Schizophrenia
Conditions
Brief summary
The primary objective of this study is to investigate whether a single infusion of intravenous sodium nitroprusside (0.5 μg/kg/min for 4 hours) is superior to placebo (5% dextrose solution) at in treating positive and negative symptoms of schizophrenia
Detailed description
This is a phase II proof of concept (POC), multi-center, prospective, randomized, placebo-controlled, Sequential Parallel Comparison Design (SPCD) study, in which a total of 60 subjects with schizophrenia will be enrolled. The study will be conducted in two stages. The study treatment will be administered in a double-blind fashion for all subjects throughout both stages of the study. A total of 60 subjects with schizophrenia will be randomized in a 1:1:1 ratio to drug-drug sequence \[n=20; i.v. sodium nitroprusside (0.5 μg/kg/min for 4 hours) at week 0 and week 2\], placebo-drug sequence \[n=20; i.v. placebo at week 0 and i.v. sodium nitroprusside (0.5 μg/kg/min for 4 hours) at week 2\], and placebo-placebo sequence \[n=20; i.v. placebo at week 0 and again at week 2\]. The 4-week double-blind phase of treatment will be divided into two phases: Phase 1, from week 0 to week 2, and Phase 2 from week 2 to week 4. At the end of Phase 1 (week 2), the randomized subjects will be assessed and categorized into responders and non-responders, based on 20% or more reduction from baseline in their PANSS total score as per the evaluations at Randomization Visit (week 0). The data from the patients deemed placebo non-responders in phase 1 who go on to either stay on placebo or to receive treatment with sodium nitroprusside will be pooled with the data from Phase 1 from all subjects, according to SPCD.
Interventions
DRUGsodium nitroprusside
intravenous
OTHERPlacebo
Placebo
Sponsors
Stanley Medical Research Institute
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Each subject must meet all of the following criteria to be eligible for this study: 1. Males or Females aged 18-65 years inclusive. 2. Primary diagnosis of Schizophrenia established by a structured psychiatric evaluation (SCID) based on Diagnostic and Statistical Manual of Mental Disorders Forth Edition (DSM-IV-TR) criteria. 3. Written informed consent in compliance with 21 CFR part 50 and in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. 4. A Positive and Negative Syndrome Scale (PANSS) (Kay et al., 1994) total score ≥ 70 with a score of \> 4 on two or more of the following PANSS items: delusions, conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content. 5. A score of ≥4 on the Clinical Global Impression-Severity (CGI-S) (Guy, 1976). 6. Confirmation of both diagnosis and severity of psychosis symptoms by an independent MGH SAFER interview. 7. Must have ongoing antipsychotic treatment for at least 8 weeks, with a stable dose for at least 4 weeks. Subjects who have failed to achieve clinically-recognized symptom reduction to at least 1 marketed antipsychotic agent, given at a Physician Desk Reference (PDR)-defined therapeutic dose for ≥ 8 weeks during the past 12 months, as assessed by the MGH FAST, will be eligible 8. Understands and is able, willing, and (in the opinion of the investigator) likely to fully comply with the study procedures and restrictions.
Exclusion criteria
Subjects who meet any of the following criteria will be excluded from the study: 1. Subjects with a history of renal insufficiency, congestive heart failure, cardiac arrhythmias or history of myocardial infarction. 2. Subjects with a history of symptomatic orthostatic hypotension defined as sitting to standing systolic blood pressure \< 90mmHg or diastolic blood pressure \< 60mm Hg with any of the following symptoms: lightheaded or dizzy upon standing, blurry vision, weakness, fainting (syncope), confusion, or nausea. 3. Subjects with any clinically significant abnormalities as determined by medical history, physical exam, clinical and lab evaluation suggestive of an underlying disease state that may, in the opinion of the investigator, confound the results of study, increase risk to the subject, or lead to difficulty complying with the protocol. 4. Subjects on chlorpromazine, PDE-5 inhibitors, nitrites and any medication with CNS effects with the exception of antipsychotic drugs (other than chlorpromazine) anticholinergics, b-adrenergic antagonists, amantadine, biperiden, diphenhydramine, lorazepam, zolpidem, and temazepam. 5. Medications which in the opinion of the PI, and in conjunction with the medical monitor, may be expected to significantly interfere with the metabolism or excretion of sodium nitroprusside, and/or may be associated with a significant drug interaction with sodium nitroprusside that may pose a significant risk to subjects' health and/or confound the study data. 6. Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed at screening visit prior to randomization and prior to baseline at visits 3 and 6. Women enrolled in this trial must use adequate birth control. 7. Subjects with a current (within the last 3 months) DSM-IV-TR diagnosis of alcohol or substance use disorder or dependence (excluding nicotine) as established by the clinical assessment (SCID) at the screening visit will be excluded. 8. Has tested positive for any of the following: cannabis, opioids, cocaine, amphetamines, barbiturates methadone, methamphetamine and phencyclidine at the screening or baseline visits. If positive, the urine drug toxicology screen may be repeated once based on investigator judgment, but due to safety concerns, the result must be negative for the subject to continue in the study. 9. Subjects at imminent risk of suicide or injury to self or others, as per the opinion of the investigator, or history of significant suicide attempt within the last 6 months as per C-SSRS. 10. Subjects that have taken an investigational drug or taken part in a clinical trial within 30 days prior to screening. 11. Any other reason that, in the opinion of the investigator, would compromise patient safety or integrity of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Positive and Negative Syndrome Scale (PANSS) - Total Score - Study Phases 1 and 2 | For Phase 1, timeframe is Day 0 and Day 14; Phase 2 timeframe is Day 14 and Day 28 | The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. Total score minimum = 30, maximum = 210 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PANSS - Negative Subscale - Phases 1 and 2 | Phase 1 timeframe is Day 0 and Day 14; Phase 2 timeframe is Day 14 and Day 28 | The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. Negative scale: 7 Items, (minimum score = 7, maximum score = 49) |
| PANSS - General Psychopathology Subscale - Phases 1 and 2 | Phase 1 timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28 | The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. General Psychopathology Subscale: 16 Items, (minimum score = 16, maximum score = 112) |
| Average Percent Change From Baseline in the PANSS Total Score After 2 Weeks of Treatment Using SPCD | For Phase 1, timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28 | The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. Total score minimum = 30, maximum = 210. |
| PANSS - Positive Subscale - Phases 1 and 2 | Phase 1 timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28 | The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. Positive scale: 7 Items, (minimum score = 7, maximum score = 49) |
| Average Percent Change From Baseline in the PANSS Positive Subscale Score After 2 Weeks of Treatment Using SPCD | For Phase 1, timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28 | The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. Positive subscore scale: 7 items (minimum score = 7; maximum score = 49) |
| Average Percent Change From Baseline in the PANSS Negative Subscale Score After 2 Weeks of Treatment Using SPCD | For Phase 1, timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28 | The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. Negative subscore scale: 7 items (minimum score = 7; maximum score = 49) |
| Average Percent Change From Baseline in the PANSS General Psychopathology Subscale Score After 2 Weeks of Treatment Using SPCD | For Phase 1, timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28 | The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. General Psychopathology subscore scale: 16 items (minimum score = 16; maximum score = 112) |
| Percentage of Subjects With 20% or More Reduction From Baseline in PANSS Total Score After 2 Weeks of Treatment Using SPCD | For Phase 1, timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28 | The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. Total score minimum = 30, maximum = 210. |
Other
| Measure | Time frame | Description |
|---|---|---|
| ECG Measures at All Time Points by Group | Day 0 - Baseline (pre-infusion), During Infusion (@30 min), Post-Infusion (@60min) | Infusion 1 (Day 0) - ECG measures at all time points by group |
| Incidence of Treatment-Emergent Adverse Events (TEAEs) | The period of observation for collection of treatment-emergent adverse events extends from Day 0 treatment through the final visit at Day 28. | Incidence of Treatment-Emergent Adverse Events (TEAE) by Treatment Group. A treatment emergent adverse event (TEAE) is an AE that either began following initiation of study treatment or was present prior to the initiation of the treatment, but increased in frequency or severity following initiation treatment, regardless of causality. |
| Change in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) - Phases 1 and 2 | Phase 1 timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28 | MATRICS: The Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB). The MATRICS Consensus Cognitive Battery is the standard tool for assessing cognitive change in trials of cognitive-enhancing agents in schizophrenia. The MCCB domains include: Speed of Processing; Attention/Vigilance; Working Memory; Verbal Learning; Visual Learning; Reasoning & Problem-Solving; and Social Cognition and the battery takes about 80 minutes to complete. The MCCB composite score represents a global measure of cognition. MCCB composite T scores are between 40 and 60 (normal range) and \< 40 (below normal range). |
| Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | Baseline (Day - 1), Follow-Up = reported at any assessment thereafter, including 7 hours after Infusions #1 and #2, Baseline 2 (Day 13) and final follow-up, including early termination visits. | The Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI): This is a self-rated 77-item questionnaire organized into 13 body areas assessing possible adverse events during the course of the trial. |
| Number of Subject Withdrawals Due to Treatment-Emergent Adverse Events (TEAEs) | The period of observation extends from Day 0 treatment through the final visit at Day 28 | Incidence of Treatment-Emergent Adverse Events (TEAE) by Treatment Group. A treatment emergent adverse event (TEAE) is an AE that either began following initiation of study treatment or was present prior to the initiation of the treatment, but increased in frequency or severity following initiation treatment, regardless of causality. |
| Average AIMS Total Scores (Items 1-7) by Group and Timepoint | Baseline 1 (Day -1), 7 Hours Post-Infusion 1, Baseline 2 (Day 13), 7 Hours Post-Infusion 2, Final Follow-Up, including early termination visits | Abnormal Involuntary Movement Scale (AIMS): The AIMS Total Dyskinesia Score was calculated by averaging the first 7 items of the AIMS. The 7 items included in the AIMS Dyskinesia Score are rated on a scale from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score ranges from 0 to 4; a higher score reflects increased severity. |
| Percent of Participants Rated as ≥ Mild or as Yes on AIMS Items 8-12 | Baseline (Day -1), Follow-Up = reported at any assessment thereafter, including 7 hours after Infusions #1 and #2, Baseline 2 (Day 13) and final follow-up, including early termination visits. | Abnormal Involuntary Movement Scale (AIMS): The AIMS is a 12-item anchored score that is clinician administered and scored. Items are scored on a 0 (none) to 4 (severe) basis; items 8-10 deal with global severity; items 11-12 are yes-no questions concerning problems with teeth and/or dentures. |
| Change in The University of California San Diego (UCSD) Performance-based Skills Assessment Brief (UPSA-B) - Phases 1 and 2 | Phase 1 timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28 | The University of California San Diego (UCSD) Performance-based Skills Assessment Brief (UPSA-B) consists of two of the five original UPSA domains, finances and communication. Each subscale contributes 50 points; total scores range from 0 to 100 points with higher scores reflecting better performance. |
| Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Screening Visit, Days 3 (Baseline 1), Days 7, 13 (Baseline 2), 21 and 28 | The Columbia Suicide Severity Rating Scale (C-SSRS): The C-SSRS is a low-burden measure of the spectrum of suicidal ideation and behavior that was developed in the National Institute of Mental Health Treatment of Adolescent Suicide Attempters Study to assess severity and track suicidal events through any treatment. It is a clinical interview providing a summary of both ideation and behavior that can be administered during any evaluation or risk assessment to identify the level and type of suicidality present. The C-SSRS can also be used during treatment to monitor for clinical worsening or improvement. It contains 5 rating scale questions (yes/no) for suicidal ideation increasing severity and 5 rating scale questions (yes/no) for suicidal behavior of increasing severity. The time frame is for both lifetime and the past six months for the Baseline/Screening scale and since the last visit for the Since Last Visit scale. |
| Systolic Blood Pressure Per Infusion Phase by Group | Day 0 - Phase 1 - Baseline = min000s1 and @5 min; Phase 2 - Baseline = min000 then every 10 minutes for 4 hours; Post Infusion - Baseline = min000, then every 10 minutes for 2 hours | Infusion 1 (Day 0) - Systolic Blood Pressure at all time points by group Phase in this analysis refers to the infusion stage as defined in the protocol. |
| Diastolic Blood Pressure Per Infusion Phase by Group | Day 0 - Phase 1 - Baseline = min000s1 and @5 min; Phase 2 - Baseline = min000 then every 10 minutes for 4 hours; Post Infusion - Baseline = min000, then every 10 minutes for 2 hours | Infusion 1 (Day 0) - Diastolic Blood Pressure at all time points by group Phase in this analysis refers to the infusion stage as defined in the protocol. |
| Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Day 14 - Phase 1 - Baseline = min000s1 and @5 min; Phase 2 - Baseline = min000 then every 10 minutes for 4 hours; Post Infusion - Baseline = min000, then every 10 minutes for 2 hours | Infusion 2 (Day 14) - Diastolic Blood Pressure at all time points by group |
| Heart Rate Per Infusion Phase by Group | Day 0 - Phase 1 - Baseline = min000s1 and @5 min; Phase 2 - Baseline = min000 then every 10 minutes for 4 hours; Post Infusion - Baseline = min000, then every 10 minutes for 2 hours | Infusion 1 (Day 0) - Heart rate at all time points by group Phase in this analysis refers to the infusion stage as defined in the protocol. |
Countries
United States
Participant flow
Pre-assignment details
Per the Sequential Parallel Comparison Design, the 18 subjects in the SNP-SNP group were excluded from Phase 2 analyses. There were no Phase 1 placebo responders, so no exclusions were made based on this SPCD criterion. Ph 1 (N=52): all groups; Ph 2 (N=34): (Placebo)-Placebo (N=18), (SNP)-Placebo (N=16). All subjects were followed for 28 days.
