Trial Outcomes & Findings for A Study Of Different Doses Of TBC3711 In Patients With Uncontrolled High Blood Pressure Already Taking Medications For High Blood Pressure. (NCT NCT00272961)
NCT ID: NCT00272961
Last Updated: 2013-03-05
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12
Results posted on
2013-03-05
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Placebo Run-in Phase: Up to Week 2
STARTED
|
60
|
0
|
0
|
0
|
0
|
|
Placebo Run-in Phase: Up to Week 2
COMPLETED
|
49
|
0
|
0
|
0
|
0
|
|
Placebo Run-in Phase: Up to Week 2
NOT COMPLETED
|
11
|
0
|
0
|
0
|
0
|
|
Treatment Phase: Week 3 Up to Week 12
STARTED
|
10
|
8
|
11
|
10
|
10
|
|
Treatment Phase: Week 3 Up to Week 12
COMPLETED
|
8
|
4
|
7
|
7
|
6
|
|
Treatment Phase: Week 3 Up to Week 12
NOT COMPLETED
|
2
|
4
|
4
|
3
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
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
|
|
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
Other
|
2
|
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
Participant Defaulted
|
1
|
0
|
1
|
0
|
0
|
|
Treatment Phase: Week 3 Up to Week 12
Other
|
1
|
3
|
3
|
2
|
2
|
Baseline Characteristics
A Study Of Different Doses Of TBC3711 In Patients With Uncontrolled High Blood Pressure Already Taking Medications For High Blood Pressure.
Baseline characteristics by cohort
| Measure |
Placebo
n=10 Participants
Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
|
TBC3711 10 mg
n=8 Participants
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.
|
TBC3711 50 mg
n=11 Participants
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.
|
TBC3711 100 mg
n=10 Participants
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.
|
TBC3711 200 mg
n=10 Participants
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.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
18 to 44 Years
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
3 participants
n=10 Participants
|
|
Age, Customized
45 to 64 Years
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
9 participants
n=4 Participants
|
7 participants
n=21 Participants
|
37 participants
n=10 Participants
|
|
Age, Customized
Greater Than or Equal to (>=) 65 Years
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
9 participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
17 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
32 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=10 Participants
Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
|
TBC3711 10 mg
n=8 Participants
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.
|
TBC3711 50 mg
n=11 Participants
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.
|
TBC3711 100 mg
n=10 Participants
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.
|
TBC3711 200 mg
n=10 Participants
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.
|
|---|---|---|---|---|---|
|
Maximum Blood Pressure (BP) Increase
Sitting SBP (n= 8, 6, 9, 8, 8)
|
11.48 millimeter of mercury (mmHg)
Standard Error 4.04
|
3.10 millimeter of mercury (mmHg)
Standard Error 4.67
|
11.26 millimeter of mercury (mmHg)
Standard Error 3.83
|
11.52 millimeter of mercury (mmHg)
Standard Error 4.03
|
10.46 millimeter of mercury (mmHg)
Standard Error 4.09
|
|
Maximum Blood Pressure (BP) Increase
Standing SBP (n= 10, 8, 11, 10, 10)
|
9.06 millimeter of mercury (mmHg)
Standard Error 3.24
|
2.96 millimeter of mercury (mmHg)
Standard Error 3.64
|
8.38 millimeter of mercury (mmHg)
Standard Error 3.08
|
9.63 millimeter of mercury (mmHg)
Standard Error 3.23
|
14.76 millimeter of mercury (mmHg)
Standard Error 3.23
|
|
Maximum Blood Pressure (BP) Increase
Sitting DBP (n= 8, 6, 9, 8, 8)
|
8.16 millimeter of mercury (mmHg)
Standard Error 1.75
|
2.53 millimeter of mercury (mmHg)
Standard Error 2.02
|
6.73 millimeter of mercury (mmHg)
Standard Error 1.65
|
1.79 millimeter of mercury (mmHg)
Standard Error 1.77
|
7.17 millimeter of mercury (mmHg)
Standard Error 1.81
|
|
Maximum Blood Pressure (BP) Increase
Standing DBP (n= 10, 8, 11, 10, 10)
|
7.91 millimeter of mercury (mmHg)
Standard Error 1.69
|
3.11 millimeter of mercury (mmHg)
Standard Error 1.90
|
7.11 millimeter of mercury (mmHg)
Standard Error 1.62
|
2.27 millimeter of mercury (mmHg)
Standard Error 1.69
|
6.25 millimeter of mercury (mmHg)
Standard Error 1.74
|
PRIMARY outcome
Timeframe: Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=10 Participants
Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
|
TBC3711 10 mg
n=7 Participants
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.
|
TBC3711 50 mg
n=11 Participants
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.
|
TBC3711 100 mg
n=10 Participants
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.
