NCT00219089已完成3 期
An Eight-week, Randomized, Double-blind, Parallel Group, Multicenter, Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Ramipril in Patients With Hypertension and Diabetes Mellitus
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
- 839
- 试验地点
- 3
- 主要终点
- Change from baseline in mean sitting diastolic blood pressure after 8 weeks
研究概览
简要总结
To demonstrate the efficacy and safety of aliskiren given to patients with both hypertension and diabetes mellitus
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 essential hypertension
- •Patients with a documented diagnosis of Type 1 or Type 2 diabetes mellitus.
- •Patients who are eligible and able to participate in the study
排除标准
- •Severe hypertension
- •History or evidence of a secondary form of hypertension
- •History of hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined exclusion criteria may apply
结局指标
主要结局
Change from baseline in mean sitting diastolic blood pressure after 8 weeks
次要结局
- Change from baseline to week 8 endpoint in mean sitting systolic blood pressure
- Diastolic blood pressure less than 90 mmHg or reduction of 10 mmHg or greater from baseline after 8 weeks
- Change from baseline to week 4 endpoint in mean sitting diastolic blood pressure
研究者
研究点 (3)
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