NCT00260923已完成3 期
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Comparing an Eight-week Treatment of Aliskiren 75 mg, 150 mg and 300 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
- 641
- 试验地点
- 3
- 主要终点
- Change from baseline in diastolic blood pressure after 8 weeks
研究概览
简要总结
This is a study for people diagnosed with hypertension to compare 3 doses (75 mg, 150 mg, and 300 mg) of an experimental product, aliskiren in comparison to a placebo. Each patient is in the study for 8 weeks
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
- •Male and female outpatients 18 years of age and older
- •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 inclusion/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 8 weeks
- Change from baseline in systolic blood pressure after 8 weeks
研究者
研究点 (3)
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