NCT00134173已完成3 期
Phase 3, Multi-Center, Double-Blind, Randomized, Parallel Group, Coronary Artery Intravascular Ultrasound Evaluation of the Anti-Atherosclerotic Efficacy, Safety, and Tolerability of Fixed Combination CP-529,414/Atorvastatin, Administered Orally, Once Daily (QD) for 24 Months, Compared With Atorvastatin Alone, in Subjects With Angiographically Documented Coronary Heart Disease.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,100
- 试验地点
- 144
- 主要终点
- Change coronary artery atheroma volume as measured by intravascular ultrasound.
研究概览
简要总结
The Torcetrapib project was terminated on December 2, 2006 due to safety findings.
To look at ultrasound images taken in the blood vessels of the heart and to look at various lipids in the blood of people with known coronary heart disease
详细描述
For additional information please call: 1-800-718-1021
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •angiographic evidence of coronary atherosclerosis
排除标准
- •Women who are pregnant or lactating, or planning to become pregnant.
- •Subjects with a clinically indicated need for statin (HMG-CoA reductase inhibitor) therapy other than atorvastatin or other concomitant therapy with known lipid altering effects on LDL-C and HDL-C including fibrates and nicotinic acid.
- •Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors.
- •Subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluation of response, or render unlikely that the subject would complete the study.
结局指标
主要结局
Change coronary artery atheroma volume as measured by intravascular ultrasound.
次要结局
- Changes in levels of lipids and other biomarkers.
研究者
研究点 (144)
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