NCT00392262已完成3 期
An Multicenter Study to Evaluate the Efficacy and Tolerability of a 4-week Therapy With the Combination of Valsartan 160mg + Amlodipine 5mg in Hypertensive Patients Not Adequately Responding to 4-week Treatment With Amlo 5mg or Felodipine 5mg in 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
- 224
- 试验地点
- 2
- 主要终点
- To investigate whether 4 weeks treatment with valsartan 160mg + amlo 5mg provide an add'l mean sitting systolic blood pressure reduction in patients not adequately responding to 4 weeks treatment with amlo 5mg or felodipine 5mg
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of valsartan plus amlodipine in hypertensive patients not responding to treatment with amlodipine or felodipine alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 patients (18 years)
- •Patients with moderate essential hypertension (untreated must have MSSBP ≥160 and <180 mmHg at Visit 1, treated must have MSSBP <180 mmHg at Visit 1) (WHO grade II)
排除标准
- •Severe hypertension(MSDBP ≥110 mmHg or MSSBP ≥ 180 mmHg)
- •Pregnant or nursing women
- •Treated hypertensive patients with controlled hypertension under current therapy (diastolic BP < 90 mmHg and systolic BP < 140 mmHg)
- •A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
To investigate whether 4 weeks treatment with valsartan 160mg + amlo 5mg provide an add'l mean sitting systolic blood pressure reduction in patients not adequately responding to 4 weeks treatment with amlo 5mg or felodipine 5mg
次要结局
- Mean sitting diastolic blood pressure (analogously & explorative)
- Normalization (analogously & explorative)
- Responder rate. (analogously & explorative)
研究者
研究点 (2)
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