|
TBC3711 200 mg
n=10 Participants
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.
|
|---|---|---|---|---|---|
|
Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change
Sitting SBP (n= 8, 5, 9, 8, 8)
|
318.50 mmHg
Standard Error 125.20
|
85.91 mmHg
Standard Error 158.59
|
214.83 mmHg
Standard Error 119.85
|
277.24 mmHg
Standard Error 125.27
|
152.10 mmHg
Standard Error 126.57
|
|
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
|
74.79 mmHg
Standard Error 99.66
|
122.48 mmHg
Standard Error 79.95
|
213.16 mmHg
Standard Error 83.46
|
187.24 mmHg
Standard Error 83.37
|
|
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
|
30.82 mmHg
Standard Error 85.41
|
141.61 mmHg
Standard Error 63.97
|
31.50 mmHg
Standard Error 68.88
|
123.17 mmHg
Standard Error 70.03
|
|
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
|
42.26 mmHg
Standard Error 87.57
|
124.90 mmHg
Standard Error 70.65
|
27.99 mmHg
Standard Error 73.46
|
125.23 mmHg
Standard Error 75.08
|
SECONDARY outcome
Timeframe: Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
|
TBC3711 10 mg
n=6 Participants
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.
|
TBC3711 50 mg
n=9 Participants
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.
|
TBC3711 100 mg
n=8 Participants
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.
|
TBC3711 200 mg
n=8 Participants
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.
|
|---|---|---|---|---|---|
|
Sitting Systolic Blood Pressure (SBP)
Week 3: Post-Dose (n= 8, 5, 6, 7, 8)
|
144.2 mmHg
Standard Error 4.1
|
138.1 mmHg
Standard Error 3.3
|
123.2 mmHg
Standard Error 7.5
|
138.5 mmHg
Standard Error 6.0
|
130.3 mmHg
Standard Error 7.2
|
|
Sitting Systolic Blood Pressure (SBP)
Baseline: Pre-Dose (n= 8, 6, 9, 8, 8)
|
158.6 mmHg
Standard Error 5.0
|
149.9 mmHg
Standard Error 5.6
|
146.5 mmHg
Standard Error 4.1
|
151.1 mmHg
Standard Error 3.2
|
158.4 mmHg
Standard Error 5.8
|
|
Sitting Systolic Blood Pressure (SBP)
Baseline: Post-Dose (n= 8, 6, 9, 8, 8)
|
149.9 mmHg
Standard Error 4.9
|
141 mmHg
Standard Error 6.4
|
139.7 mmHg
Standard Error 6.1
|
149.3 mmHg
Standard Error 4.4
|
148.8 mmHg
Standard Error 6.4
|
|
Sitting Systolic Blood Pressure (SBP)
Week 1: Pre-Dose (n= 8, 6, 9, 8, 8)
|
156.3 mmHg
Standard Error 5.3
|
151 mmHg
Standard Error 4.7
|
143.5 mmHg
Standard Error 4.9
|
145.3 mmHg
Standard Error 4.2
|
154.9 mmHg
Standard Error 4.9
|
|
Sitting Systolic Blood Pressure (SBP)
Week 1: Post-Dose (n= 8, 6, 9, 8, 8)
|
151.1 mmHg
Standard Error 5.2
|
141.1 mmHg
Standard Error 8.8
|
134.4 mmHg
Standard Error 5.6
|
139.4 mmHg
Standard Error 5.1
|
143.6 mmHg
Standard Error 7.4
|
|
Sitting Systolic Blood Pressure (SBP)
Week 2: Pre-Dose (n= 8, 6, 9, 8, 8)
|
149.6 mmHg
Standard Error 5.8
|
144.7 mmHg
Standard Error 7.5
|
143.5 mmHg
Standard Error 5.8
|
147.1 mmHg
Standard Error 4.4
|
153.1 mmHg
Standard Error 4.5
|
|
