A Double-Blind, Multi-Center, Randomized, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Nebivolol Added to Existing Antihypertensive Treatment in Patients With Mild to Moderate Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- The change from baseline to week 12 in the average sitting DBP at trough.
研究概览
简要总结
The purpose of this study was to contrast the efficacy and safety of 3 dose levels of nebivolol vs. placebo, when added to a patient's existing antihypertensive medication(s) for 3 months, in patients with mild to moderate hypertension
详细描述
Following a washout of any previous beta-blocker medication, if applicable, supine, sitting, and standing cuff blood pressure and pulse rate, 24-hour ambulatory blood pressure monitoring (ABPM), ECG, laboratory assessments and genomics testing were performed before randomization. Patients were randomized to receive placebo or nebivolol once daily in the morning together with their curently prescribed antihypertensive therapy. Patients had four scheduled clinical visits during the study, following the screening visit.
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
- •Average sitting diastolic blood pressure (DBP) greater then or equal to 90 mmHg and less then or equal to 109 mmHg at screening and baseline, in patients on background antihypertensive therapy taking at least one and no more than two of either ACE inhibitor, ARB, or diuretic.
排除标准
- •Recent myocardial infarction or stroke
- •Contraindications to beta-blocker therapy
结局指标
主要结局
The change from baseline to week 12 in the average sitting DBP at trough.
次要结局
- Change from baseline to week 2, 6, and 12 in the average sitting, supine, standing systolic and diastolic blood pressure and sitting HR.