Participants by arm
| Arm | Count |
|---|---|
| Drug - Drug Phase 1 - intravenous sodium Nitroprusside (Drug) Phase 2 - intravenous sodium Nitroprusside (Drug)
Subjects will receive i.v. sodium nitroprusside (0.5 μg/kg/min for 4 hours) at Day 0 (Phase 1) and Day 14 (Phase 2) | 18 |
| Placebo - Drug Phase 1 - intravenous dextrose (Placebo) Phase 2 - intravenous sodium Nitroprusside (Drug)
Subjects will receive i.v. placebo (intravenous dextrose) at Day 0 (Phase 1) and i.v. sodium nitroprusside (0.5 μg/kg/min for 4 hours) at Day 14 (Phase 2) | 16 |
| Placebo - Placebo Phase 1 - intravenous dextrose (Placebo) Phase 2 - intravenous dextrose (Placebo)
Subjects will receive i.v. placebo (intravenous dextrose) at Day 0 (Phase 1) and again at Day 14 (Phase 2). | 18 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Phase 1 (Day 0 - Day 14) | Adverse Event | 0 | 2 | 0 |
| Phase 2 (Day 14 - Day 28) | Adverse Event | 2 | 1 | 0 |
| Phase 2 (Day 14 - Day 28) | Protocol Violation | 0 | 1 | 0 |
| Started | Adverse Event | 1 | 2 | 0 |
| Started | Protocol Violation | 2 | 0 | 0 |
| Started | Withdrawal by Subject | 2 | 1 | 0 |
Baseline characteristics
| Characteristic | Drug - Drug | Placebo - Drug | Placebo - Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 47.1 years STANDARD_DEVIATION 10.5 | 45.9 years STANDARD_DEVIATION 12.3 | 40.4 years STANDARD_DEVIATION 11 | 44.5 years STANDARD_DEVIATION 11.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 15 Participants | 16 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 2 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Black | 6 Participants | 5 Participants | 11 Participants | 22 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 10 Participants | 9 Participants | 6 Participants | 25 Participants |
| Region of Enrollment United States | 18 Participants | 16 Participants | 18 Participants | 52 Participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 4 Participants | 12 Participants |
| Sex: Female, Male Male | 14 Participants | 12 Participants | 14 Participants | 40 Participants |
| The Positive and Negative Syndrome Scale (PANSS) at Baseline (Day 3) PANSS - negative | 20.9 units on a scale STANDARD_DEVIATION 5.5 | 20.3 units on a scale STANDARD_DEVIATION 5 | 21.4 units on a scale STANDARD_DEVIATION 4.6 | 20.8 units on a scale STANDARD_DEVIATION 15.1 |
| The Positive and Negative Syndrome Scale (PANSS) at Baseline (Day 3) PANSS - positive | 24.9 units on a scale STANDARD_DEVIATION 3.5 | 22.3 units on a scale STANDARD_DEVIATION 3.4 | 22.6 units on a scale STANDARD_DEVIATION 3.1 | 23.26 units on a scale STANDARD_DEVIATION 3.3 |
| The Positive and Negative Syndrome Scale (PANSS) at Baseline (Day 3) PANSS -total | 83.6 units on a scale STANDARD_DEVIATION 10 | 77.6 units on a scale STANDARD_DEVIATION 8.8 | 81.7 units on a scale STANDARD_DEVIATION 8.8 | 80.9 units on a scale STANDARD_DEVIATION 9.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 19 | 0 / 18 |
| other Total, other adverse events | 11 / 23 | 9 / 19 | 9 / 18 |
| serious Total, serious adverse events | 0 / 23 | 0 / 19 | 0 / 18 |
Outcome results
Primary
Change in Positive and Negative Syndrome Scale (PANSS) - Total Score - Study Phases 1 and 2
The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. Total score minimum = 30, maximum = 210
Time frame: For Phase 1, timeframe is Day 0 and Day 14; Phase 2 timeframe is Day 14 and Day 28
Population: Ph 1 analysis includes 34 subjects with Baseline PANSS data in the Placebo-Placebo (N=18) and Placebo-Drug (N=16) groups and 18 Drug-Drug group subjects. Per SPCD, the Ph 2 data excludes 18 Drug-Drug group subjects and includes the 14 subjects in the Placebo-Drug group and 18 subjects in the Placebo-Placebo group with PANSS Baseline data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Drug | Change in Positive and Negative Syndrome Scale (PANSS) - Total Score - Study Phases 1 and 2 | Phase 1 - Total Score - Baseline | 83.6 units on a scale | Standard Deviation 10 |
| Drug | Change in Positive and Negative Syndrome Scale (PANSS) - Total Score - Study Phases 1 and 2 | Phase 1 - Total Score - Day 14 | 77.6 units on a scale | Standard Deviation 12.2 |
| Drug | Change in Positive and Negative Syndrome Scale (PANSS) - Total Score - Study Phases 1 and 2 | Phase 1 - Total Score - Change | -6.0 units on a scale | Standard Deviation 11.3 |
| Drug | Change in Positive and Negative Syndrome Scale (PANSS) - Total Score - Study Phases 1 and 2 | Phase 2 - Total Score - Day 14 | 74.0 units on a scale | Standard Deviation 12 |
| Drug | Change in Positive and Negative Syndrome Scale (PANSS) - Total Score - Study Phases 1 and 2 | Phase 2 - Total Score - Day 28 | 71.8 units on a scale | Standard Deviation 10.6 |
| Drug | Change in Positive and Negative Syndrome Scale (PANSS) - Total Score - Study Phases 1 and 2 | Phase 2 - Total Score - Change | -1.8 units on a scale | Standard Deviation 8.2 |
| Placebo | Change in Positive and Negative Syndrome Scale (PANSS) - Total Score - Study Phases 1 and 2 | Phase 2 - Total Score - Day 28 | 74.7 units on a scale | Standard Deviation 9 |
| Placebo | Change in Positive and Negative Syndrome Scale (PANSS) - Total Score - Study Phases 1 and 2 | Phase 1 - Total Score - Baseline | 79.8 units on a scale | Standard Deviation 8.9 |
| Placebo | Change in Positive and Negative Syndrome Scale (PANSS) - Total Score - Study Phases 1 and 2 | Phase 2 - Total Score - Day 14 | 78.8 units on a scale | Standard Deviation 10.1 |
| Placebo | Change in Positive and Negative Syndrome Scale (PANSS) - Total Score - Study Phases 1 and 2 | Phase 1 - Total Score - Day 14 | 76.7 units on a scale | Standard Deviation 11 |
| Placebo | Change in Positive and Negative Syndrome Scale (PANSS) - Total Score - Study Phases 1 and 2 | Phase 2 - Total Score - Change | -4.2 units on a scale | Standard Deviation 6.4 |
| Placebo | Change in Positive and Negative Syndrome Scale (PANSS) - Total Score - Study Phases 1 and 2 | Phase 1 - Total Score - Change | -2.5 units on a scale | Standard Deviation 7.1 |
Comparison: Given the sequential parallel comparison design (SPCD), we used a two-stage test (weighted z-test, Tamura approach: CHANGE\_score = BASELINE\_value + GROUP (i.e., SNP vs. placebo)) to combine the data on treatment effects from phases 1 and 2 (weighted equally). Assessments were on Day -1 (phase 1 baseline), Day 13 (phase 1 outcome, phase 2 baseline) and Day 28 (phase 2 outcome). Only participants who at least started the infusion were included in analysis (i.e., modified intent to treat).p-value: 0.57ANCOVA
Comparison: The same analysis as in Analysis 1 was conducted, except that CLOZAPINE (i.e., patient used clozapine vs. other antipsychotic) was added as a covariate.p-value: 0.54ANCOVA
Secondary
Average Percent Change From Baseline in the PANSS General Psychopathology Subscale Score After 2 Weeks of Treatment Using SPCD
The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. General Psychopathology subscore scale: 16 items (minimum score = 16; maximum score = 112)
Time frame: For Phase 1, timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28
Population: Ph 1 analysis includes 34 subjects with Baseline PANSS data in the Placebo-Placebo (N=18) and Placebo-Drug (N=16) groups and 18 Drug-Drug group subjects. Per SPCD, the Ph 2 data excludes 18 subjects in the Drug-Drug group and includes the 14 subjects in the Placebo-Drug group and 18 subjects in the Placebo-Placebo group with PANSS Baseline data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Drug | Average Percent Change From Baseline in the PANSS General Psychopathology Subscale Score After 2 Weeks of Treatment Using SPCD | Phase 1 Average Percent Change from Baseline | -4.8 percent change | Standard Deviation 18.3 |
| Drug | Average Percent Change From Baseline in the PANSS General Psychopathology Subscale Score After 2 Weeks of Treatment Using SPCD | Phase 2 Average Percentage Change from Day 14 | 0.47 percent change | Standard Deviation 13.3 |
| Placebo | Average Percent Change From Baseline in the PANSS General Psychopathology Subscale Score After 2 Weeks of Treatment Using SPCD | Phase 1 Average Percent Change from Baseline | -1.8 percent change | Standard Deviation 10.9 |
| Placebo | Average Percent Change From Baseline in the PANSS General Psychopathology Subscale Score After 2 Weeks of Treatment Using SPCD | Phase 2 Average Percentage Change from Day 14 | -3.7 percent change | Standard Deviation 8.7 |
Secondary
Average Percent Change From Baseline in the PANSS Negative Subscale Score After 2 Weeks of Treatment Using SPCD
The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. Negative subscore scale: 7 items (minimum score = 7; maximum score = 49)
Time frame: For Phase 1, timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28
Population: Phase 1 analysis combines the 34 subjects assigned to Placebo-Placebo (N=18) and Placebo-Drug (N=16) groups and the 18 subjects assigned to the Drug-Drug group with complete data at all visits. Per SPCD, the Phase 2 data includes the 14 subjects in the Placebo-Drug group and 18 subjects in the Placebo-Placebo group with complete data at all visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Drug | Average Percent Change From Baseline in the PANSS Negative Subscale Score After 2 Weeks of Treatment Using SPCD | Phase 1 Average Percent Change from Baseline | -7.1 percent change | Standard Deviation 17.6 |
| Drug | Average Percent Change From Baseline in the PANSS Negative Subscale Score After 2 Weeks of Treatment Using SPCD | Phase 2 Average Percentage Change from Day 14 | -7.9 percent change | Standard Deviation 12.3 |
| Placebo | Average Percent Change From Baseline in the PANSS Negative Subscale Score After 2 Weeks of Treatment Using SPCD | Phase 1 Average Percent Change from Baseline | -4.6 percent change | Standard Deviation 14.9 |
| Placebo | Average Percent Change From Baseline in the PANSS Negative Subscale Score After 2 Weeks of Treatment Using SPCD | Phase 2 Average Percentage Change from Day 14 | -2.1 percent change | Standard Deviation 16.5 |
Secondary
Average Percent Change From Baseline in the PANSS Positive Subscale Score After 2 Weeks of Treatment Using SPCD
The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. Positive subscore scale: 7 items (minimum score = 7; maximum score = 49)
Time frame: For Phase 1, timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28
Population: Ph 1 analysis includes 34 subjects with Baseline PANSS data in the Placebo-Placebo (N=18) and Placebo-Drug (N=16) groups and 18 Drug-Drug group subjects. Per SPCD, the Ph 2 data excludes 18 subjects in the Drug-Drug group and includes the 14 subjects in the Placebo-Drug group and 18 subjects in the Placebo-Placebo group with PANSS Baseline data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Drug | Average Percent Change From Baseline in the PANSS Positive Subscale Score After 2 Weeks of Treatment Using SPCD | Phase 1 Average Percent Change from Baseline | -7.9 percent change | Standard Deviation 8.1 |
| Drug | Average Percent Change From Baseline in the PANSS Positive Subscale Score After 2 Weeks of Treatment Using SPCD | Phase 2 Average Percentage Change from Day 14 | -3.5 percent change | Standard Deviation 15.4 |
| Placebo | Average Percent Change From Baseline in the PANSS Positive Subscale Score After 2 Weeks of Treatment Using SPCD | Phase 1 Average Percent Change from Baseline | -3.2 percent change | Standard Deviation 13.6 |
| Placebo | Average Percent Change From Baseline in the PANSS Positive Subscale Score After 2 Weeks of Treatment Using SPCD | Phase 2 Average Percentage Change from Day 14 | -2.9 percent change | Standard Deviation 12.5 |
Secondary
Average Percent Change From Baseline in the PANSS Total Score After 2 Weeks of Treatment Using SPCD
The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. Total score minimum = 30, maximum = 210.
Time frame: For Phase 1, timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28
Population: Ph 1 analysis includes 34 subjects with Baseline PANSS data in the Placebo-Placebo (N=18) and Placebo-Drug (N=16) groups and 18 Drug-Drug group subjects. Per SPCD, the Ph 2 data excludes 18 subjects in the Drug-Drug group and includes the 14 subjects in the Placebo-Drug group and 18 subjects in the Placebo-Placebo group with PANSS Baseline data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Drug | Average Percent Change From Baseline in the PANSS Total Score After 2 Weeks of Treatment Using SPCD | Phase 1 Average Percent Change from Baseline | -6.7 percent change | Standard Deviation 12.8 |
| Drug | Average Percent Change From Baseline in the PANSS Total Score After 2 Weeks of Treatment Using SPCD | Phase 2 Average Percentage Change from Day 14 | -3.0 percent change | Standard Deviation 10.5 |
| Placebo | Average Percent Change From Baseline in the PANSS Total Score After 2 Weeks of Treatment Using SPCD | Phase 1 Average Percent Change from Baseline | -3.2 percent change | Standard Deviation 9 |
| Placebo | Average Percent Change From Baseline in the PANSS Total Score After 2 Weeks of Treatment Using SPCD | Phase 2 Average Percentage Change from Day 14 | -3.3 percent change | Standard Deviation 8.1 |
Secondary
PANSS - General Psychopathology Subscale - Phases 1 and 2
The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. General Psychopathology Subscale: 16 Items, (minimum score = 16, maximum score = 112)
Time frame: Phase 1 timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28
Population: Ph 1 analysis includes the 34 subjects with Baseline PANSS data in the Placebo-Placebo (N=18) and Placebo-Drug (N=16) groups and 18 Drug-Drug group subjects. Per SPCD, the Ph 2 data excludes the 18 Drug-Drug group subjects and includes the 14 subjects in the Placebo-Drug group and 18 subjects in the Placebo-Placebo group with PANSS Baseline data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Drug | PANSS - General Psychopathology Subscale - Phases 1 and 2 | Phase 2 - General Score - Day 14 | 34.7 units on a scale | Standard Deviation 6.4 |
| Drug | PANSS - General Psychopathology Subscale - Phases 1 and 2 | Phase 1 - General Score - Day 14 | 35.3 units on a scale | Standard Deviation 7.1 |
| Drug | PANSS - General Psychopathology Subscale - Phases 1 and 2 | Phase 2 - General Score - Day 28 | 32.4 units on a scale | Standard Deviation 5.6 |
| Drug | PANSS - General Psychopathology Subscale - Phases 1 and 2 | Phase 1 - General Score - Change | -2.2 units on a scale | Standard Deviation 7 |
| Drug | PANSS - General Psychopathology Subscale - Phases 1 and 2 | Phase 2 - General Score - Change | -2.1 units on a scale | Standard Deviation 5.2 |
| Drug | PANSS - General Psychopathology Subscale - Phases 1 and 2 | Phase 1 - General Score - Baseline | 37.6 units on a scale | Standard Deviation 6 |
| Placebo | PANSS - General Psychopathology Subscale - Phases 1 and 2 | Phase 2 - General Score - Change | -3.7 units on a scale | Standard Deviation 4.5 |
| Placebo | PANSS - General Psychopathology Subscale - Phases 1 and 2 | Phase 1 - General Score - Baseline | 36.4 units on a scale | Standard Deviation 5.1 |
| Placebo | PANSS - General Psychopathology Subscale - Phases 1 and 2 | Phase 1 - General Score - Change | -0.6 units on a scale | Standard Deviation 3.9 |
| Placebo | PANSS - General Psychopathology Subscale - Phases 1 and 2 | Phase 2 - General Score - Day 14 | 36.2 units on a scale | Standard Deviation 6.6 |
| Placebo | PANSS - General Psychopathology Subscale - Phases 1 and 2 | Phase 2 - General Score - Day 28 | 32.4 units on a scale | Standard Deviation 5.3 |
| Placebo | PANSS - General Psychopathology Subscale - Phases 1 and 2 | Phase 1 - General Score - Day 14 | 35.5 units on a scale | Standard Deviation 6.4 |
p-value: 0.86ANCOVA
p-value: 0.83ANCOVA
Secondary
PANSS - Negative Subscale - Phases 1 and 2
The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. Negative scale: 7 Items, (minimum score = 7, maximum score = 49)
Time frame: Phase 1 timeframe is Day 0 and Day 14; Phase 2 timeframe is Day 14 and Day 28
Population: Ph 1 analysis includes the 34 subjects with Baseline PANSS data in the Placebo-Placebo (N=18) and Placebo-Drug (N=16) groups and 18 Drug-Drug group subjects. Per SPCD, the Ph 2 data excludes the 18 Drug-Drug group subjects and includes the 14 subjects in the Placebo-Drug group and 18 subjects in the Placebo-Placebo group with PANSS Baseline data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Drug | PANSS - Negative Subscale - Phases 1 and 2 | Phase 1 - Negative Score - Baseline | 20.8 units on a scale | Standard Deviation 5.8 |
| Drug | PANSS - Negative Subscale - Phases 1 and 2 | Phase 1 - Negative Score - Day 14 | 19.0 units on a scale | Standard Deviation 4.6 |
| Drug | PANSS - Negative Subscale - Phases 1 and 2 | Phase 1 - Negative Score - Change | -1.8 units on a scale | Standard Deviation 4.1 |
| Drug | PANSS - Negative Subscale - Phases 1 and 2 | Phase 2 - Negative Score - Day 14 | 18.5 units on a scale | Standard Deviation 5.8 |
| Drug | PANSS - Negative Subscale - Phases 1 and 2 | Phase 2 - Negative Score - Day 28 | 18.0 units on a scale | Standard Deviation 6.2 |
| Drug | PANSS - Negative Subscale - Phases 1 and 2 | Phase 2 - Negative Score - Change | -0.1 units on a scale | Standard Deviation 0.9 |
| Placebo | PANSS - Negative Subscale - Phases 1 and 2 | Phase 2 - Negative Score - Day 28 | 19.8 units on a scale | Standard Deviation 4.7 |
| Placebo | PANSS - Negative Subscale - Phases 1 and 2 | Phase 1 - Negative Score - Baseline | 20.6 units on a scale | Standard Deviation 4.8 |
| Placebo | PANSS - Negative Subscale - Phases 1 and 2 | Phase 2 - Negative Score - Day 14 | 20.7 units on a scale | Standard Deviation 4.4 |
| Placebo | PANSS - Negative Subscale - Phases 1 and 2 | Phase 1 - Negative Score - Day 14 | 19.7 units on a scale | Standard Deviation 5.1 |
| Placebo | PANSS - Negative Subscale - Phases 1 and 2 | Phase 2 - Negative Score - Change | -0.9 units on a scale | Standard Deviation 2.9 |
| Placebo | PANSS - Negative Subscale - Phases 1 and 2 | Phase 1 - Negative Score - Change | -1.0 units on a scale | Standard Deviation 2.8 |
p-value: 0.85ANCOVA
p-value: 0.88ANCOVA
Secondary
PANSS - Positive Subscale - Phases 1 and 2
The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. Positive scale: 7 Items, (minimum score = 7, maximum score = 49)
Time frame: Phase 1 timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28
Population: Ph 1 analysis includes the 34 subjects with Baseline PANSS data in the Placebo-Placebo (N=18) and Placebo-Drug (N=16) groups and 22 Drug-Drug group subjects. Per SPCD, the Ph 2 data excludes the 18 Drug-Drug group subjects and includes the 14 subjects in the Placebo-Drug group and 18 subjects in the Placebo-Placebo group with PANSS Baseline data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Drug | PANSS - Positive Subscale - Phases 1 and 2 | Phase 1 - Positive Score - Baseline | 24.5 units on a scale | Standard Deviation 3.5 |
| Drug | PANSS - Positive Subscale - Phases 1 and 2 | Phase 1 - Positive Score - Day 14 | 23.1 units on a scale | Standard Deviation 4.6 |
| Drug | PANSS - Positive Subscale - Phases 1 and 2 | Phase 1 - Positive Score - Change | -1.8 units on a scale | Standard Deviation 1.8 |
| Drug | PANSS - Positive Subscale - Phases 1 and 2 | Phase 2 - Positive Score - Day 14 | 20.7 units on a scale | Standard Deviation 3.6 |
| Drug | PANSS - Positive Subscale - Phases 1 and 2 | Phase 2 - Positive Score - Day 28 | 21.3 units on a scale | Standard Deviation 4.6 |
| Drug | PANSS - Positive Subscale - Phases 1 and 2 | Phase 2 - Positive Score - Change | 0.5 units on a scale | Standard Deviation 3.8 |
| Placebo | PANSS - Positive Subscale - Phases 1 and 2 | Phase 2 - Positive Score - Day 28 | 22.3 units on a scale | Standard Deviation 3.4 |
| Placebo | PANSS - Positive Subscale - Phases 1 and 2 | Phase 1 - Positive Score - Baseline | 22.3 units on a scale | Standard Deviation 3.1 |
| Placebo | PANSS - Positive Subscale - Phases 1 and 2 | Phase 2 - Positive Score - Day 14 | 21.8 units on a scale | Standard Deviation 3.6 |
| Placebo | PANSS - Positive Subscale - Phases 1 and 2 | Phase 1 - Positive Score - Day 14 | 21.3 units on a scale | Standard Deviation 3.6 |
| Placebo | PANSS - Positive Subscale - Phases 1 and 2 | Phase 2 - Positive Score - Change | 0.5 units on a scale | Standard Deviation 2.17 |
| Placebo | PANSS - Positive Subscale - Phases 1 and 2 | Phase 1 - Positive Score - Change | -0.81 units on a scale | Standard Deviation 2.7 |
p-value: 0.35ANCOVA
p-value: 0.37ANCOVA
Secondary
Percentage of Subjects With 20% or More Reduction From Baseline in PANSS Total Score After 2 Weeks of Treatment Using SPCD
The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. Total score minimum = 30, maximum = 210.
