NCT00159718已完成4 期
Double Blind Atorvastatin Amlodipine Study (DUAAL) Effect Of Amlodipine, Atorvastatin And The Combination On Transient Myocardia Ischemia In Coronary Artery Disease.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.33 个研究点 分布在 11 个国家目标入组 360 人开始时间: 2001年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 33
- 主要终点
- From the 48 hour holter monitoring the number of ischemic episodes will be assessed at baseline (week 1), week 18 and at the final visit (week 26).
研究概览
简要总结
To evaluate and compare the safety and efficacy of amlodipine, atorvastatin and the combination in patients with symptomatic myocardial ischemia.
Amlodipine's use in angina has been well documented in clinical trials such as the Circadian Anti-Ischemia Program in Europe (CAPE), but the impact on vascular inflammation in clinical practice has not been tested. Furthermore, the potentially synergistic benefit of atorvastatin and amlodipine on inflammation ischemic activity has not been studied.
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
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Holter monitoring at baseline which demonstrates a total of 15 minutes of ischemia and/or 3 ischemic events per 48 hours.
- •Total cholesterol > 5.2 mmol/L (200 mg/dL) on diet alone.
排除标准
- •Myocardial infarction within 2 months prior to the study.
- •Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol.
结局指标
主要结局
From the 48 hour holter monitoring the number of ischemic episodes will be assessed at baseline (week 1), week 18 and at the final visit (week 26).
次要结局
- onset of angina and total exercise time will be assessed at baseline (week 2),
- week 18 and week 26.
- week 26. Inflammatory markers to be analyzed are the following: C-reactive
- protein, amyloid A and interleukin 6.
- Inflammatory markers will be assessed at baseline (week 2), week 6, week 18 and
- From the exercise tolerance tests the time to onset of 1 mm ST depression, time to
研究者
研究点 (33)
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