NCT01008345已完成4 期
Effect of Ezetimibe on Oxidized LDL Cholesterol
Hotel Dieu de France Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2008年9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
- 100
- 试验地点
- 1
- 主要终点
- level of oxidized LDL cholesterol at end of study
研究概览
简要总结
Randomized study. Patients with coronary artery disease equivalent will be randomized to receive atorvastatin 40 mg/day + placebo vs. atorvastatin 40 mg/day + ezetimibe 40 mg/day. Oxidized LDL cholesterol will be measured at baseline and after 8 weeks of treatment. Hypothesis is that ezetimibe will lower oxidized LDL
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •CAD or CAD equivalent
排除标准
- •Prior CABG or PCI within 3 months Prior use of ezetimibe within 3 months Receiving atorvastatin 40 mg/day or 80 mg/day or any dose of rosuvastatin CHF NYHA stage >2 Creatinin clearance < 30 ml/min
研究组 & 干预措施
ezetimibe
Experimental
will receive the active treatment with ezetimibe and statin
干预措施: ezetimibe (Drug)
placebo
Placebo Comparator
干预措施: ezetimibe (Drug)
结局指标
主要结局
level of oxidized LDL cholesterol at end of study
时间窗: 8 weeks of treatment
次要结局
- small dense LDL level(8 weeks of treatment)
研究者
研究点 (1)
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