Sitting Systolic Blood Pressure (SBP)
Week 2: Post-Dose (n= 8, 6, 9, 8, 7)
|
139.8 mmHg
Standard Error 5.5
|
130.6 mmHg
Standard Error 10.6
|
134.7 mmHg
Standard Error 8.7
|
139 mmHg
Standard Error 4.7
|
134.3 mmHg
Standard Error 6.9
|
|
Sitting Systolic Blood Pressure (SBP)
Week 3: Pre-Dose (n= 8, 4, 7, 7, 8)
|
148 mmHg
Standard Error 4.6
|
141.5 mmHg
Standard Error 3.9
|
137.1 mmHg
Standard Error 6.5
|
142 mmHg
Standard Error 5.2
|
141.8 mmHg
Standard Error 6.1
|
|
Sitting Systolic Blood Pressure (SBP)
Week 4: Pre-Dose (n= 7, 5, 8, 8, 8)
|
141.4 mmHg
Standard Error 4.9
|
141.2 mmHg
Standard Error 6.9
|
140.9 mmHg
Standard Error 6.9
|
135.8 mmHg
Standard Error 3.7
|
140.8 mmHg
Standard Error 6.3
|
|
Sitting Systolic Blood Pressure (SBP)
Week 4: Post-Dose (n= 7, 4, 8, 7, 8)
|
143 mmHg
Standard Error 5.4
|
137 mmHg
Standard Error 4.8
|
132.2 mmHg
Standard Error 9.1
|
132.3 mmHg
Standard Error 5.1
|
132.8 mmHg
Standard Error 10
|
|
Sitting Systolic Blood Pressure (SBP)
Week 6: Pre-Dose (n= 7, 5, 7, 7, 6)
|
149.2 mmHg
Standard Error 7.0
|
140.9 mmHg
Standard Error 6.2
|
131.7 mmHg
Standard Error 4.3
|
137.9 mmHg
Standard Error 7.8
|
137.9 mmHg
Standard Error 4.6
|
|
Sitting Systolic Blood Pressure (SBP)
Week 6: Post-Dose (n= 7, 5, 7, 7, 6)
|
141.7 mmHg
Standard Error 7.4
|
130.9 mmHg
Standard Error 3.6
|
124.4 mmHg
Standard Error 4.0
|
132.7 mmHg
Standard Error 5.7
|
135.3 mmHg
Standard Error 8.4
|
|
Sitting Systolic Blood Pressure (SBP)
Week 8: Pre-Dose (n= 7, 5, 7, 7, 6)
|
139.6 mmHg
Standard Error 4.7
|
143.2 mmHg
Standard Error 6.0
|
126.4 mmHg
Standard Error 4.4
|
141.7 mmHg
Standard Error 6.9
|
138.3 mmHg
Standard Error 5.8
|
|
Sitting Systolic Blood Pressure (SBP)
Week 8: Post-Dose (n= 7, 5, 7, 7, 6)
|
132.7 mmHg
Standard Error 6.5
|
136.8 mmHg
Standard Error 3.3
|
122.8 mmHg
Standard Error 3.4
|
136.6 mmHg
Standard Error 5.2
|
125.9 mmHg
Standard Error 9.9
|
|
Sitting Systolic Blood Pressure (SBP)
Week 10: Pre-Dose (n= 7, 4, 7, 7, 6)
|
142.1 mmHg
Standard Error 6.2
|
148.3 mmHg
Standard Error 8.5
|
134.5 mmHg
Standard Error 3.2
|
136.8 mmHg
Standard Error 5.8
|
141.6 mmHg
Standard Error 6.8
|
|
Sitting Systolic Blood Pressure (SBP)
Week 10: Post-Dose (n= 7, 4, 7, 7, 6)
|
134.1 mmHg
Standard Error 7.9
|
142 mmHg
Standard Error 6.0
|
131.3 mmHg
Standard Error 4.1
|
131.7 mmHg
Standard Error 6.8
|
132.8 mmHg
Standard Error 7.5
|
SECONDARY outcome
Timeframe: Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=10 Participants
Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
|
TBC3711 10 mg
n=8 Participants
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.
|
TBC3711 50 mg
n=11 Participants
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.
|
TBC3711 100 mg
n=10 Participants
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.
|
TBC3711 200 mg
n=10 Participants
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.