Time frame: For Phase 1, timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28
Population: Phase 1 analysis combines the 34 subjects assigned to Placebo-Placebo (N=18) and Placebo-Drug (N=16) groups and the 18 subjects assigned to the Drug-Drug group with complete data at all visits. Per SPCD, the Phase 2 data includes the 14 subjects in the Placebo-Drug group and 18 subjects in the Placebo-Placebo group with complete data at all visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Drug | Percentage of Subjects With 20% or More Reduction From Baseline in PANSS Total Score After 2 Weeks of Treatment Using SPCD | Phase 1 % of subjects with >=20% reduction | 16.67 percent of subjects |
| Drug | Percentage of Subjects With 20% or More Reduction From Baseline in PANSS Total Score After 2 Weeks of Treatment Using SPCD | Phase 2 % of subjects with >=20% reduction | 0 percent of subjects |
| Placebo | Percentage of Subjects With 20% or More Reduction From Baseline in PANSS Total Score After 2 Weeks of Treatment Using SPCD | Phase 1 % of subjects with >=20% reduction | 0 percent of subjects |
| Placebo | Percentage of Subjects With 20% or More Reduction From Baseline in PANSS Total Score After 2 Weeks of Treatment Using SPCD | Phase 2 % of subjects with >=20% reduction | 5.56 percent of subjects |
Other Pre-specified
Average AIMS Total Scores (Items 1-7) by Group and Timepoint
Abnormal Involuntary Movement Scale (AIMS): The AIMS Total Dyskinesia Score was calculated by averaging the first 7 items of the AIMS. The 7 items included in the AIMS Dyskinesia Score are rated on a scale from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score ranges from 0 to 4; a higher score reflects increased severity.
Time frame: Baseline 1 (Day -1), 7 Hours Post-Infusion 1, Baseline 2 (Day 13), 7 Hours Post-Infusion 2, Final Follow-Up, including early termination visits
Population: Includes all subjects with AIMS data at Phases 1 and 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Drug | Average AIMS Total Scores (Items 1-7) by Group and Timepoint | 7 Hours Post-Infusion 2 | 0.47 units on a scale | Standard Deviation 0.87 |
| Drug | Average AIMS Total Scores (Items 1-7) by Group and Timepoint | Baseline 2 | 0.44 units on a scale | Standard Deviation 0.92 |
| Drug | Average AIMS Total Scores (Items 1-7) by Group and Timepoint | Baseline 1 | 0.72 units on a scale | Standard Deviation 1.41 |
| Drug | Average AIMS Total Scores (Items 1-7) by Group and Timepoint | 7 Hours Post-Infusion 1 | 0.56 units on a scale | Standard Deviation 1.1 |
| Drug | Average AIMS Total Scores (Items 1-7) by Group and Timepoint | Final follow-up | 1.00 units on a scale | Standard Deviation 2.09 |
| Placebo | Average AIMS Total Scores (Items 1-7) by Group and Timepoint | Baseline 2 | 1.00 units on a scale | Standard Deviation 1.47 |
| Placebo | Average AIMS Total Scores (Items 1-7) by Group and Timepoint | Baseline 1 | 0.56 units on a scale | Standard Deviation 0.96 |
| Placebo | Average AIMS Total Scores (Items 1-7) by Group and Timepoint | 7 Hours Post-Infusion 1 | 0.31 units on a scale | Standard Deviation 0.48 |
| Placebo | Average AIMS Total Scores (Items 1-7) by Group and Timepoint | 7 Hours Post-Infusion 2 | 0.54 units on a scale | Standard Deviation 0.88 |
| Placebo | Average AIMS Total Scores (Items 1-7) by Group and Timepoint | Final follow-up | 0.93 units on a scale | Standard Deviation 1.67 |
| Placebo - Placebo | Average AIMS Total Scores (Items 1-7) by Group and Timepoint | Final follow-up | 0.93 units on a scale | Standard Deviation 1.67 |
| Placebo - Placebo | Average AIMS Total Scores (Items 1-7) by Group and Timepoint | 7 Hours Post-Infusion 2 | 0.54 units on a scale | Standard Deviation 0.88 |
| Placebo - Placebo | Average AIMS Total Scores (Items 1-7) by Group and Timepoint | Baseline 1 | 0.56 units on a scale | Standard Deviation 0.96 |
| Placebo - Placebo | Average AIMS Total Scores (Items 1-7) by Group and Timepoint | Baseline 2 | 1.00 units on a scale | Standard Deviation 1.47 |
| Placebo - Placebo | Average AIMS Total Scores (Items 1-7) by Group and Timepoint | 7 Hours Post-Infusion 1 | 0.31 units on a scale | Standard Deviation 0.48 |
Other Pre-specified
Change in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) - Phases 1 and 2
MATRICS: The Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB). The MATRICS Consensus Cognitive Battery is the standard tool for assessing cognitive change in trials of cognitive-enhancing agents in schizophrenia. The MCCB domains include: Speed of Processing; Attention/Vigilance; Working Memory; Verbal Learning; Visual Learning; Reasoning & Problem-Solving; and Social Cognition and the battery takes about 80 minutes to complete. The MCCB composite score represents a global measure of cognition. MCCB composite T scores are between 40 and 60 (normal range) and \< 40 (below normal range).
Time frame: Phase 1 timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28
Population: Ph1 analysis includes 34 subjects with Baseline MATRICS data in the Placebo-Placebo (N=18) and Placebo-Drug (N=16) groups and 18 subjects the Drug-Drug group. Per SPCD, Ph 2 excludes the 18 subjects in the Drug-Drug group and includes the 14 subjects in the Placebo-Drug group and 18 subjects in the Placebo-Placebo group with Baseline MATRICS data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Drug | Change in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) - Phases 1 and 2 | Phase 1 - Baseline | 26.2 T-scores | Standard Deviation 14.3 |
| Drug | Change in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) - Phases 1 and 2 | Phase 1 - Day 14 | 29.3 T-scores | Standard Deviation 12.9 |
| Drug | Change in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) - Phases 1 and 2 | Phase 1 - Change | 3.1 T-scores | Standard Deviation 3.9 |
| Drug | Change in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) - Phases 1 and 2 | Phase 2 - Day 14 | 28.8 T-scores | Standard Deviation 12.8 |
| Drug | Change in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) - Phases 1 and 2 | Phase 2 - Day 28 | 30.3 T-scores | Standard Deviation 13.6 |
| Drug | Change in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) - Phases 1 and 2 | Phase 2 - Change | 3.3 T-scores | Standard Deviation 4.2 |
| Placebo | Change in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) - Phases 1 and 2 | Phase 2 - Day 28 | 31.0 T-scores | Standard Deviation 18 |
| Placebo | Change in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) - Phases 1 and 2 | Phase 1 - Baseline | 26.5 T-scores | Standard Deviation 14.5 |
| Placebo | Change in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) - Phases 1 and 2 | Phase 2 - Day 14 | 28.4 T-scores | Standard Deviation 18.8 |
| Placebo | Change in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) - Phases 1 and 2 | Phase 1 - Day 14 | 28.6 T-scores | Standard Deviation 16.2 |
| Placebo | Change in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) - Phases 1 and 2 | Phase 2 - Change | 2.6 T-scores | Standard Deviation 5.2 |
| Placebo | Change in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) - Phases 1 and 2 | Phase 1 - Change | 1.4 T-scores | Standard Deviation 5.1 |
p-value: 0.33ANCOVA
p-value: 0.34ANCOVA
Other Pre-specified
Change in The University of California San Diego (UCSD) Performance-based Skills Assessment Brief (UPSA-B) - Phases 1 and 2
The University of California San Diego (UCSD) Performance-based Skills Assessment Brief (UPSA-B) consists of two of the five original UPSA domains, finances and communication. Each subscale contributes 50 points; total scores range from 0 to 100 points with higher scores reflecting better performance.
Time frame: Phase 1 timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28
Population: Ph1 analysis includes 34 subjects with Baseline UPSA-B data in the Placebo-Placebo (N=18) and Placebo-Drug (N=16) groups and 18 subjects the Drug-Drug group. Per SPCD, Ph 2 excludes the 18 subjects in the Drug-Drug group and includes the 14 subjects in the Placebo-Drug group and 18 subjects in the Placebo-Placebo group with Baseline UPSA-B data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Drug | Change in The University of California San Diego (UCSD) Performance-based Skills Assessment Brief (UPSA-B) - Phases 1 and 2 | Phase 1 - Baseline | 74.0 units on a scale | Standard Deviation 17.2 |
| Drug | Change in The University of California San Diego (UCSD) Performance-based Skills Assessment Brief (UPSA-B) - Phases 1 and 2 | Phase 1 - Day 14 | 76.7 units on a scale | Standard Deviation 17.4 |
| Drug | Change in The University of California San Diego (UCSD) Performance-based Skills Assessment Brief (UPSA-B) - Phases 1 and 2 | Phase 1 - Change | 2.7 units on a scale | Standard Deviation 7.6 |
| Drug | Change in The University of California San Diego (UCSD) Performance-based Skills Assessment Brief (UPSA-B) - Phases 1 and 2 | Phase 2 - Day 14 | 80.2 units on a scale | Standard Deviation 13.1 |
| Drug | Change in The University of California San Diego (UCSD) Performance-based Skills Assessment Brief (UPSA-B) - Phases 1 and 2 | Phase 2 - Day 28 | 85.4 units on a scale | Standard Deviation 11.2 |
| Drug | Change in The University of California San Diego (UCSD) Performance-based Skills Assessment Brief (UPSA-B) - Phases 1 and 2 | Phase 2 - Change | 5.5 units on a scale | Standard Deviation 7.7 |
| Placebo | Change in The University of California San Diego (UCSD) Performance-based Skills Assessment Brief (UPSA-B) - Phases 1 and 2 | Phase 2 - Day 28 | 74.5 units on a scale | Standard Deviation 20.9 |
| Placebo | Change in The University of California San Diego (UCSD) Performance-based Skills Assessment Brief (UPSA-B) - Phases 1 and 2 | Phase 1 - Baseline | 71.8 units on a scale | Standard Deviation 17.1 |
| Placebo | Change in The University of California San Diego (UCSD) Performance-based Skills Assessment Brief (UPSA-B) - Phases 1 and 2 | Phase 2 - Day 14 | 76.0 units on a scale | Standard Deviation 15.9 |
| Placebo | Change in The University of California San Diego (UCSD) Performance-based Skills Assessment Brief (UPSA-B) - Phases 1 and 2 | Phase 1 - Day 14 | 77.9 units on a scale | Standard Deviation 14.6 |
| Placebo | Change in The University of California San Diego (UCSD) Performance-based Skills Assessment Brief (UPSA-B) - Phases 1 and 2 | Phase 2 - Change | -1.5 units on a scale | Standard Deviation 10.9 |
| Placebo | Change in The University of California San Diego (UCSD) Performance-based Skills Assessment Brief (UPSA-B) - Phases 1 and 2 | Phase 1 - Change | 6.2 units on a scale | Standard Deviation 9.9 |
p-value: 0.34ANCOVA
p-value: 0.36ANCOVA
Other Pre-specified
Diastolic Blood Pressure Per Infusion Phase by Group
Infusion 1 (Day 0) - Diastolic Blood Pressure at all time points by group Phase in this analysis refers to the infusion stage as defined in the protocol.
