Resistant Hypertension
Conditions
Brief summary
The study was to determine the safe and effective dose of TBC3711 in patients with uncontrolled high blood pressure while already taking blood pressure medications.
Detailed description
The study was stopped due to Pfizer (sponsor) decision that the compound would not be involved in any further clinical development for the indication of resistant hypertension on 05 August 2008. This decision was not based on any safety or efficacy concern.
Interventions
DRUGPlacebo
placebo tablet once daily for 12 weeks
DRUGTBC3711
10 mg tablets once daily for 10 weeks
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of resistant hypertension. * A stable anti-hypertensive drug regimen for at least 30 days.
Exclusion criteria
* Sustained blood pressure greater than or equal to 180/120 mmHg. * Required use of thigh cuff for blood pressure readings. * Uncontrolled diabetes mellitus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Blood Pressure (BP) Increase | Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12 | BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles). Maximum increase was calculated by subtracting baseline value from each post-dose measurement and selecting maximum of these values. |
| Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change | Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12 | AUEC was calculated as the positive area under the change from baseline curve for sitting and standing SBP and DBP to Week 12, estimated by the linear trapezoidal rule corrected for the pre-dose baseline value. In the event that post-dose values returned below baseline at or before Week 12, then AUEC was calculated by setting the negative values to zero and taking only the positive area into account. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sitting Diastolic Blood Pressure (DBP) | Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10 | DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements. The same arm was used throughout the study. |
| Standing Diastolic Blood Pressure (DBP) | Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10 | DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant stood for 2 minutes. The same arm was used throughout the study. |
| Change From Standing to Sitting Systolic Blood Pressure (SBP) at Week 10 | Pre-Dose and 2 hours Post-Dose on Week 10 | SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study. |
| Sitting Systolic Blood Pressure (SBP) | Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10 | SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80 percent \[%\] of the arm) after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements. The same arm was used throughout the study. |
| Change From Pre-Dose to Post-Dose in Systolic Blood Pressure (SBP) at Week 10 | Pre-Dose and 2 hours Post-Dose on Week 10 | SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study. |
| Change From Pre-Dose to Post-Dose in Diastolic Blood Pressure (DBP) at Week 10 | Pre-Dose and 2 hours Post-Dose on Week 10 | DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study. |
| Change From Standing to Sitting Diastolic Blood Pressure (DBP) at Week 10 | Pre-Dose and 2 hours Post-Dose on Week 10 | DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study. |
| Standing Systolic Blood Pressure (SBP) | Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10 | SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant stood for 2 minutes. The same arm was used throughout the study. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase. | 10 |
| TBC3711 10 mg Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase. | 8 |
| TBC3711 50 mg Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase. | 11 |
| TBC3711 100 mg Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase. | 10 |
| TBC3711 200 mg Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase. | 10 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Placebo Run-in Phase: Up to Week 2 | Other | 2 | 0 | 0 | 0 | 0 |
| Placebo Run-in Phase: Up to Week 2 | Participant Needed Prohibited Medication | 2 | 0 | 0 | 0 | 0 |
| Placebo Run-in Phase: Up to Week 2 | Physician Decision | 1 | 0 | 0 | 0 | 0 |
| Placebo Run-in Phase: Up to Week 2 | Sponsor Decision | 1 | 0 | 0 | 0 | 0 |
| Placebo Run-in Phase: Up to Week 2 | Subject Defaulted | 5 | 0 | 0 | 0 | 0 |
| Treatment Phase: Week 3 Up to Week 12 | Adverse Event | 0 | 1 | 0 | 1 | 2 |
| Treatment Phase: Week 3 Up to Week 12 | Other | 1 | 3 | 3 | 2 | 2 |
| Treatment Phase: Week 3 Up to Week 12 | Participant Defaulted | 1 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | TBC3711 10 mg | TBC3711 50 mg | TBC3711 100 mg | TBC3711 200 mg | Total |
|---|---|---|---|---|---|---|
| Age, Customized 18 to 44 Years | 0 participants | 1 participants | 0 participants | 1 participants | 1 participants | 3 participants |
| Age, Customized 45 to 64 Years | 6 participants | 5 participants | 10 participants | 9 participants | 7 participants | 37 participants |
| Age, Customized Greater Than or Equal to (>=) 65 Years | 4 participants | 2 participants | 1 participants | 0 participants | 2 participants | 9 participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants | 4 Participants | 3 Participants | 17 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 6 Participants | 6 Participants | 7 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 10 | 3 / 8 | 3 / 11 | 4 / 10 | 5 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 8 | 1 / 11 | 1 / 10 | 0 / 10 |
Outcome results
Primary
Maximum Blood Pressure (BP) Increase
BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles). Maximum increase was calculated by subtracting baseline value from each post-dose measurement and selecting maximum of these values.
Time frame: Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12
Population: Safety analysis set included all participants who received at least 1 dose of study treatment. Here n signifies participants evaluable for specified category for each treatment arm, respectively.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Maximum Blood Pressure (BP) Increase | Standing DBP (n= 10, 8, 11, 10, 10) | 7.91 millimeter of mercury (mmHg) | Standard Error 1.69 |
| Placebo | Maximum Blood Pressure (BP) Increase | Sitting DBP (n= 8, 6, 9, 8, 8) | 8.16 millimeter of mercury (mmHg) | Standard Error 1.75 |
| Placebo | Maximum Blood Pressure (BP) Increase | Sitting SBP (n= 8, 6, 9, 8, 8) | 11.48 millimeter of mercury (mmHg) | Standard Error 4.04 |
| Placebo | Maximum Blood Pressure (BP) Increase | Standing SBP (n= 10, 8, 11, 10, 10) | 9.06 millimeter of mercury (mmHg) | Standard Error 3.24 |
| TBC3711 10 mg | Maximum Blood Pressure (BP) Increase | Sitting DBP (n= 8, 6, 9, 8, 8) | 2.53 millimeter of mercury (mmHg) | Standard Error 2.02 |
| TBC3711 10 mg | Maximum Blood Pressure (BP) Increase | Sitting SBP (n= 8, 6, 9, 8, 8) | 3.10 millimeter of mercury (mmHg) | Standard Error 4.67 |
| TBC3711 10 mg | Maximum Blood Pressure (BP) Increase | Standing SBP (n= 10, 8, 11, 10, 10) | 2.96 millimeter of mercury (mmHg) | Standard Error 3.64 |
| TBC3711 10 mg | Maximum Blood Pressure (BP) Increase | Standing DBP (n= 10, 8, 11, 10, 10) | 3.11 millimeter of mercury (mmHg) | Standard Error 1.9 |
| TBC3711 50 mg | Maximum Blood Pressure (BP) Increase | Sitting DBP (n= 8, 6, 9, 8, 8) | 6.73 millimeter of mercury (mmHg) | Standard Error 1.65 |
| TBC3711 50 mg | Maximum Blood Pressure (BP) Increase | Sitting SBP (n= 8, 6, 9, 8, 8) | 11.26 millimeter of mercury (mmHg) | Standard Error 3.83 |
| TBC3711 50 mg | Maximum Blood Pressure (BP) Increase | Standing DBP (n= 10, 8, 11, 10, 10) | 7.11 millimeter of mercury (mmHg) | Standard Error 1.62 |
| TBC3711 50 mg | Maximum Blood Pressure (BP) Increase | Standing SBP (n= 10, 8, 11, 10, 10) | 8.38 millimeter of mercury (mmHg) | Standard Error 3.08 |
| TBC3711 100 mg | Maximum Blood Pressure (BP) Increase | Standing SBP (n= 10, 8, 11, 10, 10) | 9.63 millimeter of mercury (mmHg) | Standard Error 3.23 |
| TBC3711 100 mg | Maximum Blood Pressure (BP) Increase | Sitting SBP (n= 8, 6, 9, 8, 8) | 11.52 millimeter of mercury (mmHg) | Standard Error 4.03 |
| TBC3711 100 mg | Maximum Blood Pressure (BP) Increase | Sitting DBP (n= 8, 6, 9, 8, 8) | 1.79 millimeter of mercury (mmHg) | Standard Error 1.77 |
| TBC3711 100 mg | Maximum Blood Pressure (BP) Increase | Standing DBP (n= 10, 8, 11, 10, 10) | 2.27 millimeter of mercury (mmHg) | Standard Error 1.69 |
| TBC3711 200 mg | Maximum Blood Pressure (BP) Increase | Sitting DBP (n= 8, 6, 9, 8, 8) | 7.17 millimeter of mercury (mmHg) | Standard Error 1.81 |
| TBC3711 200 mg | Maximum Blood Pressure (BP) Increase | Sitting SBP (n= 8, 6, 9, 8, 8) | 10.46 millimeter of mercury (mmHg) | Standard Error 4.09 |
| TBC3711 200 mg | Maximum Blood Pressure (BP) Increase | Standing SBP (n= 10, 8, 11, 10, 10) | 14.76 millimeter of mercury (mmHg) | Standard Error 3.23 |
| TBC3711 200 mg | Maximum Blood Pressure (BP) Increase | Standing DBP (n= 10, 8, 11, 10, 10) | 6.25 millimeter of mercury (mmHg) | Standard Error 1.74 |
Comparison: Sitting SBP: p-value was obtained using an Analysis of Co-variance (ANCOVA) model on the maximum increase observed with baseline value as a covariate.p-value: 0.18595% CI: [-4.21, 20.96]ANCOVA
Comparison: Sitting SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.p-value: 0.9795% CI: [-11.16, 11.59]ANCOVA
Comparison: Sitting SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.p-value: 0.99495% CI: [-11.66, 11.57]ANCOVA
Comparison: Sitting SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.p-value: 0.86195% CI: [-10.62, 12.64]ANCOVA
Comparison: Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.p-value: 0.22195% CI: [-3.79, 15.99]ANCOVA
Comparison: Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.p-value: 0.8895% CI: [-8.37, 9.73]ANCOVA
Comparison: Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.p-value: 0.995% CI: [-9.78, 8.63]ANCOVA
Comparison: Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.p-value: 0.21895% CI: [-14.91, 3.5]ANCOVA
Comparison: Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.p-value: 0.04495% CI: [0.17, 11.08]ANCOVA
Comparison: Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.p-value: 0.55795% CI: [-3.47, 6.33]ANCOVA
Comparison: Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.p-value: 0.01695% CI: [1.28, 11.45]ANCOVA
Comparison: Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.p-value: 0.69595% CI: [-4.09, 6.07]ANCOVA
Comparison: Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.p-value: 0.06795% CI: [-0.36, 9.95]ANCOVA
Comparison: Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.p-value: 0.73795% CI: [-3.96, 5.55]ANCOVA
Comparison: Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.p-value: 0.02395% CI: [0.8, 10.47]ANCOVA
Comparison: Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.p-value: 0.49595% CI: [-3.2, 6.5]ANCOVA
Primary
Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change
AUEC was calculated as the positive area under the change from baseline curve for sitting and standing SBP and DBP to Week 12, estimated by the linear trapezoidal rule corrected for the pre-dose baseline value. In the event that post-dose values returned below baseline at or before Week 12, then AUEC was calculated by setting the negative values to zero and taking only the positive area into account.