|
|---|---|---|---|---|---|
|
Standing Systolic Blood Pressure (SBP)
Baseline: Pre-Dose (n= 10, 8, 11, 10, 10)
|
153.6 mmHg
Standard Error 4.5
|
147.7 mmHg
Standard Error 4.4
|
147.3 mmHg
Standard Error 3.3
|
153.8 mmHg
Standard Error 4.2
|
154.1 mmHg
Standard Error 4.8
|
|
Standing Systolic Blood Pressure (SBP)
Baseline: Post-Dose (n= 10, 8, 11, 10, 10)
|
146.3 mmHg
Standard Error 4.4
|
141.9 mmHg
Standard Error 5.5
|
142.4 mmHg
Standard Error 4.4
|
149.5 mmHg
Standard Error 4.7
|
147 mmHg
Standard Error 5.8
|
|
Standing Systolic Blood Pressure (SBP)
Week 1: Pre-Dose (n= 10, 8, 11, 10, 10)
|
151.5 mmHg
Standard Error 5.1
|
147.3 mmHg
Standard Error 4.4
|
145.7 mmHg
Standard Error 4.3
|
146.8 mmHg
Standard Error 4.6
|
154.3 mmHg
Standard Error 4.1
|
|
Standing Systolic Blood Pressure (SBP)
Week 1: Post-Dose (n= 10, 8, 11, 10, 10)
|
147.8 mmHg
Standard Error 4.7
|
139.4 mmHg
Standard Error 6.9
|
139.2 mmHg
Standard Error 5.7
|
141.4 mmHg
Standard Error 5.1
|
144.8 mmHg
Standard Error 6.8
|
|
Standing Systolic Blood Pressure (SBP)
Week 2: Pre-Dose (n= 10, 8, 11, 10, 9)
|
151.1 mmHg
Standard Error 5.3
|
142.8 mmHg
Standard Error 6.3
|
145.8 mmHg
Standard Error 4.6
|
150.7 mmHg
Standard Error 4.6
|
149.7 mmHg
Standard Error 5.1
|
|
Standing Systolic Blood Pressure (SBP)
Week 2: Post-Dose (n= 10, 8, 11, 10, 9)
|
140.6 mmHg
Standard Error 4.8
|
130.8 mmHg
Standard Error 7.9
|
138.3 mmHg
Standard Error 7.3
|
142.9 mmHg
Standard Error 5.1
|
135.8 mmHg
Standard Error 6.6
|
|
Standing Systolic Blood Pressure (SBP)
Week 3: Pre-Dose (n= 10, 6, 8, 8, 10)
|
146.8 mmHg
Standard Error 4.1
|
140.9 mmHg
Standard Error 2.6
|
136.8 mmHg
Standard Error 5.8
|
147.3 mmHg
Standard Error 7.1
|
141.2 mmHg
Standard Error 6.2
|
|
Standing Systolic Blood Pressure (SBP)
Week 3: Post-Dose (n= 10, 7, 7, 8, 10)
|
142.4 mmHg
Standard Error 3.6
|
137.2 mmHg
Standard Error 2.8
|
124.9 mmHg
Standard Error 6.4
|
143.1 mmHg
Standard Error 7.6
|
128.6 mmHg
Standard Error 7.8
|
|
Standing Systolic Blood Pressure (SBP)
Week 4: Pre-Dose (n= 9, 7, 9, 9, 10)
|
141.8 mmHg
Standard Error 4.3
|
139.6 mmHg
Standard Error 4.3
|
141.5 mmHg
Standard Error 5.8
|
137.4 mmHg
Standard Error 5.7
|
139.5 mmHg
Standard Error 6.1
|
|
Standing Systolic Blood Pressure (SBP)
Week 4: Post-Dose (n= 9, 6, 9, 8, 10)
|
141 mmHg
Standard Error 4.8
|
133.4 mmHg
Standard Error 4.7
|
132.6 mmHg
Standard Error 7.7
|
132.6 mmHg
Standard Error 5.1
|
129.5 mmHg
Standard Error 9.3
|
|
Standing Systolic Blood Pressure (SBP)
Week 6: Pre-Dose (n= 9, 7, 8, 8, 8)
|
145.3 mmHg
Standard Error 5.3
|
138.2 mmHg
Standard Error 5.1
|
131.3 mmHg
Standard Error 3.5
|
138.9 mmHg
Standard Error 8.2
|
134.1 mmHg
Standard Error 4.4
|
|
Standing Systolic Blood Pressure (SBP)
Week 6: Post-Dose (n= 9, 7, 8, 8, 8)
|
139.2 mmHg
Standard Error 6.7
|
130.5 mmHg
Standard Error 4.4
|
122.8 mmHg
Standard Error 4.7
|
130.6 mmHg
Standard Error 5.1
|
127.9 mmHg
Standard Error 7.2
|
|
Standing Systolic Blood Pressure (SBP)
Week 8: Pre-Dose (n= 8, 6, 8, 8, 7)
|
139.2 mmHg
Standard Error 5.0
|
143.2 mmHg
Standard Error 3.2
|
125.9 mmHg
Standard Error 4.0
|
141.5 mmHg
Standard Error 6.0
|
135.5 mmHg
Standard Error 6.1
|
|
Standing Systolic Blood Pressure (SBP)
Week 8: Post-Dose (n= 8, 6, 8, 8, 7)
|
131.3 mmHg
Standard Error 6.6
|
138.6 mmHg
Standard Error 2.3
|
124.1 mmHg
Standard Error 3.5
|
139.3 mmHg
Standard Error 7.4
|
123.3 mmHg
Standard Error 9.2
|
|
Standing Systolic Blood Pressure (SBP)
Week 10: Pre-Dose (n= 8, 4, 7, 7, 6)
|
141.1 mmHg
Standard Error 4.6
|
147 mmHg
Standard Error 7.4
|
133.4 mmHg
Standard Error 3.7
|
137.6 mmHg
Standard Error 6.7
|
141 mmHg
Standard Error 7.7
|
|
Standing Systolic Blood Pressure (SBP)
Week 10: Post-Dose (n= 8, 4, 7, 7, 6)
|
133.5 mmHg
Standard Error 7.3
|
141.2 mmHg
Standard Error 6.3
|
131 mmHg
Standard Error 5.3
|
133.5 mmHg
Standard Error 8.9
|
128.9 mmHg
Standard Error 8.0
|
SECONDARY outcome
Timeframe: Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
|
TBC3711 10 mg
n=6 Participants
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.
