NCT00219102已完成3 期
A 12-week, Randomized, Double-blind, Placebo Controlled, Parallel Group Study Evaluating the Efficacy & Safety of Aliskiren in Patients With Diabetes & Hypertension Not Adequately Responsive to the Combination of Valsartan 160 mg & Hydrochlorothiazide 25 mg
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
- 336
- 试验地点
- 7
- 主要终点
- Change from baseline in diastolic blood pressure after 12 weeks
研究概览
简要总结
To evaluate the blood pressure lowering effect and safety of aliskiren used in combination with valsartan/hydrochlorothiazide in diabetic patients with essential hypertension, not adequately responsive to the combination of valsartan and hydrochlorothiazide
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 with a documented diagnosis of Type 1 or Type 2 diabetes mellitus.
- •Patients who are eligible and able to participate in the study
排除标准
- •Severe hypertension
- •Uncontrolled diabetes type I and II
- •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 12 weeks
次要结局
- Change from baseline in systolic blood pressure after 12 weeks
- Change from baseline in systolic and diastolic blood pressure after 6 weeks
- Achieve mean sitting blood pressure control target of < 130/80 mmHg after 12 weeks
- Diastolic blood pressure of < 80 mmHg or a reduction from baseline of diastolic blood pressure of > 10 mmHg after 12 weeks
研究者
研究点 (7)
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