Time frame: Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12
Population: Safety analysis set: all participants who received at least 1 dose of study treatment. N(number of participants analyzed): participants evaluable for this measure and n: participants with non-missing baseline and at least 2 non-missing values in treatment phase or in follow-up for specified category for each treatment arm, respectively.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change | Standing DBP (n= 10, 7, 11, 10, 10) | 282.89 mmHg | Standard Error 73.31 |
| Placebo | Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change | Sitting SBP (n= 8, 5, 9, 8, 8) | 318.50 mmHg | Standard Error 125.2 |
| Placebo | Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change | Sitting DBP (n= 8, 5, 9, 8, 8) | 256.38 mmHg | Standard Error 67.58 |
| Placebo | Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change | Standing SBP (n= 10, 7, 11, 10, 10) | 237.83 mmHg | Standard Error 83.52 |
| TBC3711 10 mg | Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change | Standing DBP (n= 10, 7, 11, 10, 10) | 42.26 mmHg | Standard Error 87.57 |
| TBC3711 10 mg | Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change | Standing SBP (n= 10, 7, 11, 10, 10) | 74.79 mmHg | Standard Error 99.66 |
| TBC3711 10 mg | Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change | Sitting DBP (n= 8, 5, 9, 8, 8) | 30.82 mmHg | Standard Error 85.41 |
| TBC3711 10 mg | Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change | Sitting SBP (n= 8, 5, 9, 8, 8) | 85.91 mmHg | Standard Error 158.59 |
| TBC3711 50 mg | Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change | Standing SBP (n= 10, 7, 11, 10, 10) | 122.48 mmHg | Standard Error 79.95 |
| TBC3711 50 mg | Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change | Sitting SBP (n= 8, 5, 9, 8, 8) | 214.83 mmHg | Standard Error 119.85 |
| TBC3711 50 mg | Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change | Sitting DBP (n= 8, 5, 9, 8, 8) | 141.61 mmHg | Standard Error 63.97 |
| TBC3711 50 mg | Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change | Standing DBP (n= 10, 7, 11, 10, 10) | 124.90 mmHg | Standard Error 70.65 |
| TBC3711 100 mg | Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change | Sitting DBP (n= 8, 5, 9, 8, 8) | 31.50 mmHg | Standard Error 68.88 |
| TBC3711 100 mg | Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change | Sitting SBP (n= 8, 5, 9, 8, 8) | 277.24 mmHg | Standard Error 125.27 |
| TBC3711 100 mg | Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change | Standing DBP (n= 10, 7, 11, 10, 10) | 27.99 mmHg | Standard Error 73.46 |
| TBC3711 100 mg | Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change | Standing SBP (n= 10, 7, 11, 10, 10) | 213.16 mmHg | Standard Error 83.46 |
| TBC3711 200 mg | Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change | Sitting SBP (n= 8, 5, 9, 8, 8) | 152.10 mmHg | Standard Error 126.57 |
| TBC3711 200 mg | Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change | Sitting DBP (n= 8, 5, 9, 8, 8) | 123.17 mmHg | Standard Error 70.03 |
| TBC3711 200 mg | Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change | Standing SBP (n= 10, 7, 11, 10, 10) | 187.24 mmHg | Standard Error 83.37 |
| TBC3711 200 mg | Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change | Standing DBP (n= 10, 7, 11, 10, 10) | 125.23 mmHg | Standard Error 75.08 |
Comparison: Sitting SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.p-value: 0.257795% CI: [-178.5, 643.7]ANCOVA
Comparison: Sitting SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.p-value: 0.555295% CI: [-250.5, 457.8]ANCOVA
Comparison: Sitting SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.p-value: 0.817495% CI: [-319.8, 402.3]ANCOVA
Comparison: Sitting SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.p-value: 0.355795% CI: [-195.3, 528.1]ANCOVA
Comparison: Standing SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.p-value: 0.217295% CI: [-99.6, 425.7]ANCOVA
Comparison: Standing SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.p-value: 0.325895% CI: [-118.8, 349.5]ANCOVA
Comparison: Standing SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.p-value: 0.835295% CI: [-213.2, 262.6]ANCOVA
Comparison: Standing SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.p-value: 0.670195% CI: [-187.4, 288.6]ANCOVA
Comparison: Sitting DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.p-value: 0.046695% CI: [3.6, 447.5]ANCOVA
Comparison: Sitting DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.p-value: 0.227495% CI: [-75.2, 304.8]ANCOVA
Comparison: Sitting DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.p-value: 0.026995% CI: [27.5, 422.3]ANCOVA
Comparison: Sitting DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.p-value: 0.17895% CI: [-63.8, 330.3]ANCOVA
Comparison: Standing DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.p-value: 0.041395% CI: [9.9, 471.4]ANCOVA
Comparison: Standing DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.p-value: 0.129795% CI: [-48.3, 364.3]ANCOVA
Comparison: Standing DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.p-value: 0.018595% CI: [45, 464.8]ANCOVA
Comparison: Standing DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.p-value: 0.138295% CI: [-52.9, 368.2]ANCOVA
Secondary
Change From Pre-Dose to Post-Dose in Diastolic Blood Pressure (DBP) at Week 10
DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.
Time frame: Pre-Dose and 2 hours Post-Dose on Week 10
Population: FAS:all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. N (number of participants analyzed): participants evaluable for this measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Pre-Dose to Post-Dose in Diastolic Blood Pressure (DBP) at Week 10 | Week 10: Standing | -6.90 mmHg | Standard Error 2.44 |
| Placebo | Change From Pre-Dose to Post-Dose in Diastolic Blood Pressure (DBP) at Week 10 | Week 10: Sitting | -8.57 mmHg | Standard Error 2.5 |
| TBC3711 10 mg | Change From Pre-Dose to Post-Dose in Diastolic Blood Pressure (DBP) at Week 10 | Week 10: Sitting | -9.79 mmHg | Standard Error 3.26 |
| TBC3711 10 mg | Change From Pre-Dose to Post-Dose in Diastolic Blood Pressure (DBP) at Week 10 | Week 10: Standing | -10.35 mmHg | Standard Error 3.36 |
| TBC3711 50 mg | Change From Pre-Dose to Post-Dose in Diastolic Blood Pressure (DBP) at Week 10 | Week 10: Sitting | -3.69 mmHg | Standard Error 2.46 |
| TBC3711 50 mg | Change From Pre-Dose to Post-Dose in Diastolic Blood Pressure (DBP) at Week 10 | Week 10: Standing | -5.51 mmHg | Standard Error 2.55 |
| TBC3711 100 mg | Change From Pre-Dose to Post-Dose in Diastolic Blood Pressure (DBP) at Week 10 | Week 10: Standing | -11.67 mmHg | Standard Error 2.61 |
| TBC3711 100 mg | Change From Pre-Dose to Post-Dose in Diastolic Blood Pressure (DBP) at Week 10 | Week 10: Sitting | -11.28 mmHg | Standard Error 2.52 |
| TBC3711 200 mg | Change From Pre-Dose to Post-Dose in Diastolic Blood Pressure (DBP) at Week 10 | Week 10: Sitting | -7.23 mmHg | Standard Error 2.66 |
| TBC3711 200 mg | Change From Pre-Dose to Post-Dose in Diastolic Blood Pressure (DBP) at Week 10 | Week 10: Standing | -7.97 mmHg | Standard Error 2.78 |
Comparison: Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.p-value: 0.768595% CI: [-7.19, 9.62]ANCOVA
Comparison: Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.p-value: 0.173995% CI: [-12.07, 2.3]ANCOVA
Comparison: Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.p-value: 0.461295% CI: [-4.74, 10.15]ANCOVA
Comparison: Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.p-value: 0.717295% CI: [-8.9, 6.21]ANCOVA
Comparison: Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.p-value: 0.409895% CI: [-5.01, 11.91]ANCOVA
Comparison: Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.p-value: 0.694395% CI: [-8.54, 5.78]ANCOVA
Comparison: Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.p-value: 0.204295% CI: [-2.76, 12.31]ANCOVA
Comparison: Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.p-value: 0.779195% CI: [-6.69, 8.83]ANCOVA
Secondary
Change From Pre-Dose to Post-Dose in Systolic Blood Pressure (SBP) at Week 10
SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.
Time frame: Pre-Dose and 2 hours Post-Dose on Week 10
Population: FAS:all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. N (number of participants analyzed): participants evaluable for this measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Pre-Dose to Post-Dose in Systolic Blood Pressure (SBP) at Week 10 | Week 10: Standing | -7.34 mmHg | Standard Error 2.95 |
| Placebo | Change From Pre-Dose to Post-Dose in Systolic Blood Pressure (SBP) at Week 10 | Week 10: Sitting | -8.33 mmHg | Standard Error 3.23 |
| TBC3711 10 mg | Change From Pre-Dose to Post-Dose in Systolic Blood Pressure (SBP) at Week 10 | Week 10: Standing | -4.41 mmHg | Standard Error 4.19 |
| TBC3711 10 mg | Change From Pre-Dose to Post-Dose in Systolic Blood Pressure (SBP) at Week 10 | Week 10: Sitting | -4.59 mmHg | Standard Error 4.3 |
| TBC3711 50 mg | Change From Pre-Dose to Post-Dose in Systolic Blood Pressure (SBP) at Week 10 | Week 10: Standing | -3.13 mmHg | Standard Error 3.16 |
| TBC3711 50 mg | Change From Pre-Dose to Post-Dose in Systolic Blood Pressure (SBP) at Week 10 | Week 10: Sitting | -4.49 mmHg | Standard Error 3.25 |
| TBC3711 100 mg | Change From Pre-Dose to Post-Dose in Systolic Blood Pressure (SBP) at Week 10 | Week 10: Standing | -5.24 mmHg | Standard Error 3.17 |
| TBC3711 100 mg | Change From Pre-Dose to Post-Dose in Systolic Blood Pressure (SBP) at Week 10 | Week 10: Sitting | -5.87 mmHg | Standard Error 3.23 |
| TBC3711 200 mg | Change From Pre-Dose to Post-Dose in Systolic Blood Pressure (SBP) at Week 10 | Week 10: Standing | -11.17 mmHg | Standard Error 3.42 |
| TBC3711 200 mg | Change From Pre-Dose to Post-Dose in Systolic Blood Pressure (SBP) at Week 10 | Week 10: Sitting | -7.03 mmHg | Standard Error 3.53 |
Comparison: Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.p-value: 0.493395% CI: [-14.84, 7.35]ANCOVA
Comparison: Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.p-value: 0.40895% CI: [-13.26, 5.57]ANCOVA
Comparison: Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.p-value: 0.593695% CI: [-11.86, 6.93]ANCOVA
Comparison: Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.p-value: 0.788395% CI: [-11.17, 8.57]ANCOVA
Comparison: Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.p-value: 0.571995% CI: [-13.46, 7.6]ANCOVA
Comparison: Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.p-value: 0.340195% CI: [-13.11, 4.7]ANCOVA
Comparison: Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.p-value: 0.632995% CI: [-11.01, 6.82]ANCOVA
Comparison: Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.p-value: 0.403795% CI: [-5.45, 13.11]ANCOVA
Secondary
Change From Standing to Sitting Diastolic Blood Pressure (DBP) at Week 10
DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.
Time frame: Pre-Dose and 2 hours Post-Dose on Week 10
Population: FAS:all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. N (number of participants analyzed): participants evaluable for this measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Standing to Sitting Diastolic Blood Pressure (DBP) at Week 10 | Week 10: Pre-Dose | -0.95 mmHg | Standard Error 0.95 |
| Placebo | Change From Standing to Sitting Diastolic Blood Pressure (DBP) at Week 10 | Week 10: Post-Dose | -1.28 mmHg | Standard Error 1.32 |
| TBC3711 10 mg | Change From Standing to Sitting Diastolic Blood Pressure (DBP) at Week 10 | Week 10: Post-Dose | 1.50 mmHg | Standard Error 1.77 |
| TBC3711 10 mg | Change From Standing to Sitting Diastolic Blood Pressure (DBP) at Week 10 | Week 10: Pre-Dose | 2.04 mmHg | Standard Error 1.27 |
| TBC3711 50 mg | Change From Standing to Sitting Diastolic Blood Pressure (DBP) at Week 10 | Week 10: Post-Dose | -0.09 mmHg | Standard Error 1.32 |
| TBC3711 50 mg | Change From Standing to Sitting Diastolic Blood Pressure (DBP) at Week 10 | Week 10: Pre-Dose | -1.42 mmHg | Standard Error 0.95 |
| TBC3711 100 mg | Change From Standing to Sitting Diastolic Blood Pressure (DBP) at Week 10 | Week 10: Post-Dose | 0.68 mmHg | Standard Error 1.36 |
| TBC3711 100 mg | Change From Standing to Sitting Diastolic Blood Pressure (DBP) at Week 10 | Week 10: Pre-Dose | -1.18 mmHg | Standard Error 0.98 |
| TBC3711 200 mg | Change From Standing to Sitting Diastolic Blood Pressure (DBP) at Week 10 | Week 10: Post-Dose | 0.80 mmHg | Standard Error 1.43 |
| TBC3711 200 mg | Change From Standing to Sitting Diastolic Blood Pressure (DBP) at Week 10 | Week 10: Pre-Dose | -0.43 mmHg | Standard Error 1.03 |
Comparison: Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.p-value: 0.071495% CI: [-6.25, 0.28]ANCOVA
Comparison: Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.p-value: 0.726995% CI: [-2.29, 3.24]ANCOVA
Comparison: Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.p-value: 0.865695% CI: [-2.58, 3.04]ANCOVA
Comparison: Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.p-value: 0.711395% CI: [-3.41, 2.36]ANCOVA
Comparison: Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.p-value: 0.220495% CI: [-7.32, 1.77]ANCOVA
Comparison: Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.p-value: 0.529895% CI: [-5.04, 2.66]ANCOVA
Comparison: Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.p-value: 0.313595% CI: [-5.86, 1.96]ANCOVA
Comparison: Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.p-value: 0.296295% CI: [-6.09, 1.93]ANCOVA
Secondary
Change From Standing to Sitting Systolic Blood Pressure (SBP) at Week 10
SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.