Time frame: Day 0 - Phase 1 - Baseline = min000s1 and @5 min; Phase 2 - Baseline = min000 then every 10 minutes for 4 hours; Post Infusion - Baseline = min000, then every 10 minutes for 2 hours
Population: Includes all subjects during Phase 1 (i.e., infusion 1)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min000 | 67.58 mmHg | Standard Deviation 10.18 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min005 | 67.17 mmHg | Standard Deviation 9.67 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min110 | 63.94 mmHg | Standard Deviation 6.97 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min070 | 70.22 mmHg | Standard Deviation 10.33 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min000 | 62.56 mmHg | Standard Deviation 8.69 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min120 | 66.94 mmHg | Standard Deviation 12.02 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min020 | 62.06 mmHg | Standard Deviation 9.33 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min240 | 63.47 mmHg | Standard Deviation 8.46 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min130 | 62.47 mmHg | Standard Deviation 8.87 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 1 - min005s1 | 68.79 mmHg | Standard Deviation 10.12 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min230 | 60.82 mmHg | Standard Deviation 9.13 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min140 | 61.94 mmHg | Standard Deviation 8.75 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min060 | 68.83 mmHg | Standard Deviation 10.44 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min220 | 63.47 mmHg | Standard Deviation 10.4 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min150 | 64.53 mmHg | Standard Deviation 6.38 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min025 | 62.33 mmHg | Standard Deviation 8.61 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min210 | 63.82 mmHg | Standard Deviation 9.51 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min160 | 61.88 mmHg | Standard Deviation 8.99 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min100 | 69.50 mmHg | Standard Deviation 9.24 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min200 | 64.18 mmHg | Standard Deviation 7.57 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min170 | 62.29 mmHg | Standard Deviation 6.28 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min050 | 69.56 mmHg | Standard Deviation 10.78 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min190 | 63.47 mmHg | Standard Deviation 9.41 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min180 | 62.06 mmHg | Standard Deviation 9.05 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min030 | 60.78 mmHg | Standard Deviation 8.93 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min005 | 66.37 mmHg | Standard Deviation 12.88 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min040 | 68.06 mmHg | Standard Deviation 11.43 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min040 | 61.29 mmHg | Standard Deviation 7.46 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min120 | 70.61 mmHg | Standard Deviation 9.86 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min030 | 69.67 mmHg | Standard Deviation 9 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min050 | 60.65 mmHg | Standard Deviation 7.52 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min090 | 69.89 mmHg | Standard Deviation 7.08 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min025 | 66.72 mmHg | Standard Deviation 11.4 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min060 | 61.88 mmHg | Standard Deviation 9.5 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min010 | 65.72 mmHg | Standard Deviation 14.7 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 1 - min000s1 | 71.63 mmHg | Standard Deviation 19.03 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min070 | 64.53 mmHg | Standard Deviation 11.21 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min110 | 71.61 mmHg | Standard Deviation 8.13 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min020 | 71.72 mmHg | Standard Deviation 11.1 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min080 | 62.41 mmHg | Standard Deviation 10.89 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min080 | 71.89 mmHg | Standard Deviation 10.02 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min015 | 69.00 mmHg | Standard Deviation 10.84 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min090 | 64.18 mmHg | Standard Deviation 11.48 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min015 | 62.67 mmHg | Standard Deviation 9.94 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min010 | 66.78 mmHg | Standard Deviation 9.9 |
| Drug | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min100 | 62.29 mmHg | Standard Deviation 8.96 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min020 | 77.80 mmHg | Standard Deviation 12.25 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 1 - min000s1 | 75.13 mmHg | Standard Deviation 10.44 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 1 - min005s1 | 75.38 mmHg | Standard Deviation 6.3 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min000 | 74.44 mmHg | Standard Deviation 7.28 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min005 | 74.31 mmHg | Standard Deviation 7.01 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min010 | 75.50 mmHg | Standard Deviation 8.09 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min015 | 74.75 mmHg | Standard Deviation 8.38 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min020 | 75.19 mmHg | Standard Deviation 8.29 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min025 | 74.31 mmHg | Standard Deviation 6.02 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min030 | 75.50 mmHg | Standard Deviation 8.09 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min040 | 75.06 mmHg | Standard Deviation 9.76 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min050 | 76.47 mmHg | Standard Deviation 10.23 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min060 | 75.80 mmHg | Standard Deviation 9.3 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min070 | 75.27 mmHg | Standard Deviation 9.62 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min080 | 76.73 mmHg | Standard Deviation 9.8 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min090 | 74.53 mmHg | Standard Deviation 9.81 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min100 | 74.87 mmHg | Standard Deviation 7.74 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min110 | 77.07 mmHg | Standard Deviation 12.02 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min120 | 74.20 mmHg | Standard Deviation 8.94 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min130 | 76.27 mmHg | Standard Deviation 8.44 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min140 | 78.27 mmHg | Standard Deviation 8.96 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min150 | 75.60 mmHg | Standard Deviation 8.1 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min160 | 75.53 mmHg | Standard Deviation 17.01 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min170 | 74.40 mmHg | Standard Deviation 9.3 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min180 | 74.20 mmHg | Standard Deviation 9.67 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min190 | 74.67 mmHg | Standard Deviation 7.48 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min200 | 78.60 mmHg | Standard Deviation 9.83 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min210 | 76.20 mmHg | Standard Deviation 8.83 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min220 | 76.00 mmHg | Standard Deviation 9.06 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min230 | 76.40 mmHg | Standard Deviation 7.95 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min240 | 76.53 mmHg | Standard Deviation 7.79 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min000 | 77.50 mmHg | Standard Deviation 8.4 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min005 | 76.40 mmHg | Standard Deviation 8.49 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min010 | 78.07 mmHg | Standard Deviation 9.03 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min015 | 76.20 mmHg | Standard Deviation 9.65 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min025 | 78.87 mmHg | Standard Deviation 10.8 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min030 | 78.81 mmHg | Standard Deviation 9.7 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min040 | 77.53 mmHg | Standard Deviation 10.85 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min050 | 78.40 mmHg | Standard Deviation 7.27 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min060 | 79.33 mmHg | Standard Deviation 11.17 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min070 | 78.13 mmHg | Standard Deviation 7.49 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min080 | 76.60 mmHg | Standard Deviation 7.49 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min090 | 79.07 mmHg | Standard Deviation 9.06 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min100 | 76.80 mmHg | Standard Deviation 10.75 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min110 | 76.53 mmHg | Standard Deviation 10.64 |
| Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min120 | 78.27 mmHg | Standard Deviation 8.4 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min000 | 74.67 mmHg | Standard Deviation 11.11 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min100 | 73.94 mmHg | Standard Deviation 11.5 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min120 | 75.89 mmHg | Standard Deviation 8.53 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min005 | 76.18 mmHg | Standard Deviation 9.19 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min090 | 73.11 mmHg | Standard Deviation 14.06 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min080 | 75.06 mmHg | Standard Deviation 13.17 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min010 | 75.56 mmHg | Standard Deviation 13.17 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min080 | 71.61 mmHg | Standard Deviation 11.69 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min005 | 74.39 mmHg | Standard Deviation 8.42 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min015 | 75.78 mmHg | Standard Deviation 11.33 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min070 | 71.11 mmHg | Standard Deviation 12.74 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min060 | 71.94 mmHg | Standard Deviation 11.11 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min020 | 75.61 mmHg | Standard Deviation 12.53 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min050 | 71.28 mmHg | Standard Deviation 10.06 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min110 | 74.22 mmHg | Standard Deviation 9.74 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min025 | 77.06 mmHg | Standard Deviation 10.8 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min040 | 72.67 mmHg | Standard Deviation 11.66 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min090 | 74.44 mmHg | Standard Deviation 10.07 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min030 | 75.33 mmHg | Standard Deviation 11.75 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min030 | 72.06 mmHg | Standard Deviation 11.67 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min000 | 74.72 mmHg | Standard Deviation 11.88 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min040 | 75.89 mmHg | Standard Deviation 11.84 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min025 | 72.83 mmHg | Standard Deviation 11.2 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 1 - min000s1 | 75.11 mmHg | Standard Deviation 10.12 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min050 | 75.17 mmHg | Standard Deviation 11.81 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min180 | 72.22 mmHg | Standard Deviation 12.74 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min170 | 72.83 mmHg | Standard Deviation 11.74 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min020 | 74.33 mmHg | Standard Deviation 12.25 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min190 | 73.56 mmHg | Standard Deviation 11.93 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min160 | 72.22 mmHg | Standard Deviation 10.5 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min100 | 73.56 mmHg | Standard Deviation 10.61 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min200 | 74.33 mmHg | Standard Deviation 11.63 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min150 | 73.83 mmHg | Standard Deviation 11.74 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min060 | 74.61 mmHg | Standard Deviation 10.87 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min210 | 75.56 mmHg | Standard Deviation 11.22 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min140 | 71.06 mmHg | Standard Deviation 10.98 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min015 | 72.78 mmHg | Standard Deviation 8.61 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min220 | 75.17 mmHg | Standard Deviation 12.94 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min130 | 69.72 mmHg | Standard Deviation 13.47 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 1 - min005s1 | 74.94 mmHg | Standard Deviation 9.91 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min230 | 74.17 mmHg | Standard Deviation 9.82 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min120 | 72.28 mmHg | Standard Deviation 14.71 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min070 | 75.28 mmHg | Standard Deviation 9.37 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min240 | 74.00 mmHg | Standard Deviation 10.19 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min110 | 72.06 mmHg | Standard Deviation 12.98 |
| Placebo - Placebo | Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min010 | 73.72 mmHg | Standard Deviation 9.5 |
Other Pre-specified
ECG Measures at All Time Points by Group
Infusion 2 (Day 14) - ECG measures at all time points by group
Time frame: Day 14 - Baseline (pre-infusion), During Infusion (@30 min), Post-Infusion (@60min)
Population: All subjects receiving a complete or partial Phase 2 infusion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Drug | ECG Measures at All Time Points by Group | Baseline_QRS Interval | 92.82 mm/sec | Standard Deviation 11.29 |
| Drug | ECG Measures at All Time Points by Group | 30min_PR Interval | 156.18 mm/sec | Standard Deviation 21.95 |
| Drug | ECG Measures at All Time Points by Group | End_QT Interval | 387.06 mm/sec | Standard Deviation 38.89 |
| Drug | ECG Measures at All Time Points by Group | End_QRS Interval | 95.41 mm/sec | Standard Deviation 9.9 |
| Drug | ECG Measures at All Time Points by Group | 30min_QRS Interval | 90.18 mm/sec | Standard Deviation 11.95 |
| Drug | ECG Measures at All Time Points by Group | Baseline_RR Interval | 0.80 mm/sec | Standard Deviation 0.17 |
| Drug | ECG Measures at All Time Points by Group | End_RR Interval | 0.80 mm/sec | Standard Deviation 0.16 |
| Drug | ECG Measures at All Time Points by Group | 30min_QT Interval | 389.18 mm/sec | Standard Deviation 25.33 |
| Drug | ECG Measures at All Time Points by Group | End_PR Interval | 160.41 mm/sec | Standard Deviation 26.48 |
| Drug | ECG Measures at All Time Points by Group | Baseline_QT Interval | 379.35 mm/sec | Standard Deviation 29.59 |
| Drug | ECG Measures at All Time Points by Group | 30min_RR Interval | 0.75 mm/sec | Standard Deviation 0.11 |
| Drug | ECG Measures at All Time Points by Group | Baseline_PR Interval | 155.47 mm/sec | Standard Deviation 23.46 |
| Placebo | ECG Measures at All Time Points by Group | 30min_RR Interval | 0.77 mm/sec | Standard Deviation 0.18 |
| Placebo | ECG Measures at All Time Points by Group | End_PR Interval | 153.55 mm/sec | Standard Deviation 19.87 |
| Placebo | ECG Measures at All Time Points by Group | End_QRS Interval | 86.64 mm/sec | Standard Deviation 9.9 |
| Placebo | ECG Measures at All Time Points by Group | End_QT Interval | 384.91 mm/sec | Standard Deviation 29.89 |
| Placebo | ECG Measures at All Time Points by Group | End_RR Interval | 0.86 mm/sec | Standard Deviation 0.11 |
| Placebo | ECG Measures at All Time Points by Group | Baseline_RR Interval | 0.86 mm/sec | Standard Deviation 0.16 |
| Placebo | ECG Measures at All Time Points by Group | 30min_PR Interval | 146.69 mm/sec | Standard Deviation 14.85 |
| Placebo | ECG Measures at All Time Points by Group | Baseline_QRS Interval | 86.46 mm/sec | Standard Deviation 10.05 |
| Placebo | ECG Measures at All Time Points by Group | 30min_QRS Interval | 87.00 mm/sec | Standard Deviation 7.98 |
| Placebo | ECG Measures at All Time Points by Group | Baseline_PR Interval | 149.46 mm/sec | Standard Deviation 15.61 |
| Placebo | ECG Measures at All Time Points by Group | 30min_QT Interval | 360.08 mm/sec | Standard Deviation 46.52 |
| Placebo | ECG Measures at All Time Points by Group | Baseline_QT Interval | 385.69 mm/sec | Standard Deviation 35.84 |
| Placebo - Placebo | ECG Measures at All Time Points by Group | End_RR Interval | 0.81 mm/sec | Standard Deviation 0.16 |
| Placebo - Placebo | ECG Measures at All Time Points by Group | Baseline_PR Interval | 167.61 mm/sec | Standard Deviation 20.02 |
| Placebo - Placebo | ECG Measures at All Time Points by Group | Baseline_QRS Interval | 91.33 mm/sec | Standard Deviation 12.45 |
| Placebo - Placebo | ECG Measures at All Time Points by Group | Baseline_QT Interval | 387.33 mm/sec | Standard Deviation 38.27 |
| Placebo - Placebo | ECG Measures at All Time Points by Group | Baseline_RR Interval | 0.84 mm/sec | Standard Deviation 0.19 |
| Placebo - Placebo | ECG Measures at All Time Points by Group | 30min_PR Interval | 172.00 mm/sec | Standard Deviation 19.76 |
| Placebo - Placebo | ECG Measures at All Time Points by Group | 30min_QRS Interval | 88.44 mm/sec | Standard Deviation 10.76 |
| Placebo - Placebo | ECG Measures at All Time Points by Group | 30min_QT Interval | 380.44 mm/sec | Standard Deviation 33.3 |
| Placebo - Placebo | ECG Measures at All Time Points by Group | 30min_RR Interval | 0.82 mm/sec | Standard Deviation 0.18 |
| Placebo - Placebo | ECG Measures at All Time Points by Group | End_QRS Interval | 89.50 mm/sec | Standard Deviation 9.97 |
| Placebo - Placebo | ECG Measures at All Time Points by Group | End_QT Interval | 383.25 mm/sec | Standard Deviation 31.6 |
| Placebo - Placebo | ECG Measures at All Time Points by Group | End_PR Interval | 165.63 mm/sec | Standard Deviation 21.08 |
Other Pre-specified
ECG Measures at All Time Points by Group
Infusion 1 (Day 0) - ECG measures at all time points by group
Time frame: Day 0 - Baseline (pre-infusion), During Infusion (@30 min), Post-Infusion (@60min)
Population: All subjects receiving a complete or partial Phase 1 infusion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Drug | ECG Measures at All Time Points by Group | Baseline_PR Interval | 162.84 mm/sec | Standard Deviation 30.09 |
| Drug | ECG Measures at All Time Points by Group | Baseline_QRS Interval | 91.37 mm/sec | Standard Deviation 11.37 |
| Drug | ECG Measures at All Time Points by Group | Baseline_QT Interval | 380.16 mm/sec | Standard Deviation 26.6 |
| Drug | ECG Measures at All Time Points by Group | Baseline_RR Interval | 0.81 mm/sec | Standard Deviation 0.19 |
| Drug | ECG Measures at All Time Points by Group | 30min_PR Interval | 159.63 mm/sec | Standard Deviation 34.81 |
| Drug | ECG Measures at All Time Points by Group | 30min_QRS Interval | 89.79 mm/sec | Standard Deviation 11.22 |
| Drug | ECG Measures at All Time Points by Group | 30min_QT Interval | 385.11 mm/sec | Standard Deviation 25.55 |
| Drug | ECG Measures at All Time Points by Group | 30min_RR Interval | 0.76 mm/sec | Standard Deviation 0.12 |
| Drug | ECG Measures at All Time Points by Group | End_PR Interval | 165.94 mm/sec | Standard Deviation 38.63 |
| Drug | ECG Measures at All Time Points by Group | End_QRS Interval | 91.67 mm/sec | Standard Deviation 13.43 |
| Drug | ECG Measures at All Time Points by Group | End_QT Interval | 371.94 mm/sec | Standard Deviation 41.97 |
| Drug | ECG Measures at All Time Points by Group | End_RR Interval | 0.79 mm/sec | Standard Deviation 0.12 |
| Placebo | ECG Measures at All Time Points by Group | End_RR Interval | 0.80 mm/sec | Standard Deviation 0.11 |
| Placebo | ECG Measures at All Time Points by Group | Baseline_PR Interval | 149.11 mm/sec | Standard Deviation 11.52 |
| Placebo | ECG Measures at All Time Points by Group | 30min_QT Interval | 385.27 mm/sec | Standard Deviation 29.72 |
| Placebo | ECG Measures at All Time Points by Group | End_PR Interval | 149.43 mm/sec | Standard Deviation 11.33 |
| Placebo | ECG Measures at All Time Points by Group | Baseline_QRS Interval | 86.89 mm/sec | Standard Deviation 8.76 |
| Placebo | ECG Measures at All Time Points by Group | 30min_QRS Interval | 88.00 mm/sec | Standard Deviation 10.39 |
| Placebo | ECG Measures at All Time Points by Group | End_QT Interval | 377.00 mm/sec | Standard Deviation 25.33 |
| Placebo | ECG Measures at All Time Points by Group | Baseline_QT Interval | 384.28 mm/sec | Standard Deviation 31.47 |
| Placebo | ECG Measures at All Time Points by Group | 30min_RR Interval | 0.81 mm/sec | Standard Deviation 0.16 |
| Placebo | ECG Measures at All Time Points by Group | 30min_PR Interval | 152.40 mm/sec | Standard Deviation 12.44 |
| Placebo | ECG Measures at All Time Points by Group | Baseline_RR Interval | 0.82 mm/sec | Standard Deviation 0.15 |
| Placebo | ECG Measures at All Time Points by Group | End_QRS Interval | 87.50 mm/sec | Standard Deviation 9.63 |
| Placebo - Placebo | ECG Measures at All Time Points by Group | Baseline_RR Interval | 0.81 mm/sec | Standard Deviation 0.19 |
| Placebo - Placebo | ECG Measures at All Time Points by Group | 30min_PR Interval | 167.59 mm/sec | Standard Deviation 21.3 |
| Placebo - Placebo | ECG Measures at All Time Points by Group | End_QRS Interval | 89.00 mm/sec | Standard Deviation 10.09 |
| Placebo - Placebo | ECG Measures at All Time Points by Group | 30min_QRS Interval | 89.12 mm/sec | Standard Deviation 9.97 |
| Placebo - Placebo | ECG Measures at All Time Points by Group | 30min_QT Interval | 385.53 mm/sec | Standard Deviation 42.92 |
| Placebo - Placebo | ECG Measures at All Time Points by Group | 30min_RR Interval | 0.81 mm/sec | Standard Deviation 0.2 |
| Placebo - Placebo | ECG Measures at All Time Points by Group | End_QT Interval | 391.13 mm/sec | Standard Deviation 43.35 |
| Placebo - Placebo | ECG Measures at All Time Points by Group | Baseline_PR Interval | 164.56 mm/sec | Standard Deviation 19.61 |
| Placebo - Placebo | ECG Measures at All Time Points by Group | Baseline_QRS Interval | 88.11 mm/sec | Standard Deviation 10.12 |
| Placebo - Placebo | ECG Measures at All Time Points by Group | End_PR Interval | 165.63 mm/sec | Standard Deviation 25.23 |
| Placebo - Placebo | ECG Measures at All Time Points by Group | Baseline_QT Interval | 381.94 mm/sec | Standard Deviation 36.5 |
| Placebo - Placebo | ECG Measures at All Time Points by Group | End_RR Interval | 0.82 mm/sec | Standard Deviation 0.2 |
Other Pre-specified
Heart Rate Per Infusion Phase by Group
Infusion 1 (Day 0) - Heart rate at all time points by group Phase in this analysis refers to the infusion stage as defined in the protocol.