|
TBC3711 50 mg
n=9 Participants
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.
|
TBC3711 100 mg
n=8 Participants
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.
|
TBC3711 200 mg
n=8 Participants
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.
|
|---|---|---|---|---|---|
|
Sitting Diastolic Blood Pressure (DBP)
Baseline: Pre-Dose (n= 8, 6, 9, 8, 8)
|
95.1 mmHg
Standard Error 6.2
|
87 mmHg
Standard Error 1.8
|
87.3 mmHg
Standard Error 3.0
|
87.8 mmHg
Standard Error 3.5
|
99.3 mmHg
Standard Error 2.1
|
|
Sitting Diastolic Blood Pressure (DBP)
Baseline: Post-Dose (n= 8, 6, 9, 8, 8)
|
91.7 mmHg
Standard Error 5.5
|
81 mmHg
Standard Error 3.1
|
82.4 mmHg
Standard Error 3.8
|
82.7 mmHg
Standard Error 3.8
|
93.7 mmHg
Standard Error 3.6
|
|
Sitting Diastolic Blood Pressure (DBP)
Week 1: Pre-Dose (n= 8, 6, 9, 8, 8)
|
92.6 mmHg
Standard Error 5.6
|
88.4 mmHg
Standard Error 3.1
|
87.5 mmHg
Standard Error 2.8
|
83.6 mmHg
Standard Error 4.2
|
99.3 mmHg
Standard Error 2.1
|
|
Sitting Diastolic Blood Pressure (DBP)
Week 1: Post-Dose (n= 8, 6, 9, 8, 8)
|
89.3 mmHg
Standard Error 5.2
|
80.3 mmHg
Standard Error 4.0
|
80 mmHg
Standard Error 3.5
|
77.6 mmHg
Standard Error 4.8
|
94.4 mmHg
Standard Error 3.8
|
|
Sitting Diastolic Blood Pressure (DBP)
Week 2: Pre-Dose (n= 8, 6, 9, 8, 8)
|
90.6 mmHg
Standard Error 5.8
|
86.1 mmHg
Standard Error 4.4
|
87.1 mmHg
Standard Error 4.0
|
84.4 mmHg
Standard Error 4.8
|
96.3 mmHg
Standard Error 2.5
|
|
Sitting Diastolic Blood Pressure (DBP)
Week 2: Post-Dose (n= 8, 6, 9, 8, 7)
|
83.7 mmHg
Standard Error 6.5
|
77.8 mmHg
Standard Error 6.5
|
76.3 mmHg
Standard Error 5.2
|
71.8 mmHg
Standard Error 3.4
|
83.7 mmHg
Standard Error 4.8
|
|
Sitting Diastolic Blood Pressure (DBP)
Week 3: Pre-Dose (n= 8, 4, 7, 7, 8)
|
89.3 mmHg
Standard Error 5.4
|
82.5 mmHg
Standard Error 4.4
|
86 mmHg
Standard Error 6.7
|
79.8 mmHg
Standard Error 7.1
|
91.6 mmHg
Standard Error 1.9
|
|
Sitting Diastolic Blood Pressure (DBP)
Week 3: Post-Dose (n= 8, 5, 6, 7, 8)
|
87.5 mmHg
Standard Error 4.8
|
74.9 mmHg
Standard Error 4.1
|
72.8 mmHg
Standard Error 4.2
|
71.8 mmHg
Standard Error 6.1
|
79.9 mmHg
Standard Error 3.2
|
|
Sitting Diastolic Blood Pressure (DBP)
Week 4: Pre-Dose (n= 7, 5, 8, 8, 8)
|
83.6 mmHg
Standard Error 3.7
|
79.2 mmHg
Standard Error 3.8
|
86 mmHg
Standard Error 5.3
|
78.1 mmHg
Standard Error 4.8
|
89.3 mmHg
Standard Error 3.6
|
|
Sitting Diastolic Blood Pressure (DBP)
Week 4: Post-Dose (n= 7, 4, 8, 7, 8)
|
82 mmHg
Standard Error 3.7
|
74.3 mmHg
Standard Error 4.9
|
76.6 mmHg
Standard Error 5.7
|
68.6 mmHg
Standard Error 3.7
|
81 mmHg
Standard Error 4.5
|
|
Sitting Diastolic Blood Pressure (DBP)
Week 6: Pre-Dose (n= 7, 5, 7, 7, 6)
|
86.8 mmHg
Standard Error 5.3
|
78.9 mmHg
Standard Error 3.5
|
78.3 mmHg
Standard Error 3.4
|
80.7 mmHg
Standard Error 5.2
|
92.1 mmHg
Standard Error 3.1
|
|
Sitting Diastolic Blood Pressure (DBP)
Week 6: Post-Dose (n= 7, 5, 7, 7, 6)
|
84.1 mmHg
Standard Error 5.4
