matched Baseline | 72.22 mmHg | Standard Deviation 11.76 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 4.5 hrs: Cycle Day 2 Change | 7.33 mmHg | Standard Deviation 9.64 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 4.5 hrs: Time Matched Baseline | 81.56 mmHg | Standard Deviation 14.34 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 4 hrs: Cycle Day 2 Change | 7.44 mmHg | Standard Deviation 13.53 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 9 hrs: Time Matched Baseline | 71.89 mmHg | Standard Deviation 15.89 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse | 6 hrs: Cycle Day 2 Change | 8.56 mmHg | Standard Deviation 8.79 |
Primary
Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure
Thirty-minute average is the average of ABPM assessments over 30 minutes intervals from the time of dosing. Time-matched baseline is the 30 minutes average during the placebo cycle (Day 2). Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose at given time point are presented as the second row of data.
Time frame: Time-Matched Baseline (Placebo Cycle); Cycle Day 2: 0.5 hr, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, 10 hrs, 10.5 hrs, 11 hrs, 11.5 hrs, 12 hrs
Population: PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 8.5 hrs: Time Matched Baseline | 126.10 mmHg | Standard Deviation 12.13 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 5 hrs: Cycle Day 2 Change | -1.90 mmHg | Standard Deviation 13.89 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 10.5 hrs: Cycle Day 2 Change | -5.20 mmHg | Standard Deviation 22.09 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 11.5 hrs: Time Matched Baseline | 126.30 mmHg | Standard Deviation 10.04 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 3 hrs: Time Matched Baseline | 119.10 mmHg | Standard Deviation 13.04 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 7 hrs: Cycle Day 2 Change | -5.50 mmHg | Standard Deviation 13.88 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 5 hrs: Time Matched Baseline | 120.80 mmHg | Standard Deviation 14.44 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 10 hrs: Cycle Day 2 Change | -2.78 mmHg | Standard Deviation 20.11 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 1 hr: Cycle Day 2 Change | -7.70 mmHg | Standard Deviation 12.36 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 3 hrs: Cycle Day 2 Change | -3.20 mmHg | Standard Deviation 16.29 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 8 hrs: Time Matched Baseline | 124.90 mmHg | Standard Deviation 12.68 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 4.5 hrs: Cycle Day 2 Change | -10.70 mmHg | Standard Deviation 11.98 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 4.5 hrs: Time Matched Baseline | 129.80 mmHg | Standard Deviation 13.6 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 6.5 hrs: Time Matched Baseline | 121.40 mmHg | Standard Deviation 7.68 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 3.5 hrs: Time Matched Baseline | 120.89 mmHg | Standard Deviation 13.77 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 8.5 hrs: Cycle Day 2 Change | -5.00 mmHg | Standard Deviation 13.32 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 11 hrs: Time Matched Baseline | 133.44 mmHg | Standard Deviation 14.97 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 1 hr: Time Matched Baseline | 128.60 mmHg | Standard Deviation 12.56 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 11 hrs: Cycle Day 2 Change | -3.00 mmHg | Standard Deviation 16.05 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 3.5 hrs: Cycle Day 2 Change | -6.56 mmHg | Standard Deviation 15.95 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 7.5 hrs: Cycle Day 2 Change | -8.00 mmHg | Standard Deviation 16.8 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 0.5 hr: Time Matched Baseline | 140.30 mmHg | Standard Deviation 18.66 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 6 hrs: Cycle Day 2 Change | -6.90 mmHg | Standard Deviation 16.04 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 4 hrs: Cycle Day 2 Change | -8.00 mmHg | Standard Deviation 8.94 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 4 hrs: Time Matched Baseline | 126.30 mmHg | Standard Deviation 12.57 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 1.5 hrs: Time Matched Baseline | 125.10 mmHg | Standard Deviation 13.99 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 7 hrs: Time Matched Baseline | 125.50 mmHg | Standard Deviation 10.17 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 9 hrs: Time Matched Baseline | 127.20 mmHg | Standard Deviation 11.12 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 7.5 hrs: Time Matched Baseline | 126.30 mmHg | Standard Deviation 12.31 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 6 hrs: Time Matched Baseline | 122.00 mmHg | Standard Deviation 11.27 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 12 hrs: Cycle Day 2 Change | 3.45 mmHg | Standard Deviation 9.54 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 9.5 hrs: Time Matched Baseline | 128.30 mmHg | Standard Deviation 14.38 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 9 hrs: Cycle Day 2 Change | -2.60 mmHg | Standard Deviation 17.44 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 10 hrs: Time Matched Baseline | 128.56 mmHg | Standard Deviation 14.78 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 10.5 hrs: Time Matched Baseline | 136.90 mmHg | Standard Deviation 19.17 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 8 hrs: Cycle Day 2 Change | -6.40 mmHg | Standard Deviation 21.29 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 11.5 hrs: Cycle Day 2 Change | -3.20 mmHg | Standard Deviation 8.4 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 2 hrs: Cycle Day 2 Change | -5.10 mmHg | Standard Deviation 14.42 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 1.5 hrs: Cycle Day 2 Change | -5.00 mmHg | Standard Deviation 11.75 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 12 hrs: Time Matched Baseline | 124.05 mmHg | Standard Deviation 9.42 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 0.5 hr: Cycle Day 2 Change | -4.90 mmHg | Standard Deviation 6.89 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 5.5 hrs: Cycle Day 2 Change | -3.10 mmHg | Standard Deviation 15.74 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 2.5 hrs: Time Matched Baseline | 120.20 mmHg | Standard Deviation 6.05 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 6.5 hrs: Cycle Day 2 Change | -2.00 mmHg | Standard Deviation 17.95 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 5.5 hrs: Time Matched Baseline | 123.50 mmHg | Standard Deviation 16.18 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 2 hrs: Time Matched Baseline | 122.70 mmHg | Standard Deviation 10.68 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 9.5 hrs: Cycle Day 2 Change | -1.90 mmHg | Standard Deviation 23.19 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 2.5 hrs: Cycle Day 2 Change | 0 mmHg | Standard Deviation 13.55 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 7.5 hrs: Time Matched Baseline | 126.30 mmHg | Standard Deviation 12.31 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 7.5 hrs: Cycle Day 2 Change | -12.30 mmHg | Standard Deviation 17.75 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 8 hrs: Time Matched Baseline | 124.90 mmHg | Standard Deviation 12.68 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 11.5 hrs: Cycle Day 2 Change | -3.20 mmHg | Standard Deviation 12.93 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 9.5 hrs: Cycle Day 2 Change | -14.00 mmHg | Standard Deviation 22.14 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 8 hrs: Cycle Day 2 Change | -9.10 mmHg | Standard Deviation 13.54 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 8.5 hrs: Time Matched Baseline | 126.10 mmHg | Standard Deviation 12.13 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 2 hrs: Time Matched Baseline | 122.70 mmHg | Standard Deviation 10.68 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 8.5 hrs: Cycle Day 2 Change | -8.40 mmHg | Standard Deviation 17.58 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 9.5 hrs: Time Matched Baseline | 128.30 mmHg | Standard Deviation 14.38 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 9 hrs: Time Matched Baseline | 127.20 mmHg | Standard Deviation 11.12 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 9 hrs: Cycle Day 2 Change | -7.90 mmHg | Standard Deviation 21.66 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 1.5 hrs: Cycle Day 2 Change | -9.10 mmHg | Standard Deviation 18.46 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 2 hrs: Cycle Day 2 Change | -6.30 mmHg | Standard Deviation 10.56 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 2.5 hrs: Time Matched Baseline | 120.20 mmHg | Standard Deviation 6.05 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 0.5 hr: Cycle Day 2 Change | -14.80 mmHg | Standard Deviation 8.78 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 11.5 hrs: Time Matched Baseline | 126.30 mmHg | Standard Deviation 10.04 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 2.5 hrs: Cycle Day 2 Change | -10.10 mmHg | Standard Deviation 12.56 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 3 hrs: Time Matched Baseline | 119.10 mmHg | Standard Deviation 13.04 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 12 hrs: Cycle Day 2 Change | -4.10 mmHg | Standard Deviation 13.33 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 3 hrs: Cycle Day 2 Change | -6.40 mmHg | Standard Deviation 19.78 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 11 hrs: Cycle Day 2 Change | -15.50 mmHg | Standard Deviation 11.64 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 3.5 hrs: Time Matched Baseline | 120.89 mmHg | Standard Deviation 13.77 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 3.5 hrs: Cycle Day 2 Change | -14.11 mmHg | Standard Deviation 14.29 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 1 hr: Time Matched Baseline | 128.60 mmHg | Standard Deviation 12.56 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 4 hrs: Time Matched Baseline | 126.30 mmHg | Standard Deviation 12.57 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 11 hrs: Time Matched Baseline | 133.70 mmHg | Standard Deviation 14.13 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 4 hrs: Cycle Day 2 Change | -11.30 mmHg | Standard Deviation 12.7 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 4.5 hrs: Time Matched Baseline | 129.80 mmHg | Standard Deviation 13.6 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 12 hrs: Time Matched Baseline | 124.05 mmHg | Standard Deviation 9.42 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 4.5 hrs: Cycle Day 2 Change | -10.50 mmHg | Standard Deviation 14.69 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 10.5 hrs: Cycle Day 2 Change | -5.78 mmHg | Standard Deviation 18.03 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 5 hrs: Time Matched Baseline | 120.80 mmHg | Standard Deviation 14.44 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 1 hr: Cycle Day 2 Change | -12.50 mmHg | Standard Deviation 14 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 5 hrs: Cycle Day 2 Change | -6.20 mmHg | Standard Deviation 14.54 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 5.5 hrs: Time Matched Baseline | 123.50 mmHg | Standard Deviation 16.18 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 0.5 hr: Time Matched Baseline | 140.30 mmHg | Standard Deviation 18.66 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 10.5 hrs: Time Matched Baseline | 137.89 mmHg | Standard Deviation 20.07 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 5.5 hrs: Cycle Day 2 Change | -9.40 mmHg | Standard Deviation 14.95 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 6 hrs: Time Matched Baseline | 124.89 mmHg | Standard Deviation 7.01 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 6 hrs: Cycle Day 2 Change | -12.00 mmHg | Standard Deviation 11.86 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 1.5 hrs: Time Matched Baseline | 125.10 mmHg | Standard Deviation 13.99 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 10 hrs: Cycle Day 2 Change | -10.67 mmHg | Standard Deviation 19.54 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 6.5 hrs: Time Matched Baseline | 121.40 mmHg | Standard Deviation 7.68 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 6.5 hrs: Cycle Day 2 Change | -7.60 mmHg | Standard Deviation 15.9 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 7 hrs: Time Matched Baseline | 125.50 mmHg | Standard Deviation 10.17 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 10 hrs: Time Matched Baseline | 128.56 mmHg | Standard Deviation 14.78 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 7 hrs: Cycle Day 2 Change | -11.60 mmHg | Standard Deviation 15.28 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 0.5 hr: Cycle Day 2 Change | -10.10 mmHg | Standard Deviation 10.09 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 2.5 hrs: Cycle Day 2 Change | -7.40 mmHg | Standard Deviation 12.81 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 0.5 hr: Time Matched Baseline | 140.30 mmHg | Standard Deviation 18.66 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 5 hrs: Cycle Day 2 Change | -5.20 mmHg | Standard Deviation 19.86 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 1 hr: Cycle Day 2 Change | -10.80 mmHg | Standard Deviation 16.19 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 10.5 hrs: Time Matched Baseline | 136.90 mmHg | Standard Deviation 19.17 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 2.5 hrs: Time Matched Baseline | 120.20 mmHg | Standard Deviation 6.05 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 10 hrs: Time Matched Baseline | 128.56 mmHg | Standard Deviation 14.78 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 5.5 hrs: Time Matched Baseline | 123.50 mmHg | Standard Deviation 16.18 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 8 hrs: Time Matched Baseline | 124.90 mmHg | Standard Deviation 12.68 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 7.5 hrs: Cycle Day 2 Change | -12.30 mmHg | Standard Deviation 21.43 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 11.5 hrs: Time Matched Baseline | 126.30 mmHg | Standard Deviation 10.04 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 7 hrs: Time Matched Baseline | 125.50 mmHg | Standard Deviation 10.17 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 5.5 hrs: Cycle Day 2 Change | -9.20 mmHg | Standard Deviation 14.9 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 2 hrs: Cycle Day 2 Change | -8.90 mmHg | Standard Deviation 9.92 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 9 hrs: Cycle Day 2 Change | -7.20 mmHg | Standard Deviation 18.33 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 9 hrs: Time Matched Baseline | 127.20 mmHg | Standard Deviation 11.12 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 11.5 hrs: Cycle Day 2 Change | -8.70 mmHg | Standard Deviation 6.06 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 6 hrs: Time Matched Baseline | 122.00 mmHg | Standard Deviation 11.27 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 2 hrs: Time Matched Baseline | 122.70 mmHg | Standard Deviation 10.68 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 10 hrs: Cycle Day 2 Change | -5.44 mmHg | Standard Deviation 13.42 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 8.5 hrs: Cycle Day 2 Change | -1.33 mmHg | Standard Deviation 9.42 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 1.5 hrs: Cycle Day 2 Change | -10.40 mmHg | Standard Deviation 14.39 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 6 hrs: Cycle Day 2 Change | -7.80 mmHg | Standard Deviation 13.8 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 9.5 hrs: Cycle Day 2 Change | -4.70 mmHg | Standard Deviation 18.69 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 7.5 hrs: Time Matched Baseline | 126.30 mmHg | Standard Deviation 12.31 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 4 hrs: Time Matched Baseline | 123.78 mmHg | Standard Deviation 10.31 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 1 hr: Time Matched Baseline | 128.60 mmHg | Standard Deviation 12.56 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 9.5 hrs: Time Matched Baseline | 128.30 mmHg | Standard Deviation 14.38 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 11 hrs: Time Matched Baseline | 133.44 mmHg | Standard Deviation 14.97 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 7 hrs: Cycle Day 2 Change | -10.70 mmHg | Standard Deviation 16.34 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 4 hrs: Cycle Day 2 Change | -5.56 mmHg | Standard Deviation 13.31 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 3.5 hrs: Cycle Day 2 Change | -10.67 mmHg | Standard Deviation 12.36 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 3.5 hrs: Time Matched Baseline | 120.89 mmHg | Standard Deviation 13.77 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 12 hrs: Time Matched Baseline | 124.05 mmHg | Standard Deviation 9.42 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 6.5 hrs: Time Matched Baseline | 121.40 mmHg | Standard Deviation 7.68 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 4.5 hrs: Time Matched Baseline | 129.80 mmHg | Standard Deviation 13.6 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 1.5 hrs: Time Matched Baseline | 125.10 mmHg | Standard Deviation 13.99 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 10.5 hrs: Cycle Day 2 Change | -8.10 mmHg | Standard Deviation 16.13 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 3 hrs: Cycle Day 2 Change | -4.70 mmHg | Standard Deviation 17.61 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 8.5 hrs: Time Matched Baseline | 125.11 mmHg | Standard Deviation 12.43 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 4.5 hrs: Cycle Day 2 Change | -14.70 mmHg | Standard Deviation 10.71 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 11 hrs: Cycle Day 2 Change | -12.56 mmHg | Standard Deviation 9.17 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 8 hrs: Cycle Day 2 Change | -7.70 mmHg | Standard Deviation 19.81 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 3 hrs: Time Matched Baseline | 119.10 mmHg | Standard Deviation 13.04 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 12 hrs: Cycle Day 2 Change | -2.55 mmHg | Standard Deviation 10.93 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 5 hrs: Time Matched Baseline | 120.80 mmHg | Standard Deviation 14.44 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 6.5 hrs: Cycle Day 2 Change | -4.60 mmHg | Standard Deviation 17.6 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 9 hrs: Cycle Day 2 Change | -13.78 mmHg | Standard Deviation 19.77 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 0.5 hr: Time Matched Baseline | 138.22 mmHg | Standard Deviation 18.53 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 0.5 hr: Cycle Day 2 Change | -11.67 mmHg | Standard Deviation 13.06 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 1 hr: Time Matched Baseline | 128.89 mmHg | Standard Deviation 13.29 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 1 hr: Cycle Day 2 Change | -8.56 mmHg | Standard Deviation 17.41 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 1.5 hrs: Time Matched Baseline | 125.67 mmHg | Standard Deviation 14.71 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 1.5 hrs: Cycle Day 2 Change | -14.33 mmHg | Standard Deviation 12.71 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 2 hrs: Time Matched Baseline | 123.22 mmHg | Standard Deviation 11.19 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 2 hrs: Cycle Day 2 Change | -12.56 mmHg | Standard Deviation 13.25 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 2.5 hrs: Time Matched Baseline | 120.22 mmHg | Standard Deviation 6.42 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 2.5 hrs: Cycle Day 2 Change | -13.11 mmHg | Standard Deviation 13.16 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 3 hrs: Time Matched Baseline | 118.78 mmHg | Standard Deviation 13.79 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 3 hrs: Cycle Day 2 Change | -8.22 mmHg | Standard Deviation 18.77 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 3.5 hrs: Time Matched Baseline | 120.75 mmHg | Standard Deviation 14.71 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 3.5 hrs: Cycle Day 2 Change | -9.25 mmHg | Standard Deviation 19.03 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 4 hrs: Time Matched Baseline | 127.56 mmHg | Standard Deviation 12.65 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 4 hrs: Cycle Day 2 Change | -13.78 mmHg | Standard Deviation 12.66 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 4.5 hrs: Time Matched Baseline | 127.33 mmHg | Standard Deviation 11.82 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 4.5 hrs: Cycle Day 2 Change | -8.78 mmHg | Standard Deviation 11.2 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 5 hrs: Time Matched Baseline | 119.56 mmHg | Standard Deviation 14.73 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 5 hrs: Cycle Day 2 Change | -7.33 mmHg | Standard Deviation 17.33 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 5.5 hrs: Time Matched Baseline | 123.33 mmHg | Standard Deviation 17.15 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 5.5 hrs: Cycle Day 2 Change | -18.11 mmHg | Standard Deviation 19.66 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 6 hrs: Time Matched Baseline | 120.78 mmHg | Standard Deviation 11.23 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 6 hrs: Cycle Day 2 Change | -15.33 mmHg | Standard Deviation 17.73 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 6.5 hrs: Time Matched Baseline | 121.44 mmHg | Standard Deviation 8.14 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 6.5 hrs: Cycle Day 2 Change | -12.44 mmHg | Standard Deviation 18.41 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 7 hrs: Time Matched Baseline | 126.22 mmHg | Standard Deviation 10.51 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 7 hrs: Cycle Day 2 Change | -15.44 mmHg | Standard Deviation 13.46 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 7.5 hrs: Time Matched Baseline | 125.44 mmHg | Standard Deviation 12.74 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 7.5 hrs: Cycle Day 2 Change | -16.56 mmHg | Standard Deviation 22.57 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 8 hrs: Time Matched Baseline | 122.44 mmHg | Standard Deviation 10.63 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 8 hrs: Cycle Day 2 Change | -12.11 mmHg | Standard Deviation 22.83 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 8.5 hrs: Time Matched Baseline | 123.89 mmHg | Standard Deviation 10.52 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 8.5 hrs: Cycle Day 2 Change | -12.11 mmHg | Standard Deviation 16.97 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 9 hrs: Time Matched Baseline | 125.67 mmHg | Standard Deviation 10.62 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 9.5 hrs: Time Matched Baseline | 126.78 mmHg | Standard Deviation 14.38 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 9.5 hrs: Cycle Day 2 Change | -12.11 mmHg | Standard Deviation 22.79 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 10 hrs: Time Matched Baseline | 126.50 mmHg | Standard Deviation 14.36 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 10 hrs: Cycle Day 2 Change | -9.63 mmHg | Standard Deviation 22.49 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 10.5 hrs: Time Matched Baseline | 133.33 mmHg | Standard Deviation 16.45 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 10.5 hrs: Cycle Day 2 Change | -11.33 mmHg | Standard Deviation 11.96 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 11 hrs: Time Matched Baseline | 133.11 mmHg | Standard Deviation 14.86 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 11 hrs: Cycle Day 2 Change | -15.78 mmHg | Standard Deviation 16.54 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 11.5 hrs: Time Matched Baseline | 126.11 mmHg | Standard Deviation 10.64 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 11.5 hrs: Cycle Day 2 Change | -4.56 mmHg | Standard Deviation 8.26 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 12 hrs: Time Matched Baseline | 123.17 mmHg | Standard Deviation 9.55 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 12 hrs: Cycle Day 2 Change | -4.94 mmHg | Standard Deviation 7.27 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 7 hrs: Time Matched Baseline | 126.22 mmHg | Standard Deviation 10.51 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 6.5 hrs: Cycle Day 2 Change | -14.44 mmHg | Standard Deviation 13.97 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 1 hr: Cycle Day 2 Change | -14.22 mmHg | Standard Deviation 15.74 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 10 hrs: Time Matched Baseline | 126.50 mmHg | Standard Deviation 14.36 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 6.5 hrs: Time Matched Baseline | 121.44 mmHg | Standard Deviation 8.14 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 6 hrs: Cycle Day 2 Change | -16.11 mmHg | Standard Deviation 14.48 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 6 hrs: Time Matched Baseline | 120.78 mmHg | Standard Deviation 11.23 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 1 hr: Time Matched Baseline | 128.89 mmHg | Standard Deviation 13.29 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 10 hrs: Cycle Day 2 Change | -4.25 mmHg | Standard Deviation 24.81 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 5.5 hrs: Cycle Day 2 Change | -17.44 mmHg | Standard Deviation 20.73 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 5.5 hrs: Time Matched Baseline | 123.33 mmHg | Standard Deviation 17.15 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 5 hrs: Cycle Day 2 Change | -11.67 mmHg | Standard Deviation 17.43 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 0.5 hr: Cycle Day 2 Change | -10.67 mmHg | Standard Deviation 9.95 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 10.5 hrs: Time Matched Baseline | 133.33 mmHg | Standard Deviation 16.45 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 5 hrs: Time Matched Baseline | 119.56 mmHg | Standard Deviation 14.73 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 4.5 hrs: Cycle Day 2 Change | -13.44 mmHg | Standard Deviation 17.4 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 4.5 hrs: Time Matched Baseline | 127.33 mmHg | Standard Deviation 11.82 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 12 hrs: Cycle Day 2 Change | -6.72 mmHg | Standard Deviation 14.85 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 10.5 hrs: Cycle Day 2 Change | -11.78 mmHg | Standard Deviation 16.28 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 4 hrs: Cycle Day 2 Change | -15.33 mmHg | Standard Deviation 18.41 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 4 hrs: Time Matched Baseline | 127.56 mmHg | Standard Deviation 12.65 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 3.5 hrs: Cycle Day 2 Change | -12.88 mmHg | Standard Deviation 22.4 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 12 hrs: Time Matched Baseline | 123.17 mmHg | Standard Deviation 9.55 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 3.5 hrs: Time Matched Baseline | 120.75 mmHg | Standard Deviation 14.71 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 3 hrs: Cycle Day 2 Change | -11.56 mmHg | Standard Deviation 18.42 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 3 hrs: Time Matched Baseline | 118.78 mmHg | Standard Deviation 13.79 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 0.5 hr: Time Matched Baseline | 138.22 mmHg | Standard Deviation 18.53 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 11 hrs: Cycle Day 2 Change | -19.00 mmHg | Standard Deviation 21.04 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 2.5 hrs: Cycle Day 2 Change | -12.33 mmHg | Standard Deviation 12.11 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 2.5 hrs: Time Matched Baseline | 120.22 mmHg | Standard Deviation 6.42 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 2 hrs: Cycle Day 2 Change | -13.11 mmHg | Standard Deviation 16.32 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 11 hrs: Time Matched Baseline | 133.11 mmHg | Standard Deviation 14.86 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 11.5 hrs: Time Matched Baseline | 126.11 mmHg | Standard Deviation 10.64 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 2 hrs: Time Matched Baseline | 123.22 mmHg | Standard Deviation 11.19 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 1.5 hrs: Cycle Day 2 Change | -13.67 mmHg | Standard Deviation 16.81 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 1.5 hrs: Time Matched Baseline | 125.67 mmHg | Standard Deviation 14.71 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 9 hrs: Cycle Day 2 Change | -15.44 mmHg | Standard Deviation 15.16 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 9 hrs: Time Matched Baseline | 125.67 mmHg | Standard Deviation 10.62 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 8.5 hrs: Cycle Day 2 Change | -12.11 mmHg | Standard Deviation 17.51 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 8.5 hrs: Time Matched Baseline | 123.89 mmHg | Standard Deviation 10.52 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 7.5 hrs: Time Matched Baseline | 125.44 mmHg | Standard Deviation 12.74 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 9.5 hrs: Time Matched Baseline | 126.78 mmHg | Standard Deviation 14.38 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 8 hrs: Cycle Day 2 Change | -12.22 mmHg | Standard Deviation 15.7 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 8 hrs: Time Matched Baseline | 122.44 mmHg | Standard Deviation 10.63 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 7.5 hrs: Cycle Day 2 Change | -14.33 mmHg | Standard Deviation 20.27 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 11.5 hrs: Cycle Day 2 Change | -12.22 mmHg | Standard Deviation 14.01 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 9.5 hrs: Cycle Day 2 Change | -11.56 mmHg | Standard Deviation 19.64 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure | 7 hrs: Cycle Day 2 Change | -13.78 mmHg | Standard Deviation 11.36 |
Primary
Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Diastolic Blood Pressure
Four-hour average is the average of ABPM assessments over 4 hours intervals from the time of dosing. Time-matched baseline is the 4 hours average during the placebo cycle (Day 2). Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose at given time point are presented as the second row of data.
