A Multicenter, Double-blind, Randomized, Parallel-group Study to Evaluate the Safety, Tolerability, and Efficacy of Once Daily Amlodipine/Valsartan 5/80 mg as Compared to Amlodipine/Valsartan 5/40 mg or to Amlodipine 5 mg Once Daily in Elderly Patients With Essential Hypertension Not Adequately Controlled After Four Weeks on Amlodipine 5 mg Once Daily
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 965
- 试验地点
- 15
- 主要终点
- Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)
研究概览
简要总结
To characterize the safety, tolerability, and efficacy profile of amlodipine/valsartan 5/80 mg as compared to amlodipine/valsartan 5/40 mg (with optional titration to 5/80 mg) and amlodipine 5 mg monotherapy in elderly patients (≥ 65 years of age) with essential hypertension. All three regimens are expected to be well tolerated.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（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
Amlodipine 5 mg
1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
干预措施: Amlodipine 5 mg (Drug)
Amlodipine/Valsartan 5/80 mg
1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
干预措施: Amlodipine 5 mg (Drug)
Amlodipine/Valsartan 5/80 mg
1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
干预措施: Valsartan 80 mg (Drug)
Amlodipine/Valsartan 5/40 mg
1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
干预措施: Amlodipine 5 mg (Drug)
Amlodipine/Valsartan 5/40 mg
1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
干预措施: Valsartan 40 mg (Drug)
Amlodipine 5 mg
1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)
时间窗: Baseline to end of study (Week 8)
At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings. A negative change from baseline indicates lowered BP.
次要结局
- Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)(Baseline to end of study (Week 8))
- Percentage of Patients Achieving a Systolic Blood Pressure Response at Week 8(Baseline to end of study (Week 8))
- Percentage of Patients Achieving Systolic Blood Pressure Control at the End of the Study (Week 8)(End of study (Week 8))
- Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8)(End of study (Week 8))