|
73.2 mmHg
Standard Error 2.8
|
74.2 mmHg
Standard Error 4.2
|
68.9 mmHg
Standard Error 3.5
|
84.7 mmHg
Standard Error 5.3
|
|
Sitting Diastolic Blood Pressure (DBP)
Week 8: Pre-Dose (n= 7, 5, 7, 7, 6)
|
84.8 mmHg
Standard Error 5.9
|
82.9 mmHg
Standard Error 3.8
|
79.3 mmHg
Standard Error 2.7
|
80.6 mmHg
Standard Error 5.7
|
93.7 mmHg
Standard Error 3.9
|
|
Sitting Diastolic Blood Pressure (DBP)
Week 8: Post-Dose (n= 7, 5, 7, 7, 6)
|
78.8 mmHg
Standard Error 5.9
|
76.1 mmHg
Standard Error 2.6
|
73.2 mmHg
Standard Error 3.8
|
73.7 mmHg
Standard Error 5.5
|
83.8 mmHg
Standard Error 6.1
|
|
Sitting Diastolic Blood Pressure (DBP)
Week 10: Pre-Dose (n= 7, 4, 7, 7, 6)
|
87.6 mmHg
Standard Error 4.1
|
85.5 mmHg
Standard Error 2.2
|
84.8 mmHg
Standard Error 3.4
|
79.1 mmHg
Standard Error 5.1
|
93 mmHg
Standard Error 3.2
|
|
Sitting Diastolic Blood Pressure (DBP)
Week 10: Post-Dose (n= 7, 4, 7, 7, 6)
|
79.9 mmHg
Standard Error 5.6
|
76.2 mmHg
Standard Error 0.9
|
81.3 mmHg
Standard Error 3.1
|
66.8 mmHg
Standard Error 3.6
|
85.4 mmHg
Standard Error 4.4
|
SECONDARY outcome
Timeframe: Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=10 Participants
Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
|
TBC3711 10 mg
n=8 Participants
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.
|
TBC3711 50 mg
n=11 Participants
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.
|
TBC3711 100 mg
n=10 Participants
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.
|
TBC3711 200 mg
n=10 Participants
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.
|
|---|---|---|---|---|---|
|
Standing Diastolic Blood Pressure (DBP)
Week 2: Pre-Dose (n= 10, 8, 11, 10, 10)
|
92.7 mmHg
Standard Error 4.8
|
87.7 mmHg
Standard Error 3.8
|
87.9 mmHg
Standard Error 3.4
|
89.5 mmHg
Standard Error 3.7
|
96.9 mmHg
Standard Error 2.6
|
|
Standing Diastolic Blood Pressure (DBP)
Week 2: Post-Dose (n= 10, 8, 11, 10, 9)
|
87.3 mmHg
Standard Error 4.8
|
81.4 mmHg
Standard Error 5.7
|
80.8 mmHg
Standard Error 4.5
|
77.1 mmHg
Standard Error 3.2
|
84.8 mmHg
Standard Error 4.3
|
|
Standing Diastolic Blood Pressure (DBP)
Week 3: Pre-Dose (n= 10, 6, 8, 8, 10)
|
91.9 mmHg
Standard Error 5.0
|
86 mmHg
Standard Error 5.3
|
85.7 mmHg
Standard Error 6.0
|
84.5 mmHg
Standard Error 6.5
|
91.8 mmHg
Standard Error 2.5
|
|
Standing Diastolic Blood Pressure (DBP)
Week 3: Post-Dose (n= 10, 7, 7, 8, 10)
|
90 mmHg
Standard Error 4.2
|
77.8 mmHg
Standard Error 4.3
|
75.7 mmHg
Standard Error 4.8
|
78.6 mmHg
Standard Error 6.4
|
80.7 mmHg
Standard Error 3.1
|
|
Standing Diastolic Blood Pressure (DBP)
Week 4: Pre-Dose (n= 9, 7, 9, 9, 10)
|
86.4 mmHg
Standard Error 3.6
|
81.8 mmHg
Standard Error 3.2
|
85.9 mmHg
Standard Error 5.2
|
81.2 mmHg
Standard Error 4.0
|
88.9 mmHg
Standard Error 3.0
|
|
Standing Diastolic Blood Pressure (DBP)
Week 4: Post-Dose (n= 9, 6, 9, 8, 10)
|
85.9 mmHg
Standard Error 3.4
|
75.1 mmHg
Standard Error 3.4
|
77.3 mmHg
Standard Error 5.0
|
71.6 mmHg