Time frame: Day 0 - Phase 1 - Baseline = min000s1 and @5 min; Phase 2 - Baseline = min000 then every 10 minutes for 4 hours; Post Infusion - Baseline = min000, then every 10 minutes for 2 hours
Population: Includes all subjects during Phase 1 (i.e., infusion 1)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min000 | 84.00 bpm | Standard Deviation 13.81 |
| Drug | Heart Rate Per Infusion Phase by Group | Post Infusion - min005 | 80.39 bpm | Standard Deviation 12.46 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min110 | 85.18 bpm | Standard Deviation 12.54 |
| Drug | Heart Rate Per Infusion Phase by Group | Post Infusion - min070 | 79.83 bpm | Standard Deviation 10.74 |
| Drug | Heart Rate Per Infusion Phase by Group | Post Infusion - min000 | 86.28 bpm | Standard Deviation 11.96 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min120 | 83.71 bpm | Standard Deviation 11.97 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min020 | 83.00 bpm | Standard Deviation 13.84 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min240 | 85.29 bpm | Standard Deviation 12.01 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min130 | 83.59 bpm | Standard Deviation 12.5 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 1 - min005s1 | 81.21 bpm | Standard Deviation 15.79 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min230 | 84.47 bpm | Standard Deviation 12.96 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min140 | 81.76 bpm | Standard Deviation 11.99 |
| Drug | Heart Rate Per Infusion Phase by Group | Post Infusion - min060 | 79.17 bpm | Standard Deviation 11.93 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min220 | 82.94 bpm | Standard Deviation 12.29 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min150 | 82.06 bpm | Standard Deviation 13.38 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min025 | 83.83 bpm | Standard Deviation 14.61 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min210 | 81.24 bpm | Standard Deviation 11.68 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min160 | 83.41 bpm | Standard Deviation 11.49 |
| Drug | Heart Rate Per Infusion Phase by Group | Post Infusion - min100 | 79.17 bpm | Standard Deviation 12.66 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min200 | 83.41 bpm | Standard Deviation 11.37 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min170 | 83.88 bpm | Standard Deviation 11.19 |
| Drug | Heart Rate Per Infusion Phase by Group | Post Infusion - min050 | 79.06 bpm | Standard Deviation 12.32 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min190 | 83.24 bpm | Standard Deviation 12.4 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min180 | 82.12 bpm | Standard Deviation 10.34 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min030 | 83.94 bpm | Standard Deviation 14.21 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min005 | 85.47 bpm | Standard Deviation 13.49 |
| Drug | Heart Rate Per Infusion Phase by Group | Post Infusion - min040 | 79.72 bpm | Standard Deviation 12.55 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min040 | 83.06 bpm | Standard Deviation 13.98 |
| Drug | Heart Rate Per Infusion Phase by Group | Post Infusion - min120 | 79.56 bpm | Standard Deviation 11.98 |
| Drug | Heart Rate Per Infusion Phase by Group | Post Infusion - min030 | 79.39 bpm | Standard Deviation 13.56 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min050 | 83.65 bpm | Standard Deviation 14.28 |
| Drug | Heart Rate Per Infusion Phase by Group | Post Infusion - min090 | 79.11 bpm | Standard Deviation 12.36 |
| Drug | Heart Rate Per Infusion Phase by Group | Post Infusion - min025 | 79.78 bpm | Standard Deviation 11.83 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min060 | 83.59 bpm | Standard Deviation 13.86 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min010 | 85.17 bpm | Standard Deviation 13.44 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 1 - min000s1 | 78.47 bpm | Standard Deviation 13.11 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min070 | 82.53 bpm | Standard Deviation 13.73 |
| Drug | Heart Rate Per Infusion Phase by Group | Post Infusion - min110 | 79.67 bpm | Standard Deviation 11.74 |
| Drug | Heart Rate Per Infusion Phase by Group | Post Infusion - min020 | 82.06 bpm | Standard Deviation 10.78 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min080 | 84.76 bpm | Standard Deviation 13.37 |
| Drug | Heart Rate Per Infusion Phase by Group | Post Infusion - min080 | 78.44 bpm | Standard Deviation 10.92 |
| Drug | Heart Rate Per Infusion Phase by Group | Post Infusion - min015 | 80.67 bpm | Standard Deviation 10.32 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min090 | 83.82 bpm | Standard Deviation 12.73 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min015 | 84.33 bpm | Standard Deviation 13.97 |
| Drug | Heart Rate Per Infusion Phase by Group | Post Infusion - min010 | 80.78 bpm | Standard Deviation 12.74 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min100 | 84.29 bpm | Standard Deviation 12.46 |
| Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min020 | 82.13 bpm | Standard Deviation 13.91 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 1 - min000s1 | 79.00 bpm | Standard Deviation 15.84 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 1 - min005s1 | 77.81 bpm | Standard Deviation 14.39 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min000 | 76.94 bpm | Standard Deviation 15.05 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min005 | 77.88 bpm | Standard Deviation 15.13 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min010 | 77.25 bpm | Standard Deviation 14.75 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min015 | 78.00 bpm | Standard Deviation 14.01 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min020 | 76.44 bpm | Standard Deviation 14.77 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min025 | 77.13 bpm | Standard Deviation 13.61 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min030 | 76.69 bpm | Standard Deviation 14.38 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min040 | 77.88 bpm | Standard Deviation 14.42 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min050 | 76.67 bpm | Standard Deviation 13.28 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min060 | 78.13 bpm | Standard Deviation 12.88 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min070 | 77.07 bpm | Standard Deviation 12.66 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min080 | 76.47 bpm | Standard Deviation 15.08 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min090 | 77.80 bpm | Standard Deviation 14.36 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min100 | 78.53 bpm | Standard Deviation 12.82 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min110 | 76.73 bpm | Standard Deviation 11.66 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min120 | 78.47 bpm | Standard Deviation 13.52 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min130 | 77.33 bpm | Standard Deviation 12.66 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min140 | 77.60 bpm | Standard Deviation 12.79 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min150 | 79.67 bpm | Standard Deviation 11.79 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min160 | 78.73 bpm | Standard Deviation 11.81 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min170 | 79.07 bpm | Standard Deviation 13.57 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min180 | 77.53 bpm | Standard Deviation 13.72 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min190 | 79.40 bpm | Standard Deviation 15.08 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min200 | 79.27 bpm | Standard Deviation 13.42 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min210 | 80.27 bpm | Standard Deviation 14.39 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min220 | 79.93 bpm | Standard Deviation 14.1 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min230 | 79.87 bpm | Standard Deviation 15.06 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min240 | 79.40 bpm | Standard Deviation 13.74 |
| Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min000 | 82.44 bpm | Standard Deviation 14.81 |
| Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min005 | 80.80 bpm | Standard Deviation 15.81 |
| Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min010 | 78.67 bpm | Standard Deviation 1317 |
| Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min015 | 79.93 bpm | Standard Deviation 13.34 |
| Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min025 | 81.60 bpm | Standard Deviation 13.83 |
| Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min030 | 82.13 bpm | Standard Deviation 13.07 |
| Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min040 | 81.47 bpm | Standard Deviation 13.41 |
| Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min050 | 78.47 bpm | Standard Deviation 13.45 |
| Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min060 | 79.40 bpm | Standard Deviation 12.4 |
| Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min070 | 81.87 bpm | Standard Deviation 15.81 |
| Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min080 | 83.87 bpm | Standard Deviation 11.54 |
| Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min090 | 82.33 bpm | Standard Deviation 12.82 |
| Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min100 | 84.67 bpm | Standard Deviation 12.58 |
| Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min110 | 82.80 bpm | Standard Deviation 13.61 |
| Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min120 | 83.47 bpm | Standard Deviation 13.44 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min000 | 78.11 bpm | Standard Deviation 16.91 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min100 | 75.94 bpm | Standard Deviation 16.31 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min120 | 80.00 bpm | Standard Deviation 16.37 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min005 | 80.29 bpm | Standard Deviation 16.13 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min090 | 76.22 bpm | Standard Deviation 17.13 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min080 | 80.33 bpm | Standard Deviation 16.22 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min010 | 78.83 bpm | Standard Deviation 14.77 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min080 | 76.89 bpm | Standard Deviation 17.83 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min005 | 78.00 bpm | Standard Deviation 17.19 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min015 | 79.39 bpm | Standard Deviation 15.79 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min070 | 77.11 bpm | Standard Deviation 17.27 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min060 | 78.56 bpm | Standard Deviation 17.12 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min020 | 80.33 bpm | Standard Deviation 16.94 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min050 | 79.50 bpm | Standard Deviation 18.06 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min110 | 80.61 bpm | Standard Deviation 16.55 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min025 | 78.22 bpm | Standard Deviation 17.13 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min040 | 77.56 bpm | Standard Deviation 18.1 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min090 | 79.22 bpm | Standard Deviation 17.16 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min030 | 79.72 bpm | Standard Deviation 16.44 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min030 | 78.83 bpm | Standard Deviation 17.57 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min000 | 79.94 bpm | Standard Deviation 16.86 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min040 | 78.72 bpm | Standard Deviation 15.97 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min025 | 77.06 bpm | Standard Deviation 17.12 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 1 - min000s1 | 79.94 bpm | Standard Deviation 17.67 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min050 | 81.28 bpm | Standard Deviation 15.18 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min180 | 78.56 bpm | Standard Deviation 16.76 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min170 | 76.44 bpm | Standard Deviation 18.07 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min020 | 79.28 bpm | Standard Deviation 17.28 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min190 | 76.89 bpm | Standard Deviation 16.36 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min160 | 79.33 bpm | Standard Deviation 16.11 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min100 | 80.00 bpm | Standard Deviation 16.95 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min200 | 80.00 bpm | Standard Deviation 15.98 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min150 | 76.06 bpm | Standard Deviation 15.42 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min060 | 78.83 bpm | Standard Deviation 15.96 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min210 | 77.50 bpm | Standard Deviation 15.57 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min140 | 75.28 bpm | Standard Deviation 16.35 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min015 | 77.89 bpm | Standard Deviation 17.33 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min220 | 77.33 bpm | Standard Deviation 16.83 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min130 | 75.94 bpm | Standard Deviation 15.69 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 1 - min005s1 | 79.44 bpm | Standard Deviation 16.33 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min230 | 78.78 bpm | Standard Deviation 16.75 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min120 | 78.39 bpm | Standard Deviation 20.37 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min070 | 79.94 bpm | Standard Deviation 14.49 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min240 | 78.56 bpm | Standard Deviation 16.85 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min110 | 75.44 bpm | Standard Deviation 16.76 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min010 | 79.61 bpm | Standard Deviation 16.75 |
Other Pre-specified
Heart Rate Per Infusion Phase by Group
Infusion 2 (Day 14) - Heart rate at all time points by group Phase in this analysis refers to the infusion stage as defined in the protocol.
Time frame: Day 14 - Phase 1 - Baseline = min000s1 and @5 min; Phase 2 - Baseline = min000 then every 10 minutes for 4 hours; Post Infusion - Baseline = min000, then every 10 minutes for 2 hours
Population: Includes all subjects during Phase 1 (i.e., infusion 1)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min000 | 81.06 bpm | Standard Deviation 11.25 |
| Drug | Heart Rate Per Infusion Phase by Group | Post Infusion - min005 | 77.44 bpm | Standard Deviation 12.19 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min110 | 83.33 bpm | Standard Deviation 11.58 |
| Drug | Heart Rate Per Infusion Phase by Group | Post Infusion - min070 | 78.81 bpm | Standard Deviation 11.12 |
| Drug | Heart Rate Per Infusion Phase by Group | Post Infusion - min000 | 81.50 bpm | Standard Deviation 13.85 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min120 | 82.47 bpm | Standard Deviation 12.97 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min020 | 82.06 bpm | Standard Deviation 12.13 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min240 | 82.53 bpm | Standard Deviation 13.73 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min130 | 82.13 bpm | Standard Deviation 13.03 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 1 - min005s1 | 79.69 bpm | Standard Deviation 12.43 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min230 | 85.07 bpm | Standard Deviation 11.78 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min140 | 81.73 bpm | Standard Deviation 13.95 |
| Drug | Heart Rate Per Infusion Phase by Group | Post Infusion - min060 | 78.00 bpm | Standard Deviation 11.35 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min220 | 84.07 bpm | Standard Deviation 12.55 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min150 | 81.40 bpm | Standard Deviation 12.57 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min025 | 82.31 bpm | Standard Deviation 12.35 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min210 | 84.73 bpm | Standard Deviation 11.93 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min160 | 81.53 bpm | Standard Deviation 13.2 |
| Drug | Heart Rate Per Infusion Phase by Group | Post Infusion - min100 | 80.06 bpm | Standard Deviation 10.51 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min200 | 81.60 bpm | Standard Deviation 14.39 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min170 | 81.60 bpm | Standard Deviation 14.46 |
| Drug | Heart Rate Per Infusion Phase by Group | Post Infusion - min050 | 79.00 bpm | Standard Deviation 11.89 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min190 | 80.93 bpm | Standard Deviation 12.91 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min180 | 80.00 bpm | Standard Deviation 12.91 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min030 | 81.50 bpm | Standard Deviation 10.22 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min005 | 82.31 bpm | Standard Deviation 12.88 |
| Drug | Heart Rate Per Infusion Phase by Group | Post Infusion - min040 | 80.63 bpm | Standard Deviation 16.66 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min040 | 79.88 bpm | Standard Deviation 13.61 |
| Drug | Heart Rate Per Infusion Phase by Group | Post Infusion - min120 | 80.19 bpm | Standard Deviation 11.73 |
| Drug | Heart Rate Per Infusion Phase by Group | Post Infusion - min030 | 80.31 bpm | Standard Deviation 11.16 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min050 | 80.25 bpm | Standard Deviation 12.23 |
| Drug | Heart Rate Per Infusion Phase by Group | Post Infusion - min090 | 80.25 bpm | Standard Deviation 10.07 |
| Drug | Heart Rate Per Infusion Phase by Group | Post Infusion - min025 | 79.25 bpm | Standard Deviation 12.46 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min060 | 79.69 bpm | Standard Deviation 15.12 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min010 | 81.50 bpm | Standard Deviation 13.46 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 1 - min000s1 | 77.38 bpm | Standard Deviation 11.77 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min070 | 81.69 bpm | Standard Deviation 13.85 |
| Drug | Heart Rate Per Infusion Phase by Group | Post Infusion - min110 | 79.88 bpm | Standard Deviation 10.25 |
| Drug | Heart Rate Per Infusion Phase by Group | Post Infusion - min020 | 78.88 bpm | Standard Deviation 13.72 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min080 | 79.44 bpm | Standard Deviation 13.93 |
| Drug | Heart Rate Per Infusion Phase by Group | Post Infusion - min080 | 80.69 bpm | Standard Deviation 10.87 |
| Drug | Heart Rate Per Infusion Phase by Group | Post Infusion - min015 | 75.13 bpm | Standard Deviation 13.59 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min090 | 78.00 bpm | Standard Deviation 14.58 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min015 | 81.38 bpm | Standard Deviation 12.99 |
| Drug | Heart Rate Per Infusion Phase by Group | Post Infusion - min010 | 77.38 bpm | Standard Deviation 13.64 |
| Drug | Heart Rate Per Infusion Phase by Group | Phase 2 - min100 | 79.94 bpm | Standard Deviation 14.29 |
| Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min020 | 76.92 bpm | Standard Deviation 11.24 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 1 - min000s1 | 75.08 bpm | Standard Deviation 13.94 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 1 - min005s1 | 76.77 bpm | Standard Deviation 14.86 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min000 | 77.77 bpm | Standard Deviation 15.24 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min005 | 81.38 bpm | Standard Deviation 15.32 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min010 | 80.62 bpm | Standard Deviation 16.44 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min015 | 80.92 bpm | Standard Deviation 15.4 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min020 | 79.69 bpm | Standard Deviation 16.73 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min025 | 80.69 bpm | Standard Deviation 18.08 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min030 | 81.15 bpm | Standard Deviation 16.32 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min040 | 81.69 bpm | Standard Deviation 15.5 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min050 | 78.85 bpm | Standard Deviation 15.42 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min060 | 79.69 bpm | Standard Deviation 14.63 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min070 | 81.31 bpm | Standard Deviation 13.53 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min080 | 80.23 bpm | Standard Deviation 14.11 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min090 | 79.58 bpm | Standard Deviation 14.71 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min100 | 78.17 bpm | Standard Deviation 14.66 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min110 | 80.15 bpm | Standard Deviation 15.51 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min120 | 81.25 bpm | Standard Deviation 16.16 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min130 | 78.75 bpm | Standard Deviation 15.24 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min140 | 80.69 bpm | Standard Deviation 14.92 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min150 | 78.75 bpm | Standard Deviation 13.59 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min160 | 80.00 bpm | Standard Deviation 11.26 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min170 | 78.75 bpm | Standard Deviation 12.55 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min180 | 81.25 bpm | Standard Deviation 12.81 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min190 | 80.58 bpm | Standard Deviation 16.37 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min200 | 80.33 bpm | Standard Deviation 14.27 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min210 | 80.75 bpm | Standard Deviation 17.12 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min220 | 79.92 bpm | Standard Deviation 13.92 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min230 | 78.00 bpm | Standard Deviation 14.59 |
| Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min240 | 80.42 bpm | Standard Deviation 12.55 |
| Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min000 | 79.25 bpm | Standard Deviation 14.77 |
| Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min005 | 73.25 bpm | Standard Deviation 13.97 |
| Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min010 | 73.75 bpm | Standard Deviation 13.6 |
| Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min015 | 75.17 bpm | Standard Deviation 12.71 |
| Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min025 | 75.75 bpm | Standard Deviation 14.14 |
| Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min030 | 74.83 bpm | Standard Deviation 11.76 |
| Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min040 | 74.92 bpm | Standard Deviation 10.42 |
| Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min050 | 75.67 bpm | Standard Deviation 12.2 |
| Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min060 | 77.08 bpm | Standard Deviation 13.21 |
| Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min070 | 77.75 bpm | Standard Deviation 13.92 |
| Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min080 | 75.92 bpm | Standard Deviation 14.85 |
| Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min090 | 78.42 bpm | Standard Deviation 16.55 |
| Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min100 | 79.75 bpm | Standard Deviation 16.8 |
| Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min110 | 77.50 bpm | Standard Deviation 16.94 |
| Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min120 | 80.83 bpm | Standard Deviation 17.02 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min000 | 76.22 bpm | Standard Deviation 16.13 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min100 | 76.11 bpm | Standard Deviation 15.15 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min120 | 78.44 bpm | Standard Deviation 14.3 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min005 | 79.06 bpm | Standard Deviation 16 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min090 | 73.78 bpm | Standard Deviation 15.56 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min080 | 78.06 bpm | Standard Deviation 14.94 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min010 | 77.78 bpm | Standard Deviation 15.38 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min080 | 75.39 bpm | Standard Deviation 14.61 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min005 | 76.39 bpm | Standard Deviation 17.77 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min015 | 78.83 bpm | Standard Deviation 14.5 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min070 | 75.06 bpm | Standard Deviation 16.28 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min060 | 75.50 bpm | Standard Deviation 15.75 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min020 | 78.39 bpm | Standard Deviation 14.74 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min050 | 75.00 bpm | Standard Deviation 16.3 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min110 | 80.22 bpm | Standard Deviation 14.72 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min025 | 77.44 bpm | Standard Deviation 12.87 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min040 | 76.72 bpm | Standard Deviation 15.35 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min090 | 78.89 bpm | Standard Deviation 14.29 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min030 | 78.33 bpm | Standard Deviation 13.92 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min030 | 76.17 bpm | Standard Deviation 15.73 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min000 | 78.72 bpm | Standard Deviation 17.75 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min040 | 78.39 bpm | Standard Deviation 13.85 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min025 | 76.22 bpm | Standard Deviation 16.81 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 1 - min000s1 | 76.94 bpm | Standard Deviation 18.5 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min050 | 78.33 bpm | Standard Deviation 14.58 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min180 | 74.78 bpm | Standard Deviation 14.1 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min170 | 75.06 bpm | Standard Deviation 14.43 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min020 | 74.89 bpm | Standard Deviation 16.97 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min190 | 73.94 bpm | Standard Deviation 14.18 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min160 | 75.33 bpm | Standard Deviation 13.75 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min100 | 80.17 bpm | Standard Deviation 14.29 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min200 | 75.00 bpm | Standard Deviation 12.63 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min150 | 75.78 bpm | Standard Deviation 14.53 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min060 | 79.11 bpm | Standard Deviation 13.64 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min210 | 75.33 bpm | Standard Deviation 15.04 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min140 | 75.89 bpm | Standard Deviation 15.87 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min015 | 76.06 bpm | Standard Deviation 17.11 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min220 | 74.61 bpm | Standard Deviation 14.46 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min130 | 75.11 bpm | Standard Deviation 13.6 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 1 - min005s1 | 78.67 bpm | Standard Deviation 17.85 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min230 | 77.56 bpm | Standard Deviation 14.61 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min120 | 74.56 bpm | Standard Deviation 14.27 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Post Infusion - min070 | 77.50 bpm | Standard Deviation 13.95 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min240 | 76.72 bpm | Standard Deviation 15.69 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min110 | 75.17 bpm | Standard Deviation 15.52 |
| Placebo - Placebo | Heart Rate Per Infusion Phase by Group | Phase 2 - min010 | 77.12 bpm | Standard Deviation 17.19 |
Other Pre-specified
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Incidence of Treatment-Emergent Adverse Events (TEAE) by Treatment Group. A treatment emergent adverse event (TEAE) is an AE that either began following initiation of study treatment or was present prior to the initiation of the treatment, but increased in frequency or severity following initiation treatment, regardless of causality.
