A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled, Factorial Study to Evaluate the Efficacy and Safety of 8-week Treatment With Valsartan (40 and 80 mg) and Amlodipine (2.5 and 5 mg) Combined and Alone in Essential Hypertensive Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,474
- 试验地点
- 1
- 主要终点
- Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to End of Study (Week 8)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of fixed combination of valsartan (40 mg and 80 mg) and amlodipine (2.5 mg and 5 mg), valsartan and amlodipine alone, and placebo in reducing blood pressure. The study will investigate the dose response relationship for the combinations, monotherapies, and placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（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
Valsartan + amlodipine 40/2.5 mg
干预措施: Valsartan + amlodipine 40/2.5 mg (Drug)
Valsartan + amlodipine 40/5 mg
干预措施: Valsartan + amlodipine 40/5 mg (Drug)
Valsartan + amlodipine 80/2.5 mg
干预措施: Valsartan + amlodipine 80/2.5 mg (Drug)
Valsartan + amlodipine 80/5 mg
干预措施: Valsartan + amlodipine 80/5 mg (Drug)
Valsartan 40 mg
干预措施: Valsartan 40 mg (Drug)
Valsartan 80 mg
干预措施: Valsartan 80 mg (Drug)
Amlodipine 2.5 mg
干预措施: Amlodipine 2.5 mg (Drug)
Amlodipine 5 mg
干预措施: Amlodipine 5 mg (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to End of Study (Week 8)
时间窗: Baseline to end of study (Week 8)
At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.
次要结局
- Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Study (Week 8)(Baseline to end of study (Week 8))
- Percentage of Patients Achieving MSDBP < 90 mmHg or a => 10 mm Hg Decrease Compared to Baseline at the End of the Study (Week 8)(Baseline to end of study (Week 8))
- Percentage of Patients Achieving MSDBP < 90mmHg at the End of the Study (Week 8)(Baseline to end of study (Week 8))
- Percentage of Patients Achieving MSDBP < 90 mm Hg and MSSBP < 140 mm Hg at the End of the Study (Week 8)(Baseline to end of study (Week 8))