Time frame: Pre-Dose and 2 hours Post-Dose on Week 10
Population: FAS:all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. N (number of participants analyzed): participants evaluable for this measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Standing to Sitting Systolic Blood Pressure (SBP) at Week 10 | Week 10: Pre-Dose | 1.32 mmHg | Standard Error 1.78 |
| Placebo | Change From Standing to Sitting Systolic Blood Pressure (SBP) at Week 10 | Week 10: Post-Dose | 2.63 mmHg | Standard Error 1.97 |
| TBC3711 10 mg | Change From Standing to Sitting Systolic Blood Pressure (SBP) at Week 10 | Week 10: Pre-Dose | 0.46 mmHg | Standard Error 2.34 |
| TBC3711 10 mg | Change From Standing to Sitting Systolic Blood Pressure (SBP) at Week 10 | Week 10: Post-Dose | -0.55 mmHg | Standard Error 2.59 |
| TBC3711 50 mg | Change From Standing to Sitting Systolic Blood Pressure (SBP) at Week 10 | Week 10: Pre-Dose | 1.67 mmHg | Standard Error 1.76 |
| TBC3711 50 mg | Change From Standing to Sitting Systolic Blood Pressure (SBP) at Week 10 | Week 10: Post-Dose | 1.28 mmHg | Standard Error 1.95 |
| TBC3711 100 mg | Change From Standing to Sitting Systolic Blood Pressure (SBP) at Week 10 | Week 10: Post-Dose | -1.30 mmHg | Standard Error 1.93 |
| TBC3711 100 mg | Change From Standing to Sitting Systolic Blood Pressure (SBP) at Week 10 | Week 10: Pre-Dose | -0.54 mmHg | Standard Error 1.74 |
| TBC3711 200 mg | Change From Standing to Sitting Systolic Blood Pressure (SBP) at Week 10 | Week 10: Pre-Dose | -0.85 mmHg | Standard Error 2.01 |
| TBC3711 200 mg | Change From Standing to Sitting Systolic Blood Pressure (SBP) at Week 10 | Week 10: Post-Dose | 1.66 mmHg | Standard Error 2.22 |
Comparison: Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.p-value: 0.775895% CI: [-5.31, 7.03]ANCOVA
Comparison: Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.p-value: 0.88895% CI: [-5.4, 4.71]ANCOVA
Comparison: Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.p-value: 0.457395% CI: [-3.21, 6.93]ANCOVA
Comparison: Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.p-value: 0.442495% CI: [-3.56, 7.91]ANCOVA
Comparison: Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.p-value: 0.34795% CI: [-3.65, 10.01]ANCOVA
Comparison: Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.p-value: 0.624995% CI: [-4.25, 6.94]ANCOVA
Comparison: Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.p-value: 0.162595% CI: [-1.69, 9.54]ANCOVA
Comparison: Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.p-value: 0.755695% CI: [-5.38, 7.31]ANCOVA
Secondary
Sitting Diastolic Blood Pressure (DBP)
DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements. The same arm was used throughout the study.
Time frame: Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10
Population: FAS: all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. Here N (number of participants analyzed): participants evaluable for this measure, n: participants with non-missing value for specified time-point for each treatment arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Sitting Diastolic Blood Pressure (DBP) | Week 4: Pre-Dose (n= 7, 5, 8, 8, 8) | 83.6 mmHg | Standard Error 3.7 |
| Placebo | Sitting Diastolic Blood Pressure (DBP) | Week 3: Post-Dose (n= 8, 5, 6, 7, 8) | 87.5 mmHg | Standard Error 4.8 |
| Placebo | Sitting Diastolic Blood Pressure (DBP) | Week 3: Pre-Dose (n= 8, 4, 7, 7, 8) | 89.3 mmHg | Standard Error 5.4 |
| Placebo | Sitting Diastolic Blood Pressure (DBP) | Week 1: Post-Dose (n= 8, 6, 9, 8, 8) | 89.3 mmHg | Standard Error 5.2 |
| Placebo | Sitting Diastolic Blood Pressure (DBP) | Week 2: Post-Dose (n= 8, 6, 9, 8, 7) | 83.7 mmHg | Standard Error 6.5 |
| Placebo | Sitting Diastolic Blood Pressure (DBP) | Week 2: Pre-Dose (n= 8, 6, 9, 8, 8) | 90.6 mmHg | Standard Error 5.8 |
| Placebo | Sitting Diastolic Blood Pressure (DBP) | Week 10: Pre-Dose (n= 7, 4, 7, 7, 6) | 87.6 mmHg | Standard Error 4.1 |
| Placebo | Sitting Diastolic Blood Pressure (DBP) | Week 8: Post-Dose (n= 7, 5, 7, 7, 6) | 78.8 mmHg | Standard Error 5.9 |
| Placebo | Sitting Diastolic Blood Pressure (DBP) | Week 8: Pre-Dose (n= 7, 5, 7, 7, 6) | 84.8 mmHg | Standard Error 5.9 |
| Placebo | Sitting Diastolic Blood Pressure (DBP) | Baseline: Post-Dose (n= 8, 6, 9, 8, 8) | 91.7 mmHg | Standard Error 5.5 |
| Placebo | Sitting Diastolic Blood Pressure (DBP) | Week 10: Post-Dose (n= 7, 4, 7, 7, 6) | 79.9 mmHg | Standard Error 5.6 |
| Placebo | Sitting Diastolic Blood Pressure (DBP) | Week 6: Post-Dose (n= 7, 5, 7, 7, 6) | 84.1 mmHg | Standard Error 5.4 |
| Placebo | Sitting Diastolic Blood Pressure (DBP) | Week 6: Pre-Dose (n= 7, 5, 7, 7, 6) | 86.8 mmHg | Standard Error 5.3 |
| Placebo | Sitting Diastolic Blood Pressure (DBP) | Week 4: Post-Dose (n= 7, 4, 8, 7, 8) | 82 mmHg | Standard Error 3.7 |
| Placebo | Sitting Diastolic Blood Pressure (DBP) | Week 1: Pre-Dose (n= 8, 6, 9, 8, 8) | 92.6 mmHg | Standard Error 5.6 |
| Placebo | Sitting Diastolic Blood Pressure (DBP) | Baseline: Pre-Dose (n= 8, 6, 9, 8, 8) | 95.1 mmHg | Standard Error 6.2 |
| TBC3711 10 mg | Sitting Diastolic Blood Pressure (DBP) | Week 1: Post-Dose (n= 8, 6, 9, 8, 8) | 80.3 mmHg | Standard Error 4 |
| TBC3711 10 mg | Sitting Diastolic Blood Pressure (DBP) | Week 6: Post-Dose (n= 7, 5, 7, 7, 6) | 73.2 mmHg | Standard Error 2.8 |
| TBC3711 10 mg | Sitting Diastolic Blood Pressure (DBP) | Week 8: Pre-Dose (n= 7, 5, 7, 7, 6) | 82.9 mmHg | Standard Error 3.8 |
| TBC3711 10 mg | Sitting Diastolic Blood Pressure (DBP) | Baseline: Pre-Dose (n= 8, 6, 9, 8, 8) | 87 mmHg | Standard Error 1.8 |
| TBC3711 10 mg | Sitting Diastolic Blood Pressure (DBP) | Baseline: Post-Dose (n= 8, 6, 9, 8, 8) | 81 mmHg | Standard Error 3.1 |
| TBC3711 10 mg | Sitting Diastolic Blood Pressure (DBP) | Week 1: Pre-Dose (n= 8, 6, 9, 8, 8) | 88.4 mmHg | Standard Error 3.1 |
| TBC3711 10 mg | Sitting Diastolic Blood Pressure (DBP) | Week 2: Pre-Dose (n= 8, 6, 9, 8, 8) | 86.1 mmHg | Standard Error 4.4 |
| TBC3711 10 mg | Sitting Diastolic Blood Pressure (DBP) | Week 2: Post-Dose (n= 8, 6, 9, 8, 7) | 77.8 mmHg | Standard Error 6.5 |
| TBC3711 10 mg | Sitting Diastolic Blood Pressure (DBP) | Week 3: Pre-Dose (n= 8, 4, 7, 7, 8) | 82.5 mmHg | Standard Error 4.4 |
| TBC3711 10 mg | Sitting Diastolic Blood Pressure (DBP) | Week 3: Post-Dose (n= 8, 5, 6, 7, 8) | 74.9 mmHg | Standard Error 4.1 |
| TBC3711 10 mg | Sitting Diastolic Blood Pressure (DBP) | Week 4: Pre-Dose (n= 7, 5, 8, 8, 8) | 79.2 mmHg | Standard Error 3.8 |
| TBC3711 10 mg | Sitting Diastolic Blood Pressure (DBP) | Week 4: Post-Dose (n= 7, 4, 8, 7, 8) | 74.3 mmHg | Standard Error 4.9 |
| TBC3711 10 mg | Sitting Diastolic Blood Pressure (DBP) | Week 6: Pre-Dose (n= 7, 5, 7, 7, 6) | 78.9 mmHg | Standard Error 3.5 |
| TBC3711 10 mg | Sitting Diastolic Blood Pressure (DBP) | Week 8: Post-Dose (n= 7, 5, 7, 7, 6) | 76.1 mmHg | Standard Error 2.6 |
