NCT00219050已完成3 期
An Eight-week, Randomized, Double-blind, Multi-center, Active-controlled, Parallel Group Study to Evaluate the Safety and Efficacy of an Aliskiren-based Regimen Compared to a Lisinopril-based Regimen in Patients With Uncomplicated Severe 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
- 180
- 试验地点
- 4
- 主要终点
- Evaluate safety through adverse events and laboratory abnormalities after 8 weeks
研究概览
简要总结
To compare the safety and efficacy of an aliskiren-based regimen to a lisinopril-based regimen in the treatment of severe 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 severe hypertension
排除标准
- •History or evidence of a secondary form of hypertension
- •History of hypertensive encephalopathy or cerebrovascular accident.
- •Diabetic patients requiring insulin Other protocol-defined inclusion/exclusion criteria also apply
结局指标
主要结局
Evaluate safety through adverse events and laboratory abnormalities after 8 weeks
次要结局
- Change from baseline in diastolic blood pressure after 8 weeks
- Change from baseline in systolic blood pressure after 8 weeks
- Change from baseline in standing systolic blood and diastolic pressure after 8 weeks
- Diastolic blood pressure is less than 90 mmHg or reduction of 10 mmHg or greater from baseline after 8 weeks
研究者
研究点 (4)
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