NCT00220233已完成3 期
Add-on Study of Olmesartan Medoxomil in Patients With Moderate to Severe Hypertension Not Achieving Target Blood Pressure on Amlodipine 5 mg Alone
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 632
- 试验地点
- 5
- 主要终点
- Mean change in trough seated diastolic blood pressure
研究概览
简要总结
This study is to test the efficacy and safety of the combination of olmesartan and amlodipine in hypertensive patients whose blood pressure is not adequately controlled with amlodipine 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
- 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
- •Without antihypertensive pre-treatment mean seated BP greater than 160/100 mmHg
- •Pre-treatment with amlodipine 5 or 10 mg: mean seated BP greater than or equal to 140/90 mmHg
排除标准
- •Secondary hypertension
- •Any serious disorder which may limit the ability to evaluate the efficacy or safety of the test drugs
结局指标
主要结局
Mean change in trough seated diastolic blood pressure
次要结局
- Percent of patients achieving target blood pressure goal
- Mean change in trough seated systolic BP
- Safety and tolerability
- Mean change in daytime, nighttime and 24 hour ambulatory blood pressure
研究者
研究点 (5)
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