| TBC3711 10 mg | Sitting Diastolic Blood Pressure (DBP) | Week 10: Pre-Dose (n= 7, 4, 7, 7, 6) | 85.5 mmHg | Standard Error 2.2 |
| TBC3711 10 mg | Sitting Diastolic Blood Pressure (DBP) | Week 10: Post-Dose (n= 7, 4, 7, 7, 6) | 76.2 mmHg | Standard Error 0.9 |
| TBC3711 50 mg | Sitting Diastolic Blood Pressure (DBP) | Week 8: Post-Dose (n= 7, 5, 7, 7, 6) | 73.2 mmHg | Standard Error 3.8 |
| TBC3711 50 mg | Sitting Diastolic Blood Pressure (DBP) | Week 10: Pre-Dose (n= 7, 4, 7, 7, 6) | 84.8 mmHg | Standard Error 3.4 |
| TBC3711 50 mg | Sitting Diastolic Blood Pressure (DBP) | Week 3: Pre-Dose (n= 8, 4, 7, 7, 8) | 86 mmHg | Standard Error 6.7 |
| TBC3711 50 mg | Sitting Diastolic Blood Pressure (DBP) | Week 3: Post-Dose (n= 8, 5, 6, 7, 8) | 72.8 mmHg | Standard Error 4.2 |
| TBC3711 50 mg | Sitting Diastolic Blood Pressure (DBP) | Week 1: Pre-Dose (n= 8, 6, 9, 8, 8) | 87.5 mmHg | Standard Error 2.8 |
| TBC3711 50 mg | Sitting Diastolic Blood Pressure (DBP) | Week 4: Pre-Dose (n= 7, 5, 8, 8, 8) | 86 mmHg | Standard Error 5.3 |
| TBC3711 50 mg | Sitting Diastolic Blood Pressure (DBP) | Week 6: Post-Dose (n= 7, 5, 7, 7, 6) | 74.2 mmHg | Standard Error 4.2 |
| TBC3711 50 mg | Sitting Diastolic Blood Pressure (DBP) | Week 4: Post-Dose (n= 7, 4, 8, 7, 8) | 76.6 mmHg | Standard Error 5.7 |
| TBC3711 50 mg | Sitting Diastolic Blood Pressure (DBP) | Week 6: Pre-Dose (n= 7, 5, 7, 7, 6) | 78.3 mmHg | Standard Error 3.4 |
| TBC3711 50 mg | Sitting Diastolic Blood Pressure (DBP) | Baseline: Post-Dose (n= 8, 6, 9, 8, 8) | 82.4 mmHg | Standard Error 3.8 |
| TBC3711 50 mg | Sitting Diastolic Blood Pressure (DBP) | Week 8: Pre-Dose (n= 7, 5, 7, 7, 6) | 79.3 mmHg | Standard Error 2.7 |
| TBC3711 50 mg | Sitting Diastolic Blood Pressure (DBP) | Baseline: Pre-Dose (n= 8, 6, 9, 8, 8) | 87.3 mmHg | Standard Error 3 |
| TBC3711 50 mg | Sitting Diastolic Blood Pressure (DBP) | Week 10: Post-Dose (n= 7, 4, 7, 7, 6) | 81.3 mmHg | Standard Error 3.1 |
| TBC3711 50 mg | Sitting Diastolic Blood Pressure (DBP) | Week 1: Post-Dose (n= 8, 6, 9, 8, 8) | 80 mmHg | Standard Error 3.5 |
| TBC3711 50 mg | Sitting Diastolic Blood Pressure (DBP) | Week 2: Pre-Dose (n= 8, 6, 9, 8, 8) | 87.1 mmHg | Standard Error 4 |
| TBC3711 50 mg | Sitting Diastolic Blood Pressure (DBP) | Week 2: Post-Dose (n= 8, 6, 9, 8, 7) | 76.3 mmHg | Standard Error 5.2 |
| TBC3711 100 mg | Sitting Diastolic Blood Pressure (DBP) | Week 1: Post-Dose (n= 8, 6, 9, 8, 8) | 77.6 mmHg | Standard Error 4.8 |
| TBC3711 100 mg | Sitting Diastolic Blood Pressure (DBP) | Week 6: Pre-Dose (n= 7, 5, 7, 7, 6) | 80.7 mmHg | Standard Error 5.2 |
| TBC3711 100 mg | Sitting Diastolic Blood Pressure (DBP) | Baseline: Post-Dose (n= 8, 6, 9, 8, 8) | 82.7 mmHg | Standard Error 3.8 |
| TBC3711 100 mg | Sitting Diastolic Blood Pressure (DBP) | Week 2: Pre-Dose (n= 8, 6, 9, 8, 8) | 84.4 mmHg | Standard Error 4.8 |
| TBC3711 100 mg | Sitting Diastolic Blood Pressure (DBP) | Week 6: Post-Dose (n= 7, 5, 7, 7, 6) | 68.9 mmHg | Standard Error 3.5 |
| TBC3711 100 mg | Sitting Diastolic Blood Pressure (DBP) | Week 3: Pre-Dose (n= 8, 4, 7, 7, 8) | 79.8 mmHg | Standard Error 7.1 |
| TBC3711 100 mg | Sitting Diastolic Blood Pressure (DBP) | Week 4: Post-Dose (n= 7, 4, 8, 7, 8) | 68.6 mmHg | Standard Error 3.7 |
| TBC3711 100 mg | Sitting Diastolic Blood Pressure (DBP) | Week 1: Pre-Dose (n= 8, 6, 9, 8, 8) | 83.6 mmHg | Standard Error 4.2 |
| TBC3711 100 mg | Sitting Diastolic Blood Pressure (DBP) | Week 10: Pre-Dose (n= 7, 4, 7, 7, 6) | 79.1 mmHg | Standard Error 5.1 |
| TBC3711 100 mg | Sitting Diastolic Blood Pressure (DBP) | Week 2: Post-Dose (n= 8, 6, 9, 8, 7) | 71.8 mmHg | Standard Error 3.4 |
| TBC3711 100 mg | Sitting Diastolic Blood Pressure (DBP) | Week 3: Post-Dose (n= 8, 5, 6, 7, 8) | 71.8 mmHg | Standard Error 6.1 |
| TBC3711 100 mg | Sitting Diastolic Blood Pressure (DBP) | Baseline: Pre-Dose (n= 8, 6, 9, 8, 8) | 87.8 mmHg | Standard Error 3.5 |
| TBC3711 100 mg | Sitting Diastolic Blood Pressure (DBP) | Week 8: Post-Dose (n= 7, 5, 7, 7, 6) | 73.7 mmHg | Standard Error 5.5 |
| TBC3711 100 mg | Sitting Diastolic Blood Pressure (DBP) | Week 10: Post-Dose (n= 7, 4, 7, 7, 6) | 66.8 mmHg | Standard Error 3.6 |
| TBC3711 100 mg | Sitting Diastolic Blood Pressure (DBP) | Week 8: Pre-Dose (n= 7, 5, 7, 7, 6) | 80.6 mmHg | Standard Error 5.7 |
| TBC3711 100 mg | Sitting Diastolic Blood Pressure (DBP) | Week 4: Pre-Dose (n= 7, 5, 8, 8, 8) | 78.1 mmHg | Standard Error 4.8 |
| TBC3711 200 mg | Sitting Diastolic Blood Pressure (DBP) | Week 8: Pre-Dose (n= 7, 5, 7, 7, 6) | 93.7 mmHg | Standard Error 3.9 |
| TBC3711 200 mg | Sitting Diastolic Blood Pressure (DBP) | Baseline: Post-Dose (n= 8, 6, 9, 8, 8) | 93.7 mmHg | Standard Error 3.6 |
| TBC3711 200 mg | Sitting Diastolic Blood Pressure (DBP) | Week 1: Post-Dose (n= 8, 6, 9, 8, 8) | 94.4 mmHg | Standard Error 3.8 |
| TBC3711 200 mg | Sitting Diastolic Blood Pressure (DBP) | Week 4: Post-Dose (n= 7, 4, 8, 7, 8) | 81 mmHg | Standard Error 4.5 |
| TBC3711 200 mg | Sitting Diastolic Blood Pressure (DBP) | Week 10: Post-Dose (n= 7, 4, 7, 7, 6) | 85.4 mmHg | Standard Error 4.4 |
| TBC3711 200 mg | Sitting Diastolic Blood Pressure (DBP) | Baseline: Pre-Dose (n= 8, 6, 9, 8, 8) | 99.3 mmHg | Standard Error 2.1 |
| TBC3711 200 mg | Sitting Diastolic Blood Pressure (DBP) | Week 6: Pre-Dose (n= 7, 5, 7, 7, 6) | 92.1 mmHg | Standard Error 3.1 |
| TBC3711 200 mg | Sitting Diastolic Blood Pressure (DBP) | Week 6: Post-Dose (n= 7, 5, 7, 7, 6) | 84.7 mmHg | Standard Error 5.3 |
| TBC3711 200 mg | Sitting Diastolic Blood Pressure (DBP) | Week 4: Pre-Dose (n= 7, 5, 8, 8, 8) | 89.3 mmHg | Standard Error 3.6 |
| TBC3711 200 mg | Sitting Diastolic Blood Pressure (DBP) | Week 2: Post-Dose (n= 8, 6, 9, 8, 7) | 83.7 mmHg | Standard Error 4.8 |
| TBC3711 200 mg | Sitting Diastolic Blood Pressure (DBP) | Week 1: Pre-Dose (n= 8, 6, 9, 8, 8) | 99.3 mmHg | Standard Error 2.1 |
| TBC3711 200 mg | Sitting Diastolic Blood Pressure (DBP) | Week 2: Pre-Dose (n= 8, 6, 9, 8, 8) | 96.3 mmHg | Standard Error 2.5 |
| TBC3711 200 mg | Sitting Diastolic Blood Pressure (DBP) | Week 3: Pre-Dose (n= 8, 4, 7, 7, 8) | 91.6 mmHg | Standard Error 1.9 |
| TBC3711 200 mg | Sitting Diastolic Blood Pressure (DBP) | Week 3: Post-Dose (n= 8, 5, 6, 7, 8) | 79.9 mmHg | Standard Error 3.2 |
| TBC3711 200 mg | Sitting Diastolic Blood Pressure (DBP) | Week 10: Pre-Dose (n= 7, 4, 7, 7, 6) | 93 mmHg | Standard Error 3.2 |
| TBC3711 200 mg | Sitting Diastolic Blood Pressure (DBP) | Week 8: Post-Dose (n= 7, 5, 7, 7, 6) | 83.8 mmHg | Standard Error 6.1 |
Secondary
Sitting Systolic Blood Pressure (SBP)
SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80 percent \[%\] of the arm) after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements. The same arm was used throughout the study.
