Trial Outcomes & Findings for A Pharmacodynamic Study to Evaluate the Effect of a Fixed Dose Combination Pill on Blood Pressure (NCT NCT01005290)
NCT ID: NCT01005290
Last Updated: 2012-07-26
Results Overview
Difference in the adjusted mean 24-h systolic pressure results using ABPM (Ambulatory Blood Pressure Monitoring)in the PP population.
TERMINATED
PHASE2
38 participants
Days 7 and 36 of Period 1 and days 49 and 85 of Period 2
2012-07-26
Participant Flow
Ninety-four subjects were screened for eligibility, participants met eligibility requirements and entered the run-in period
52 subjects enrered the run-in period with ramipril 2.5 mg, 38 subjects were randomized. 20 subjects were randomized to Sequence Combination pill/ Ramipril and 18 subjects to sequence Ramipril /Combination pill.
Participant milestones
| Measure |
Pre-randomization Run-In
Screening period with ramipril 2.5 mg once daily
|
Combination Pill Then Ramipril
After randomization, in Period 1 participants received a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 4 weeks; participants received no intervention during wash-out; in Period 2 participants received a once daily oral dose of 5 mg ramipril for one week followed by a once daily oral dose of 10 mg ramipril for 4 weeks
|
Ramipril Then Combination Pill
After randomization, in Period 1 participants received a once daily oral dose of 5 mg ramipril for one week followed by a once daily oral dose of 10 mg ramipril for 4 weeks; participants received no intervention during wash-out; in Period 2 participants received a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 4 weeks.
|
|---|---|---|---|
|
Run-In
STARTED
|
52
|
0
|
0
|
|
Run-In
COMPLETED
|
38
|
0
|
0
|
|
Run-In
NOT COMPLETED
|
14
|
0
|
0
|
|
Period 1 (5 Weeks)
STARTED
|
0
|
20
|
18
|
|
Period 1 (5 Weeks)
COMPLETED
|
0
|
13
|
9
|
|
Period 1 (5 Weeks)
NOT COMPLETED
|
0
|
7
|
9
|
|
Washout Period (2 Weeks)
STARTED
|
0
|
13
|
9
|
|
Washout Period (2 Weeks)
COMPLETED
|
0
|
13
|
9
|
|
Washout Period (2 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
|
Period 2 (5 Weeks)
STARTED
|
0
|
13
|
9
|
|
Period 2 (5 Weeks)
COMPLETED
|
0
|
13
|
7
|
|
Period 2 (5 Weeks)
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pharmacodynamic Study to Evaluate the Effect of a Fixed Dose Combination Pill on Blood Pressure
Baseline characteristics by cohort
| Measure |
Randomized Patiens
n=38 Participants
All patients who were randomized to both treatment sequences
|
|---|---|
|
Age Continuous
|
39.8 years
STANDARD_DEVIATION 11.71 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 7 and 36 of Period 1 and days 49 and 85 of Period 2Population: The PP set included all randomized subjects who received at least one dose of IMP, had a baseline primary endpoint measurement, had at least one post baseline primary endpoint measurement, and who had no major protocol deviations. The PP set served as the primary analysis set for analysis of the primary endpoint.
Difference in the adjusted mean 24-h systolic pressure results using ABPM (Ambulatory Blood Pressure Monitoring)in the PP population.
Outcome measures
| Measure |
Combination Pill
n=17 Participants
Difference in the adjusted mean 24-h systolic pressure results (using ABPM) between the basal and the final visit of each treatment period.
|
Ramipril
n=17 Participants
Difference in the adjusted mean 24-h diastolic pressure results (using ABPM) between the basal and the final visit of each treatment period.
|
|---|---|---|
|
Difference in the Adjusted Mean 24-h Systolic Pressure Results (Using ABPM) Between the Basal and the Final Visit of Each Treatment Period.
|
-2.40 mm Hg
Standard Deviation 8.726
|
-4.40 mm Hg
Standard Deviation 8.173
|
SECONDARY outcome
Timeframe: Days 7 and 36 of Period 1 and days 49 and 85 of Period 2Population: The PP set included all randomized subjects who received at least one dose of IMP, had a baseline primary endpoint measurement, had at least one post baseline primary endpoint measurement, and who had no major protocol deviations. The PP set served as the primary analysis set for analysis of the primary endpoint.
Difference in the Adjusted Mean 24-h Diastolic Pressure Results (Using ABPM) Between the Basal and the Final Visit of Each Treatment Period
Outcome measures
| Measure |
Combination Pill
n=17 Participants
Difference in the adjusted mean 24-h systolic pressure results (using ABPM) between the basal and the final visit of each treatment period.
|
Ramipril
n=17 Participants
Difference in the adjusted mean 24-h diastolic pressure results (using ABPM) between the basal and the final visit of each treatment period.
|
|---|---|---|
|
Difference in the Adjusted Mean 24-h Diastolic Pressure Results Between the Basal and the Final Visit of Each Treatment Period
|
-1.85 mm Hg
Standard Deviation 6.714
|
-2.88 mm Hg
Standard Deviation 5.731
|
Adverse Events
Combination Pill
Ramipril
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Combination Pill
n=29 participants at risk
|
Ramipril
n=31 participants at risk
|
|---|---|---|
|
Nervous system disorders
Headache
|
10.3%
3/29 • Number of events 3 • Participants were followed for the whole study duration, an average of 18 weeks.
|
3.2%
1/31 • Number of events 1 • Participants were followed for the whole study duration, an average of 18 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Communications and publication must be agreed between sponsor and PI
- Publication restrictions are in place
Restriction type: OTHER