Time frame: The period of observation for collection of treatment-emergent adverse events extends from Day 0 treatment through the final visit at Day 28.
Population: Number of Treatment-Emergent Adverse Events (TEAEs) in Each Treatment Group
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Drug | Incidence of Treatment-Emergent Adverse Events (TEAEs) | 13 # of TEAEs |
| Placebo | Incidence of Treatment-Emergent Adverse Events (TEAEs) | 8 # of TEAEs |
| Placebo - Placebo | Incidence of Treatment-Emergent Adverse Events (TEAEs) | 10 # of TEAEs |
Other Pre-specified
Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS)
The Columbia Suicide Severity Rating Scale (C-SSRS): The C-SSRS is a low-burden measure of the spectrum of suicidal ideation and behavior that was developed in the National Institute of Mental Health Treatment of Adolescent Suicide Attempters Study to assess severity and track suicidal events through any treatment. It is a clinical interview providing a summary of both ideation and behavior that can be administered during any evaluation or risk assessment to identify the level and type of suicidality present. The C-SSRS can also be used during treatment to monitor for clinical worsening or improvement. It contains 5 rating scale questions (yes/no) for suicidal ideation increasing severity and 5 rating scale questions (yes/no) for suicidal behavior of increasing severity. The time frame is for both lifetime and the past six months for the Baseline/Screening scale and since the last visit for the Since Last Visit scale.
Time frame: Screening Visit, Days 3 (Baseline 1), Days 7, 13 (Baseline 2), 21 and 28
Population: All subjects with C-SSRS data reporting suicidal ideation/behavior
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Drug | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Suicidal ideation (SI) (% any of the following) | 2 Participants |
| Drug | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Wish to be dead | 1 Participants |
| Drug | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Non-specific active suicidal thoughts | 2 Participants |
| Drug | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Active SI w/any method (no plan) W/O intent to act | 0 Participants |
| Drug | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Active SI w/some intent to act, W/O specific plan | 0 Participants |
| Drug | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Active SI with specific plan & intent | 0 Participants |
| Drug | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Suicidal behavior (% any of the following) | 0 Participants |
| Drug | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Prepatory acts or behavior | 0 Participants |
| Drug | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Aborted attempt | 0 Participants |
| Drug | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Interrupted attempt | 0 Participants |
| Drug | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Non-fatal suicide attempt | 0 Participants |
| Drug | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Self-injurious behavior W/O suicidal intent | 0 Participants |
| Placebo | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Self-injurious behavior W/O suicidal intent | 0 Participants |
| Placebo | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Suicidal ideation (SI) (% any of the following) | 1 Participants |
| Placebo | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Suicidal behavior (% any of the following) | 0 Participants |
| Placebo | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Aborted attempt | 0 Participants |
| Placebo | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Wish to be dead | 1 Participants |
| Placebo | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Active SI with specific plan & intent | 0 Participants |
| Placebo | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Non-fatal suicide attempt | 0 Participants |
| Placebo | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Non-specific active suicidal thoughts | 1 Participants |
| Placebo | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Prepatory acts or behavior | 0 Participants |
| Placebo | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Active SI w/some intent to act, W/O specific plan | 0 Participants |
| Placebo | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Active SI w/any method (no plan) W/O intent to act | 0 Participants |
| Placebo | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Interrupted attempt | 0 Participants |
| Placebo - Placebo | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Active SI w/any method (no plan) W/O intent to act | 0 Participants |
| Placebo - Placebo | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Active SI w/some intent to act, W/O specific plan | 0 Participants |
| Placebo - Placebo | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Interrupted attempt | 0 Participants |
| Placebo - Placebo | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Active SI with specific plan & intent | 0 Participants |
| Placebo - Placebo | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Suicidal behavior (% any of the following) | 0 Participants |
| Placebo - Placebo | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Prepatory acts or behavior | 0 Participants |
| Placebo - Placebo | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Non-fatal suicide attempt | 0 Participants |
| Placebo - Placebo | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Suicidal ideation (SI) (% any of the following) | 2 Participants |
| Placebo - Placebo | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Wish to be dead | 1 Participants |
| Placebo - Placebo | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Aborted attempt | 0 Participants |
| Placebo - Placebo | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Non-specific active suicidal thoughts | 1 Participants |
| Placebo - Placebo | Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS) | Self-injurious behavior W/O suicidal intent | 0 Participants |
Other Pre-specified
Number of Subject Withdrawals Due to Treatment-Emergent Adverse Events (TEAEs)
Incidence of Treatment-Emergent Adverse Events (TEAE) by Treatment Group. A treatment emergent adverse event (TEAE) is an AE that either began following initiation of study treatment or was present prior to the initiation of the treatment, but increased in frequency or severity following initiation treatment, regardless of causality.
Time frame: The period of observation extends from Day 0 treatment through the final visit at Day 28
Population: All subjects withdrawn from the study due to TEAEs
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Drug | Number of Subject Withdrawals Due to Treatment-Emergent Adverse Events (TEAEs) | 3 participants |
| Placebo | Number of Subject Withdrawals Due to Treatment-Emergent Adverse Events (TEAEs) | 4 participants |
| Placebo - Placebo | Number of Subject Withdrawals Due to Treatment-Emergent Adverse Events (TEAEs) | 0 participants |
Other Pre-specified
Percent of Participants Rated as ≥ Mild or as Yes on AIMS Items 8-12
Abnormal Involuntary Movement Scale (AIMS): The AIMS is a 12-item anchored score that is clinician administered and scored. Items are scored on a 0 (none) to 4 (severe) basis; items 8-10 deal with global severity; items 11-12 are yes-no questions concerning problems with teeth and/or dentures.
Time frame: Baseline (Day -1), Follow-Up = reported at any assessment thereafter, including 7 hours after Infusions #1 and #2, Baseline 2 (Day 13) and final follow-up, including early termination visits.
Population: For each item, percentages of participants rated as exhibiting behaviors at the mild level or higher, or for items 11 and 12, as being present versus not (yes/no rated) are provided per treatment group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Drug | Percent of Participants Rated as ≥ Mild or as Yes on AIMS Items 8-12 | Follow-Up - Incapacitation (Item 9) | 0.0 percentage of participants |
| Drug | Percent of Participants Rated as ≥ Mild or as Yes on AIMS Items 8-12 | Follow-Up - Dental Problem (Item 11; % yes) | 27.8 percentage of participants |
| Drug | Percent of Participants Rated as ≥ Mild or as Yes on AIMS Items 8-12 | Follow-Up - Overall Severity Index (Item 8) | 16.7 percentage of participants |
| Drug | Percent of Participants Rated as ≥ Mild or as Yes on AIMS Items 8-12 | Baseline - Awareness (Item 10) | 11.1 percentage of participants |
| Drug | Percent of Participants Rated as ≥ Mild or as Yes on AIMS Items 8-12 | Baseline - Incapacitation (Item 9) | 0.0 percentage of participants |
| Drug | Percent of Participants Rated as ≥ Mild or as Yes on AIMS Items 8-12 | Follow-Up - Awareness (Item 10) | 5.6 percentage of participants |
| Drug | Percent of Participants Rated as ≥ Mild or as Yes on AIMS Items 8-12 | Follow-Up - Dentures (Item 12; % yes) | 11.1 percentage of participants |
| Drug | Percent of Participants Rated as ≥ Mild or as Yes on AIMS Items 8-12 | Baseline - Dentures (Item 12; % yes) | 5.6 percentage of participants |
| Drug | Percent of Participants Rated as ≥ Mild or as Yes on AIMS Items 8-12 | Baseline - Dental Problem (Item 11; % yes) | 22.2 percentage of participants |
| Drug | Percent of Participants Rated as ≥ Mild or as Yes on AIMS Items 8-12 | Baseline - Overall Severity Index (Item 8) | 5.6 percentage of participants |
| Placebo | Percent of Participants Rated as ≥ Mild or as Yes on AIMS Items 8-12 | Baseline - Dental Problem (Item 11; % yes) | 31.3 percentage of participants |
| Placebo | Percent of Participants Rated as ≥ Mild or as Yes on AIMS Items 8-12 | Follow-Up - Dental Problem (Item 11; % yes) | 37.5 percentage of participants |
| Placebo | Percent of Participants Rated as ≥ Mild or as Yes on AIMS Items 8-12 | Baseline - Dentures (Item 12; % yes) | 18.8 percentage of participants |
| Placebo | Percent of Participants Rated as ≥ Mild or as Yes on AIMS Items 8-12 | Baseline - Incapacitation (Item 9) | 0.0 percentage of participants |
| Placebo | Percent of Participants Rated as ≥ Mild or as Yes on AIMS Items 8-12 | Follow-Up - Dentures (Item 12; % yes) | 31.3 percentage of participants |
| Placebo | Percent of Participants Rated as ≥ Mild or as Yes on AIMS Items 8-12 | Follow-Up - Incapacitation (Item 9) | 6.3 percentage of participants |
| Placebo | Percent of Participants Rated as ≥ Mild or as Yes on AIMS Items 8-12 | Baseline - Awareness (Item 10) | 6.3 percentage of participants |
| Placebo | Percent of Participants Rated as ≥ Mild or as Yes on AIMS Items 8-12 | Follow-Up - Awareness (Item 10) | 18.8 percentage of participants |
| Placebo | Percent of Participants Rated as ≥ Mild or as Yes on AIMS Items 8-12 | Follow-Up - Overall Severity Index (Item 8) | 18.8 percentage of participants |
| Placebo | Percent of Participants Rated as ≥ Mild or as Yes on AIMS Items 8-12 | Baseline - Overall Severity Index (Item 8) | 6.3 percentage of participants |
| Placebo - Placebo | Percent of Participants Rated as ≥ Mild or as Yes on AIMS Items 8-12 | Follow-Up - Dentures (Item 12; % yes) | 22.2 percentage of participants |
| Placebo - Placebo | Percent of Participants Rated as ≥ Mild or as Yes on AIMS Items 8-12 | Baseline - Overall Severity Index (Item 8) | 11.1 percentage of participants |
| Placebo - Placebo | Percent of Participants Rated as ≥ Mild or as Yes on AIMS Items 8-12 | Follow-Up - Overall Severity Index (Item 8) | 16.7 percentage of participants |
| Placebo - Placebo | Percent of Participants Rated as ≥ Mild or as Yes on AIMS Items 8-12 | Baseline - Incapacitation (Item 9) | 5.6 percentage of participants |
| Placebo - Placebo | Percent of Participants Rated as ≥ Mild or as Yes on AIMS Items 8-12 | Follow-Up - Incapacitation (Item 9) | 0.0 percentage of participants |
| Placebo - Placebo | Percent of Participants Rated as ≥ Mild or as Yes on AIMS Items 8-12 | Follow-Up - Awareness (Item 10) | 5.6 percentage of participants |
| Placebo - Placebo | Percent of Participants Rated as ≥ Mild or as Yes on AIMS Items 8-12 | Baseline - Dental Problem (Item 11; % yes) | 16.7 percentage of participants |
| Placebo - Placebo | Percent of Participants Rated as ≥ Mild or as Yes on AIMS Items 8-12 | Follow-Up - Dental Problem (Item 11; % yes) | 22.2 percentage of participants |
| Placebo - Placebo | Percent of Participants Rated as ≥ Mild or as Yes on AIMS Items 8-12 | Baseline - Dentures (Item 12; % yes) | 16.7 percentage of participants |
| Placebo - Placebo | Percent of Participants Rated as ≥ Mild or as Yes on AIMS Items 8-12 | Baseline - Awareness (Item 10) | 5.6 percentage of participants |
Other Pre-specified
Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group
Infusion 2 (Day 14) - Diastolic Blood Pressure at all time points by group
Time frame: Day 14 - Phase 1 - Baseline = min000s1 and @5 min; Phase 2 - Baseline = min000 then every 10 minutes for 4 hours; Post Infusion - Baseline = min000, then every 10 minutes for 2 hours
Population: Includes all subjects during Phase 1 (i.e., infusion 1)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min015 | 61.44 mmHg | Standard Deviation 9.06 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min000 | 59.81 mmHg | Standard Deviation 8.42 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min110 | 59.73 mmHg | Standard Deviation 5.97 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min000 | 63.94 mmHg | Standard Deviation 8.46 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min240 | 59.60 mmHg | Standard Deviation 8.58 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min120 | 59.47 mmHg | Standard Deviation 8.59 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min070 | 68.81 mmHg | Standard Deviation 9.72 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min230 | 62.00 mmHg | Standard Deviation 8.12 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min130 | 60.33 mmHg | Standard Deviation 8.16 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min020 | 63.19 mmHg | Standard Deviation 8.72 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min220 | 59.13 mmHg | Standard Deviation 8.6 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min140 | 58.73 mmHg | Standard Deviation 10.23 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 1 - min005s1 | 63.56 mmHg | Standard Deviation 8.78 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min210 | 60.27 mmHg | Standard Deviation 9 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min150 | 61.87 mmHg | Standard Deviation 10.1 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min060 | 67.69 mmHg | Standard Deviation 7.88 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min200 | 58.40 mmHg | Standard Deviation 7.03 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min160 | 60.53 mmHg | Standard Deviation 7.68 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min025 | 59.25 mmHg | Standard Deviation 8.29 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min190 | 59.73 mmHg | Standard Deviation 10.23 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min170 | 61.87 mmHg | Standard Deviation 11.6 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min100 | 69.38 mmHg | Standard Deviation 8.61 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min180 | 60.27 mmHg | Standard Deviation 9 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min050 | 70.25 mmHg | Standard Deviation 10.79 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min030 | 61.75 mmHg | Standard Deviation 7.87 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min005 | 61.00 mmHg | Standard Deviation 6.23 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min040 | 70.31 mmHg | Standard Deviation 14.89 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min040 | 59.94 mmHg | Standard Deviation 8.82 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min120 | 70.56 mmHg | Standard Deviation 7.69 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min030 | 68.81 mmHg | Standard Deviation 12.45 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min050 | 60.25 mmHg | Standard Deviation 8.42 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min090 | 69.88 mmHg | Standard Deviation 8.87 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min025 | 66.88 mmHg | Standard Deviation 12.94 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min060 | 60.38 mmHg | Standard Deviation 11.97 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 1 - min000s1 | 69.38 mmHg | Standard Deviation 7.8 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min020 | 69.44 mmHg | Standard Deviation 12.44 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min070 | 59.19 mmHg | Standard Deviation 10.78 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min010 | 61.63 mmHg | Standard Deviation 7.57 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min015 | 65.13 mmHg | Standard Deviation 10.2 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min080 | 59.00 mmHg | Standard Deviation 7.38 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min110 | 70.81 mmHg | Standard Deviation 9.09 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min010 | 67.06 mmHg | Standard Deviation 9.26 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min090 | 57.13 mmHg | Standard Deviation 7.83 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min080 | 68.88 mmHg | Standard Deviation 7.87 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min005 | 63.31 mmHg | Standard Deviation 7.87 |