Time frame: Time-Matched Baseline (Placebo Cycle); Cycle Day 2: 0-4 hrs, 4-8 hrs, 8-12 hrs
Population: PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Diastolic Blood Pressure | 0-4 hrs: Time Matched Baseline | 75.59 mmHg | Standard Deviation 6.05 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Diastolic Blood Pressure | 0-4 hrs: Cycle Day 2 Change | -2.96 mmHg | Standard Deviation 3.75 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Diastolic Blood Pressure | 4-8 hrs: Time Matched Baseline | 74.54 mmHg | Standard Deviation 7.54 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Diastolic Blood Pressure | 4-8 hrs: Cycle Day 2 Change | -2.28 mmHg | Standard Deviation 7.46 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Diastolic Blood Pressure | 8-12 hrs: Time Matched Baseline | 77.05 mmHg | Standard Deviation 6.31 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Diastolic Blood Pressure | 8-12 hrs: Cycle Day 2 Change | 1.41 mmHg | Standard Deviation 5.71 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Diastolic Blood Pressure | 8-12 hrs: Time Matched Baseline | 77.05 mmHg | Standard Deviation 6.31 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Diastolic Blood Pressure | 8-12 hrs: Cycle Day 2 Change | -3.70 mmHg | Standard Deviation 5.89 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Diastolic Blood Pressure | 0-4 hrs: Time Matched Baseline | 75.59 mmHg | Standard Deviation 6.05 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Diastolic Blood Pressure | 4-8 hrs: Time Matched Baseline | 74.54 mmHg | Standard Deviation 7.54 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Diastolic Blood Pressure | 4-8 hrs: Cycle Day 2 Change | -4.03 mmHg | Standard Deviation 6.37 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Diastolic Blood Pressure | 0-4 hrs: Cycle Day 2 Change | -7.59 mmHg | Standard Deviation 6.04 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Diastolic Blood Pressure | 4-8 hrs: Cycle Day 2 Change | -3.49 mmHg | Standard Deviation 8.91 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Diastolic Blood Pressure | 8-12 hrs: Time Matched Baseline | 77.05 mmHg | Standard Deviation 6.31 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Diastolic Blood Pressure | 0-4 hrs: Time Matched Baseline | 75.59 mmHg | Standard Deviation 6.05 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Diastolic Blood Pressure | 4-8 hrs: Time Matched Baseline | 74.54 mmHg | Standard Deviation 7.54 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Diastolic Blood Pressure | 0-4 hrs: Cycle Day 2 Change | -5.96 mmHg | Standard Deviation 5.53 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Diastolic Blood Pressure | 8-12 hrs: Cycle Day 2 Change | -1.45 mmHg | Standard Deviation 4.79 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Diastolic Blood Pressure | 4-8 hrs: Cycle Day 2 Change | -7.61 mmHg | Standard Deviation 5.88 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Diastolic Blood Pressure | 0-4 hrs: Cycle Day 2 Change | -7.94 mmHg | Standard Deviation 4.75 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Diastolic Blood Pressure | 4-8 hrs: Time Matched Baseline | 72.88 mmHg | Standard Deviation 5.74 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Diastolic Blood Pressure | 8-12 hrs: Cycle Day 2 Change | -4.63 mmHg | Standard Deviation 4.92 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Diastolic Blood Pressure | 8-12 hrs: Time Matched Baseline | 75.75 mmHg | Standard Deviation 5.08 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Diastolic Blood Pressure | 0-4 hrs: Time Matched Baseline | 74.94 mmHg | Standard Deviation 6.04 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Diastolic Blood Pressure | 8-12 hrs: Time Matched Baseline | 75.75 mmHg | Standard Deviation 5.08 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Diastolic Blood Pressure | 4-8 hrs: Time Matched Baseline | 72.88 mmHg | Standard Deviation 5.74 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Diastolic Blood Pressure | 0-4 hrs: Cycle Day 2 Change | -8.32 mmHg | Standard Deviation 6.28 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Diastolic Blood Pressure | 8-12 hrs: Cycle Day 2 Change | -4.84 mmHg | Standard Deviation 6.78 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Diastolic Blood Pressure | 4-8 hrs: Cycle Day 2 Change | -5.92 mmHg | Standard Deviation 7.12 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Diastolic Blood Pressure | 0-4 hrs: Time Matched Baseline | 74.94 mmHg | Standard Deviation 6.04 |
Primary
Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Mean Arterial Pressure
Four-hour average is the average of ABPM assessments over 4 hours intervals from the time of dosing. Time-matched baseline is the 4 hours average during the placebo cycle (Day 2). Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose at given time point are presented as the second row of data.
Time frame: Time-Matched Baseline (Placebo Cycle); Cycle Day 2: 0-4 hrs, 4-8 hrs, 8-12 hrs
Population: PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Mean Arterial Pressure | 0-4 hrs: Cycle Day 2 Change | -3.93 mmHg | Standard Deviation 3.38 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Mean Arterial Pressure | 0-4 hrs: Time Matched Baseline | 92.61 mmHg | Standard Deviation 6.23 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Mean Arterial Pressure | 4-8 hrs: Time Matched Baseline | 91.38 mmHg | Standard Deviation 6.49 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Mean Arterial Pressure | 8-12 hrs: Cycle Day 2 Change | 0.36 mmHg | Standard Deviation 8.87 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Mean Arterial Pressure | 8-12 hrs: Time Matched Baseline | 93.99 mmHg | Standard Deviation 6.38 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Mean Arterial Pressure | 4-8 hrs: Cycle Day 2 Change | -3.50 mmHg | Standard Deviation 7.59 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Mean Arterial Pressure | 4-8 hrs: Time Matched Baseline | 91.38 mmHg | Standard Deviation 6.49 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Mean Arterial Pressure | 0-4 hrs: Time Matched Baseline | 92.61 mmHg | Standard Deviation 6.23 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Mean Arterial Pressure | 0-4 hrs: Cycle Day 2 Change | -8.93 mmHg | Standard Deviation 6.29 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Mean Arterial Pressure | 4-8 hrs: Cycle Day 2 Change | -5.80 mmHg | Standard Deviation 6.58 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Mean Arterial Pressure | 8-12 hrs: Time Matched Baseline | 93.99 mmHg | Standard Deviation 6.38 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Mean Arterial Pressure | 8-12 hrs: Cycle Day 2 Change | -4.34 mmHg | Standard Deviation 7.72 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Mean Arterial Pressure | 4-8 hrs: Time Matched Baseline | 91.38 mmHg | Standard Deviation 6.49 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Mean Arterial Pressure | 8-12 hrs: Cycle Day 2 Change | -3.00 mmHg | Standard Deviation 6.44 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Mean Arterial Pressure | 4-8 hrs: Cycle Day 2 Change | -5.55 mmHg | Standard Deviation 9.34 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Mean Arterial Pressure | 8-12 hrs: Time Matched Baseline | 93.99 mmHg | Standard Deviation 6.38 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Mean Arterial Pressure | 0-4 hrs: Time Matched Baseline | 92.61 mmHg | Standard Deviation 6.23 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Mean Arterial Pressure | 0-4 hrs: Cycle Day 2 Change | -7.64 mmHg | Standard Deviation 6.16 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Mean Arterial Pressure | 0-4 hrs: Time Matched Baseline | 92.21 mmHg | Standard Deviation 6.47 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Mean Arterial Pressure | 4-8 hrs: Time Matched Baseline | 89.99 mmHg | Standard Deviation 5.06 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Mean Arterial Pressure | 8-12 hrs: Cycle Day 2 Change | -6.81 mmHg | Standard Deviation 5.8 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Mean Arterial Pressure | 0-4 hrs: Cycle Day 2 Change | -9.13 mmHg | Standard Deviation 6.21 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Mean Arterial Pressure | 8-12 hrs: Time Matched Baseline | 92.51 mmHg | Standard Deviation 4.63 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Mean Arterial Pressure | 4-8 hrs: Cycle Day 2 Change | -10.29 mmHg | Standard Deviation 6.73 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Mean Arterial Pressure | 8-12 hrs: Cycle Day 2 Change | -6.58 mmHg | Standard Deviation 8.05 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Mean Arterial Pressure | 4-8 hrs: Cycle Day 2 Change | -8.65 mmHg | Standard Deviation 6.93 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Mean Arterial Pressure | 8-12 hrs: Time Matched Baseline | 92.51 mmHg | Standard Deviation 4.63 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Mean Arterial Pressure | 4-8 hrs: Time Matched Baseline | 89.99 mmHg | Standard Deviation 5.06 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Mean Arterial Pressure | 0-4 hrs: Time Matched Baseline | 92.21 mmHg | Standard Deviation 6.47 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Mean Arterial Pressure | 0-4 hrs: Cycle Day 2 Change | -9.67 mmHg | Standard Deviation 8.37 |
Primary
Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Pulse
Four-hour average is the average of ABPM assessments over 4 hours intervals from the time of dosing. Time-matched baseline is the 4 hours average during the placebo cycle (Day 2). Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose at given time point are presented as the second row of data.
Time frame: Time-Matched Baseline (Placebo Cycle); Cycle Day 2: 0-4 hrs, 4-8 hrs, 8-12 hrs
Population: PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Pulse | 0-4 hrs: Time Matched Baseline | 75.61 mmHg | Standard Deviation 12.37 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Pulse | 0-4 hrs: Cycle Day 2 Change | 2.49 mmHg | Standard Deviation 3.62 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Pulse | 4-8 hrs: Time Matched Baseline | 73.24 mmHg | Standard Deviation 11.19 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Pulse | 4-8 hrs: Cycle Day 2 Change | 9.24 mmHg | Standard Deviation 5.3 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Pulse | 8-12 hrs: Time Matched Baseline | 76.22 mmHg | Standard Deviation 12.59 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Pulse | 8-12 hrs: Cycle Day 2 Change | 1.91 mmHg | Standard Deviation 7.04 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Pulse | 8-12 hrs: Time Matched Baseline | 76.22 mmHg | Standard Deviation 12.59 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Pulse | 8-12 hrs: Cycle Day 2 Change | -1.20 mmHg | Standard Deviation 6.52 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Pulse | 0-4 hrs: Time Matched Baseline | 75.61 mmHg | Standard Deviation 12.37 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Pulse | 4-8 hrs: Time Matched Baseline | 73.24 mmHg | Standard Deviation 11.19 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Pulse | 4-8 hrs: Cycle Day 2 Change | 7.56 mmHg | Standard Deviation 6.51 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Pulse | 0-4 hrs: Cycle Day 2 Change | 6.11 mmHg | Standard Deviation 4.49 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Pulse | 4-8 hrs: Cycle Day 2 Change | 6.50 mmHg | Standard Deviation 7.82 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Pulse | 8-12 hrs: Time Matched Baseline | 76.22 mmHg | Standard Deviation 12.59 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Pulse | 0-4 hrs: Time Matched Baseline | 75.61 mmHg | Standard Deviation 12.37 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Pulse | 4-8 hrs: Time Matched Baseline | 73.24 mmHg | Standard Deviation 11.19 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Pulse | 0-4 hrs: Cycle Day 2 Change | 8.91 mmHg | Standard Deviation 7.6 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Pulse | 8-12 hrs: Cycle Day 2 Change | 1.51 mmHg | Standard Deviation 5.34 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Pulse | 4-8 hrs: Cycle Day 2 Change | 12.82 mmHg | Standard Deviation 7.16 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Pulse | 0-4 hrs: Cycle Day 2 Change | 7.10 mmHg | Standard Deviation 4.43 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Pulse | 4-8 hrs: Time Matched Baseline | 73.81 mmHg | Standard Deviation 11.72 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Pulse | 8-12 hrs: Cycle Day 2 Change | 2.53 mmHg | Standard Deviation 5.55 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Pulse | 8-12 hrs: Time Matched Baseline | 76.95 mmHg | Standard Deviation 13.13 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Pulse | 0-4 hrs: Time Matched Baseline | 76.59 mmHg | Standard Deviation 12.7 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Pulse | 8-12 hrs: Time Matched Baseline | 76.95 mmHg | Standard Deviation 13.13 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Pulse | 4-8 hrs: Time Matched Baseline | 73.81 mmHg | Standard Deviation 11.72 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Pulse | 0-4 hrs: Cycle Day 2 Change | 7.38 mmHg | Standard Deviation 6.58 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Pulse | 8-12 hrs: Cycle Day 2 Change | 3.35 mmHg | Standard Deviation 8.48 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Pulse | 4-8 hrs: Cycle Day 2 Change | 8.89 mmHg | Standard Deviation 8.83 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Pulse | 0-4 hrs: Time Matched Baseline | 76.59 mmHg | Standard Deviation 12.7 |
Primary
Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Diastolic Blood Pressure
Daytime average is the average of ABPM assessments over 12 hours from the time of dosing. Time-matched baseline is the daytime average during the placebo cycle (Day 2). Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment). To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose are presented as the second row of data.
Time frame: Time-Matched Baseline (Placebo Cycle); Cycle Day 2
Population: PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Diastolic Blood Pressure | Time-Matched Baseline | 75.71 mmHg | Standard Deviation 6.27 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Diastolic Blood Pressure | Cycle Day 2 Change | -1.26 mmHg | Standard Deviation 4.08 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Diastolic Blood Pressure | Time-Matched Baseline | 75.71 mmHg | Standard Deviation 6.27 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Diastolic Blood Pressure | Cycle Day 2 Change | -5.10 mmHg | Standard Deviation 4.67 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Diastolic Blood Pressure | Time-Matched Baseline | 75.71 mmHg | Standard Deviation 6.27 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Diastolic Blood Pressure | Cycle Day 2 Change | -3.59 mmHg | Standard Deviation 5.72 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Diastolic Blood Pressure | Cycle Day 2 Change | -6.71 mmHg | Standard Deviation 4.38 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Diastolic Blood Pressure | Time-Matched Baseline | 74.51 mmHg | Standard Deviation 5.28 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Diastolic Blood Pressure | Time-Matched Baseline | 74.51 mmHg | Standard Deviation 5.28 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Diastolic Blood Pressure | Cycle Day 2 Change | -6.34 mmHg | Standard Deviation 5.84 |
Primary
Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Mean Arterial Pressure
Daytime average is the average of ABPM assessments over 12 hours from the time of dosing. Time-matched baseline is the daytime average during the placebo cycle (Day 2). Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment). To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose are presented as the second row of data.
Time frame: Time-Matched Baseline (Placebo Cycle); Cycle Day 2
Population: PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Mean Arterial Pressure | Time-Matched Baseline | 92.64 mmHg | Standard Deviation 5.77 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Mean Arterial Pressure | Cycle Day 2 Change | -2.33 mmHg | Standard Deviation 5.21 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Mean Arterial Pressure | Time-Matched Baseline | 92.64 mmHg | Standard Deviation 5.77 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Mean Arterial Pressure | Cycle Day 2 Change | -6.33 mmHg | Standard Deviation 5.44 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Mean Arterial Pressure | Cycle Day 2 Change | -5.34 mmHg | Standard Deviation 6.58 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Mean Arterial Pressure | Time-Matched Baseline | 92.64 mmHg | Standard Deviation 5.77 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Mean Arterial Pressure | Cycle Day 2 Change | -8.72 mmHg | Standard Deviation 5.43 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Mean Arterial Pressure | Time-Matched Baseline | 91.55 mmHg | Standard Deviation 4.9 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Mean Arterial Pressure | Cycle Day 2 Change | -8.28 mmHg | Standard Deviation 6.54 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Mean Arterial Pressure | Time-Matched Baseline | 91.55 mmHg | Standard Deviation 4.9 |
Primary
Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Pulse
Daytime average is the average of ABPM assessments over 12 hours from the time of dosing. Time-matched baseline is the daytime average during the placebo cycle (Day 2). Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment). To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose are presented as the second row of data.
