NCT00171002已完成3 期
A Multicenter Trial to Evaluate the Safety and Efficacy of the Combination of Valsartan/Amlodipine 160/10 mg Versus Amlodipine 10 mg Alone for 8 Weeks in Hypertensive Patients Who Are Not Adequately Controlled on Amlodipine 10 mg Monotherapy
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 936
- 试验地点
- 2
- 主要终点
- Change from baseline in diastolic blood pressure after 8 weeks
研究概览
简要总结
This study will test the effectiveness and safety of a combination treatment in patients whose blood pressure is not controlled with a single medication
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
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
- •Patients with uncomplicated, essential hypertension
排除标准
- •Severe hypertension
- •History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm
- •Liver, kidney, or pancreas disease
- •Insulin dependent diabetes
- •Allergy to certain medications used to treat high blood pressure
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Change from baseline in diastolic blood pressure after 8 weeks
次要结局
- Change from baseline in systolic blood pressure after 8 weeks
- Decrease in diastolic blood pressure of at least 10 mmHg or diastolic blood pressure less than 90 mmHg after 8 weeks
- Diastolic blood pressure less than 90 mmHg after 8 weeks
研究者
研究点 (2)
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