NCT00200460已完成3 期
A Double-Blind, Multi-Center, Randomized, Placebo-Controlled, Parallel Group Dosing Study Evaluating the Effects of Nebivolol on Blood Pressure in Patients With Mild to Moderate 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
- 825
- 试验地点
- 2
- 主要终点
- The change of the average sitting diastolic blood pressure taken at trough drug plasma level at the end of treatment compared to baseline
研究概览
简要总结
The purpose of this study is to evaluate the effects of various doses of nebivolol in patients with mild to moderate hypertension.
详细描述
This was a multi-center, randomized, double-blind, parallel group, placebo-controlled study of nebivolol over a range of doses in patients with mild to moderate hypertension. The study consisted of 2 phases: screening/washout/single-blind placebo run-in followed by randomization/double-blind treatment. During the double-blind phase, patients received nebivolol or placebo. Patients had 7 scheduled clinical visits during the study.
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
- •An average sitting diastolic blood pressure of greater then or equal to 95 mmHg and less then or equal to 109 mmHg at baseline
排除标准
- •Recent myocardial infarction or stroke
- •Secondary hypertension
- •Contraindications to beta-blocker treatment or discontinuation of current antihypertensive therapy
- •Pregnancy, nursing, or women of child-bearing potential not using appropriate contraception
结局指标
主要结局
The change of the average sitting diastolic blood pressure taken at trough drug plasma level at the end of treatment compared to baseline
次要结局
- - Sitting SBP
- - Supine SBP and DBP
- - Standing SBP and DBP
- - Response rate
- - Correlation between plasma levels
研究者
研究点 (2)
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