A Multi-national, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel Study Comparing the Efficacy and Safety of Valsartan/Amlodipine 80/5 mg to Amlodipine 5 mg Alone Once Daily in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Amlodipine 5 mg Monotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 698
- 试验地点
- 12
- 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
This study will evaluate the safety and efficacy of the fixed combination of valsartan/amlodipine in adult patients with mild to moderate hypertension
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 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 80/5 mg
干预措施: Valsartan/amlodipine 80/5 mg (Drug)
Amlodipine 5 mg
干预措施: Amlodipine 5 mg (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)
Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. A negative change score indicates lowered BP.
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 a Diastolic Response at the End of the Study (Week 8)(Baseline to end of study (Week 8))
- Percentage of Patients Achieving Diastolic Control at the End of the Study (Week 8)(Baseline to end of study (Week 8))
- Percentage of Patients Achieving Overall Control at the End of the Study (Week 8)(Baseline to end of study (Week 8))
- Change in 24-hour Mean Ambulatory Diastolic and Systolic BP From Baseline at the End of the Study (Week 8)(Baseline to end of study (Week 8))