Time frame: Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10
Population: Full analysis set (FAS):all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. N (number of participants analyzed): participants evaluable for this measure, n: participants with non-missing value for specified time-point for each treatment arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Sitting Systolic Blood Pressure (SBP) | Week 1: Post-Dose (n= 8, 6, 9, 8, 8) | 151.1 mmHg | Standard Error 5.2 |
| Placebo | Sitting Systolic Blood Pressure (SBP) | Week 3: Pre-Dose (n= 8, 4, 7, 7, 8) | 148 mmHg | Standard Error 4.6 |
| Placebo | Sitting Systolic Blood Pressure (SBP) | Week 8: Post-Dose (n= 7, 5, 7, 7, 6) | 132.7 mmHg | Standard Error 6.5 |
| Placebo | Sitting Systolic Blood Pressure (SBP) | Week 4: Pre-Dose (n= 7, 5, 8, 8, 8) | 141.4 mmHg | Standard Error 4.9 |
| Placebo | Sitting Systolic Blood Pressure (SBP) | Baseline: Pre-Dose (n= 8, 6, 9, 8, 8) | 158.6 mmHg | Standard Error 5 |
| Placebo | Sitting Systolic Blood Pressure (SBP) | Week 3: Post-Dose (n= 8, 5, 6, 7, 8) | 144.2 mmHg | Standard Error 4.1 |
| Placebo | Sitting Systolic Blood Pressure (SBP) | Week 8: Pre-Dose (n= 7, 5, 7, 7, 6) | 139.6 mmHg | Standard Error 4.7 |
| Placebo | Sitting Systolic Blood Pressure (SBP) | Week 2: Pre-Dose (n= 8, 6, 9, 8, 8) | 149.6 mmHg | Standard Error 5.8 |
| Placebo | Sitting Systolic Blood Pressure (SBP) | Week 10: Post-Dose (n= 7, 4, 7, 7, 6) | 134.1 mmHg | Standard Error 7.9 |
| Placebo | Sitting Systolic Blood Pressure (SBP) | Week 6: Post-Dose (n= 7, 5, 7, 7, 6) | 141.7 mmHg | Standard Error 7.4 |
| Placebo | Sitting Systolic Blood Pressure (SBP) | Week 1: Pre-Dose (n= 8, 6, 9, 8, 8) | 156.3 mmHg | Standard Error 5.3 |
| Placebo | Sitting Systolic Blood Pressure (SBP) | Week 6: Pre-Dose (n= 7, 5, 7, 7, 6) | 149.2 mmHg | Standard Error 7 |
| Placebo | Sitting Systolic Blood Pressure (SBP) | Week 2: Post-Dose (n= 8, 6, 9, 8, 7) | 139.8 mmHg | Standard Error 5.5 |
| Placebo | Sitting Systolic Blood Pressure (SBP) | Baseline: Post-Dose (n= 8, 6, 9, 8, 8) | 149.9 mmHg | Standard Error 4.9 |
| Placebo | Sitting Systolic Blood Pressure (SBP) | Week 10: Pre-Dose (n= 7, 4, 7, 7, 6) | 142.1 mmHg | Standard Error 6.2 |
| Placebo | Sitting Systolic Blood Pressure (SBP) | Week 4: Post-Dose (n= 7, 4, 8, 7, 8) | 143 mmHg | Standard Error 5.4 |
| TBC3711 10 mg | Sitting Systolic Blood Pressure (SBP) | Week 4: Post-Dose (n= 7, 4, 8, 7, 8) | 137 mmHg | Standard Error 4.8 |
| TBC3711 10 mg | Sitting Systolic Blood Pressure (SBP) | Week 3: Pre-Dose (n= 8, 4, 7, 7, 8) | 141.5 mmHg | Standard Error 3.9 |
| TBC3711 10 mg | Sitting Systolic Blood Pressure (SBP) | Week 4: Pre-Dose (n= 7, 5, 8, 8, 8) | 141.2 mmHg | Standard Error 6.9 |
| TBC3711 10 mg | Sitting Systolic Blood Pressure (SBP) | Week 3: Post-Dose (n= 8, 5, 6, 7, 8) | 138.1 mmHg | Standard Error 3.3 |
| TBC3711 10 mg | Sitting Systolic Blood Pressure (SBP) | Baseline: Pre-Dose (n= 8, 6, 9, 8, 8) | 149.9 mmHg | Standard Error 5.6 |
| TBC3711 10 mg | Sitting Systolic Blood Pressure (SBP) | Baseline: Post-Dose (n= 8, 6, 9, 8, 8) | 141 mmHg | Standard Error 6.4 |
| TBC3711 10 mg | Sitting Systolic Blood Pressure (SBP) | Week 10: Post-Dose (n= 7, 4, 7, 7, 6) | 142 mmHg | Standard Error 6 |
| TBC3711 10 mg | Sitting Systolic Blood Pressure (SBP) | Week 10: Pre-Dose (n= 7, 4, 7, 7, 6) | 148.3 mmHg | Standard Error 8.5 |
| TBC3711 10 mg | Sitting Systolic Blood Pressure (SBP) | Week 1: Pre-Dose (n= 8, 6, 9, 8, 8) | 151 mmHg | Standard Error 4.7 |
| TBC3711 10 mg | Sitting Systolic Blood Pressure (SBP) | Week 8: Post-Dose (n= 7, 5, 7, 7, 6) | 136.8 mmHg | Standard Error 3.3 |
| TBC3711 10 mg | Sitting Systolic Blood Pressure (SBP) | Week 1: Post-Dose (n= 8, 6, 9, 8, 8) | 141.1 mmHg | Standard Error 8.8 |
| TBC3711 10 mg | Sitting Systolic Blood Pressure (SBP) | Week 8: Pre-Dose (n= 7, 5, 7, 7, 6) | 143.2 mmHg | Standard Error 6 |
| TBC3711 10 mg | Sitting Systolic Blood Pressure (SBP) | Week 2: Pre-Dose (n= 8, 6, 9, 8, 8) | 144.7 mmHg | Standard Error 7.5 |
| TBC3711 10 mg | Sitting Systolic Blood Pressure (SBP) | Week 6: Pre-Dose (n= 7, 5, 7, 7, 6) | 140.9 mmHg | Standard Error 6.2 |
| TBC3711 10 mg | Sitting Systolic Blood Pressure (SBP) | Week 2: Post-Dose (n= 8, 6, 9, 8, 7) | 130.6 mmHg | Standard Error 10.6 |
| TBC3711 10 mg | Sitting Systolic Blood Pressure (SBP) | Week 6: Post-Dose (n= 7, 5, 7, 7, 6) | 130.9 mmHg | Standard Error 3.6 |
| TBC3711 50 mg | Sitting Systolic Blood Pressure (SBP) | Week 1: Post-Dose (n= 8, 6, 9, 8, 8) | 134.4 mmHg | Standard Error 5.6 |
| TBC3711 50 mg | Sitting Systolic Blood Pressure (SBP) | Week 6: Post-Dose (n= 7, 5, 7, 7, 6) | 124.4 mmHg | Standard Error 4 |
| TBC3711 50 mg | Sitting Systolic Blood Pressure (SBP) | Baseline: Pre-Dose (n= 8, 6, 9, 8, 8) | 146.5 mmHg | Standard Error 4.1 |
| TBC3711 50 mg | Sitting Systolic Blood Pressure (SBP) | Baseline: Post-Dose (n= 8, 6, 9, 8, 8) | 139.7 mmHg | Standard Error 6.1 |
| TBC3711 50 mg | Sitting Systolic Blood Pressure (SBP) | Week 1: Pre-Dose (n= 8, 6, 9, 8, 8) | 143.5 mmHg | Standard Error 4.9 |
| TBC3711 50 mg | Sitting Systolic Blood Pressure (SBP) | Week 2: Pre-Dose (n= 8, 6, 9, 8, 8) | 143.5 mmHg | Standard Error 5.8 |
| TBC3711 50 mg | Sitting Systolic Blood Pressure (SBP) | Week 2: Post-Dose (n= 8, 6, 9, 8, 7) | 134.7 mmHg | Standard Error 8.7 |
| TBC3711 50 mg | Sitting Systolic Blood Pressure (SBP) | Week 3: Pre-Dose (n= 8, 4, 7, 7, 8) | 137.1 mmHg | Standard Error 6.5 |
| TBC3711 50 mg | Sitting Systolic Blood Pressure (SBP) | Week 3: Post-Dose (n= 8, 5, 6, 7, 8) | 123.2 mmHg | Standard Error 7.5 |
| TBC3711 50 mg | Sitting Systolic Blood Pressure (SBP) | Week 4: Pre-Dose (n= 7, 5, 8, 8, 8) | 140.9 mmHg | Standard Error 6.9 |
| TBC3711 50 mg | Sitting Systolic Blood Pressure (SBP) | Week 4: Post-Dose (n= 7, 4, 8, 7, 8) | 132.2 mmHg | Standard Error 9.1 |
| TBC3711 50 mg | Sitting Systolic Blood Pressure (SBP) | Week 6: Pre-Dose (n= 7, 5, 7, 7, 6) | 131.7 mmHg | Standard Error 4.3 |
| TBC3711 50 mg | Sitting Systolic Blood Pressure (SBP) | Week 8: Pre-Dose (n= 7, 5, 7, 7, 6) | 126.4 mmHg | Standard Error 4.4 |
| TBC3711 50 mg | Sitting Systolic Blood Pressure (SBP) | Week 8: Post-Dose (n= 7, 5, 7, 7, 6) | 122.8 mmHg | Standard Error 3.4 |
| TBC3711 50 mg | Sitting Systolic Blood Pressure (SBP) | Week 10: Pre-Dose (n= 7, 4, 7, 7, 6) | 134.5 mmHg | Standard Error 3.2 |
| TBC3711 50 mg | Sitting Systolic Blood Pressure (SBP) | Week 10: Post-Dose (n= 7, 4, 7, 7, 6) | 131.3 mmHg | Standard Error 4.1 |
| TBC3711 100 mg | Sitting Systolic Blood Pressure (SBP) | Week 6: Pre-Dose (n= 7, 5, 7, 7, 6) | 137.9 mmHg | Standard Error 7.8 |
| TBC3711 100 mg | Sitting Systolic Blood Pressure (SBP) | Week 4: Post-Dose (n= 7, 4, 8, 7, 8) | 132.3 mmHg | Standard Error 5.1 |
| TBC3711 100 mg | Sitting Systolic Blood Pressure (SBP) | Week 1: Pre-Dose (n= 8, 6, 9, 8, 8) | 145.3 mmHg | Standard Error 4.2 |
| TBC3711 100 mg | Sitting Systolic Blood Pressure (SBP) | Week 6: Post-Dose (n= 7, 5, 7, 7, 6) | 132.7 mmHg | Standard Error 5.7 |
| TBC3711 100 mg | Sitting Systolic Blood Pressure (SBP) | Week 8: Post-Dose (n= 7, 5, 7, 7, 6) | 136.6 mmHg | Standard Error 5.2 |
| TBC3711 100 mg | Sitting Systolic Blood Pressure (SBP) | Week 2: Pre-Dose (n= 8, 6, 9, 8, 8) | 147.1 mmHg | Standard Error 4.4 |
| TBC3711 100 mg | Sitting Systolic Blood Pressure (SBP) | Week 2: Post-Dose (n= 8, 6, 9, 8, 7) | 139 mmHg | Standard Error 4.7 |
| TBC3711 100 mg | Sitting Systolic Blood Pressure (SBP) | Baseline: Post-Dose (n= 8, 6, 9, 8, 8) | 149.3 mmHg | Standard Error 4.4 |
| TBC3711 100 mg | Sitting Systolic Blood Pressure (SBP) | Week 10: Post-Dose (n= 7, 4, 7, 7, 6) | 131.7 mmHg | Standard Error 6.8 |
| TBC3711 100 mg | Sitting Systolic Blood Pressure (SBP) | Week 3: Post-Dose (n= 8, 5, 6, 7, 8) | 138.5 mmHg | Standard Error 6 |
| TBC3711 100 mg | Sitting Systolic Blood Pressure (SBP) | Week 1: Post-Dose (n= 8, 6, 9, 8, 8) | 139.4 mmHg | Standard Error 5.1 |
| TBC3711 100 mg | Sitting Systolic Blood Pressure (SBP) | Baseline: Pre-Dose (n= 8, 6, 9, 8, 8) | 151.1 mmHg | Standard Error 3.2 |
| TBC3711 100 mg | Sitting Systolic Blood Pressure (SBP) | Week 3: Pre-Dose (n= 8, 4, 7, 7, 8) | 142 mmHg | Standard Error 5.2 |
| TBC3711 100 mg | Sitting Systolic Blood Pressure (SBP) | Week 10: Pre-Dose (n= 7, 4, 7, 7, 6) | 136.8 mmHg | Standard Error 5.8 |
| TBC3711 100 mg | Sitting Systolic Blood Pressure (SBP) | Week 4: Pre-Dose (n= 7, 5, 8, 8, 8) | 135.8 mmHg | Standard Error 3.7 |
| TBC3711 100 mg | Sitting Systolic Blood Pressure (SBP) | Week 8: Pre-Dose (n= 7, 5, 7, 7, 6) | 141.7 mmHg | Standard Error 6.9 |
| TBC3711 200 mg | Sitting Systolic Blood Pressure (SBP) | Week 4: Pre-Dose (n= 7, 5, 8, 8, 8) | 140.8 mmHg | Standard Error 6.3 |
| TBC3711 200 mg | Sitting Systolic Blood Pressure (SBP) | Week 10: Pre-Dose (n= 7, 4, 7, 7, 6) | 141.6 mmHg | Standard Error 6.8 |
| TBC3711 200 mg | Sitting Systolic Blood Pressure (SBP) | Week 4: Post-Dose (n= 7, 4, 8, 7, 8) | 132.8 mmHg | Standard Error 10 |
| TBC3711 200 mg | Sitting Systolic Blood Pressure (SBP) | Week 2: Pre-Dose (n= 8, 6, 9, 8, 8) | 153.1 mmHg | Standard Error 4.5 |
| TBC3711 200 mg | Sitting Systolic Blood Pressure (SBP) | Baseline: Pre-Dose (n= 8, 6, 9, 8, 8) | 158.4 mmHg | Standard Error 5.8 |
| TBC3711 200 mg | Sitting Systolic Blood Pressure (SBP) | Week 6: Pre-Dose (n= 7, 5, 7, 7, 6) | 137.9 mmHg | Standard Error 4.6 |
| TBC3711 200 mg | Sitting Systolic Blood Pressure (SBP) | Week 6: Post-Dose (n= 7, 5, 7, 7, 6) | 135.3 mmHg | Standard Error 8.4 |
| TBC3711 200 mg | Sitting Systolic Blood Pressure (SBP) | Week 1: Post-Dose (n= 8, 6, 9, 8, 8) | 143.6 mmHg | Standard Error 7.4 |
| TBC3711 200 mg | Sitting Systolic Blood Pressure (SBP) | Week 8: Pre-Dose (n= 7, 5, 7, 7, 6) | 138.3 mmHg | Standard Error 5.8 |
| TBC3711 200 mg | Sitting Systolic Blood Pressure (SBP) | Week 1: Pre-Dose (n= 8, 6, 9, 8, 8) | 154.9 mmHg | Standard Error 4.9 |
| TBC3711 200 mg | Sitting Systolic Blood Pressure (SBP) | Week 10: Post-Dose (n= 7, 4, 7, 7, 6) | 132.8 mmHg | Standard Error 7.5 |
| TBC3711 200 mg | Sitting Systolic Blood Pressure (SBP) | Week 8: Post-Dose (n= 7, 5, 7, 7, 6) | 125.9 mmHg | Standard Error 9.9 |
| TBC3711 200 mg | Sitting Systolic Blood Pressure (SBP) | Baseline: Post-Dose (n= 8, 6, 9, 8, 8) | 148.8 mmHg | Standard Error 6.4 |
| TBC3711 200 mg | Sitting Systolic Blood Pressure (SBP) | Week 3: Post-Dose (n= 8, 5, 6, 7, 8) | 130.3 mmHg | Standard Error 7.2 |
| TBC3711 200 mg | Sitting Systolic Blood Pressure (SBP) | Week 3: Pre-Dose (n= 8, 4, 7, 7, 8) | 141.8 mmHg | Standard Error 6.1 |
| TBC3711 200 mg | Sitting Systolic Blood Pressure (SBP) | Week 2: Post-Dose (n= 8, 6, 9, 8, 7) | 134.3 mmHg | Standard Error 6.9 |
Secondary
Standing Diastolic Blood Pressure (DBP)
DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant stood for 2 minutes. The same arm was used throughout the study.