Standard Error 2.8
|
83.1 mmHg
Standard Error 3.8
|
|
Standing Diastolic Blood Pressure (DBP)
Week 6: Pre-Dose (n= 9, 7, 8, 8, 8)
|
87.9 mmHg
Standard Error 4.8
|
82.7 mmHg
Standard Error 3.7
|
81.6 mmHg
Standard Error 2.6
|
81.6 mmHg
Standard Error 4.7
|
91.3 mmHg
Standard Error 2.1
|
|
Standing Diastolic Blood Pressure (DBP)
Week 6: Post-Dose (n= 9, 7, 8, 8, 8)
|
85.4 mmHg
Standard Error 4.1
|
74.2 mmHg
Standard Error 3.4
|
74.4 mmHg
Standard Error 4.3
|
70.1 mmHg
Standard Error 3.4
|
83.3 mmHg
Standard Error 3.8
|
|
Standing Diastolic Blood Pressure (DBP)
Week 8: Pre-Dose (n= 8, 6, 8, 8, 7)
|
87.3 mmHg
Standard Error 5.3
|
85.2 mmHg
Standard Error 4.0
|
79.8 mmHg
Standard Error 3.2
|
83.7 mmHg
Standard Error 4.9
|
92 mmHg
Standard Error 4.4
|
|
Standing Diastolic Blood Pressure (DBP)
Week 8: Post-Dose (n= 8, 6, 8, 8, 7)
|
81.1 mmHg
Standard Error 5.0
|
78.7 mmHg
Standard Error 4.0
|
75.4 mmHg
Standard Error 4.4
|
75.3 mmHg
Standard Error 5.0
|
84.5 mmHg
Standard Error 5.2
|
|
Standing Diastolic Blood Pressure (DBP)
Baseline: Pre-Dose (n= 10, 8, 11, 10, 10)
|
95.9 mmHg
Standard Error 5.1
|
89 mmHg
Standard Error 2.7
|
87.9 mmHg
Standard Error 2.5
|
90.3 mmHg
Standard Error 2.9
|
97.7 mmHg
Standard Error 2.8
|
|
Standing Diastolic Blood Pressure (DBP)
Baseline: Post-Dose (n= 10, 8, 11, 10, 10)
|
92.3 mmHg
Standard Error 4.8
|
85 mmHg
Standard Error 3.3
|
83.1 mmHg
Standard Error 3.2
|
85.1 mmHg
Standard Error 3.3
|
95.5 mmHg
Standard Error 2.9
|
|
Standing Diastolic Blood Pressure (DBP)
Week 1: Pre-Dose (n= 10, 8, 11, 10, 10)
|
95.1 mmHg
Standard Error 5
|
90.3 mmHg
Standard Error 3.0
|
88.7 mmHg
Standard Error 3.0
|
87.2 mmHg
Standard Error 4.0
|
98.9 mmHg
Standard Error 1.9
|
|
Standing Diastolic Blood Pressure (DBP)
Week 1: Post-Dose (n= 10, 8, 11, 10, 10)
|
91.5 mmHg
Standard Error 4.5
|
81.3 mmHg
Standard Error 4.7
|
82.7 mmHg
Standard Error 3.4
|
81.4 mmHg
Standard Error 4.6
|
93.7 mmHg
Standard Error 3.1
|
|
Standing Diastolic Blood Pressure (DBP)
Week 10: Pre-Dose (n= 8, 4, 7, 7, 6)
|
88.7 mmHg
Standard Error 3.8
|
83.5 mmHg
Standard Error 2.2
|
86.2 mmHg
Standard Error 3.8
|
80.3 mmHg
Standard Error 5.1
|
93.4 mmHg
Standard Error 3.1
|
|
Standing Diastolic Blood Pressure (DBP)
Week 10: Post-Dose (n= 8, 4, 7, 7, 6)
|
83.2 mmHg
Standard Error 4.9
|
73.8 mmHg
Standard Error 1.5
|
81.3 mmHg
Standard Error 3.8
|
67 mmHg
Standard Error 3.7
|
84.2 mmHg
Standard Error 4.8
|
SECONDARY outcome
Timeframe: Pre-Dose and 2 hours Post-Dose on Week 10Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=7 Participants
Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
|
TBC3711 10 mg
n=4 Participants
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.
|
TBC3711 50 mg
n=7 Participants
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.
|
TBC3711 100 mg
n=7 Participants
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.
|
TBC3711 200 mg
n=6 Participants
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.