Time frame: Time-Matched Baseline (Placebo Cycle); Cycle Day 2
Population: PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Pulse | Time-Matched Baseline | 75.01 mmHg | Standard Deviation 11.95 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Pulse | Cycle Day 2 Change | 4.55 mmHg | Standard Deviation 4.43 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Pulse | Time-Matched Baseline | 75.01 mmHg | Standard Deviation 11.95 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Pulse | Cycle Day 2 Change | 4.14 mmHg | Standard Deviation 4.8 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Pulse | Time-Matched Baseline | 75.01 mmHg | Standard Deviation 11.95 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Pulse | Cycle Day 2 Change | 5.70 mmHg | Standard Deviation 6.22 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Pulse | Cycle Day 2 Change | 7.49 mmHg | Standard Deviation 3.88 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Pulse | Time-Matched Baseline | 75.78 mmHg | Standard Deviation 12.42 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Pulse | Time-Matched Baseline | 75.78 mmHg | Standard Deviation 12.42 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Pulse | Cycle Day 2 Change | 6.55 mmHg | Standard Deviation 7.3 |
Primary
Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Systolic Blood Pressure
Daytime average is the average of ABPM assessments over 12 hours from the time of dosing. Time-matched baseline is the daytime average during the placebo cycle (Day 2). Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose at given time point are presented as the second row of data.
Time frame: Time-Matched Baseline (Placebo Cycle); Cycle Day 2
Population: PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Systolic Blood Pressure | Time-Matched Baseline | 126.27 mmHg | Standard Deviation 8.62 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Systolic Blood Pressure | Cycle Day 2 Change | -4.42 mmHg | Standard Deviation 8.59 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Systolic Blood Pressure | Time-Matched Baseline | 126.27 mmHg | Standard Deviation 8.62 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Systolic Blood Pressure | Cycle Day 2 Change | -9.55 mmHg | Standard Deviation 9.98 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Systolic Blood Pressure | Time-Matched Baseline | 126.27 mmHg | Standard Deviation 8.62 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Systolic Blood Pressure | Cycle Day 2 Change | -8.22 mmHg | Standard Deviation 9.74 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Systolic Blood Pressure | Cycle Day 2 Change | -11.74 mmHg | Standard Deviation 10.71 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Systolic Blood Pressure | Time-Matched Baseline | 125.45 mmHg | Standard Deviation 8.72 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Systolic Blood Pressure | Time-Matched Baseline | 125.45 mmHg | Standard Deviation 8.72 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Systolic Blood Pressure | Cycle Day 2 Change | -13.05 mmHg | Standard Deviation 10.66 |
Primary
Change From Time-Matched Baseline (Placebo Cycle) Over Time in Ambulatory Blood Pressure Monitoring (ABPM) 4-Hour Averages of Systolic Blood Pressure
Four-hour average is the average of ABPM assessments over 4 hours intervals from the time of dosing. Time-matched baseline is the 4 hours average during the placebo cycle (Day 2). Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose at given time point are presented as the second row of data.
Time frame: Time-Matched Baseline (Placebo Cycle); Cycle Day 2: 0-4 hrs, 4-8 hrs, 8-12 hrs
Population: PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Ambulatory Blood Pressure Monitoring (ABPM) 4-Hour Averages of Systolic Blood Pressure | 0-4 hrs: Time Matched Baseline | 125.67 mmHg | Standard Deviation 10.39 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Ambulatory Blood Pressure Monitoring (ABPM) 4-Hour Averages of Systolic Blood Pressure | 0-4 hrs: Cycle Day 2 Change | -5.18 mmHg | Standard Deviation 5.7 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Ambulatory Blood Pressure Monitoring (ABPM) 4-Hour Averages of Systolic Blood Pressure | 4-8 hrs: Time Matched Baseline | 124.28 mmHg | Standard Deviation 8.07 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Ambulatory Blood Pressure Monitoring (ABPM) 4-Hour Averages of Systolic Blood Pressure | 4-8 hrs: Cycle Day 2 Change | -5.56 mmHg | Standard Deviation 10.61 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Ambulatory Blood Pressure Monitoring (ABPM) 4-Hour Averages of Systolic Blood Pressure | 8-12 hrs: Time Matched Baseline | 128.95 mmHg | Standard Deviation 9.99 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Ambulatory Blood Pressure Monitoring (ABPM) 4-Hour Averages of Systolic Blood Pressure | 8-12 hrs: Cycle Day 2 Change | -2.65 mmHg | Standard Deviation 12.85 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Ambulatory Blood Pressure Monitoring (ABPM) 4-Hour Averages of Systolic Blood Pressure | 8-12 hrs: Time Matched Baseline | 128.95 mmHg | Standard Deviation 9.99 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Ambulatory Blood Pressure Monitoring (ABPM) 4-Hour Averages of Systolic Blood Pressure | 8-12 hrs: Cycle Day 2 Change | -8.80 mmHg | Standard Deviation 14.91 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Ambulatory Blood Pressure Monitoring (ABPM) 4-Hour Averages of Systolic Blood Pressure | 0-4 hrs: Time Matched Baseline | 125.67 mmHg | Standard Deviation 10.39 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Ambulatory Blood Pressure Monitoring (ABPM) 4-Hour Averages of Systolic Blood Pressure | 4-8 hrs: Time Matched Baseline | 124.28 mmHg | Standard Deviation 8.07 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Ambulatory Blood Pressure Monitoring (ABPM) 4-Hour Averages of Systolic Blood Pressure | 4-8 hrs: Cycle Day 2 Change | -9.45 mmHg | Standard Deviation 9.68 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Ambulatory Blood Pressure Monitoring (ABPM) 4-Hour Averages of Systolic Blood Pressure | 0-4 hrs: Cycle Day 2 Change | -10.57 mmHg | Standard Deviation 8.67 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Ambulatory Blood Pressure Monitoring (ABPM) 4-Hour Averages of Systolic Blood Pressure | 4-8 hrs: Cycle Day 2 Change | -9.03 mmHg | Standard Deviation 12.55 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Ambulatory Blood Pressure Monitoring (ABPM) 4-Hour Averages of Systolic Blood Pressure | 8-12 hrs: Time Matched Baseline | 128.95 mmHg | Standard Deviation 9.99 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Ambulatory Blood Pressure Monitoring (ABPM) 4-Hour Averages of Systolic Blood Pressure | 0-4 hrs: Time Matched Baseline | 125.67 mmHg | Standard Deviation 10.39 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Ambulatory Blood Pressure Monitoring (ABPM) 4-Hour Averages of Systolic Blood Pressure | 4-8 hrs: Time Matched Baseline | 124.28 mmHg | Standard Deviation 8.07 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Ambulatory Blood Pressure Monitoring (ABPM) 4-Hour Averages of Systolic Blood Pressure | 0-4 hrs: Cycle Day 2 Change | -8.98 mmHg | Standard Deviation 9.08 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Ambulatory Blood Pressure Monitoring (ABPM) 4-Hour Averages of Systolic Blood Pressure | 8-12 hrs: Cycle Day 2 Change | -6.81 mmHg | Standard Deviation 10.27 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Ambulatory Blood Pressure Monitoring (ABPM) 4-Hour Averages of Systolic Blood Pressure | 4-8 hrs: Cycle Day 2 Change | -13.26 mmHg | Standard Deviation 11.78 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Ambulatory Blood Pressure Monitoring (ABPM) 4-Hour Averages of Systolic Blood Pressure | 0-4 hrs: Cycle Day 2 Change | -11.57 mmHg | Standard Deviation 11 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Ambulatory Blood Pressure Monitoring (ABPM) 4-Hour Averages of Systolic Blood Pressure | 4-8 hrs: Time Matched Baseline | 123.32 mmHg | Standard Deviation 7.94 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Ambulatory Blood Pressure Monitoring (ABPM) 4-Hour Averages of Systolic Blood Pressure | 8-12 hrs: Cycle Day 2 Change | -10.51 mmHg | Standard Deviation 12.34 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Ambulatory Blood Pressure Monitoring (ABPM) 4-Hour Averages of Systolic Blood Pressure | 8-12 hrs: Time Matched Baseline | 127.42 mmHg | Standard Deviation 9.26 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Ambulatory Blood Pressure Monitoring (ABPM) 4-Hour Averages of Systolic Blood Pressure | 0-4 hrs: Time Matched Baseline | 125.72 mmHg | Standard Deviation 11.02 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Ambulatory Blood Pressure Monitoring (ABPM) 4-Hour Averages of Systolic Blood Pressure | 8-12 hrs: Time Matched Baseline | 127.42 mmHg | Standard Deviation 9.26 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Ambulatory Blood Pressure Monitoring (ABPM) 4-Hour Averages of Systolic Blood Pressure | 4-8 hrs: Time Matched Baseline | 123.32 mmHg | Standard Deviation 7.94 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Ambulatory Blood Pressure Monitoring (ABPM) 4-Hour Averages of Systolic Blood Pressure | 0-4 hrs: Cycle Day 2 Change | -13.15 mmHg | Standard Deviation 12.59 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Ambulatory Blood Pressure Monitoring (ABPM) 4-Hour Averages of Systolic Blood Pressure | 8-12 hrs: Cycle Day 2 Change | -11.93 mmHg | Standard Deviation 13.47 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Ambulatory Blood Pressure Monitoring (ABPM) 4-Hour Averages of Systolic Blood Pressure | 4-8 hrs: Cycle Day 2 Change | -14.18 mmHg | Standard Deviation 10.07 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Ambulatory Blood Pressure Monitoring (ABPM) 4-Hour Averages of Systolic Blood Pressure | 0-4 hrs: Time Matched Baseline | 125.72 mmHg | Standard Deviation 11.02 |
Primary
Change From Time-Matched Baseline (Placebo Cycle) Over Time in Endothelial Function: RHI
Time-matched baseline for each timepoint is defined as the corresponding assessment during the placebo cycle. Endothelial function was assessed by RHI value determined using the noninvasive EndoPAT™ (Itamar Medical; Caesarea, Israel) device. RHI is a validated measure of endothelial function, with a higher RHI indicating better endothelial function compared to a lower value. The full EndoPAT 2000 user manual (software version 3.7.x) recommends using RHI values \>1.67 as a cutoff for normal endothelial function, with values ≤1.67 indicating endothelial dysfunction. Baseline is designated per protocol as Day 3 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 3 of each IW-1973 dose at given time point are presented as the second row of data.
Time frame: Time-matched Baseline (Placebo Cycle); Cycle Day 3: 0 h, 4 h, 12 h
Population: PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Endothelial Function: RHI | Time-Matched Baseline, 0 h | 2.13 units on a scale | Standard Deviation 0.57 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Endothelial Function: RHI | Change at Cycle Day 3, 0 h | -0.07 units on a scale | Standard Deviation 0.74 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Endothelial Function: RHI | Time-Matched Baseline, 4 h | 1.82 units on a scale | Standard Deviation 0.26 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Endothelial Function: RHI | Change at Cycle Day 3, 4 h | 0.47 units on a scale | Standard Deviation 1.02 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Endothelial Function: RHI | Time-Matched Baseline, 12 h | 2.18 units on a scale | Standard Deviation 0.48 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Endothelial Function: RHI | Change at Cycle Day 3, 12 h | 0.36 units on a scale | Standard Deviation 0.77 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Endothelial Function: RHI | Time-Matched Baseline, 12 h | 2.18 units on a scale | Standard Deviation 0.48 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Endothelial Function: RHI | Change at Cycle Day 3, 12 h | 0.32 units on a scale | Standard Deviation 0.39 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Endothelial Function: RHI | Time-Matched Baseline, 0 h | 2.15 units on a scale | Standard Deviation 0.6 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Endothelial Function: RHI | Time-Matched Baseline, 4 h | 1.82 units on a scale | Standard Deviation 0.26 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Endothelial Function: RHI | Change at Cycle Day 3, 4 h | 0.40 units on a scale | Standard Deviation 0.5 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Endothelial Function: RHI | Change at Cycle Day 3, 0 h | 0 units on a scale | Standard Deviation 0.87 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Endothelial Function: RHI | Change at Cycle Day 3, 4 h | 0.25 units on a scale | Standard Deviation 0.6 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Endothelial Function: RHI | Time-Matched Baseline, 12 h | 2.16 units on a scale | Standard Deviation 0.51 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Endothelial Function: RHI | Time-Matched Baseline, 0 h | 2.24 units on a scale | Standard Deviation 0.49 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Endothelial Function: RHI | Time-Matched Baseline, 4 h | 1.82 units on a scale | Standard Deviation 0.27 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Endothelial Function: RHI | Change at Cycle Day 3, 0 h | 0.28 units on a scale | Standard Deviation 0.64 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Endothelial Function: RHI | Change at Cycle Day 3, 12 h | 0.20 units on a scale | Standard Deviation 0.54 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Endothelial Function: RHI | Change at Cycle Day 3, 4 h | 0.26 units on a scale | Standard Deviation 0.67 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Endothelial Function: RHI | Change at Cycle Day 3, 0 h | 0.19 units on a scale | Standard Deviation 0.39 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Endothelial Function: RHI | Time-Matched Baseline, 4 h | 1.84 units on a scale | Standard Deviation 0.27 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Endothelial Function: RHI | Change at Cycle Day 3, 12 h | 0.32 units on a scale | Standard Deviation 0.66 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Endothelial Function: RHI | Time-Matched Baseline, 12 h | 2.12 units on a scale | Standard Deviation 0.51 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Endothelial Function: RHI | Time-Matched Baseline, 0 h | 2.28 units on a scale | Standard Deviation 0.5 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Endothelial Function: RHI | Time-Matched Baseline, 12 h | 2.12 units on a scale | Standard Deviation 0.51 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Endothelial Function: RHI | Time-Matched Baseline, 4 h | 1.84 units on a scale | Standard Deviation 0.27 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Endothelial Function: RHI | Change at Cycle Day 3, 0 h | -0.09 units on a scale | Standard Deviation 1.01 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Endothelial Function: RHI | Change at Cycle Day 3, 12 h | 0.53 units on a scale | Standard Deviation 0.68 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Endothelial Function: RHI | Change at Cycle Day 3, 4 h | 0.37 units on a scale | Standard Deviation 0.75 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Endothelial Function: RHI | Time-Matched Baseline, 0 h | 2.28 units on a scale | Standard Deviation 0.5 |
Primary
Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure
Time-matched baseline for each timepoint is defined as the corresponding assessment during the placebo cycle. Baseline is designated per protocol as Day 1 or 3 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 1 or 3 of each IW-1973 dose at given time point are presented as the second row of data.