| Drug | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min100 | 58.13 mmHg | Standard Deviation 8.37 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min060 | 71.44 mmHg | Standard Deviation 12.23 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 1 - min000s1 | 74.50 mmHg | Standard Deviation 8.89 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 1 - min005s1 | 73.89 mmHg | Standard Deviation 8.7 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min000 | 72.72 mmHg | Standard Deviation 8.84 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min005 | 71.28 mmHg | Standard Deviation 7.28 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min010 | 74.65 mmHg | Standard Deviation 9.03 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min015 | 73.50 mmHg | Standard Deviation 7.15 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min020 | 70.94 mmHg | Standard Deviation 7.07 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min025 | 71.56 mmHg | Standard Deviation 9.1 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min030 | 71.11 mmHg | Standard Deviation 7.23 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min040 | 73.17 mmHg | Standard Deviation 9.07 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min050 | 71.89 mmHg | Standard Deviation 12.07 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min070 | 71.00 mmHg | Standard Deviation 10.77 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min080 | 70.72 mmHg | Standard Deviation 12.81 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min090 | 70.22 mmHg | Standard Deviation 12.34 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min100 | 71.00 mmHg | Standard Deviation 12.39 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min110 | 71.89 mmHg | Standard Deviation 11.54 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min120 | 68.28 mmHg | Standard Deviation 10.65 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min130 | 73.44 mmHg | Standard Deviation 11.94 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min140 | 71.56 mmHg | Standard Deviation 10.87 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min150 | 74.06 mmHg | Standard Deviation 12.8 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min160 | 73.94 mmHg | Standard Deviation 10.41 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min170 | 74.61 mmHg | Standard Deviation 8.43 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min180 | 72.28 mmHg | Standard Deviation 8.17 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min190 | 73.00 mmHg | Standard Deviation 10.99 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min200 | 73.56 mmHg | Standard Deviation 10.35 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min210 | 74.11 mmHg | Standard Deviation 11.53 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min220 | 72.22 mmHg | Standard Deviation 9.62 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min230 | 72.33 mmHg | Standard Deviation 10.48 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min240 | 70.11 mmHg | Standard Deviation 8.05 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min090 | 73.83 mmHg | Standard Deviation 11.4 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min000 | 70.39 mmHg | Standard Deviation 8.1 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min005 | 71.94 mmHg | Standard Deviation 9.14 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min010 | 73.39 mmHg | Standard Deviation 9.76 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min015 | 75.67 mmHg | Standard Deviation 10.79 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min020 | 74.89 mmHg | Standard Deviation 9.62 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min025 | 76.89 mmHg | Standard Deviation 8.66 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min030 | 76.89 mmHg | Standard Deviation 14.57 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min040 | 72.39 mmHg | Standard Deviation 11.32 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min050 | 74.72 mmHg | Standard Deviation 12.56 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min060 | 74.11 mmHg | Standard Deviation 11.9 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min070 | 76.78 mmHg | Standard Deviation 10.28 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min080 | 74.61 mmHg | Standard Deviation 11.25 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min100 | 74.28 mmHg | Standard Deviation 12.15 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min110 | 77.11 mmHg | Standard Deviation 10.78 |
| Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min120 | 78.00 mmHg | Standard Deviation 9.15 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min070 | 76.78 mmHg | Standard Deviation 10.28 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min000 | 70.39 mmHg | Standard Deviation 8.1 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min090 | 70.22 mmHg | Standard Deviation 12.34 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min010 | 74.65 mmHg | Standard Deviation 9.03 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min005 | 71.94 mmHg | Standard Deviation 9.14 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min080 | 70.72 mmHg | Standard Deviation 12.81 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min110 | 77.11 mmHg | Standard Deviation 10.78 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min010 | 73.39 mmHg | Standard Deviation 9.76 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min070 | 71.00 mmHg | Standard Deviation 10.77 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min080 | 74.61 mmHg | Standard Deviation 11.25 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min015 | 75.67 mmHg | Standard Deviation 10.79 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min060 | 71.44 mmHg | Standard Deviation 12.23 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min005 | 71.28 mmHg | Standard Deviation 7.28 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min020 | 74.89 mmHg | Standard Deviation 8.66 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min050 | 71.89 mmHg | Standard Deviation 12.07 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min090 | 73.83 mmHg | Standard Deviation 11.4 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min025 | 76.89 mmHg | Standard Deviation 8.66 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min040 | 73.17 mmHg | Standard Deviation 9.07 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min000 | 72.72 mmHg | Standard Deviation 8.84 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min030 | 76.89 mmHg | Standard Deviation 14.57 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min030 | 71.11 mmHg | Standard Deviation 7.23 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 1 - min000s1 | 74.50 mmHg | Standard Deviation 8.89 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min040 | 72.39 mmHg | Standard Deviation 11.32 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min170 | 74.61 mmHg | Standard Deviation 8.43 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min025 | 71.56 mmHg | Standard Deviation 9.1 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min180 | 72.28 mmHg | Standard Deviation 8.17 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min160 | 73.94 mmHg | Standard Deviation 10.41 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min100 | 74.28 mmHg | Standard Deviation 12.15 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min190 | 73.00 mmHg | Standard Deviation 10.99 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min150 | 74.06 mmHg | Standard Deviation 12.8 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min050 | 74.72 mmHg | Standard Deviation 12.56 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min200 | 73.56 mmHg | Standard Deviation 10.35 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min140 | 71.56 mmHg | Standard Deviation 10.87 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min020 | 70.94 mmHg | Standard Deviation 7.07 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min210 | 74.11 mmHg | Standard Deviation 11.53 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min130 | 73.44 mmHg | Standard Deviation 11.94 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 1 - min005s1 | 73.89 mmHg | Standard Deviation 8.7 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min220 | 72.22 mmHg | Standard Deviation 9.62 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min120 | 68.28 mmHg | Standard Deviation 10.65 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min060 | 74.11 mmHg | Standard Deviation 11.9 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min230 | 72.33 mmHg | Standard Deviation 10.48 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min110 | 71.89 mmHg | Standard Deviation 11.54 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min015 | 73.50 mmHg | Standard Deviation 7.15 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min240 | 70.11 mmHg | Standard Deviation 8.05 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min120 | 78.00 mmHg | Standard Deviation 9.15 |
| Placebo - Placebo | Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min100 | 71.00 mmHg | Standard Deviation 12.39 |
Other Pre-specified
Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization
The Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI): This is a self-rated 77-item questionnaire organized into 13 body areas assessing possible adverse events during the course of the trial.
Time frame: Baseline (Day - 1), Follow-Up = reported at any assessment thereafter, including 7 hours after Infusions #1 and #2, Baseline 2 (Day 13) and final follow-up, including early termination visits.
Population: Includes all subjects with SAFTEE data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Drug | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 34. Baseline - Frequent need to urinate | 0.0 percentage of participants |
| Drug | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 7. Follow-Up - Poor memory | 5.6 percentage of participants |
| Drug | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 10. Baseline - Hearing or seeing things | 22.2 percentage of participants |
| Drug | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 18. Follow-Up - Dry mouth | 5.6 percentage of participants |
| Drug | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 1. Baseline - Trouble Sleeping | 16.7 percentage of participants |
| Drug | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 3. Follow-Up - Feeling drowsy or sleepy | 22.2 percentage of participants |
| Drug | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 18. Baseline - Dry mouth | 5.6 percentage of participants |
| Drug | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 1. Follow-Up - Trouble Sleeping | 11.1 percentage of participants |
| Drug | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 52. Follow-Up - Hot flashes | 11.1 percentage of participants |
| Drug | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 4. Follow-Up - Feeling nervous or hyper | 5.6 percentage of participants |
| Drug | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 4. Baseline - Feeling nervous or hyper | 5.6 percentage of participants |
| Drug | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 17. Follow-Up - Stuffy nose | 5.6 percentage of participants |
| Drug | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 8. Baseline - Trouble concentrating | 16.7 percentage of participants |
| Drug | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 52. Baseline - Hot flashes | 0.0 percentage of participants |
| Drug | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 17. Baseline - Stuffy nose | 5.6 percentage of participants |
| Drug | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 8. Follow-Up - Trouble concentrating | 11.1 percentage of participants |
| Drug | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 3. Baseline - Feeling drowsy or sleepy | 16.7 percentage of participants |
| Drug | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 34. Follow-Up - Frequent need to urinate | 5.6 percentage of participants |
| Drug | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 7. Baseline - Poor memory | 11.1 percentage of participants |
| Drug | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 10. Follow-Up - Hearing or seeing things | 33.3 percentage of participants |
| Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 17. Follow-Up - Stuffy nose | 18.8 percentage of participants |
| Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 10. Baseline - Hearing or seeing things | 25.0 percentage of participants |
| Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 10. Follow-Up - Hearing or seeing things | 31.3 percentage of participants |
| Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 3. Baseline - Feeling drowsy or sleepy | 0.0 percentage of participants |
| Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 3. Follow-Up - Feeling drowsy or sleepy | 25.0 percentage of participants |
| Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 8. Baseline - Trouble concentrating | 6.3 percentage of participants |
| Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 8. Follow-Up - Trouble concentrating | 18.8 percentage of participants |
| Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 7. Baseline - Poor memory | 6.3 percentage of participants |
| Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 7. Follow-Up - Poor memory | 25.0 percentage of participants |
| Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 1. Baseline - Trouble Sleeping | 6.3 percentage of participants |
| Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 1. Follow-Up - Trouble Sleeping | 12.5 percentage of participants |
| Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 4. Baseline - Feeling nervous or hyper | 18.8 percentage of participants |
| Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 4. Follow-Up - Feeling nervous or hyper | 18.8 percentage of participants |
| Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 18. Baseline - Dry mouth | 12.5 percentage of participants |
| Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 18. Follow-Up - Dry mouth | 25.0 percentage of participants |
| Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 34. Baseline - Frequent need to urinate | 6.3 percentage of participants |
| Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 34. Follow-Up - Frequent need to urinate | 18.8 percentage of participants |
| Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 17. Baseline - Stuffy nose | 6.3 percentage of participants |
| Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 52. Baseline - Hot flashes | 6.3 percentage of participants |
| Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 52. Follow-Up - Hot flashes | 6.3 percentage of participants |
| Placebo - Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 10. Follow-Up - Hearing or seeing things | 16.7 percentage of participants |
| Placebo - Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 18. Follow-Up - Dry mouth | 16.7 percentage of participants |
| Placebo - Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 7. Baseline - Poor memory | 27.8 percentage of participants |
| Placebo - Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 52. Follow-Up - Hot flashes | 16.7 percentage of participants |
| Placebo - Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 34. Baseline - Frequent need to urinate | 11.1 percentage of participants |
| Placebo - Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 8. Follow-Up - Trouble concentrating | 27.8 percentage of participants |
| Placebo - Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 52. Baseline - Hot flashes | 5.6 percentage of participants |
| Placebo - Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 34. Follow-Up - Frequent need to urinate | 16.7 percentage of participants |
| Placebo - Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 8. Baseline - Trouble concentrating | 22.2 percentage of participants |
| Placebo - Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 10. Baseline - Hearing or seeing things | 22.2 percentage of participants |
| Placebo - Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 17. Baseline - Stuffy nose | 16.7 percentage of participants |
| Placebo - Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 3. Follow-Up - Feeling drowsy or sleepy | 22.2 percentage of participants |
| Placebo - Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 4. Baseline - Feeling nervous or hyper | 33.3 percentage of participants |
| Placebo - Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 1. Follow-Up - Trouble Sleeping | 22.2 percentage of participants |
| Placebo - Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 3. Baseline - Feeling drowsy or sleepy | 22.2 percentage of participants |
| Placebo - Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 4. Follow-Up - Feeling nervous or hyper | 22.2 percentage of participants |
| Placebo - Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 1. Baseline - Trouble Sleeping | 27.8 percentage of participants |
| Placebo - Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 17. Follow-Up - Stuffy nose | 11.1 percentage of participants |
| Placebo - Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 18. Baseline - Dry mouth | 11.1 percentage of participants |
| Placebo - Placebo | Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization | 7. Follow-Up - Poor memory | 22.2 percentage of participants |
Other Pre-specified
Systolic Blood Pressure Per Infusion Phase by Group
Infusion 2 (Day 14) - Systolic Blood Pressure at all time points by group Phase in this analysis refers to the infusion stage as defined in the protocol.
