NCT00294710已完成3 期
A Twenty Six-week, Dose Titration Study to Evaluate the Efficacy and Safety of Aliskiren Compared to HCTZ With the Optional Addition of Amlodipine, Followed by a Second Twenty Six Weeks of Blinded Treatment, 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
- 976
- 试验地点
- 3
- 主要终点
- Change from baseline in diastolic blood pressure after 52 weeks
研究概览
简要总结
This study is designed to compare the long-term efficacy and safety of an aliskiren based regimen to an HCTZ based treatment regimen with optional addition of amlodipine 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with essential hypertension
排除标准
- •Severe hypertension
- •History or evidence of a secondary form of hypertension
- •History of myocardial infarction.
- •Other protocol-defined inclusion exclusion criteria also apply.
结局指标
主要结局
Change from baseline in diastolic blood pressure after 52 weeks
次要结局
- Change from baseline in systolic and diastolic blood pressure after 52 weeks
- Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 52 weeks
- Achieve blood pressure control target of < 140/90 mmHg after 12 weeks
研究者
研究点 (3)
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