A Prospective, Open Label, Randomized, Comparative Study of Ramipril 5mg Plus Felodipine 5mg Combined Regimen and Ramipril 10mg in Uncontrolled Hypertensive Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Seated SBP at office
研究概览
简要总结
The objective of this study is to compare the reduction in office seated systolic blood pressure (BP) following a 8 weeks regimen of ramipril 5mg plus felodipine 5mg versus ramipril 10mg.
To compare the response rate (defined as office systolic blood pressure (SBP) / Diastolic blood pressure (DBP) reduce more than 10mmHg from baseline), and BP controlled rate (defined as SBP<140mmHg and/or DBP<90mmHg) and as SBP < 130 mmHg and /or DBP < 80 mmHg in diabetes,chronic kidney disease, known Coronary Arterial Disease (CAD) or CAD equivalent, or 10-year Framingham risk score > 10%.
To ascertain the safety and tolerability of ramipril/felodipine versus ramipril in Taiwanese population.
To compare compliance with fixed dose combination of ramipril/felodipine versus ramipril treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
2 weeks run-in of Ramipril 5 mg followed by 8 weeks of Ramipril + Felodipine
干预措施: Ramipril + Felodipine (Drug)
1
2 weeks run-in of Ramipril 5 mg followed by 8 weeks of Ramipril + Felodipine
干预措施: Ramipril (Drug)
2
2 weeks run-in of Ramipril 5 mg followed by 8 weeks of Ramipril 10 mg
干预措施: Ramipril (Drug)
结局指标
主要结局
Seated SBP at office
时间窗: After 8-week treatment
次要结局
- Seated DBP at office(After 4 and 8-week treatment)
- Seated SBP at office(After 4-week treatment)
- Response rate(After 4 and 8-week treatment)
- BP controlled rate(After 4 and 8-week treatment)