NCT00673075已完成4 期
Efficacy and Tolerability of Nebivolol Compared With Carvedilol in Patients With Coronary Artery Disease and Stage I or II Hypertension
Forest Laboratories2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2008年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Peripheral Diastolic Blood Pressure (DBP)
研究概览
简要总结
This study is being done to see if the blood pressure lowering effect of an approved drug nebivolol is comparable to that of another approved drug carvedilol for the treatment of hypertension in patients who have coronary artery disease.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ambulatory outpatients 18 to 85 of age at screening
- •Coronary artery disease as defined by: status post myocardial infarction (heart attack) greater than 14 days post event with no upper time limit (and followed by stress testing with additional imaging (echocardiographic or nuclear) within the 12 months prior to enrollment) and/or angiographic evidence of one or more major coronary arteries narrowing of greater than 50% and/or a history of percutaneous or surgical coronary revascularization greater than 4 months after that procedure at the time of enrollment.
- •Qualifying blood pressure criteria for study entry and for randomization
- •Willing to adhere to exercise stress (treadmill) tests
排除标准
- •Unstable angina within 7 days of screening
- •Potential coronary surgical/intervention within the next 6 months
- •Have any form of secondary hypertension
- •Have a history of hypersensitivity to nebivolol, metoprolol, carvedilol, or any beta blocker
研究组 & 干预措施
1
Active Comparator
Encapsulated Nebivolol
干预措施: Nebivolol (Drug)
2
Active Comparator
Encapsulated Carvedilol
干预措施: Carvedilol (Drug)
结局指标
主要结局
Peripheral Diastolic Blood Pressure (DBP)
时间窗: 18 weeks post initiation of randomized treatment
Peripheral diastolic blood pressure (DBP) at post-baseline (visit 13, week 18)
次要结局
- Proportion of Patients With Peripheral SBP <140 mm Hg and DBP <90 mm Hg at Week 18(18 weeks post-treatment)
- Peripheral Systolic Blood Pressure (SBP)(18 weeks post initiation of randomized treatment)
- Left Ventricular Ejection Fraction (LVEF) (%) at Week 18(18 weeks post-treatment)
研究者
研究点 (2)
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