NCT00219128已完成3 期
An Eight-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Comparing Aliskiren 150 mg, 300 mg, and 600 mg to Placebo in Patients With Essential Hypertension
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
- 671
- 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
Evaluate the blood pressure lowering effect of aliskiren 150mg, 300mg and 600mg compared to placebo in patients with essential 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
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 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 diastolic blood pressure after 8 weeks
次要结局
- Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 4 weeks and 8 weeks
- Change from baseline in systolic blood pressure after 8 weeks
- Blood pressure <140/90 mmHg after 4 weeks and 8 weeks
- Evaluate potential return of hypertension at 4 days and 2 weeks after 8 weeks
- Evaluate high and low level drug effect using 24 hour blood pressure monitoring
研究者
研究点 (2)
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