Hypertension
Conditions
Keywords
cardiovascular, fixed, dose, combination, pill, hypertension
Brief summary
The purpose of this study is to compare the effect on systolic pressure of the 3 drugs given together in the cardiovascular combination pill (acetylsalicylic acid, simvastatin, and ramipril) to the effect on systolic pressure of ramipril given alone.
Interventions
DRUGCombination pill
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.
DRUGRamipril
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.
Sponsors
Ferrer Internacional S.A.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects will be ≥18 years old * Previously untreated systolic pressure result of ≥120\<160 mmHg and diastolic pressure result of ≥80\<100 mmHg
Exclusion criteria
* Subjects must not have previously received any anti-hypertensive medication * must not have a systolic pressure \<120 mmHg or ≥160 mmHg and diastolic pressure result of \<80 mmHg or ≥100 mmHg * must not have had a previous coronary artery bypass graft (CABG) * must not have had a previous percutaneous transluminal coronary angioplasty (PTCA) with a drug-eluting stent * must not have severe congestive heart failure (New York Heart Classification \[NYHC\] III-IV).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the Adjusted Mean 24-h Systolic Pressure Results (Using ABPM) Between the Basal and the Final Visit of Each Treatment Period. | Days 7 and 36 of Period 1 and days 49 and 85 of Period 2 | Difference in the adjusted mean 24-h systolic pressure results using ABPM (Ambulatory Blood Pressure Monitoring)in the PP population. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the Adjusted Mean 24-h Diastolic Pressure Results Between the Basal and the Final Visit of Each Treatment Period | Days 7 and 36 of Period 1 and days 49 and 85 of Period 2 | Difference in the Adjusted Mean 24-h Diastolic Pressure Results (Using ABPM) Between the Basal and the Final Visit of Each Treatment Period |
Countries
United States
Participant flow
Recruitment details
Ninety-four subjects were screened for eligibility, participants met eligibility requirements and entered the run-in period
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Randomized Patiens All patients who were randomized to both treatment sequences | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | Randomized Patiens |
|---|---|
| Age Continuous | 39.8 years STANDARD_DEVIATION 11.71 |
| Region of Enrollment United States | 38 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 29 | 1 / 31 |
| serious Total, serious adverse events | 0 / 29 | 0 / 31 |
Outcome results
Primary
Difference in the Adjusted Mean 24-h Systolic 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 (Ambulatory Blood Pressure Monitoring)in the PP population.
Time frame: Days 7 and 36 of Period 1 and days 49 and 85 of Period 2
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combination Pill | 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 |
| Ramipril | Difference in the Adjusted Mean 24-h Systolic Pressure Results (Using ABPM) Between the Basal and the Final Visit of Each Treatment Period. | -4.40 mm Hg | Standard Deviation 8.173 |
Secondary
Difference in the Adjusted Mean 24-h Diastolic Pressure Results Between the Basal and the Final Visit of Each Treatment Period
Difference in the Adjusted Mean 24-h Diastolic Pressure Results (Using ABPM) Between the Basal and the Final Visit of Each Treatment Period
Time frame: Days 7 and 36 of Period 1 and days 49 and 85 of Period 2
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combination Pill | 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 |
| Ramipril | Difference in the Adjusted Mean 24-h Diastolic Pressure Results Between the Basal and the Final Visit of Each Treatment Period | -2.88 mm Hg | Standard Deviation 5.731 |