Time frame: Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10
Population: FAS: all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. Here N (number of participants analyzed): participants evaluable for this measure, n: participants with non-missing value for specified time-point for each treatment arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Standing Diastolic Blood Pressure (DBP) | Week 8: Pre-Dose (n= 8, 6, 8, 8, 7) | 87.3 mmHg | Standard Error 5.3 |
| Placebo | Standing Diastolic Blood Pressure (DBP) | Week 10: Pre-Dose (n= 8, 4, 7, 7, 6) | 88.7 mmHg | Standard Error 3.8 |
| Placebo | Standing Diastolic Blood Pressure (DBP) | Week 8: Post-Dose (n= 8, 6, 8, 8, 7) | 81.1 mmHg | Standard Error 5 |
| Placebo | Standing Diastolic Blood Pressure (DBP) | Week 1: Post-Dose (n= 10, 8, 11, 10, 10) | 91.5 mmHg | Standard Error 4.5 |
| Placebo | Standing Diastolic Blood Pressure (DBP) | Week 6: Post-Dose (n= 9, 7, 8, 8, 8) | 85.4 mmHg | Standard Error 4.1 |
| Placebo | Standing Diastolic Blood Pressure (DBP) | Week 2: Pre-Dose (n= 10, 8, 11, 10, 10) | 92.7 mmHg | Standard Error 4.8 |
| Placebo | Standing Diastolic Blood Pressure (DBP) | Week 6: Pre-Dose (n= 9, 7, 8, 8, 8) | 87.9 mmHg | Standard Error 4.8 |
| Placebo | Standing Diastolic Blood Pressure (DBP) | Baseline: Post-Dose (n= 10, 8, 11, 10, 10) | 92.3 mmHg | Standard Error 4.8 |
| Placebo | Standing Diastolic Blood Pressure (DBP) | Week 4: Post-Dose (n= 9, 6, 9, 8, 10) | 85.9 mmHg | Standard Error 3.4 |
| Placebo | Standing Diastolic Blood Pressure (DBP) | Week 4: Pre-Dose (n= 9, 7, 9, 9, 10) | 86.4 mmHg | Standard Error 3.6 |
| Placebo | Standing Diastolic Blood Pressure (DBP) | Week 3: Post-Dose (n= 10, 7, 7, 8, 10) | 90 mmHg | Standard Error 4.2 |
| Placebo | Standing Diastolic Blood Pressure (DBP) | Week 3: Pre-Dose (n= 10, 6, 8, 8, 10) | 91.9 mmHg | Standard Error 5 |
| Placebo | Standing Diastolic Blood Pressure (DBP) | Week 2: Post-Dose (n= 10, 8, 11, 10, 9) | 87.3 mmHg | Standard Error 4.8 |
| Placebo | Standing Diastolic Blood Pressure (DBP) | Week 1: Pre-Dose (n= 10, 8, 11, 10, 10) | 95.1 mmHg | Standard Error 5 |
| Placebo | Standing Diastolic Blood Pressure (DBP) | Baseline: Pre-Dose (n= 10, 8, 11, 10, 10) | 95.9 mmHg | Standard Error 5.1 |
| Placebo | Standing Diastolic Blood Pressure (DBP) | Week 10: Post-Dose (n= 8, 4, 7, 7, 6) | 83.2 mmHg | Standard Error 4.9 |
| TBC3711 10 mg | Standing Diastolic Blood Pressure (DBP) | Week 4: Post-Dose (n= 9, 6, 9, 8, 10) | 75.1 mmHg | Standard Error 3.4 |
| TBC3711 10 mg | Standing Diastolic Blood Pressure (DBP) | Baseline: Post-Dose (n= 10, 8, 11, 10, 10) | 85 mmHg | Standard Error 3.3 |
| TBC3711 10 mg | Standing Diastolic Blood Pressure (DBP) | Week 8: Pre-Dose (n= 8, 6, 8, 8, 7) | 85.2 mmHg | Standard Error 4 |
| TBC3711 10 mg | Standing Diastolic Blood Pressure (DBP) | Week 8: Post-Dose (n= 8, 6, 8, 8, 7) | 78.7 mmHg | Standard Error 4 |
| TBC3711 10 mg | Standing Diastolic Blood Pressure (DBP) | Week 10: Pre-Dose (n= 8, 4, 7, 7, 6) | 83.5 mmHg | Standard Error 2.2 |
| TBC3711 10 mg | Standing Diastolic Blood Pressure (DBP) | Week 10: Post-Dose (n= 8, 4, 7, 7, 6) | 73.8 mmHg | Standard Error 1.5 |
| TBC3711 10 mg | Standing Diastolic Blood Pressure (DBP) | Baseline: Pre-Dose (n= 10, 8, 11, 10, 10) | 89 mmHg | Standard Error 2.7 |
| TBC3711 10 mg | Standing Diastolic Blood Pressure (DBP) | Week 1: Pre-Dose (n= 10, 8, 11, 10, 10) | 90.3 mmHg | Standard Error 3 |
| TBC3711 10 mg | Standing Diastolic Blood Pressure (DBP) | Week 1: Post-Dose (n= 10, 8, 11, 10, 10) | 81.3 mmHg | Standard Error 4.7 |
| TBC3711 10 mg | Standing Diastolic Blood Pressure (DBP) | Week 2: Pre-Dose (n= 10, 8, 11, 10, 10) | 87.7 mmHg | Standard Error 3.8 |
| TBC3711 10 mg | Standing Diastolic Blood Pressure (DBP) | Week 2: Post-Dose (n= 10, 8, 11, 10, 9) | 81.4 mmHg | Standard Error 5.7 |
| TBC3711 10 mg | Standing Diastolic Blood Pressure (DBP) | Week 3: Pre-Dose (n= 10, 6, 8, 8, 10) | 86 mmHg | Standard Error 5.3 |
| TBC3711 10 mg | Standing Diastolic Blood Pressure (DBP) | Week 3: Post-Dose (n= 10, 7, 7, 8, 10) | 77.8 mmHg | Standard Error 4.3 |
| TBC3711 10 mg | Standing Diastolic Blood Pressure (DBP) | Week 4: Pre-Dose (n= 9, 7, 9, 9, 10) | 81.8 mmHg | Standard Error 3.2 |
| TBC3711 10 mg | Standing Diastolic Blood Pressure (DBP) | Week 6: Pre-Dose (n= 9, 7, 8, 8, 8) | 82.7 mmHg | Standard Error 3.7 |
| TBC3711 10 mg | Standing Diastolic Blood Pressure (DBP) | Week 6: Post-Dose (n= 9, 7, 8, 8, 8) | 74.2 mmHg | Standard Error 3.4 |
| TBC3711 50 mg | Standing Diastolic Blood Pressure (DBP) | Week 10: Post-Dose (n= 8, 4, 7, 7, 6) | 81.3 mmHg | Standard Error 3.8 |
| TBC3711 50 mg | Standing Diastolic Blood Pressure (DBP) | Baseline: Pre-Dose (n= 10, 8, 11, 10, 10) | 87.9 mmHg | Standard Error 2.5 |
| TBC3711 50 mg | Standing Diastolic Blood Pressure (DBP) | Baseline: Post-Dose (n= 10, 8, 11, 10, 10) | 83.1 mmHg | Standard Error 3.2 |
| TBC3711 50 mg | Standing Diastolic Blood Pressure (DBP) | Week 3: Pre-Dose (n= 10, 6, 8, 8, 10) | 85.7 mmHg | Standard Error 6 |
| TBC3711 50 mg | Standing Diastolic Blood Pressure (DBP) | Week 1: Pre-Dose (n= 10, 8, 11, 10, 10) | 88.7 mmHg | Standard Error 3 |
| TBC3711 50 mg | Standing Diastolic Blood Pressure (DBP) | Week 6: Post-Dose (n= 9, 7, 8, 8, 8) | 74.4 mmHg | Standard Error 4.3 |
| TBC3711 50 mg | Standing Diastolic Blood Pressure (DBP) | Week 1: Post-Dose (n= 10, 8, 11, 10, 10) | 82.7 mmHg | Standard Error 3.4 |
| TBC3711 50 mg | Standing Diastolic Blood Pressure (DBP) | Week 6: Pre-Dose (n= 9, 7, 8, 8, 8) | 81.6 mmHg | Standard Error 2.6 |
| TBC3711 50 mg | Standing Diastolic Blood Pressure (DBP) | Week 2: Pre-Dose (n= 10, 8, 11, 10, 10) | 87.9 mmHg | Standard Error 3.4 |
| TBC3711 50 mg | Standing Diastolic Blood Pressure (DBP) | Week 2: Post-Dose (n= 10, 8, 11, 10, 9) | 80.8 mmHg | Standard Error 4.5 |
| TBC3711 50 mg | Standing Diastolic Blood Pressure (DBP) | Week 4: Post-Dose (n= 9, 6, 9, 8, 10) | 77.3 mmHg | Standard Error 5 |
| TBC3711 50 mg | Standing Diastolic Blood Pressure (DBP) | Week 3: Post-Dose (n= 10, 7, 7, 8, 10) | 75.7 mmHg | Standard Error 4.8 |
| TBC3711 50 mg | Standing Diastolic Blood Pressure (DBP) | Week 4: Pre-Dose (n= 9, 7, 9, 9, 10) | 85.9 mmHg | Standard Error 5.2 |
| TBC3711 50 mg | Standing Diastolic Blood Pressure (DBP) | Week 8: Post-Dose (n= 8, 6, 8, 8, 7) | 75.4 mmHg | Standard Error 4.4 |
| TBC3711 50 mg | Standing Diastolic Blood Pressure (DBP) | Week 8: Pre-Dose (n= 8, 6, 8, 8, 7) | 79.8 mmHg | Standard Error 3.2 |
| TBC3711 50 mg | Standing Diastolic Blood Pressure (DBP) | Week 10: Pre-Dose (n= 8, 4, 7, 7, 6) | 86.2 mmHg | Standard Error 3.8 |
| TBC3711 100 mg | Standing Diastolic Blood Pressure (DBP) | Week 8: Post-Dose (n= 8, 6, 8, 8, 7) | 75.3 mmHg | Standard Error 5 |
| TBC3711 100 mg | Standing Diastolic Blood Pressure (DBP) | Week 10: Post-Dose (n= 8, 4, 7, 7, 6) | 67 mmHg | Standard Error 3.7 |
| TBC3711 100 mg | Standing Diastolic Blood Pressure (DBP) | Week 4: Post-Dose (n= 9, 6, 9, 8, 10) | 71.6 mmHg | Standard Error 2.8 |
| TBC3711 100 mg | Standing Diastolic Blood Pressure (DBP) | Week 6: Pre-Dose (n= 9, 7, 8, 8, 8) | 81.6 mmHg | Standard Error 4.7 |
| TBC3711 100 mg | Standing Diastolic Blood Pressure (DBP) | Week 10: Pre-Dose (n= 8, 4, 7, 7, 6) | 80.3 mmHg | Standard Error 5.1 |
