An Open-label, Randomized Study Evaluating the Long-term Effects of Metoprolol (MET) Versus Nebivolol (NEB) as Monotherapy or in Combination With Amlodipine or Hydrochlorothiazide for the Treatment of Patients With Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 336
- 试验地点
- 1
- 主要终点
- Change in Average Sitting Diastolic Blood Pressure (DBP) Taken at Trough at the End of Treatment Compared to Baseline
研究概览
简要总结
The purpose of this study is to evaluate long-term safety,tolerability and blood pressure effects of metoprolol versus nebivolol in patients with hypertension. These drugs may be given alone or in combination with other drugs that are commonly used in the treatment of hypertension
详细描述
Approximately 50 million Americans have hypertension defined as a systolic blood pressure (SBP) greater then or equal to 140 mmHg and/or a diastolic blood pressure (DBP) greater then or equal to 90 mmHg. To control blood pressure, more than 2 agents are required in many patients. The current study is a randomized, titration-to-effect, open-label, multi center study. Patients will be randomized to either nebivolol or metoprolol. The dose of the randomized treatment can be titrated as needed to achieve blood pressure control. If necessary, additional antihypertensive agents (calcium antagonist, diuretic, etc.) can be added to achieve control. Patients will be seen every 1-3 months for approximately 18 months to assess long-term safety, tolerability and effectiveness of nebivolol versus metoprolol.
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
- •Completion of previous nebivolol study
- •Stage 1-2 Hypertension (HTN) at baseline of first study
排除标准
- •Recent myocardial infarction or stroke
- •Contraindications to beta blocker therapy
研究组 & 干预措施
1-NEB
Nebivolol
干预措施: Nebivolol (NEB) (Drug)
2-MET
Metoprolol
干预措施: Metoprolol (MET) (Drug)
结局指标
主要结局
Change in Average Sitting Diastolic Blood Pressure (DBP) Taken at Trough at the End of Treatment Compared to Baseline
时间窗: Through study duration (approximately 18 months)
The primary efficacy parameter was the change in the average trough sitting DBP at the end of treatment (Visit 10 or Early Termination) compared with baseline (baseline was defined as the baseline visit in Study NEB 310 \[NCT00145210\]).
次要结局
- Change From Baseline in Mean Trough Sitting Diastolic Blood Pressure (DBP) at Each Study Visit (Visits 1 Through 9) Compared to Baseline(Through study completion (approximately 18 months))
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(Through study completion (approximately 18 months))