Time frame: Time-Matched Baseline (Placebo Cycle); Cycle Day 1, 0 h; Cycle Day 1, 1 h; Cycle Day 1, 2 h; Cycle Day 1, 4 h; Cycle Day 1, 8 h; Cycle Day 1, 12 h; Cycle Day 3, 0 h; Cycle Day 3, 1 h; Cycle Day 3, 2 h; Cycle Day 3, 8 h
Population: PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 12 h | -2.1 mmHg | Standard Deviation 7.2 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 1 h | -3.3 mmHg | Standard Deviation 4.6 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 2 h) | 72.0 mmHg | Standard Deviation 5.5 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 8 h | -1.5 mmHg | Standard Deviation 5.5 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 0 h | -1.1 mmHg | Standard Deviation 6.2 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 2 h | -5.1 mmHg | Standard Deviation 4 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 1 h) | 73.5 mmHg | Standard Deviation 8 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 1 h) | 72.7 mmHg | Standard Deviation 6.1 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 2 h | -2.5 mmHg | Standard Deviation 6 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 0 h) | 77.1 mmHg | Standard Deviation 5.3 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 12 h) | 73.8 mmHg | Standard Deviation 7.7 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 2 h) | 75.6 mmHg | Standard Deviation 6.3 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 0 h | 2.0 mmHg | Standard Deviation 4.4 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 4 h) | 72.2 mmHg | Standard Deviation 6.1 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 1 h | -1.1 mmHg | Standard Deviation 6.5 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 8 h) | 73.2 mmHg | Standard Deviation 7.3 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 8 h | 0.5 mmHg | Standard Deviation 9.9 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 0 h) | 75.7 mmHg | Standard Deviation 4.3 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 4 h | 0 mmHg | Standard Deviation 7 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 8 h) | 72.8 mmHg | Standard Deviation 6.5 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 4 h | -1.9 mmHg | Standard Deviation 6.1 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 12 h | -3.2 mmHg | Standard Deviation 10.7 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 8 h) | 73.2 mmHg | Standard Deviation 7.3 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 8 h | -4.3 mmHg | Standard Deviation 8.4 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 0 h | -3.6 mmHg | Standard Deviation 3.7 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 2 h | -8.0 mmHg | Standard Deviation 6.4 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 2 h) | 75.6 mmHg | Standard Deviation 6.3 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 1 h | -5.6 mmHg | Standard Deviation 7.4 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 0 h) | 77.1 mmHg | Standard Deviation 5.3 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 1 h | -6.5 mmHg | Standard Deviation 6 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 2 h) | 72.0 mmHg | Standard Deviation 5.5 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 1 h) | 73.5 mmHg | Standard Deviation 8 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 8 h | -3.6 mmHg | Standard Deviation 4 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 1 h) | 72.7 mmHg | Standard Deviation 6.1 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 12 h) | 73.8 mmHg | Standard Deviation 7.7 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 2 h | -4.5 mmHg | Standard Deviation 5.4 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 0 h | -1.0 mmHg | Standard Deviation 4.8 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 4 h) | 72.2 mmHg | Standard Deviation 6.1 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 8 h) | 72.8 mmHg | Standard Deviation 6.5 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 0 h) | 75.7 mmHg | Standard Deviation 4.3 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 2 h | -8.3 mmHg | Standard Deviation 4.7 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 0 h) | 77.0 mmHg | Standard Deviation 5.6 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 0 h | -3.5 mmHg | Standard Deviation 4.4 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 1 h) | 74.1 mmHg | Standard Deviation 8.2 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 1 h | -7.5 mmHg | Standard Deviation 7.3 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 2 h) | 71.9 mmHg | Standard Deviation 5.8 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 4 h) | 72.5 mmHg | Standard Deviation 6.4 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 4 h | -4.3 mmHg | Standard Deviation 6.6 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 8 h) | 71.9 mmHg | Standard Deviation 6.2 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 8 h | -2.1 mmHg | Standard Deviation 7.9 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 12 h) | 72.9 mmHg | Standard Deviation 7.4 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 12 h | -3.3 mmHg | Standard Deviation 6.8 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 0 h) | 76.1 mmHg | Standard Deviation 4.4 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 0 h | -3.2 mmHg | Standard Deviation 4.6 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 1 h) | 72.9 mmHg | Standard Deviation 6.3 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 1 h | -6.6 mmHg | Standard Deviation 5.9 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 2 h) | 75.3 mmHg | Standard Deviation 6.7 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 2 h | -7.0 mmHg | Standard Deviation 6.2 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 8 h) | 73.0 mmHg | Standard Deviation 6.8 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 8 h | -4.8 mmHg | Standard Deviation 5.3 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 0 h) | 75.7 mmHg | Standard Deviation 3.8 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 4 h) | 71.0 mmHg | Standard Deviation 4.5 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 8 h | -5.7 mmHg | Standard Deviation 3.9 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 0 h) | 75.7 mmHg | Standard Deviation 4.4 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 2 h | -4.9 mmHg | Standard Deviation 6.8 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 8 h) | 73.0 mmHg | Standard Deviation 6.8 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 0 h | -4.9 mmHg | Standard Deviation 3.3 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 2 h) | 71.4 mmHg | Standard Deviation 5.9 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 1 h) | 72.6 mmHg | Standard Deviation 6.6 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 1 h | -5.2 mmHg | Standard Deviation 5.3 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 2 h | -8.5 mmHg | Standard Deviation 4.9 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 1 h | -7.7 mmHg | Standard Deviation 7.3 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 1 h) | 72.1 mmHg | Standard Deviation 5.6 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 2 h) | 75.4 mmHg | Standard Deviation 7.1 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 0 h | -3.8 mmHg | Standard Deviation 2.5 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 8 h | -1.1 mmHg | Standard Deviation 10.6 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 8 h) | 70.9 mmHg | Standard Deviation 5.7 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 12 h) | 71.3 mmHg | Standard Deviation 5.9 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 4 h | -4.8 mmHg | Standard Deviation 6 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 12 h | -3.0 mmHg | Standard Deviation 5.4 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 4 h | -3.6 mmHg | Standard Deviation 3.3 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 12 h | -4.1 mmHg | Standard Deviation 5.6 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 4 h) | 71.0 mmHg | Standard Deviation 4.5 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 1 h) | 72.1 mmHg | Standard Deviation 5.6 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 8 h | -6.0 mmHg | Standard Deviation 6.2 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 1 h | -7.6 mmHg | Standard Deviation 5.5 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 0 h) | 75.7 mmHg | Standard Deviation 4.4 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 2 h | -6.6 mmHg | Standard Deviation 5.7 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 12 h) | 71.3 mmHg | Standard Deviation 5.9 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 2 h) | 75.4 mmHg | Standard Deviation 7.1 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 0 h | -3.3 mmHg | Standard Deviation 4.9 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 0 h | -2.8 mmHg | Standard Deviation 6.3 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 2 h) | 71.4 mmHg | Standard Deviation 5.9 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 0 h) | 75.7 mmHg | Standard Deviation 3.8 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 8 h) | 73.0 mmHg | Standard Deviation 6.8 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 8 h | -4.2 mmHg | Standard Deviation 5.5 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 1 h) | 72.6 mmHg | Standard Deviation 6.6 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 1, 1 h | -7.6 mmHg | Standard Deviation 5.8 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 8 h) | 70.9 mmHg | Standard Deviation 5.7 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure | Change at Cycle Day 3, 2 h | -13.3 mmHg | Standard Deviation 5.1 |
Primary
Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse
Time-matched baseline for each timepoint is defined as the corresponding assessment during the placebo cycle. Baseline is designated per protocol as Day 1 or 3 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 1 or 3 of each IW-1973 dose at given time point are presented as the second row of data.
Time frame: Time-Matched Baseline (Placebo Cycle); Cycle Day 1, 0 h; Cycle Day 1, 1 h; Cycle Day 1, 2 h; Cycle Day 1, 4 h; Cycle Day 1, 8 h; Cycle Day 1, 12 h; Cycle Day 3, 0 h; Cycle Day 3, 1 h; Cycle Day 3, 2 h; Cycle Day 3, 8 h
Population: PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 1, 8 h) | 68.8 bpm | Standard Deviation 10.9 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 1, 0 h) | 66.5 bpm | Standard Deviation 10.8 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 3, 2 h) | 73.8 bpm | Standard Deviation 15 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 3, 1 h | 5.7 bpm | Standard Deviation 8.6 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 1, 2 h) | 70.2 bpm | Standard Deviation 11.7 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 1, 12 h | 6.4 bpm | Standard Deviation 6.3 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 1, 0 h | -1.1 bpm | Standard Deviation 5.5 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 3, 8 h) | 71.0 bpm | Standard Deviation 12.9 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 3, 1 h) | 70.2 bpm | Standard Deviation 13.6 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 1, 2 h | 5.2 bpm | Standard Deviation 4.3 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 1, 1 h) | 71.9 bpm | Standard Deviation 12.6 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 1, 12 h) | 69.7 bpm | Standard Deviation 11.5 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 3, 2 h | 3.7 bpm | Standard Deviation 6.2 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 3, 0 h | -2.1 bpm | Standard Deviation 4.2 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 1, 4 h) | 68.5 bpm | Standard Deviation 10.4 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 3, 8 h | 1.6 bpm | Standard Deviation 5.9 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 1, 8 h | 5.3 bpm | Standard Deviation 6.3 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 1, 1 h | -1.8 bpm | Standard Deviation 3.2 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 3, 0 h) | 67.9 bpm | Standard Deviation 11.9 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 1, 4 h | 1.3 bpm | Standard Deviation 6.2 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 1, 1 h | 1.8 bpm | Standard Deviation 5 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 1, 12 h) | 69.7 bpm | Standard Deviation 11.5 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 1, 8 h) | 68.8 bpm | Standard Deviation 10.9 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 1, 8 h | 4.0 bpm | Standard Deviation 3.8 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 1, 0 h | -0.4 bpm | Standard Deviation 5.2 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 3, 1 h | 7.4 bpm | Standard Deviation 9.9 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 3, 8 h) | 71.0 bpm | Standard Deviation 12.9 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 1, 1 h) | 71.9 bpm | Standard Deviation 12.6 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 3, 2 h | 5.1 bpm | Standard Deviation 6.2 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 3, 2 h) | 73.8 bpm | Standard Deviation 15 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 1, 4 h | 5.2 bpm | Standard Deviation 7.7 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 1, 2 h) | 70.2 bpm | Standard Deviation 11.7 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 1, 0 h) | 66.5 bpm | Standard Deviation 10.8 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 3, 1 h) | 70.2 bpm | Standard Deviation 13.6 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 1, 2 h | 8.1 bpm | Standard Deviation 6.7 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 1, 12 h | 5.2 bpm | Standard Deviation 5.9 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 3, 0 h | -1.0 bpm | Standard Deviation 6.4 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 1, 4 h) | 68.5 bpm | Standard Deviation 10.4 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 3, 8 h | -0.6 bpm | Standard Deviation 8.4 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 3, 0 h) | 67.9 bpm | Standard Deviation 11.9 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 1, 8 h | 2.7 bpm | Standard Deviation 4.8 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 1, 0 h) | 66.7 bpm | Standard Deviation 11.3 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 1, 0 h | -1.2 bpm | Standard Deviation 5.7 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 1, 1 h) | 72.6 bpm | Standard Deviation 13 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 1, 1 h | 5.8 bpm | Standard Deviation 4.7 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 1, 2 h) | 70.8 bpm | Standard Deviation 12.2 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 1, 2 h | 13.8 bpm | Standard Deviation 7.2 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 1, 4 h) | 68.3 bpm | Standard Deviation 10.9 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 1, 4 h | 5.1 bpm | Standard Deviation 7.5 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 1, 8 h) | 68.6 bpm | Standard Deviation 11.5 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 1, 12 h) | 70.0 bpm | Standard Deviation 12.1 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 1, 12 h | 2.7 bpm | Standard Deviation 4 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 3, 0 h) | 66.6 bpm | Standard Deviation 11.7 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 3, 0 h | 0.7 bpm | Standard Deviation 6.1 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 3, 1 h) | 70.6 bpm | Standard Deviation 14.3 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 3, 1 h | 8.2 bpm | Standard Deviation 5.4 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 3, 2 h) | 74.2 bpm | Standard Deviation 15.9 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 3, 2 h | 8.0 bpm | Standard Deviation 6.3 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 3, 8 h) | 69.8 bpm | Standard Deviation 14.1 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 3, 8 h | -0.6 bpm | Standard Deviation 5.2 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 1, 12 h | 6.2 bpm | Standard Deviation 7.3 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 1, 4 h) | 68.4 bpm | Standard Deviation 11.6 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 3, 8 h | 2.1 bpm | Standard Deviation 6.5 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 3, 0 h) | 67.1 bpm | Standard Deviation 12.3 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 1, 2 h | 15.3 bpm | Standard Deviation 7.2 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 3, 8 h) | 70.8 bpm | Standard Deviation 14.1 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 3, 0 h | -0.7 bpm | Standard Deviation 2.9 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 1, 2 h) | 71.8 bpm | Standard Deviation 12.5 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 3, 1 h) | 71.2 bpm | Standard Deviation 15 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 3, 1 h | 10.8 bpm | Standard Deviation 6.9 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 1, 1 h | 0.8 bpm | Standard Deviation 4.5 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 1, 0 h) | 67.0 bpm | Standard Deviation 12 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 3, 2 h) | 75.6 bpm | Standard Deviation 16.4 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 1, 1 h) | 73.4 bpm | Standard Deviation 13.5 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 3, 2 h | 10.3 bpm | Standard Deviation 6.9 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 1, 8 h | 2.7 bpm | Standard Deviation 5.8 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 1, 8 h) | 68.9 bpm | Standard Deviation 12.1 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 1, 12 h) | 70.2 bpm | Standard Deviation 12.8 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 1, 4 h | 8.4 bpm | Standard Deviation 6.8 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 1, 0 h | 1.3 bpm | Standard Deviation 7 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 3, 1 h | 12.0 bpm | Standard Deviation 6.4 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 1, 12 h | 3.8 bpm | Standard Deviation 5.2 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 1, 4 h) | 68.4 bpm | Standard Deviation 11.6 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 1, 8 h) | 68.9 bpm | Standard Deviation 12.1 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 1, 1 h) | 73.4 bpm | Standard Deviation 13.5 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 1, 0 h | -0.1 bpm | Standard Deviation 8.4 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 3, 0 h) | 67.1 bpm | Standard Deviation 12.3 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 1, 2 h | 10.4 bpm | Standard Deviation 5.8 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 1, 8 h | 4.1 bpm | Standard Deviation 4.9 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 3, 2 h) | 75.6 bpm | Standard Deviation 16.4 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 1, 12 h) | 70.2 bpm | Standard Deviation 12.8 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 3, 0 h | -0.2 bpm | Standard Deviation 3.8 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 1, 2 h) | 71.8 bpm | Standard Deviation 12.5 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 3, 8 h | 6.7 bpm | Standard Deviation 14.4 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 3, 8 h) | 70.8 bpm | Standard Deviation 14.1 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 1, 4 h | 5.0 bpm | Standard Deviation 4.5 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 3, 1 h) | 71.2 bpm | Standard Deviation 15 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 1, 1 h | 4.6 bpm | Standard Deviation 4.3 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Time Matched Baseline (Cycle Day 1, 0 h) | 67.0 bpm | Standard Deviation 12 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse | Change at Cycle Day 3, 2 h | 10.4 bpm | Standard Deviation 8.3 |
Primary
Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure
Time-matched baseline for each timepoint is defined as the corresponding assessment during the placebo cycle. Baseline is designated per protocol as Day 1 or 3 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 1 or 3 of each IW-1973 dose at given time point are presented as the second row of data.
