NCT00170976已完成3 期
A 54 Week, Extension to the Double-blind, Multicenter, Multifactorial, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Valsartan (160 mg and 320 mg) and Amlodipine (10 mg) Combined and Alone in Hypertensive Patients
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
- 403
- 试验地点
- 2
- 主要终点
- Adverse events and serious adverse events at each study visit for 6 or 12 months
研究概览
简要总结
A ONE YEAR SAFETY STUDY FOR PATIENTS WHO COMPLETE STUDY VAA489A2307.
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
- •SUCCESSFUL COMPLETION OF VAA489A2307 CORE TRIAL
- •VISIT 7 BLOOD PRESSURE MUST BE MSDBP ≤ 95 mmHg AND MSSBP ≤ 150 mmHg
排除标准
- •PATIENTS WHO EXPERIENCED ANY ADVERSE EVENTS CONSIDERED SERIOUS AND DRUG RELATED IN VAA489A2307 CORE
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Adverse events and serious adverse events at each study visit for 6 or 12 months
次要结局
- Hematology and blood chemistry after 6 or 12 months
- Change from baseline in diastolic blood pressure from baseline after 6 or 12 months
- Change from baseline in systolic blood pressure from baseline after 6 or 12 months
- Change from baseline in standing diastolic and systolic blood pressure after 6 or 12 months
- Change from baseline in sitting and standing pulse after 6 or 12 months
研究者
研究点 (2)
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