NCT00386139已完成3 期
An Eight-week Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / HCTZ (300/12.5 mg and 300/25 mg) in Comparison With Aliskiren 300 mg in Patients With Essential Hypertension Not Adequately Responsive to Aliskiren 300 mg Monotherapy
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
- 881
- 试验地点
- 3
- 主要终点
- Mean Sitting Diastolic Blood Pressure lowering effect at baseline, and week 8.
研究概览
简要总结
Evaluate the diastolic blood pressure lowering effect of combination of aliskiren 300 mg and HCTZ (12.5 mg and 25 mg) in hypertensive patients who do not show sufficient blood pressure response to aliskiren 300 mg.
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 or female outpatients 18 years old or older.
- •Patients with a diagnosis of hypertension.
- •Patients who are eligible and consent to participate in the study
排除标准
- •Severe hypertension
- •Previous or current diagnosis of heart failure.
- •History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI).
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Mean Sitting Diastolic Blood Pressure lowering effect at baseline, and week 8.
次要结局
- Mean sitting systolic blood pressure (msDBP) lowering from baseline to week 8
- Safety and tolerability
- Proportion of patients achieving a blood pressure control target at week 8
研究者
研究点 (3)
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