Time frame: Time-Matched Baseline (Placebo Cycle); Cycle Day 1, 0 h; Cycle Day 1, 1 h; Cycle Day 1, 2 h; Cycle Day 1, 4 h; Cycle Day 1, 8 h; Cycle Day 1, 12 h; Cycle Day 3, 0 h; Cycle Day 3, 1 h; Cycle Day 3, 2 h; Cycle Day 3, 8 h
Population: PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 12 h) | 121.9 mmHg | Standard Deviation 10.7 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 2 h) | 119.0 mmHg | Standard Deviation 8.8 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 1 h) | 121.5 mmHg | Standard Deviation 11.3 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 8 h | -1.1 mmHg | Standard Deviation 12.8 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 1 h | -6.0 mmHg | Standard Deviation 7.9 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 0 h) | 127.4 mmHg | Standard Deviation 9.1 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 2 h | -5.3 mmHg | Standard Deviation 11.4 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 2 h | -5.5 mmHg | Standard Deviation 6.8 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 0 h | -0.9 mmHg | Standard Deviation 14 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 1 h) | 120.2 mmHg | Standard Deviation 12.6 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 8 h) | 119.6 mmHg | Standard Deviation 9.9 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 4 h) | 122.7 mmHg | Standard Deviation 6.4 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 1 h | -3.3 mmHg | Standard Deviation 12.1 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 12 h | -1.2 mmHg | Standard Deviation 13.7 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 0 h | 0.3 mmHg | Standard Deviation 11.3 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 8 h) | 120.9 mmHg | Standard Deviation 12 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 4 h | -4.8 mmHg | Standard Deviation 8.8 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 2 h) | 119.2 mmHg | Standard Deviation 10.8 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 8 h | -5.1 mmHg | Standard Deviation 10.3 |
| Control | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 0 h) | 123.0 mmHg | Standard Deviation 11.4 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 1 h | -8.8 mmHg | Standard Deviation 10.4 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 8 h) | 119.6 mmHg | Standard Deviation 9.9 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 0 h) | 127.4 mmHg | Standard Deviation 9.1 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 12 h) | 121.9 mmHg | Standard Deviation 10.7 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 8 h | -8.6 mmHg | Standard Deviation 11.1 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 2 h | -10.4 mmHg | Standard Deviation 6 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 1 h) | 121.5 mmHg | Standard Deviation 11.3 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 2 h) | 119.2 mmHg | Standard Deviation 10.8 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 1 h | -10.8 mmHg | Standard Deviation 11.1 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 8 h | -8.1 mmHg | Standard Deviation 9.2 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 12 h | -9.5 mmHg | Standard Deviation 9.8 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 2 h) | 119.0 mmHg | Standard Deviation 8.8 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 8 h) | 120.9 mmHg | Standard Deviation 12 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 1 h) | 120.2 mmHg | Standard Deviation 12.6 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 2 h | -10.3 mmHg | Standard Deviation 11.4 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 0 h | -5.0 mmHg | Standard Deviation 12.2 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 4 h) | 122.7 mmHg | Standard Deviation 6.4 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 0 h | -9.8 mmHg | Standard Deviation 9.9 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 0 h) | 123.0 mmHg | Standard Deviation 11.4 |
| 10 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 4 h | -10.8 mmHg | Standard Deviation 11.3 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 4 h | -11.8 mmHg | Standard Deviation 11.6 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 0 h) | 126.3 mmHg | Standard Deviation 8.9 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 0 h | -8.5 mmHg | Standard Deviation 7.9 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 1 h) | 121.2 mmHg | Standard Deviation 11.8 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 1 h | -11.3 mmHg | Standard Deviation 10.6 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 2 h) | 117.6 mmHg | Standard Deviation 7.9 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 2 h | -11.6 mmHg | Standard Deviation 7.5 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 4 h) | 121.8 mmHg | Standard Deviation 5.9 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 8 h) | 117.3 mmHg | Standard Deviation 6.5 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 8 h | -5.1 mmHg | Standard Deviation 11.4 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 12 h) | 120.7 mmHg | Standard Deviation 10.4 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 12 h | -7.7 mmHg | Standard Deviation 10.7 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 0 h) | 124.0 mmHg | Standard Deviation 11.5 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 0 h | -8.6 mmHg | Standard Deviation 10.8 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 1 h) | 121.0 mmHg | Standard Deviation 12.9 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 1 h | -13.4 mmHg | Standard Deviation 11.3 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 2 h) | 119.4 mmHg | Standard Deviation 11.5 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 2 h | -13.9 mmHg | Standard Deviation 5 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 8 h) | 120.6 mmHg | Standard Deviation 13.2 |
| 20 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 8 h | -12.1 mmHg | Standard Deviation 10.6 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 0 h | -7.3 mmHg | Standard Deviation 7.4 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 4 h | -14.8 mmHg | Standard Deviation 10.4 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 0 h) | 124.3 mmHg | Standard Deviation 12.1 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 4 h) | 120.7 mmHg | Standard Deviation 4.9 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 8 h | -14.1 mmHg | Standard Deviation 10.4 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 0 h | -8.3 mmHg | Standard Deviation 10.2 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 2 h | -10.9 mmHg | Standard Deviation 8.1 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 8 h) | 122.1 mmHg | Standard Deviation 13.1 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 1 h) | 121.3 mmHg | Standard Deviation 13.7 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 2 h) | 117.2 mmHg | Standard Deviation 8.3 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 1 h | -13.1 mmHg | Standard Deviation 15.7 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 1 h | -9.7 mmHg | Standard Deviation 11.4 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 0 h) | 125.2 mmHg | Standard Deviation 8.7 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 2 h) | 120.4 mmHg | Standard Deviation 11.9 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 1 h) | 119.7 mmHg | Standard Deviation 11.5 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 2 h | -16.3 mmHg | Standard Deviation 9.5 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 8 h | -7.9 mmHg | Standard Deviation 11.4 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 12 h) | 119.0 mmHg | Standard Deviation 9.5 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 8 h) | 116.4 mmHg | Standard Deviation 6.3 |
| 30 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 12 h | -8.4 mmHg | Standard Deviation 9.2 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 4 h | -13.1 mmHg | Standard Deviation 10.4 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 12 h | -9.6 mmHg | Standard Deviation 12.5 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 8 h | -14.1 mmHg | Standard Deviation 9.3 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 4 h) | 120.7 mmHg | Standard Deviation 4.9 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 0 h) | 125.2 mmHg | Standard Deviation 8.7 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 1 h) | 119.7 mmHg | Standard Deviation 11.5 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 0 h) | 124.3 mmHg | Standard Deviation 12.1 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 8 h) | 116.4 mmHg | Standard Deviation 6.3 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 2 h | -11.6 mmHg | Standard Deviation 6.8 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 2 h | -14.8 mmHg | Standard Deviation 4.7 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 2 h) | 120.4 mmHg | Standard Deviation 11.9 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 0 h | -10.2 mmHg | Standard Deviation 16.6 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 1 h | -14.1 mmHg | Standard Deviation 10.6 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 2 h) | 117.2 mmHg | Standard Deviation 8.3 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 0 h | -8.4 mmHg | Standard Deviation 11.8 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 3, 8 h | -9.8 mmHg | Standard Deviation 13.9 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 1 h) | 121.3 mmHg | Standard Deviation 13.7 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 1, 12 h) | 119.0 mmHg | Standard Deviation 9.5 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Change at Cycle Day 1, 1 h | -14.0 mmHg | Standard Deviation 11.5 |
| 40 mg IW-1973 | Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure | Time Matched Baseline (Cycle Day 3, 8 h) | 122.1 mmHg | Standard Deviation 13.1 |
Primary
Number of Participants With Clinically Significant Findings or Shifts in Baseline in Electrocardiograms (ECGs)
Time frame: Study Baseline, Cycle Day 1: 0 (≤ 15m) predose; 1h, 4h (± 15m) postdose; Day 19
Population: Safety Population: all participants who received ≥1 dose of study drug, grouped according to actual study drug taken.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participants With Clinically Significant Findings or Shifts in Baseline in Electrocardiograms (ECGs) | 0 Participants |
Primary
Number of Participants With Clinically Significant Findings or Shifts in Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF)
Time frame: Study Baseline, Cycle Day 1: 0 (≤ 15m) predose; 1h, 4h (± 15m) postdose; Day 19
Population: Safety Population: all participants who received ≥1 dose of study drug, grouped according to actual study drug taken.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participants With Clinically Significant Findings or Shifts in Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) | 0 Participants |
| 10 mg IW-1973 | Number of Participants With Clinically Significant Findings or Shifts in Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) | 0 Participants |
| 20 mg IW-1973 | Number of Participants With Clinically Significant Findings or Shifts in Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) | 0 Participants |
| 30 mg IW-1973 | Number of Participants With Clinically Significant Findings or Shifts in Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) | 0 Participants |
| 40 mg IW-1973 | Number of Participants With Clinically Significant Findings or Shifts in Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) | 0 Participants |
| 50 mg IW-1973 | Number of Participants With Clinically Significant Findings or Shifts in Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) | 0 Participants |
Primary
Number of Participants With Notable Changes in Post Baseline Vital Signs Values
Supine systolic blood pressure (SSBP): ≥ 180 mmHg and increase (↑) from baseline (BL) ≥ 30 mmHg; ≤ 90 mmHg and decrease (↓) from BL ≥ 30 mmHg. Supine Diastolic Blood Pressure (SDBP): ≥ 105 mmHg and ↑ from BL ≥ 20 mmHg; ≤ 50 mmHg and ↓ from BL ≥ 20 mmHg. Supine pulse rate (SPR): ≥ 110 beats per minute (bpm) and ↑ from BL ≥ 20 bpm; ≤ 50 bpm and ↓ from BL ≥ 20 bpm. Standing systolic blood pressure (StSBP): ≥ 180 mmHg and increase (↑) from baseline (BL) ≥ 30 mmHg; ≤ 90 mmHg and decrease (↓) from BL ≥ 30 mmHg. Standing Diastolic Blood Pressure (StDBP): ≥ 105 mmHg and ↑ from BL ≥ 20 mmHg; ≤ 50 mmHg and ↓ from BL ≥ 20 mmHg. Standing pulse rate (StPR): ≥ 110 beats per minute (bpm) and ↑ from BL ≥ 20 bpm; ≤ 50 bpm and ↓ from BL ≥ 20 bpm.