Time frame: Day 14 - Phase 1 - Baseline = min000s1 and @5 min; Phase 2 - Baseline = min000 then every 10 minutes for 4 hours; Post Infusion - Baseline = min000, then every 10 minutes for 2 hours
Population: Includes all subjects during Phase 2 (i.e., infusion 2)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min015 | 108.88 mmHg | Standard Deviation 9.06 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min005 | 111.06 mmHg | Standard Deviation 12.41 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min110 | 105.67 mmHg | Standard Deviation 7.8 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min110 | 123.50 mmHg | Standard Deviation 13.57 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min000 | 107.75 mmHg | Standard Deviation 9.94 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min120 | 105.87 mmHg | Standard Deviation 9.19 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min070 | 122.44 mmHg | Standard Deviation 19.68 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min240 | 108.53 mmHg | Standard Deviation 9.48 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min130 | 108.53 mmHg | Standard Deviation 10.7 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min020 | 108.19 mmHg | Standard Deviation 8.93 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min230 | 110.27 mmHg | Standard Deviation 12.79 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min140 | 111.27 mmHg | Standard Deviation 10.5 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min000 | 110.88 mmHg | Standard Deviation 11.61 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min220 | 109.20 mmHg | Standard Deviation 15.18 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min150 | 112.13 mmHg | Standard Deviation 11.42 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min060 | 125.31 mmHg | Standard Deviation 14.93 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min210 | 113.13 mmHg | Standard Deviation 14.71 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min160 | 109.87 mmHg | Standard Deviation 11.11 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min025 | 110.81 mmHg | Standard Deviation 11.11 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min200 | 110.40 mmHg | Standard Deviation 13.47 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min170 | 114.33 mmHg | Standard Deviation 12.61 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min120 | 122.31 mmHg | Standard Deviation 16.41 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min190 | 110.47 mmHg | Standard Deviation 9.82 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min180 | 111.27 mmHg | Standard Deviation 9.38 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min050 | 122.75 mmHg | Standard Deviation 22.66 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min030 | 109.88 mmHg | Standard Deviation 8.43 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min100 | 121.94 mmHg | Standard Deviation 21.68 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min040 | 118.44 mmHg | Standard Deviation 11.4 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min040 | 108.06 mmHg | Standard Deviation 8.46 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min005 | 107.50 mmHg | Standard Deviation 11.36 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min030 | 117.50 mmHg | Standard Deviation 12.56 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min050 | 109.00 mmHg | Standard Deviation 10.22 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 1 - min005s1 | 112.69 mmHg | Standard Deviation 12.38 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min060 | 109.63 mmHg | Standard Deviation 13.2 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min090 | 122.25 mmHg | Standard Deviation 14.19 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min025 | 116.00 mmHg | Standard Deviation 12.41 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min070 | 108.56 mmHg | Standard Deviation 10.46 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min010 | 108.50 mmHg | Standard Deviation 9.39 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min020 | 115.00 mmHg | Standard Deviation 11.55 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min080 | 108.50 mmHg | Standard Deviation 10.98 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 1 - min000s1 | 120.69 mmHg | Standard Deviation 11.84 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min015 | 114.75 mmHg | Standard Deviation 15.07 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min090 | 109.06 mmHg | Standard Deviation 10.59 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min080 | 122.38 mmHg | Standard Deviation 15.21 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min010 | 116.88 mmHg | Standard Deviation 16.7 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min100 | 106.94 mmHg | Standard Deviation 11.58 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min020 | 122.92 mmHg | Standard Deviation 13.24 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 1 - min000s1 | 121.92 mmHg | Standard Deviation 9.66 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 1 - min005s1 | 120.77 mmHg | Standard Deviation 12.38 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min000 | 120.92 mmHg | Standard Deviation 14.2 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min005 | 116.31 mmHg | Standard Deviation 9.96 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min010 | 113.38 mmHg | Standard Deviation 12.53 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min015 | 113.46 mmHg | Standard Deviation 10.32 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min020 | 112.62 mmHg | Standard Deviation 10.66 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min025 | 115.62 mmHg | Standard Deviation 13.88 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min030 | 113.69 mmHg | Standard Deviation 16.09 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min040 | 117.54 mmHg | Standard Deviation 16.58 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min050 | 112.77 mmHg | Standard Deviation 13.91 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min060 | 113.31 mmHg | Standard Deviation 14.12 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min070 | 113.15 mmHg | Standard Deviation 12.15 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min080 | 113.08 mmHg | Standard Deviation 15.34 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min090 | 109.00 mmHg | Standard Deviation 11.63 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min100 | 111.50 mmHg | Standard Deviation 16.1 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min110 | 112.46 mmHg | Standard Deviation 16.04 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min120 | 106.33 mmHg | Standard Deviation 10.87 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min130 | 110.17 mmHg | Standard Deviation 11.75 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min140 | 110.54 mmHg | Standard Deviation 11.23 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min150 | 110.83 mmHg | Standard Deviation 18.52 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min160 | 116.17 mmHg | Standard Deviation 13.07 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min170 | 113.33 mmHg | Standard Deviation 12.04 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min180 | 113.92 mmHg | Standard Deviation 11.77 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min190 | 114.83 mmHg | Standard Deviation 16.46 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min200 | 115.08 mmHg | Standard Deviation 16.76 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min210 | 114.33 mmHg | Standard Deviation 17.85 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min220 | 112.33 mmHg | Standard Deviation 11.54 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min230 | 113.58 mmHg | Standard Deviation 12.92 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min240 | 111.83 mmHg | Standard Deviation 12.58 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min000 | 113.25 mmHg | Standard Deviation 13.51 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min005 | 118.25 mmHg | Standard Deviation 18.23 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min010 | 122.83 mmHg | Standard Deviation 16.03 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min015 | 124.58 mmHg | Standard Deviation 16.14 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min025 | 125.83 mmHg | Standard Deviation 16.94 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min030 | 123.67 mmHg | Standard Deviation 16.54 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min040 | 123.92 mmHg | Standard Deviation 11.24 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min050 | 124.17 mmHg | Standard Deviation 13.19 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min060 | 121.08 mmHg | Standard Deviation 12.45 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min070 | 120.33 mmHg | Standard Deviation 10.46 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min080 | 121.83 mmHg | Standard Deviation 14.65 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min090 | 125.08 mmHg | Standard Deviation 13.73 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min100 | 123.92 mmHg | Standard Deviation 10.99 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min110 | 125.17 mmHg | Standard Deviation 16.51 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min120 | 125.75 mmHg | Standard Deviation 12.26 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min000 | 118.22 mmHg | Standard Deviation 120.28 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min100 | 119.00 mmHg | Standard Deviation 14.98 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min120 | 125.00 mmHg | Standard Deviation 12.29 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min005 | 120.28 mmHg | Standard Deviation 11.93 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min090 | 118.06 mmHg | Standard Deviation 12.49 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min080 | 123.17 mmHg | Standard Deviation 13.34 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min010 | 122.94 mmHg | Standard Deviation 10.91 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min080 | 118.50 mmHg | Standard Deviation 13.57 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min005 | 120.39 mmHg | Standard Deviation 12.22 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min015 | 122.78 mmHg | Standard Deviation 11.7 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min070 | 118.50 mmHg | Standard Deviation 14.2 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min050 | 118.56 mmHg | Standard Deviation 15.6 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min020 | 121.56 mmHg | Standard Deviation 12.6 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min060 | 116.94 mmHg | Standard Deviation 12.75 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min110 | 125.06 mmHg | Standard Deviation 11.88 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min025 | 126.67 mmHg | Standard Deviation 15.06 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min040 | 118.94 mmHg | Standard Deviation 11.57 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min090 | 126.28 mmHg | Standard Deviation 14.52 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min030 | 126.06 mmHg | Standard Deviation 14.86 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min030 | 116.44 mmHg | Standard Deviation 13.4 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min000 | 120.78 mmHg | Standard Deviation 12.08 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min040 | 122.11 mmHg | Standard Deviation 13.75 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min025 | 118.22 mmHg | Standard Deviation 14.4 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 1 - min000s1 | 122.61 mmHg | Standard Deviation 10.22 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min050 | 122.72 mmHg | Standard Deviation 14.82 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min180 | 117.67 mmHg | Standard Deviation 11.44 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min170 | 120.61 mmHg | Standard Deviation 12.65 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min020 | 117.94 mmHg | Standard Deviation 12.65 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min190 | 120.72 mmHg | Standard Deviation 11.74 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min160 | 121.17 mmHg | Standard Deviation 13.79 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min100 | 122.94 mmHg | Standard Deviation 16.25 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min200 | 120.94 mmHg | Standard Deviation 14.24 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min150 | 117.67 mmHg | Standard Deviation 12.76 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min060 | 123.17 mmHg | Standard Deviation 15 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min210 | 121.17 mmHg | Standard Deviation 11.75 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min140 | 120.33 mmHg | Standard Deviation 15.11 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min015 | 117.28 mmHg | Standard Deviation 13.35 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min220 | 120.06 mmHg | Standard Deviation 11.44 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min130 | 120.06 mmHg | Standard Deviation 13.58 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 1 - min005s1 | 119.39 mmHg | Standard Deviation 10.67 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min230 | 118.83 mmHg | Standard Deviation 12.64 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min120 | 118.83 mmHg | Standard Deviation 15.25 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min070 | 124.78 mmHg | Standard Deviation 14.82 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min240 | 119.00 mmHg | Standard Deviation 12.29 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min110 | 120.39 mmHg | Standard Deviation 11.95 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min010 | 120.41 mmHg | Standard Deviation 12.62 |
Other Pre-specified
Systolic Blood Pressure Per Infusion Phase by Group
Infusion 1 (Day 0) - Systolic Blood Pressure at all time points by group Phase in this analysis refers to the infusion stage as defined in the protocol.
Time frame: Day 0 - Phase 1 - Baseline = min000s1 and @5 min; Phase 2 - Baseline = min000 then every 10 minutes for 4 hours; Post Infusion - Baseline = min000, then every 10 minutes for 2 hours
Population: Includes all subjects during Phase 1 (i.e., infusion 1)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 1 - min000s1 | 121.79 mmHg | Standard Deviation 14.46 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min005 | 114.44 mmHg | Standard Deviation 11.01 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min110 | 112.29 mmHg | Standard Deviation 7.83 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min080 | 118.83 mmHg | Standard Deviation 12.78 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min000 | 107.50 mmHg | Standard Deviation 11.53 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min120 | 111.76 mmHg | Standard Deviation 10.56 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min020 | 108.28 mmHg | Standard Deviation 10.21 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min240 | 109.53 mmHg | Standard Deviation 9.13 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min130 | 109.82 mmHg | Standard Deviation 9.19 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min120 | 122.22 mmHg | Standard Deviation 13.41 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min230 | 109.35 mmHg | Standard Deviation 9.57 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min140 | 109.47 mmHg | Standard Deviation 7.34 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min070 | 122.33 mmHg | Standard Deviation 13.78 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min220 | 109.82 mmHg | Standard Deviation 9.57 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min150 | 110.12 mmHg | Standard Deviation 9.62 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min025 | 109.83 mmHg | Standard Deviation 10.7 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min210 | 109.71 mmHg | Standard Deviation 8.08 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min160 | 107.88 mmHg | Standard Deviation 9.97 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min110 | 122.61 mmHg | Standard Deviation 13.42 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min200 | 107.41 mmHg | Standard Deviation 12.57 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min170 | 109.35 mmHg | Standard Deviation 11.89 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min060 | 122.22 mmHg | Standard Deviation 12.35 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min190 | 110.12 mmHg | Standard Deviation 11.6 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min180 | 110.06 mmHg | Standard Deviation 9.85 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min030 | 108.61 mmHg | Standard Deviation 10.01 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min005 | 111.32 mmHg | Standard Deviation 11.51 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min050 | 117.33 mmHg | Standard Deviation 13.91 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min040 | 111.82 mmHg | Standard Deviation 9.8 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min000 | 114.89 mmHg | Standard Deviation 13.13 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min040 | 119.67 mmHg | Standard Deviation 12.03 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min050 | 111.00 mmHg | Standard Deviation 8.89 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min100 | 120.44 mmHg | Standard Deviation 11.87 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min030 | 118.56 mmHg | Standard Deviation 11.93 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min060 | 112.53 mmHg | Standard Deviation 11.99 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min010 | 112.72 mmHg | Standard Deviation 12.84 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min025 | 116.33 mmHg | Standard Deviation 12.58 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min070 | 114.82 mmHg | Standard Deviation 12.83 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 1 - min005s1 | 116.95 mmHg | Standard Deviation 12.78 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min020 | 117.39 mmHg | Standard Deviation 9.12 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min080 | 110.00 mmHg | Standard Deviation 9.98 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min090 | 117.67 mmHg | Standard Deviation 12.56 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min015 | 117.22 mmHg | Standard Deviation 11.07 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min090 | 111.94 mmHg | Standard Deviation 9.83 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min015 | 111.28 mmHg | Standard Deviation 9.48 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min010 | 116.28 mmHg | Standard Deviation 11.74 |
| Drug | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min100 | 111.00 mmHg | Standard Deviation 12.97 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min020 | 128.80 mmHg | Standard Deviation 13.04 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 1 - min005s1 | 126.13 mmHg | Standard Deviation 13.01 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min000 | 125.13 mmHg | Standard Deviation 11.04 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 1 - min000s1 | 121.50 mmHg | Standard Deviation 10.65 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min005 | 124.38 mmHg | Standard Deviation 10.29 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min010 | 127.06 mmHg | Standard Deviation 8.93 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min015 | 125.75 mmHg | Standard Deviation 10.51 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min020 | 124.63 mmHg | Standard Deviation 9.94 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min025 | 126.63 mmHg | Standard Deviation 11.89 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min030 | 125.13 mmHg | Standard Deviation 9.84 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min040 | 125.63 mmHg | Standard Deviation 11.86 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min050 | 125.73 mmHg | Standard Deviation 9.32 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min060 | 126.87 mmHg | Standard Deviation 9.69 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min070 | 126.27 mmHg | Standard Deviation 8.86 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min080 | 125.53 mmHg | Standard Deviation 9.62 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min090 | 125.00 mmHg | Standard Deviation 11.14 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min100 | 123.87 mmHg | Standard Deviation 11.75 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min110 | 128.33 mmHg | Standard Deviation 10.6 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min120 | 124.93 mmHg | Standard Deviation 12.57 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min130 | 125.20 mmHg | Standard Deviation 8.99 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min140 | 127.67 mmHg | Standard Deviation 9.76 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min150 | 126.93 mmHg | Standard Deviation 10.75 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min160 | 126.00 mmHg | Standard Deviation 9.56 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min170 | 124.33 mmHg | Standard Deviation 9.51 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min180 | 127.07 mmHg | Standard Deviation 12.63 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min190 | 125.13 mmHg | Standard Deviation 13.1 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min200 | 125.40 mmHg | Standard Deviation 13 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min210 | 131.87 mmHg | Standard Deviation 13.79 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min220 | 125.73 mmHg | Standard Deviation 13.24 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min230 | 126.00 mmHg | Standard Deviation 13.8 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min240 | 128.67 mmHg | Standard Deviation 14.01 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min000 | 128.38 mmHg | Standard Deviation 13.87 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min005 | 126.13 mmHg | Standard Deviation 13.84 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min010 | 127.33 mmHg | Standard Deviation 12.8 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min015 | 128.40 mmHg | Standard Deviation 16.79 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min025 | 129.53 mmHg | Standard Deviation 14.94 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min030 | 129.81 mmHg | Standard Deviation 13.96 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min040 | 128.33 mmHg | Standard Deviation 14.99 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min050 | 128.47 mmHg | Standard Deviation 11.86 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min060 | 129.93 mmHg | Standard Deviation 12.21 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min070 | 130.27 mmHg | Standard Deviation 11.51 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min080 | 128.47 mmHg | Standard Deviation 11.86 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min090 | 129.20 mmHg | Standard Deviation 13.03 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min100 | 125.67 mmHg | Standard Deviation 11.63 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min110 | 129.27 mmHg | Standard Deviation 11.49 |
| Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min120 | 128.67 mmHg | Standard Deviation 10.99 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min000 | 125.22 mmHg | Standard Deviation 13.8 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min100 | 122.11 mmHg | Standard Deviation 12.39 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min120 | 124.44 mmHg | Standard Deviation 12.34 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min005 | 123.12 mmHg | Standard Deviation 10.01 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min090 | 121.33 mmHg | Standard Deviation 12.88 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min080 | 122.94 mmHg | Standard Deviation 14.49 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min010 | 122.06 mmHg | Standard Deviation 11.62 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min080 | 120.83 mmHg | Standard Deviation 13.9 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min010 | 122.33 mmHg | Standard Deviation 11.56 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min015 | 124.67 mmHg | Standard Deviation 11.96 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min070 | 120.11 mmHg | Standard Deviation 10.76 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 1 - min000s1 | 123.78 mmHg | Standard Deviation 11.46 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min020 | 124.50 mmHg | Standard Deviation 12.08 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min060 | 120.17 mmHg | Standard Deviation 12.91 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min110 | 125.06 mmHg | Standard Deviation 14.58 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min025 | 126.72 mmHg | Standard Deviation 14.74 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min050 | 122.56 mmHg | Standard Deviation 11.46 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min090 | 124.06 mmHg | Standard Deviation 10.94 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min030 | 124.00 mmHg | Standard Deviation 14.12 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min040 | 122.56 mmHg | Standard Deviation 11.46 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min005 | 121.00 mmHg | Standard Deviation 14.12 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min040 | 123.33 mmHg | Standard Deviation 14.48 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min030 | 119.67 mmHg | Standard Deviation 13.77 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 1 - min005s1 | 121.94 mmHg | Standard Deviation 14.39 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min050 | 123.11 mmHg | Standard Deviation 13.78 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min180 | 123.22 mmHg | Standard Deviation 13.01 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min170 | 122.72 mmHg | Standard Deviation 15.14 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min025 | 121.11 mmHg | Standard Deviation 11.8 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min190 | 121.94 mmHg | Standard Deviation 12.46 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min160 | 121.72 mmHg | Standard Deviation 15.23 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min100 | 121.72 mmHg | Standard Deviation 10.65 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min200 | 122.67 mmHg | Standard Deviation 14.63 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min150 | 123.39 mmHg | Standard Deviation 12.95 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min060 | 124.61 mmHg | Standard Deviation 14.97 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min210 | 122.94 mmHg | Standard Deviation 11.34 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min140 | 119.72 mmHg | Standard Deviation 11.2 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min020 | 121.11 mmHg | Standard Deviation 10.81 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min220 | 125.89 mmHg | Standard Deviation 14.58 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min130 | 119.17 mmHg | Standard Deviation 10.63 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min000 | 121.00 mmHg | Standard Deviation 12.86 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min230 | 124.61 mmHg | Standard Deviation 13.75 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min120 | 119.06 mmHg | Standard Deviation 15.3 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Post Infusion - min070 | 122.72 mmHg | Standard Deviation 15.86 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min240 | 124.44 mmHg | Standard Deviation 14.16 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min110 | 122.83 mmHg | Standard Deviation 12.32 |
| Placebo - Placebo | Systolic Blood Pressure Per Infusion Phase by Group | Phase 2 - min015 | 121.94 mmHg | Standard Deviation 11.58 |