Cardiovascular Fixed Dose Combination Pill: A Pharmacodynamic Interaction Study to Evaluate the Effect of a Fixed Dose Combination of Acetylsalicylic Acid, Simvastatin and Ramipril (Cardiovascular Fixed Dose Combination Pill) on Blood Pressure
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Difference in the Adjusted Mean 24-h Systolic Pressure Results (Using ABPM) Between the Basal and the Final Visit of Each Treatment Period.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will be ≥18 years old
- •Previously untreated systolic pressure result of ≥120<160 mmHg and diastolic pressure result of ≥80<100 mmHg
排除标准
- •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).
研究组 & 干预措施
Combination 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.
干预措施: Combination pill (Drug)
Ramipril
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.
干预措施: Ramipril (Drug)
结局指标
主要结局
Difference in the Adjusted Mean 24-h Systolic Pressure Results (Using ABPM) Between the Basal and the Final Visit of Each Treatment Period.
时间窗: 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.
次要结局
- 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)