Time frame: Up to Day 32
Population: PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StSBP: ≥ 180 mmHg and ↑ from BL ≥ 30 mmHg | 0 Participants |
| Control | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SPR: ≥ 110 bpm and ↑ from BL | 0 Participants |
| Control | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SPR: ≤ 50 bpm and ↓ from BL ≥ 20 bpm | 0 Participants |
| Control | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StPR: ≤ 50 bpm and ↓ from BL ≥ 20 bpm | 0 Participants |
| Control | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StPR: ≥ 120 bpm and ↑ from BL | 0 Participants |
| Control | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SSBP: ≤ 90 mmHg and ↓ from BL ≥ 30 mmHg | 0 Participants |
| Control | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SSBP: ≥ 180 mmHg and ↑ from BL ≥ 30 mmHg | 0 Participants |
| Control | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StDBP: ≤ 50 mmHg and ↓ from BL ≥ 20 mmHg | 0 Participants |
| Control | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SDBP: ≥ 105 mmHg and ↑ from BL ≥ 20 mmHg | 0 Participants |
| Control | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StDBP: ≥ 105 mmHg and ↑ from BL ≥ 20 mmHg | 0 Participants |
| Control | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StSBP: ≤ 90 mmHg and ↓ from BL ≥ 30 mmHg | 0 Participants |
| Control | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SDBP: ≤ 50 mmHg and ↓ from BL ≥ 20 mmHg | 0 Participants |
| 10 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SPR: ≤ 50 bpm and ↓ from BL ≥ 20 bpm | 0 Participants |
| 10 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StDBP: ≥ 105 mmHg and ↑ from BL ≥ 20 mmHg | 0 Participants |
| 10 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SPR: ≥ 110 bpm and ↑ from BL | 0 Participants |
| 10 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SDBP: ≥ 105 mmHg and ↑ from BL ≥ 20 mmHg | 0 Participants |
| 10 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SDBP: ≤ 50 mmHg and ↓ from BL ≥ 20 mmHg | 0 Participants |
| 10 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SSBP: ≥ 180 mmHg and ↑ from BL ≥ 30 mmHg | 0 Participants |
| 10 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StPR: ≥ 120 bpm and ↑ from BL | 0 Participants |
| 10 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StPR: ≤ 50 bpm and ↓ from BL ≥ 20 bpm | 0 Participants |
| 10 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StSBP: ≤ 90 mmHg and ↓ from BL ≥ 30 mmHg | 0 Participants |
| 10 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SSBP: ≤ 90 mmHg and ↓ from BL ≥ 30 mmHg | 0 Participants |
| 10 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StSBP: ≥ 180 mmHg and ↑ from BL ≥ 30 mmHg | 0 Participants |
| 10 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StDBP: ≤ 50 mmHg and ↓ from BL ≥ 20 mmHg | 0 Participants |
| 20 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SPR: ≥ 110 bpm and ↑ from BL | 0 Participants |
| 20 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SSBP: ≥ 180 mmHg and ↑ from BL ≥ 30 mmHg | 0 Participants |
| 20 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SSBP: ≤ 90 mmHg and ↓ from BL ≥ 30 mmHg | 1 Participants |
| 20 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SDBP: ≥ 105 mmHg and ↑ from BL ≥ 20 mmHg | 0 Participants |
| 20 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SDBP: ≤ 50 mmHg and ↓ from BL ≥ 20 mmHg | 0 Participants |
| 20 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SPR: ≤ 50 bpm and ↓ from BL ≥ 20 bpm | 0 Participants |
| 20 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StSBP: ≥ 180 mmHg and ↑ from BL ≥ 30 mmHg | 0 Participants |
| 20 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StSBP: ≤ 90 mmHg and ↓ from BL ≥ 30 mmHg | 0 Participants |
| 20 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StDBP: ≥ 105 mmHg and ↑ from BL ≥ 20 mmHg | 0 Participants |
| 20 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StDBP: ≤ 50 mmHg and ↓ from BL ≥ 20 mmHg | 0 Participants |
| 20 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StPR: ≥ 120 bpm and ↑ from BL | 0 Participants |
| 20 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StPR: ≤ 50 bpm and ↓ from BL ≥ 20 bpm | 0 Participants |
| 30 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StSBP: ≥ 180 mmHg and ↑ from BL ≥ 30 mmHg | 0 Participants |
| 30 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SDBP: ≥ 105 mmHg and ↑ from BL ≥ 20 mmHg | 0 Participants |
| 30 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StSBP: ≤ 90 mmHg and ↓ from BL ≥ 30 mmHg | 0 Participants |
| 30 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SDBP: ≤ 50 mmHg and ↓ from BL ≥ 20 mmHg | 0 Participants |
| 30 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StDBP: ≥ 105 mmHg and ↑ from BL ≥ 20 mmHg | 0 Participants |
| 30 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SPR: ≥ 110 bpm and ↑ from BL | 0 Participants |
| 30 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StPR: ≤ 50 bpm and ↓ from BL ≥ 20 bpm | 0 Participants |
| 30 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StPR: ≥ 120 bpm and ↑ from BL | 0 Participants |
| 30 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SSBP: ≤ 90 mmHg and ↓ from BL ≥ 30 mmHg | 2 Participants |
| 30 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SPR: ≤ 50 bpm and ↓ from BL ≥ 20 bpm | 0 Participants |
| 30 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StDBP: ≤ 50 mmHg and ↓ from BL ≥ 20 mmHg | 0 Participants |
| 30 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SSBP: ≥ 180 mmHg and ↑ from BL ≥ 30 mmHg | 0 Participants |
| 40 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StDBP: ≤ 50 mmHg and ↓ from BL ≥ 20 mmHg | 0 Participants |
| 40 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SSBP: ≥ 180 mmHg and ↑ from BL ≥ 30 mmHg | 0 Participants |
| 40 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SPR: ≥ 110 bpm and ↑ from BL | 0 Participants |
| 40 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StSBP: ≤ 90 mmHg and ↓ from BL ≥ 30 mmHg | 1 Participants |
| 40 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StPR: ≥ 120 bpm and ↑ from BL | 0 Participants |
| 40 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SPR: ≤ 50 bpm and ↓ from BL ≥ 20 bpm | 0 Participants |
| 40 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StSBP: ≥ 180 mmHg and ↑ from BL ≥ 30 mmHg | 0 Participants |
| 40 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StDBP: ≥ 105 mmHg and ↑ from BL ≥ 20 mmHg | 0 Participants |
| 40 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SDBP: ≤ 50 mmHg and ↓ from BL ≥ 20 mmHg | 0 Participants |
| 40 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SSBP: ≤ 90 mmHg and ↓ from BL ≥ 30 mmHg | 0 Participants |
| 40 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StPR: ≤ 50 bpm and ↓ from BL ≥ 20 bpm | 0 Participants |
| 40 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SDBP: ≥ 105 mmHg and ↑ from BL ≥ 20 mmHg | 0 Participants |
| 50 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StDBP: ≥ 105 mmHg and ↑ from BL ≥ 20 mmHg | 0 Participants |
| 50 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StPR: ≥ 120 bpm and ↑ from BL | 0 Participants |
| 50 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StSBP: ≥ 180 mmHg and ↑ from BL ≥ 30 mmHg | 0 Participants |
| 50 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SDBP: ≥ 105 mmHg and ↑ from BL ≥ 20 mmHg | 0 Participants |
| 50 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StSBP: ≤ 90 mmHg and ↓ from BL ≥ 30 mmHg | 0 Participants |
| 50 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SSBP: ≤ 90 mmHg and ↓ from BL ≥ 30 mmHg | 0 Participants |
| 50 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StPR: ≤ 50 bpm and ↓ from BL ≥ 20 bpm | 0 Participants |
| 50 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SPR: ≤ 50 bpm and ↓ from BL ≥ 20 bpm | 0 Participants |
| 50 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | StDBP: ≤ 50 mmHg and ↓ from BL ≥ 20 mmHg | 0 Participants |
| 50 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SSBP: ≥ 180 mmHg and ↑ from BL ≥ 30 mmHg | 0 Participants |
| 50 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SPR: ≥ 110 bpm and ↑ from BL | 0 Participants |
| 50 mg IW-1973 | Number of Participants With Notable Changes in Post Baseline Vital Signs Values | SDBP: ≤ 50 mmHg and ↓ from BL ≥ 20 mmHg | 0 Participants |
Primary
Number of Participants With Notable Post Baseline Orthostatic Vital Signs Values
Systolic blood pressure (SBP): Decrease of \> 20 mmHg from supine to standing Diastolic blood pressure (DBP): Decrease of \> 10 mmHg from supine to standing Pulse rate (PR): Increase of \> 20 bpm from supine to standing.
Time frame: Up to Day 32
Population: PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Number of Participants With Notable Post Baseline Orthostatic Vital Signs Values | DBP: Decrease of > 10 mmHg from supine to standin | 0 Participants |
| Control | Number of Participants With Notable Post Baseline Orthostatic Vital Signs Values | SBP: Decrease of > 20 mmHg, supine to standing | 0 Participants |
| Control | Number of Participants With Notable Post Baseline Orthostatic Vital Signs Values | PR: Increase of > 20 bpm from supine to standing | 3 Participants |
| 10 mg IW-1973 | Number of Participants With Notable Post Baseline Orthostatic Vital Signs Values | DBP: Decrease of > 10 mmHg from supine to standin | 0 Participants |
| 10 mg IW-1973 | Number of Participants With Notable Post Baseline Orthostatic Vital Signs Values | SBP: Decrease of > 20 mmHg, supine to standing | 0 Participants |
| 10 mg IW-1973 | Number of Participants With Notable Post Baseline Orthostatic Vital Signs Values | PR: Increase of > 20 bpm from supine to standing | 4 Participants |
| 20 mg IW-1973 | Number of Participants With Notable Post Baseline Orthostatic Vital Signs Values | DBP: Decrease of > 10 mmHg from supine to standin | 1 Participants |
| 20 mg IW-1973 | Number of Participants With Notable Post Baseline Orthostatic Vital Signs Values | SBP: Decrease of > 20 mmHg, supine to standing | 0 Participants |
| 20 mg IW-1973 | Number of Participants With Notable Post Baseline Orthostatic Vital Signs Values | PR: Increase of > 20 bpm from supine to standing | 3 Participants |
| 30 mg IW-1973 | Number of Participants With Notable Post Baseline Orthostatic Vital Signs Values | DBP: Decrease of > 10 mmHg from supine to standin | 0 Participants |
| 30 mg IW-1973 | Number of Participants With Notable Post Baseline Orthostatic Vital Signs Values | SBP: Decrease of > 20 mmHg, supine to standing | 0 Participants |
| 30 mg IW-1973 | Number of Participants With Notable Post Baseline Orthostatic Vital Signs Values | PR: Increase of > 20 bpm from supine to standing | 5 Participants |
| 40 mg IW-1973 | Number of Participants With Notable Post Baseline Orthostatic Vital Signs Values | DBP: Decrease of > 10 mmHg from supine to standin | 1 Participants |
| 40 mg IW-1973 | Number of Participants With Notable Post Baseline Orthostatic Vital Signs Values | SBP: Decrease of > 20 mmHg, supine to standing | 0 Participants |
| 40 mg IW-1973 | Number of Participants With Notable Post Baseline Orthostatic Vital Signs Values | PR: Increase of > 20 bpm from supine to standing | 3 Participants |
| 50 mg IW-1973 | Number of Participants With Notable Post Baseline Orthostatic Vital Signs Values | SBP: Decrease of > 20 mmHg, supine to standing | 0 Participants |
| 50 mg IW-1973 | Number of Participants With Notable Post Baseline Orthostatic Vital Signs Values | PR: Increase of > 20 bpm from supine to standing | 3 Participants |
| 50 mg IW-1973 | Number of Participants With Notable Post Baseline Orthostatic Vital Signs Values | DBP: Decrease of > 10 mmHg from supine to standin | 0 Participants |
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to TEAEs
An adverse event (AE) is any untoward medical occurrence, which does not necessarily have to have a causal relationship with study treatment. An SAE is defined as any AE occurring at any dose that results in any of the following outcomes: death; life-threatening; hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; important medical events. TEAEs are defined as those AEs that started or worsened in severity after the initiation of study drug administration.
Time frame: From first dose of study drug through end of trial (Day 46 [±3 days])
Population: Safety Population: all participants who received ≥1 dose of study drug, grouped according to actual study drug taken.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to TEAEs | Discontinuations (DCs) due to AEs | 0 Participants |
| Control | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to TEAEs | SAE | 0 Participants |
| Control | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to TEAEs | ≥1 TEAE | 3 Participants |
| Control | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to TEAEs | DCs Due to Trough Blood Pressure Decline | 0 Participants |
| Control | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to TEAEs | Deaths | 0 Participants |
| 10 mg IW-1973 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to TEAEs | SAE | 0 Participants |
| 10 mg IW-1973 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to TEAEs | Discontinuations (DCs) due to AEs | 0 Participants |
| 10 mg IW-1973 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to TEAEs | ≥1 TEAE | 3 Participants |
| 10 mg IW-1973 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to TEAEs | DCs Due to Trough Blood Pressure Decline | 0 Participants |
| 10 mg IW-1973 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to TEAEs | Deaths | 0 Participants |
| 20 mg IW-1973 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to TEAEs | SAE | 0 Participants |
| 20 mg IW-1973 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to TEAEs | Discontinuations (DCs) due to AEs | 1 Participants |
| 20 mg IW-1973 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to TEAEs | DCs Due to Trough Blood Pressure Decline | 1 Participants |
| 20 mg IW-1973 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to TEAEs | Deaths | 0 Participants |
| 20 mg IW-1973 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to TEAEs | ≥1 TEAE | 2 Participants |
| 30 mg IW-1973 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to TEAEs | Deaths | 0 Participants |
| 30 mg IW-1973 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to TEAEs | ≥1 TEAE | 4 Participants |
| 30 mg IW-1973 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to TEAEs | SAE | 0 Participants |
| 30 mg IW-1973 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to TEAEs | Discontinuations (DCs) due to AEs | 0 Participants |
| 30 mg IW-1973 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to TEAEs | DCs Due to Trough Blood Pressure Decline | 1 Participants |
| 40 mg IW-1973 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to TEAEs | Discontinuations (DCs) due to AEs | 0 Participants |
| 40 mg IW-1973 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to TEAEs | ≥1 TEAE | 3 Participants |
| 40 mg IW-1973 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to TEAEs | DCs Due to Trough Blood Pressure Decline | 0 Participants |
| 40 mg IW-1973 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to TEAEs | SAE | 0 Participants |
| 40 mg IW-1973 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to TEAEs | Deaths | 0 Participants |
| 50 mg IW-1973 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to TEAEs | ≥1 TEAE | 2 Participants |
| 50 mg IW-1973 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to TEAEs | Discontinuations (DCs) due to AEs | 0 Participants |
| 50 mg IW-1973 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to TEAEs | SAE | 0 Participants |
| 50 mg IW-1973 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to TEAEs | DCs Due to Trough Blood Pressure Decline | 0 Participants |
| 50 mg IW-1973 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to TEAEs | Deaths | 0 Participants |
Primary
Orthostatic Diastolic Blood Pressure Over Time
An orthostatic measurement is obtained by subtracting the supine measurement from the standing measurement.