| TBC3711 100 mg | Standing Diastolic Blood Pressure (DBP) | Baseline: Pre-Dose (n= 10, 8, 11, 10, 10) | 90.3 mmHg | Standard Error 2.9 |
| TBC3711 100 mg | Standing Diastolic Blood Pressure (DBP) | Week 2: Pre-Dose (n= 10, 8, 11, 10, 10) | 89.5 mmHg | Standard Error 3.7 |
| TBC3711 100 mg | Standing Diastolic Blood Pressure (DBP) | Week 4: Pre-Dose (n= 9, 7, 9, 9, 10) | 81.2 mmHg | Standard Error 4 |
| TBC3711 100 mg | Standing Diastolic Blood Pressure (DBP) | Baseline: Post-Dose (n= 10, 8, 11, 10, 10) | 85.1 mmHg | Standard Error 3.3 |
| TBC3711 100 mg | Standing Diastolic Blood Pressure (DBP) | Week 2: Post-Dose (n= 10, 8, 11, 10, 9) | 77.1 mmHg | Standard Error 3.2 |
| TBC3711 100 mg | Standing Diastolic Blood Pressure (DBP) | Week 6: Post-Dose (n= 9, 7, 8, 8, 8) | 70.1 mmHg | Standard Error 3.4 |
| TBC3711 100 mg | Standing Diastolic Blood Pressure (DBP) | Week 3: Pre-Dose (n= 10, 6, 8, 8, 10) | 84.5 mmHg | Standard Error 6.5 |
| TBC3711 100 mg | Standing Diastolic Blood Pressure (DBP) | Week 8: Pre-Dose (n= 8, 6, 8, 8, 7) | 83.7 mmHg | Standard Error 4.9 |
| TBC3711 100 mg | Standing Diastolic Blood Pressure (DBP) | Week 1: Pre-Dose (n= 10, 8, 11, 10, 10) | 87.2 mmHg | Standard Error 4 |
| TBC3711 100 mg | Standing Diastolic Blood Pressure (DBP) | Week 3: Post-Dose (n= 10, 7, 7, 8, 10) | 78.6 mmHg | Standard Error 6.4 |
| TBC3711 100 mg | Standing Diastolic Blood Pressure (DBP) | Week 1: Post-Dose (n= 10, 8, 11, 10, 10) | 81.4 mmHg | Standard Error 4.6 |
| TBC3711 200 mg | Standing Diastolic Blood Pressure (DBP) | Week 10: Pre-Dose (n= 8, 4, 7, 7, 6) | 93.4 mmHg | Standard Error 3.1 |
| TBC3711 200 mg | Standing Diastolic Blood Pressure (DBP) | Week 8: Post-Dose (n= 8, 6, 8, 8, 7) | 84.5 mmHg | Standard Error 5.2 |
| TBC3711 200 mg | Standing Diastolic Blood Pressure (DBP) | Week 2: Pre-Dose (n= 10, 8, 11, 10, 10) | 96.9 mmHg | Standard Error 2.6 |
| TBC3711 200 mg | Standing Diastolic Blood Pressure (DBP) | Week 10: Post-Dose (n= 8, 4, 7, 7, 6) | 84.2 mmHg | Standard Error 4.8 |
| TBC3711 200 mg | Standing Diastolic Blood Pressure (DBP) | Week 2: Post-Dose (n= 10, 8, 11, 10, 9) | 84.8 mmHg | Standard Error 4.3 |
| TBC3711 200 mg | Standing Diastolic Blood Pressure (DBP) | Week 3: Pre-Dose (n= 10, 6, 8, 8, 10) | 91.8 mmHg | Standard Error 2.5 |
| TBC3711 200 mg | Standing Diastolic Blood Pressure (DBP) | Week 6: Pre-Dose (n= 9, 7, 8, 8, 8) | 91.3 mmHg | Standard Error 2.1 |
| TBC3711 200 mg | Standing Diastolic Blood Pressure (DBP) | Week 3: Post-Dose (n= 10, 7, 7, 8, 10) | 80.7 mmHg | Standard Error 3.1 |
| TBC3711 200 mg | Standing Diastolic Blood Pressure (DBP) | Week 1: Post-Dose (n= 10, 8, 11, 10, 10) | 93.7 mmHg | Standard Error 3.1 |
| TBC3711 200 mg | Standing Diastolic Blood Pressure (DBP) | Week 1: Pre-Dose (n= 10, 8, 11, 10, 10) | 98.9 mmHg | Standard Error 1.9 |
| TBC3711 200 mg | Standing Diastolic Blood Pressure (DBP) | Week 6: Post-Dose (n= 9, 7, 8, 8, 8) | 83.3 mmHg | Standard Error 3.8 |
| TBC3711 200 mg | Standing Diastolic Blood Pressure (DBP) | Week 4: Post-Dose (n= 9, 6, 9, 8, 10) | 83.1 mmHg | Standard Error 3.8 |
| TBC3711 200 mg | Standing Diastolic Blood Pressure (DBP) | Baseline: Pre-Dose (n= 10, 8, 11, 10, 10) | 97.7 mmHg | Standard Error 2.8 |
| TBC3711 200 mg | Standing Diastolic Blood Pressure (DBP) | Baseline: Post-Dose (n= 10, 8, 11, 10, 10) | 95.5 mmHg | Standard Error 2.9 |
| TBC3711 200 mg | Standing Diastolic Blood Pressure (DBP) | Week 8: Pre-Dose (n= 8, 6, 8, 8, 7) | 92 mmHg | Standard Error 4.4 |
| TBC3711 200 mg | Standing Diastolic Blood Pressure (DBP) | Week 4: Pre-Dose (n= 9, 7, 9, 9, 10) | 88.9 mmHg | Standard Error 3 |
Secondary
Standing Systolic Blood Pressure (SBP)
SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant stood for 2 minutes. The same arm was used throughout the study.
Time frame: Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10
Population: FAS: all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. Here N (number of participants analyzed): participants evaluable for this measure, n: participants with non-missing value for specified time-point for each treatment arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Standing Systolic Blood Pressure (SBP) | Week 2: Pre-Dose (n= 10, 8, 11, 10, 9) | 151.1 mmHg | Standard Error 5.3 |
| Placebo | Standing Systolic Blood Pressure (SBP) | Baseline: Post-Dose (n= 10, 8, 11, 10, 10) | 146.3 mmHg | Standard Error 4.4 |
| Placebo | Standing Systolic Blood Pressure (SBP) | Week 1: Pre-Dose (n= 10, 8, 11, 10, 10) | 151.5 mmHg | Standard Error 5.1 |
| Placebo | Standing Systolic Blood Pressure (SBP) | Week 1: Post-Dose (n= 10, 8, 11, 10, 10) | 147.8 mmHg | Standard Error 4.7 |
| Placebo | Standing Systolic Blood Pressure (SBP) | Baseline: Pre-Dose (n= 10, 8, 11, 10, 10) | 153.6 mmHg | Standard Error 4.5 |
| Placebo | Standing Systolic Blood Pressure (SBP) | Week 2: Post-Dose (n= 10, 8, 11, 10, 9) | 140.6 mmHg | Standard Error 4.8 |
| Placebo | Standing Systolic Blood Pressure (SBP) | Week 3: Pre-Dose (n= 10, 6, 8, 8, 10) | 146.8 mmHg | Standard Error 4.1 |
| Placebo | Standing Systolic Blood Pressure (SBP) | Week 3: Post-Dose (n= 10, 7, 7, 8, 10) | 142.4 mmHg | Standard Error 3.6 |
| Placebo | Standing Systolic Blood Pressure (SBP) | Week 4: Pre-Dose (n= 9, 7, 9, 9, 10) | 141.8 mmHg | Standard Error 4.3 |
| Placebo | Standing Systolic Blood Pressure (SBP) | Week 4: Post-Dose (n= 9, 6, 9, 8, 10) | 141 mmHg | Standard Error 4.8 |
| Placebo | Standing Systolic Blood Pressure (SBP) | Week 6: Pre-Dose (n= 9, 7, 8, 8, 8) | 145.3 mmHg | Standard Error 5.3 |
| Placebo | Standing Systolic Blood Pressure (SBP) | Week 6: Post-Dose (n= 9, 7, 8, 8, 8) | 139.2 mmHg | Standard Error 6.7 |
| Placebo | Standing Systolic Blood Pressure (SBP) | Week 8: Pre-Dose (n= 8, 6, 8, 8, 7) | 139.2 mmHg | Standard Error 5 |
| Placebo | Standing Systolic Blood Pressure (SBP) | Week 8: Post-Dose (n= 8, 6, 8, 8, 7) | 131.3 mmHg | Standard Error 6.6 |
| Placebo | Standing Systolic Blood Pressure (SBP) | Week 10: Pre-Dose (n= 8, 4, 7, 7, 6) | 141.1 mmHg | Standard Error 4.6 |
| Placebo | Standing Systolic Blood Pressure (SBP) | Week 10: Post-Dose (n= 8, 4, 7, 7, 6) | 133.5 mmHg | Standard Error 7.3 |
| TBC3711 10 mg | Standing Systolic Blood Pressure (SBP) | Week 8: Post-Dose (n= 8, 6, 8, 8, 7) | 138.6 mmHg | Standard Error 2.3 |
| TBC3711 10 mg | Standing Systolic Blood Pressure (SBP) | Week 4: Post-Dose (n= 9, 6, 9, 8, 10) | 133.4 mmHg | Standard Error 4.7 |
| TBC3711 10 mg | Standing Systolic Blood Pressure (SBP) | Week 4: Pre-Dose (n= 9, 7, 9, 9, 10) | 139.6 mmHg | Standard Error 4.3 |
| TBC3711 10 mg | Standing Systolic Blood Pressure (SBP) | Week 10: Pre-Dose (n= 8, 4, 7, 7, 6) | 147 mmHg | Standard Error 7.4 |
| TBC3711 10 mg | Standing Systolic Blood Pressure (SBP) | Week 3: Post-Dose (n= 10, 7, 7, 8, 10) | 137.2 mmHg | Standard Error 2.8 |
| TBC3711 10 mg | Standing Systolic Blood Pressure (SBP) | Week 2: Pre-Dose (n= 10, 8, 11, 10, 9) | 142.8 mmHg | Standard Error 6.3 |
| TBC3711 10 mg | Standing Systolic Blood Pressure (SBP) | Week 1: Post-Dose (n= 10, 8, 11, 10, 10) | 139.4 mmHg | Standard Error 6.9 |
| TBC3711 10 mg | Standing Systolic Blood Pressure (SBP) | Baseline: Post-Dose (n= 10, 8, 11, 10, 10) | 141.9 mmHg | Standard Error 5.5 |
| TBC3711 10 mg | Standing Systolic Blood Pressure (SBP) | Baseline: Pre-Dose (n= 10, 8, 11, 10, 10) | 147.7 mmHg | Standard Error 4.4 |
