NCT00219115已完成3 期
A 12-week Randomized Double-blind Parallel Group Study to Evaluate the Efficacy and Safety of the Combination Aliskiren With HCTZ Compared to Irbesartan or Amlodipine With HCTZ or HCTZ Alone in Hypertensive Patients With BMI ≥ 30 kg/m2 Not Adequately Responsive to HCTZ 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
- 493
- 试验地点
- 3
- 主要终点
- Change from baseline in mean sitting diastolic blood pressure after 8 weeks
研究概览
简要总结
To evaluate the blood pressure lowering effects of the combination of aliskiren 300 mg and HCTZ 25 mg in obese patients with essential hypertension inadequately treated with HCTZ 25 mg, compared to irbesartan or amlodipine with HCTZ or HCTZ alone.
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 body mass index ≥ 30 kg/m2
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 inclusion exclusion criteria also apply.
结局指标
主要结局
Change from baseline in mean sitting diastolic blood pressure after 8 weeks
次要结局
- Achieve mean sitting blood pressure control target of < 140/90 mmHg after week 8
- Change from baseline in mean sitting systolic blood pressure after 8 weeks
- Evaluate number mean sitting systolic/diastolic response from baseline to weeks 4 and 8
- Mean sitting diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after week 8
研究者
研究点 (3)
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