NCT00185133已完成3 期
A Randomized, Double-blind, Placebo-controlled Factorial Study Evaluating the Efficacy and Safety of Co-administration of Olmesartan Medoxomil Plus Amlodipine Compared to Monotherapy in Patients With Mild to Severe Hypertension
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,900
- 试验地点
- 137
- 主要终点
- Change from baseline in trough seated systolic blood pressure and seated diastolic blood pressure for each treatment arm
研究概览
简要总结
This study assesses the efficacy and safety of co-administration of olmesartan medoxomil plus amlodipine in mild to severe hypertensive patients older than 18 years of age
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
- •Male or female patients
- •18 years of age or older (20% equal to or older than 65 years)
- •With mild to severe hypertension defined as seated diastolic blood pressure of 95-120 mmHg while off any hypertensive medication
排除标准
- •Patients should not have serious concomitant conditions that could interfere with the analysis of the results or that could interfere with the well-being of the patients
结局指标
主要结局
Change from baseline in trough seated systolic blood pressure and seated diastolic blood pressure for each treatment arm
次要结局
- To evaluate the number (%) of patients achieving BP goal.
- To characterize the pharmacokinetic interactions and the corresponding pharmacodynamic (BP) correlation
研究者
研究点 (137)
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