| TBC3711 10 mg | Standing Systolic Blood Pressure (SBP) | Week 8: Pre-Dose (n= 8, 6, 8, 8, 7) | 143.2 mmHg | Standard Error 3.2 |
| TBC3711 10 mg | Standing Systolic Blood Pressure (SBP) | Week 2: Post-Dose (n= 10, 8, 11, 10, 9) | 130.8 mmHg | Standard Error 7.9 |
| TBC3711 10 mg | Standing Systolic Blood Pressure (SBP) | Week 1: Pre-Dose (n= 10, 8, 11, 10, 10) | 147.3 mmHg | Standard Error 4.4 |
| TBC3711 10 mg | Standing Systolic Blood Pressure (SBP) | Week 10: Post-Dose (n= 8, 4, 7, 7, 6) | 141.2 mmHg | Standard Error 6.3 |
| TBC3711 10 mg | Standing Systolic Blood Pressure (SBP) | Week 6: Post-Dose (n= 9, 7, 8, 8, 8) | 130.5 mmHg | Standard Error 4.4 |
| TBC3711 10 mg | Standing Systolic Blood Pressure (SBP) | Week 6: Pre-Dose (n= 9, 7, 8, 8, 8) | 138.2 mmHg | Standard Error 5.1 |
| TBC3711 10 mg | Standing Systolic Blood Pressure (SBP) | Week 3: Pre-Dose (n= 10, 6, 8, 8, 10) | 140.9 mmHg | Standard Error 2.6 |
| TBC3711 50 mg | Standing Systolic Blood Pressure (SBP) | Week 8: Post-Dose (n= 8, 6, 8, 8, 7) | 124.1 mmHg | Standard Error 3.5 |
| TBC3711 50 mg | Standing Systolic Blood Pressure (SBP) | Week 1: Post-Dose (n= 10, 8, 11, 10, 10) | 139.2 mmHg | Standard Error 5.7 |
| TBC3711 50 mg | Standing Systolic Blood Pressure (SBP) | Week 2: Pre-Dose (n= 10, 8, 11, 10, 9) | 145.8 mmHg | Standard Error 4.6 |
| TBC3711 50 mg | Standing Systolic Blood Pressure (SBP) | Week 2: Post-Dose (n= 10, 8, 11, 10, 9) | 138.3 mmHg | Standard Error 7.3 |
| TBC3711 50 mg | Standing Systolic Blood Pressure (SBP) | Week 3: Pre-Dose (n= 10, 6, 8, 8, 10) | 136.8 mmHg | Standard Error 5.8 |
| TBC3711 50 mg | Standing Systolic Blood Pressure (SBP) | Week 3: Post-Dose (n= 10, 7, 7, 8, 10) | 124.9 mmHg | Standard Error 6.4 |
| TBC3711 50 mg | Standing Systolic Blood Pressure (SBP) | Week 10: Pre-Dose (n= 8, 4, 7, 7, 6) | 133.4 mmHg | Standard Error 3.7 |
| TBC3711 50 mg | Standing Systolic Blood Pressure (SBP) | Week 4: Pre-Dose (n= 9, 7, 9, 9, 10) | 141.5 mmHg | Standard Error 5.8 |
| TBC3711 50 mg | Standing Systolic Blood Pressure (SBP) | Week 4: Post-Dose (n= 9, 6, 9, 8, 10) | 132.6 mmHg | Standard Error 7.7 |
| TBC3711 50 mg | Standing Systolic Blood Pressure (SBP) | Week 6: Pre-Dose (n= 9, 7, 8, 8, 8) | 131.3 mmHg | Standard Error 3.5 |
| TBC3711 50 mg | Standing Systolic Blood Pressure (SBP) | Week 6: Post-Dose (n= 9, 7, 8, 8, 8) | 122.8 mmHg | Standard Error 4.7 |
| TBC3711 50 mg | Standing Systolic Blood Pressure (SBP) | Week 8: Pre-Dose (n= 8, 6, 8, 8, 7) | 125.9 mmHg | Standard Error 4 |
| TBC3711 50 mg | Standing Systolic Blood Pressure (SBP) | Baseline: Pre-Dose (n= 10, 8, 11, 10, 10) | 147.3 mmHg | Standard Error 3.3 |
| TBC3711 50 mg | Standing Systolic Blood Pressure (SBP) | Week 10: Post-Dose (n= 8, 4, 7, 7, 6) | 131 mmHg | Standard Error 5.3 |
| TBC3711 50 mg | Standing Systolic Blood Pressure (SBP) | Baseline: Post-Dose (n= 10, 8, 11, 10, 10) | 142.4 mmHg | Standard Error 4.4 |
| TBC3711 50 mg | Standing Systolic Blood Pressure (SBP) | Week 1: Pre-Dose (n= 10, 8, 11, 10, 10) | 145.7 mmHg | Standard Error 4.3 |
| TBC3711 100 mg | Standing Systolic Blood Pressure (SBP) | Week 4: Post-Dose (n= 9, 6, 9, 8, 10) | 132.6 mmHg | Standard Error 5.1 |
| TBC3711 100 mg | Standing Systolic Blood Pressure (SBP) | Week 10: Post-Dose (n= 8, 4, 7, 7, 6) | 133.5 mmHg | Standard Error 8.9 |
| TBC3711 100 mg | Standing Systolic Blood Pressure (SBP) | Week 6: Pre-Dose (n= 9, 7, 8, 8, 8) | 138.9 mmHg | Standard Error 8.2 |
| TBC3711 100 mg | Standing Systolic Blood Pressure (SBP) | Week 8: Post-Dose (n= 8, 6, 8, 8, 7) | 139.3 mmHg | Standard Error 7.4 |
| TBC3711 100 mg | Standing Systolic Blood Pressure (SBP) | Week 6: Post-Dose (n= 9, 7, 8, 8, 8) | 130.6 mmHg | Standard Error 5.1 |
| TBC3711 100 mg | Standing Systolic Blood Pressure (SBP) | Week 2: Post-Dose (n= 10, 8, 11, 10, 9) | 142.9 mmHg | Standard Error 5.1 |
| TBC3711 100 mg | Standing Systolic Blood Pressure (SBP) | Week 8: Pre-Dose (n= 8, 6, 8, 8, 7) | 141.5 mmHg | Standard Error 6 |
| TBC3711 100 mg | Standing Systolic Blood Pressure (SBP) | Week 1: Post-Dose (n= 10, 8, 11, 10, 10) | 141.4 mmHg | Standard Error 5.1 |
| TBC3711 100 mg | Standing Systolic Blood Pressure (SBP) | Baseline: Pre-Dose (n= 10, 8, 11, 10, 10) | 153.8 mmHg | Standard Error 4.2 |
| TBC3711 100 mg | Standing Systolic Blood Pressure (SBP) | Week 1: Pre-Dose (n= 10, 8, 11, 10, 10) | 146.8 mmHg | Standard Error 4.6 |
| TBC3711 100 mg | Standing Systolic Blood Pressure (SBP) | Week 3: Post-Dose (n= 10, 7, 7, 8, 10) | 143.1 mmHg | Standard Error 7.6 |
| TBC3711 100 mg | Standing Systolic Blood Pressure (SBP) | Week 2: Pre-Dose (n= 10, 8, 11, 10, 9) | 150.7 mmHg | Standard Error 4.6 |
| TBC3711 100 mg | Standing Systolic Blood Pressure (SBP) | Week 4: Pre-Dose (n= 9, 7, 9, 9, 10) | 137.4 mmHg | Standard Error 5.7 |
| TBC3711 100 mg | Standing Systolic Blood Pressure (SBP) | Week 10: Pre-Dose (n= 8, 4, 7, 7, 6) | 137.6 mmHg | Standard Error 6.7 |
| TBC3711 100 mg | Standing Systolic Blood Pressure (SBP) | Week 3: Pre-Dose (n= 10, 6, 8, 8, 10) | 147.3 mmHg | Standard Error 7.1 |
| TBC3711 100 mg | Standing Systolic Blood Pressure (SBP) | Baseline: Post-Dose (n= 10, 8, 11, 10, 10) | 149.5 mmHg | Standard Error 4.7 |
| TBC3711 200 mg | Standing Systolic Blood Pressure (SBP) | Week 8: Pre-Dose (n= 8, 6, 8, 8, 7) | 135.5 mmHg | Standard Error 6.1 |
| TBC3711 200 mg | Standing Systolic Blood Pressure (SBP) | Week 4: Post-Dose (n= 9, 6, 9, 8, 10) | 129.5 mmHg | Standard Error 9.3 |
| TBC3711 200 mg | Standing Systolic Blood Pressure (SBP) | Week 10: Pre-Dose (n= 8, 4, 7, 7, 6) | 141 mmHg | Standard Error 7.7 |
| TBC3711 200 mg | Standing Systolic Blood Pressure (SBP) | Week 2: Pre-Dose (n= 10, 8, 11, 10, 9) | 149.7 mmHg | Standard Error 5.1 |
| TBC3711 200 mg | Standing Systolic Blood Pressure (SBP) | Baseline: Post-Dose (n= 10, 8, 11, 10, 10) | 147 mmHg | Standard Error 5.8 |
| TBC3711 200 mg | Standing Systolic Blood Pressure (SBP) | Week 3: Post-Dose (n= 10, 7, 7, 8, 10) | 128.6 mmHg | Standard Error 7.8 |
| TBC3711 200 mg | Standing Systolic Blood Pressure (SBP) | Week 6: Pre-Dose (n= 9, 7, 8, 8, 8) | 134.1 mmHg | Standard Error 4.4 |
| TBC3711 200 mg | Standing Systolic Blood Pressure (SBP) | Week 10: Post-Dose (n= 8, 4, 7, 7, 6) | 128.9 mmHg | Standard Error 8 |
| TBC3711 200 mg | Standing Systolic Blood Pressure (SBP) | Week 2: Post-Dose (n= 10, 8, 11, 10, 9) | 135.8 mmHg | Standard Error 6.6 |
| TBC3711 200 mg | Standing Systolic Blood Pressure (SBP) | Week 4: Pre-Dose (n= 9, 7, 9, 9, 10) | 139.5 mmHg | Standard Error 6.1 |
| TBC3711 200 mg | Standing Systolic Blood Pressure (SBP) | Baseline: Pre-Dose (n= 10, 8, 11, 10, 10) | 154.1 mmHg | Standard Error 4.8 |
| TBC3711 200 mg | Standing Systolic Blood Pressure (SBP) | Week 6: Post-Dose (n= 9, 7, 8, 8, 8) | 127.9 mmHg | Standard Error 7.2 |
| TBC3711 200 mg | Standing Systolic Blood Pressure (SBP) | Week 3: Pre-Dose (n= 10, 6, 8, 8, 10) | 141.2 mmHg | Standard Error 6.2 |
| TBC3711 200 mg | Standing Systolic Blood Pressure (SBP) | Week 8: Post-Dose (n= 8, 6, 8, 8, 7) | 123.3 mmHg | Standard Error 9.2 |
| TBC3711 200 mg | Standing Systolic Blood Pressure (SBP) | Week 1: Post-Dose (n= 10, 8, 11, 10, 10) | 144.8 mmHg | Standard Error 6.8 |
| TBC3711 200 mg | Standing Systolic Blood Pressure (SBP) | Week 1: Pre-Dose (n= 10, 8, 11, 10, 10) | 154.3 mmHg | Standard Error 4.1 |