Time frame: Cycle Day 1, Predose; Cycle Day 1, 1 h; Cycle Day 1, 2 h; Cycle Day 1, 4 h; Cycle Day 1, 8 h; Cycle Day 1, 12 h
Population: PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, 12 h | 8.6 mmHg | Standard Deviation 7.7 |
| Control | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, 2 h | 10.5 mmHg | Standard Deviation 6.5 |
| Control | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, 8 h | 9.1 mmHg | Standard Deviation 7.1 |
| Control | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, Predose | 7.0 mmHg | Standard Deviation 2.4 |
| Control | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, 1 h | 6.9 mmHg | Standard Deviation 4.1 |
| Control | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, 4 h | 9.1 mmHg | Standard Deviation 3.6 |
| 10 mg IW-1973 | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, 12 h | 7.9 mmHg | Standard Deviation 3.9 |
| 10 mg IW-1973 | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, Predose | 9.3 mmHg | Standard Deviation 4.7 |
| 10 mg IW-1973 | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, 2 h | 8.3 mmHg | Standard Deviation 3.5 |
| 10 mg IW-1973 | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, 1 h | 7.0 mmHg | Standard Deviation 3.9 |
| 10 mg IW-1973 | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, 4 h | 6.6 mmHg | Standard Deviation 7.8 |
| 10 mg IW-1973 | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, 8 h | 6.0 mmHg | Standard Deviation 5.5 |
| 20 mg IW-1973 | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, 2 h | 6.5 mmHg | Standard Deviation 5.6 |
| 20 mg IW-1973 | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, 12 h | 5.5 mmHg | Standard Deviation 6.2 |
| 20 mg IW-1973 | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, 1 h | 6.5 mmHg | Standard Deviation 3.7 |
| 20 mg IW-1973 | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, Predose | 8.1 mmHg | Standard Deviation 7.7 |
| 20 mg IW-1973 | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, 4 h | 4.9 mmHg | Standard Deviation 4.3 |
| 20 mg IW-1973 | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, 8 h | 7.9 mmHg | Standard Deviation 5.2 |
| 30 mg IW-1973 | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, 8 h | 5.5 mmHg | Standard Deviation 3.4 |
| 30 mg IW-1973 | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, 1 h | 4.7 mmHg | Standard Deviation 4.4 |
| 30 mg IW-1973 | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, 4 h | 5.1 mmHg | Standard Deviation 3.1 |
| 30 mg IW-1973 | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, Predose | 5.7 mmHg | Standard Deviation 5.1 |
| 30 mg IW-1973 | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, 12 h | 9.3 mmHg | Standard Deviation 6.3 |
| 30 mg IW-1973 | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, 2 h | 7.6 mmHg | Standard Deviation 3.7 |
| 40 mg IW-1973 | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, 1 h | 5.7 mmHg | Standard Deviation 3.6 |
| 40 mg IW-1973 | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, 2 h | 3.2 mmHg | Standard Deviation 7.2 |
| 40 mg IW-1973 | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, 12 h | 6.6 mmHg | Standard Deviation 2.5 |
| 40 mg IW-1973 | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, 8 h | 4.7 mmHg | Standard Deviation 7.6 |
| 40 mg IW-1973 | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, Predose | 8.3 mmHg | Standard Deviation 2.7 |
| 40 mg IW-1973 | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, 4 h | 6.2 mmHg | Standard Deviation 2.7 |
| 50 mg IW-1973 | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, 12 h | 6.2 mmHg | Standard Deviation 4.3 |
| 50 mg IW-1973 | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, Predose | 7.4 mmHg | Standard Deviation 4.4 |
| 50 mg IW-1973 | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, 1 h | 5.8 mmHg | Standard Deviation 3.8 |
| 50 mg IW-1973 | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, 2 h | 4.2 mmHg | Standard Deviation 4.6 |
| 50 mg IW-1973 | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, 4 h | 6.9 mmHg | Standard Deviation 5.5 |
| 50 mg IW-1973 | Orthostatic Diastolic Blood Pressure Over Time | Cycle Day 1, 8 h | 7.0 mmHg | Standard Deviation 5 |
Primary
Orthostatic Pulse Over Time
An orthostatic measurement is obtained by subtracting the supine measurement from the standing measurement.
Time frame: Cycle Day 1, Predose; Cycle Day 1, 1 h; Cycle Day 1, 2 h; Cycle Day 1, 4 h; Cycle Day 1, 8 h; Cycle Day 1, 12 h
Population: PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Orthostatic Pulse Over Time | Cycle Day 1, 12 h | 10.7 bpm | Standard Deviation 4.8 |
| Control | Orthostatic Pulse Over Time | Cycle Day 1, 2 h | 10.9 bpm | Standard Deviation 4.1 |
| Control | Orthostatic Pulse Over Time | Cycle Day 1, 1 h | 9.7 bpm | Standard Deviation 5.4 |
| Control | Orthostatic Pulse Over Time | Cycle Day 1, 8 h | 10.8 bpm | Standard Deviation 7.8 |
| Control | Orthostatic Pulse Over Time | Cycle Day 1, 4 h | 9.5 bpm | Standard Deviation 7.7 |
| Control | Orthostatic Pulse Over Time | Cycle Day 1, Predose | 9.7 bpm | Standard Deviation 3.8 |
| 10 mg IW-1973 | Orthostatic Pulse Over Time | Cycle Day 1, 2 h | 10.6 bpm | Standard Deviation 5.9 |
| 10 mg IW-1973 | Orthostatic Pulse Over Time | Cycle Day 1, 4 h | 10.3 bpm | Standard Deviation 9.5 |
| 10 mg IW-1973 | Orthostatic Pulse Over Time | Cycle Day 1, Predose | 11.6 bpm | Standard Deviation 5.6 |
| 10 mg IW-1973 | Orthostatic Pulse Over Time | Cycle Day 1, 1 h | 11.5 bpm | Standard Deviation 7.1 |
| 10 mg IW-1973 | Orthostatic Pulse Over Time | Cycle Day 1, 8 h | 10.3 bpm | Standard Deviation 6.7 |
| 10 mg IW-1973 | Orthostatic Pulse Over Time | Cycle Day 1, 12 h | 10.6 bpm | Standard Deviation 5.1 |
| 20 mg IW-1973 | Orthostatic Pulse Over Time | Cycle Day 1, 2 h | 12.3 bpm | Standard Deviation 8.4 |
| 20 mg IW-1973 | Orthostatic Pulse Over Time | Cycle Day 1, 4 h | 11.0 bpm | Standard Deviation 6.4 |
| 20 mg IW-1973 | Orthostatic Pulse Over Time | Cycle Day 1, 1 h | 12.6 bpm | Standard Deviation 6.4 |
| 20 mg IW-1973 | Orthostatic Pulse Over Time | Cycle Day 1, 12 h | 9.9 bpm | Standard Deviation 13 |
| 20 mg IW-1973 | Orthostatic Pulse Over Time | Cycle Day 1, 8 h | 12.7 bpm | Standard Deviation 6.5 |
| 20 mg IW-1973 | Orthostatic Pulse Over Time | Cycle Day 1, Predose | 11.0 bpm | Standard Deviation 4.1 |
| 30 mg IW-1973 | Orthostatic Pulse Over Time | Cycle Day 1, 12 h | 10.8 bpm | Standard Deviation 7.5 |
| 30 mg IW-1973 | Orthostatic Pulse Over Time | Cycle Day 1, 1 h | 17.8 bpm | Standard Deviation 6.1 |
| 30 mg IW-1973 | Orthostatic Pulse Over Time | Cycle Day 1, 4 h | 14.6 bpm | Standard Deviation 5.3 |
| 30 mg IW-1973 | Orthostatic Pulse Over Time | Cycle Day 1, 8 h | 13.0 bpm | Standard Deviation 3.4 |
| 30 mg IW-1973 | Orthostatic Pulse Over Time | Cycle Day 1, 2 h | 14.6 bpm | Standard Deviation 6.8 |
| 30 mg IW-1973 | Orthostatic Pulse Over Time | Cycle Day 1, Predose | 11.9 bpm | Standard Deviation 3.8 |
| 40 mg IW-1973 | Orthostatic Pulse Over Time | Cycle Day 1, Predose | 11.0 bpm | Standard Deviation 3.9 |
| 40 mg IW-1973 | Orthostatic Pulse Over Time | Cycle Day 1, 8 h | 15.2 bpm | Standard Deviation 4.4 |
| 40 mg IW-1973 | Orthostatic Pulse Over Time | Cycle Day 1, 12 h | 13.0 bpm | Standard Deviation 7.4 |
| 40 mg IW-1973 | Orthostatic Pulse Over Time | Cycle Day 1, 1 h | 17.8 bpm | Standard Deviation 7.6 |
| 40 mg IW-1973 | Orthostatic Pulse Over Time | Cycle Day 1, 4 h | 12.3 bpm | Standard Deviation 9.3 |
| 40 mg IW-1973 | Orthostatic Pulse Over Time | Cycle Day 1, 2 h | 13.9 bpm | Standard Deviation 5.9 |
| 50 mg IW-1973 | Orthostatic Pulse Over Time | Cycle Day 1, 4 h | 14.8 bpm | Standard Deviation 8 |
| 50 mg IW-1973 | Orthostatic Pulse Over Time | Cycle Day 1, 1 h | 16.0 bpm | Standard Deviation 7.4 |
| 50 mg IW-1973 | Orthostatic Pulse Over Time | Cycle Day 1, 8 h | 11.0 bpm | Standard Deviation 7.6 |
| 50 mg IW-1973 | Orthostatic Pulse Over Time | Cycle Day 1, Predose | 10.4 bpm | Standard Deviation 2.7 |
| 50 mg IW-1973 | Orthostatic Pulse Over Time | Cycle Day 1, 12 h | 11.3 bpm | Standard Deviation 6.8 |
| 50 mg IW-1973 | Orthostatic Pulse Over Time | Cycle Day 1, 2 h | 15.6 bpm | Standard Deviation 5.7 |
Primary
Orthostatic Systolic Blood Pressure Over Time
An orthostatic measurement is obtained by subtracting the supine measurement from the standing measurement.
Time frame: Cycle Day 1, Predose; Cycle Day 1, 1 h; Cycle Day 1, 2 h; Cycle Day 1, 4 h; Cycle Day 1, 8 h; Cycle Day 1, 12 h
Population: PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, Predose | 4.4 mmHg | Standard Deviation 7.2 |
| Control | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, 1 h | 7.0 mmHg | Standard Deviation 5.6 |
| Control | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, 2 h | 8.5 mmHg | Standard Deviation 12.4 |
| Control | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, 4 h | 3.6 mmHg | Standard Deviation 9.2 |
| Control | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, 8 h | 8.4 mmHg | Standard Deviation 5.8 |
| Control | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, 12 h | 9.7 mmHg | Standard Deviation 10.5 |
| 10 mg IW-1973 | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, 1 h | 9.1 mmHg | Standard Deviation 8.4 |
| 10 mg IW-1973 | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, 4 h | 3.2 mmHg | Standard Deviation 8.7 |
| 10 mg IW-1973 | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, 12 h | 6.2 mmHg | Standard Deviation 5.3 |
| 10 mg IW-1973 | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, Predose | 3.7 mmHg | Standard Deviation 6.5 |
| 10 mg IW-1973 | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, 2 h | 8.2 mmHg | Standard Deviation 4.6 |
| 10 mg IW-1973 | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, 8 h | 5.4 mmHg | Standard Deviation 5.8 |
| 20 mg IW-1973 | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, 12 h | 6.0 mmHg | Standard Deviation 6.1 |
| 20 mg IW-1973 | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, 8 h | 8.1 mmHg | Standard Deviation 14.1 |
| 20 mg IW-1973 | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, 4 h | 4.2 mmHg | Standard Deviation 5.8 |
| 20 mg IW-1973 | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, 2 h | 6.2 mmHg | Standard Deviation 8.7 |
| 20 mg IW-1973 | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, Predose | 5.9 mmHg | Standard Deviation 7.3 |
| 20 mg IW-1973 | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, 1 h | 5.2 mmHg | Standard Deviation 3.5 |
| 30 mg IW-1973 | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, 4 h | 4.3 mmHg | Standard Deviation 5 |
| 30 mg IW-1973 | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, 1 h | 5.8 mmHg | Standard Deviation 8.2 |
| 30 mg IW-1973 | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, 2 h | 7.3 mmHg | Standard Deviation 8.4 |
| 30 mg IW-1973 | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, 12 h | 8.0 mmHg | Standard Deviation 6.7 |
| 30 mg IW-1973 | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, 8 h | 5.5 mmHg | Standard Deviation 7.8 |
| 30 mg IW-1973 | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, Predose | 4.0 mmHg | Standard Deviation 13 |
| 40 mg IW-1973 | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, Predose | 3.4 mmHg | Standard Deviation 5.3 |
| 40 mg IW-1973 | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, 8 h | 5.6 mmHg | Standard Deviation 4.9 |
| 40 mg IW-1973 | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, 1 h | 4.0 mmHg | Standard Deviation 6.8 |
| 40 mg IW-1973 | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, 2 h | 3.3 mmHg | Standard Deviation 6.5 |
| 40 mg IW-1973 | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, 4 h | 6.3 mmHg | Standard Deviation 9.2 |
| 40 mg IW-1973 | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, 12 h | 2.1 mmHg | Standard Deviation 4.5 |
| 50 mg IW-1973 | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, 4 h | 6.7 mmHg | Standard Deviation 7.7 |
| 50 mg IW-1973 | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, 2 h | 4.6 mmHg | Standard Deviation 8.3 |
| 50 mg IW-1973 | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, 8 h | 8.0 mmHg | Standard Deviation 4.5 |
| 50 mg IW-1973 | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, 12 h | 3.4 mmHg | Standard Deviation 7.9 |
| 50 mg IW-1973 | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, 1 h | 6.2 mmHg | Standard Deviation 6.7 |
| 50 mg IW-1973 | Orthostatic Systolic Blood Pressure Over Time | Cycle Day 1, Predose | 4.2 mmHg | Standard Deviation 9.1 |