A Double-Blind, Multicenter, Randomized, Placebo-Controlled, Parallel Group Dosing Study of the Effects of Nebivolol on Blood Pressure in Black Patients With Mild to Moderate Hypertension.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- -Change in trough sitting diastolic blood pressure (DBP)at end of study compared to baseline
研究概览
简要总结
The purpose of this study was to determine if nebivolol is superior to placebo for the treatment of elevated blood pressure in Black patients with mild to moderate hypertension.
详细描述
This study was a Phase II, 12-week multicenter, randomized, double-blind, parallel group, placebo-controlled study of nebivolol over a range of doses in Black patients with mild to moderate hypertension. Treatment was administered once daily (qd) for 12 weeks. The study consisted of 2 phases: (1) screening/washout/single-blind placebo run-in and (2) randomization/treatment. Patients had 7 scheduled clinic visits during the study (6 clinic visits for patients not on current antihypertensive medication).
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
- •Black adults with 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
- •Contraindication to beta-blocker therapy
结局指标
主要结局
-Change in trough sitting diastolic blood pressure (DBP)at end of study compared to baseline
次要结局
- -Change in sitting systolic blood pressure (SBP)
- -Change in supine and standing DBP and SBP
- -Response rate