NCT00219024已完成3 期
An 8 Week Double-blind, Multicenter, Randomized, Multifactorial, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Hydrochlorothiazide 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
- 2,775
- 试验地点
- 2
- 主要终点
- Change from baseline in diastolic blood pressure after 8 weeks
研究概览
简要总结
To demonstrate the efficacy and safety of aliskiren given to patients with essential hypertension, at doses of 75 mg, 150 mg and 300 mg alone, and in combination with hydrochlorothiazide (HCTZ)
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 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 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
- Change from baseline in systolic blood pressure after 8 weeks
- Diastolic blood pressure is < 90 mmHg or a reduction from baseline of > 10 mmHg after 8 weeks
- Blood pressure < 140/90 mmHg
- Change from baseline in standing diastolic blood pressure after 8 weeks
- Change from baseline in standing systolic blood pressure after 8 weeks
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Amlodipine in Essential HypertensionHypertensionNCT00739973Novartis Pharmaceuticals2,694
已完成
3 期
A Clinical Study to Evaluate the Safety and Efficacy of Aliskiren Alone and in Combination With Ramipril in Hypertensive, Diabetic Patients.Hypertension, Diabetes MellitusNCT00219089Novartis839
已完成
4 期
Aliskiren Plus HCTZ Compared to Aliskiren in Metabolic Syndrome Patients With Stage 2 Systolic HypertensionHypertensionNCT00797316Novartis532
已完成
3 期
Efficacy and Safety of Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Moderate-severe HypertensionHypertensionNCT00765674Novartis1,191
已完成
4 期
Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine Versus Amlodipine Alone in African American Patients With Stage 2 HypertensionHypertensionNCT00853957Novartis443