|
|---|---|---|---|---|---|
|
Change From Standing to Sitting Systolic Blood Pressure (SBP) at Week 10
Week 10: Pre-Dose
|
1.32 mmHg
Standard Error 1.78
|
0.46 mmHg
Standard Error 2.34
|
1.67 mmHg
Standard Error 1.76
|
-0.54 mmHg
Standard Error 1.74
|
-0.85 mmHg
Standard Error 2.01
|
|
Change From Standing to Sitting Systolic Blood Pressure (SBP) at Week 10
Week 10: Post-Dose
|
2.63 mmHg
Standard Error 1.97
|
-0.55 mmHg
Standard Error 2.59
|
1.28 mmHg
Standard Error 1.95
|
-1.30 mmHg
Standard Error 1.93
|
1.66 mmHg
Standard Error 2.22
|
SECONDARY outcome
Timeframe: Pre-Dose and 2 hours Post-Dose on Week 10Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=7 Participants
Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
|
TBC3711 10 mg
n=4 Participants
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.
|
TBC3711 50 mg
n=7 Participants
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.
|
TBC3711 100 mg
n=7 Participants
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.
|
TBC3711 200 mg
n=6 Participants
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.
|
|---|---|---|---|---|---|
|
Change From Standing to Sitting Diastolic Blood Pressure (DBP) at Week 10
Week 10: Pre-Dose
|
-0.95 mmHg
Standard Error 0.95
|
2.04 mmHg
Standard Error 1.27
|
-1.42 mmHg
Standard Error 0.95
|
-1.18 mmHg
Standard Error 0.98
|
-0.43 mmHg
Standard Error 1.03
|
|
Change From Standing to Sitting Diastolic Blood Pressure (DBP) at Week 10
Week 10: Post-Dose
|
-1.28 mmHg
Standard Error 1.32
|
1.50 mmHg
Standard Error 1.77
|
-0.09 mmHg
Standard Error 1.32
|
0.68 mmHg
Standard Error 1.36
|
0.80 mmHg
Standard Error 1.43
|
SECONDARY outcome
Timeframe: Pre-Dose and 2 hours Post-Dose on Week 10Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=7 Participants
Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
|
TBC3711 10 mg
n=4 Participants
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.
|
TBC3711 50 mg
n=7 Participants
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.
|
TBC3711 100 mg
n=7 Participants
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.
|
TBC3711 200 mg
n=6 Participants
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.
|
|---|---|---|---|---|---|
|
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
|
-4.59 mmHg
Standard Error 4.30
|
-4.49 mmHg
Standard Error 3.25
|
-5.87 mmHg
Standard Error 3.23
|
-7.03 mmHg
Standard Error 3.53
|
|
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
|
-4.41 mmHg
Standard Error 4.19
|
-3.13 mmHg
Standard Error 3.16
|
-5.24 mmHg
Standard Error 3.17
|
-11.17 mmHg
Standard Error 3.42
|
SECONDARY outcome
Timeframe: Pre-Dose and 2 hours Post-Dose on Week 10Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=7 Participants
Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
|
TBC3711 10 mg
n=4 Participants
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.
|
TBC3711 50 mg
n=7 Participants
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.
|
TBC3711 100 mg
n=7 Participants
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.
|
TBC3711 200 mg
n=6 Participants
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.
|
|---|---|---|---|---|---|
|
Change From Pre-Dose to Post-Dose in Diastolic Blood Pressure (DBP) at Week 10
Week 10: Sitting
|
-8.57 mmHg
Standard Error 2.50
|
-9.79 mmHg
Standard Error 3.26
|
-3.69 mmHg
Standard Error 2.46
|
-11.28 mmHg
Standard Error 2.52
|
-7.23 mmHg
Standard Error 2.66
|
|
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
|
-10.35 mmHg
Standard Error 3.36
|
-5.51 mmHg
Standard Error 2.55
|
-11.67 mmHg
Standard Error 2.61
|
-7.97 mmHg
Standard Error 2.78
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
TBC3711 10 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
TBC3711 50 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
TBC3711 100 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
TBC3711 200 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=10 participants at risk
Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
|
TBC3711 10 mg
n=8 participants at risk
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.
|
TBC3711 50 mg
n=11 participants at risk
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.
|
TBC3711 100 mg
n=10 participants at risk
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.
|
TBC3711 200 mg
n=10 participants at risk
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.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
9.1%
1/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
9.1%
1/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Placebo
n=10 participants at risk
Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
|
TBC3711 10 mg
n=8 participants at risk
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.
|
TBC3711 50 mg
n=11 participants at risk
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.
|
TBC3711 100 mg
n=10 participants at risk
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.
|
TBC3711 200 mg
n=10 participants at risk
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.
|
|---|---|---|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
2/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema peripheral
|
20.0%
2/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
9.1%
1/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
2/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
9.1%
1/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
18.2%
2/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
2/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
2/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dyspnoea
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
18.2%
2/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.0%
1/10
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER