NCT00145431终止3 期
Phase 3, Multi-Center, Double-Blind, Randomized, Crossover Study Of The Efficacy, Safety, And Tolerability Of Fixed Combination Torcetrapib (Cp-529,414)/Atorvastatin, Compared With Atorvastatin Therapy Alone, And Fenofibrate Alone, In Subjects With Fredrickson Type III Hyperlipoproteinemia (Familial Dysbetalipoproteinemia).
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 41
- 试验地点
- 28
- 主要终点
- Change in LDL-C and non-HDL-C levels.
研究概览
简要总结
The Torcetrapib project was terminated on December 2, 2006 due to safety findings.
To evaluate the efficacy and safety of the lipid drug torcetrapib/atorvastatin in subjects with a rare genetically known disorder of high cholesterol and triglyceride levels.
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
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
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
- •Diagnosis of Familial Dysbetalipoproteinemia (Fredrickson Type III hyperlipoproteinemia)
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 in LDL-C and non-HDL-C levels.
次要结局
- Changes in other lipid and biomarker variable levels.
研究者
研究点 (28)
Loading locations...
相似试验
已完成
3 期
Study To Evaluate The Safety And Efficacy Of Torcetrapib/Atorvastatin In Subjects With Familial HypercholerolemiaHypercholesterolemia, FamilialHyperlipidemiaNCT00134485Pfizer400
已完成
3 期
A Study Comparing The Efficacy & Safety Of Torcetrapib/Atorvastatin And Atorvastatin In Subjects With High TriglyceridesHyperlipoproteinemia Type IVHypertriglyceridemiaNCT00134498Pfizer160
终止
3 期
A Study Examining Torcetrapib/Atorvastatin And Atorvastatin Effects On Clinical CV Events In Patients With Heart DiseaseCoronary DiseaseDiabetes MellitusNCT00134264Pfizer15,067
已完成
3 期
A Coronary IVUS Study to Compare Torcetrapib/Atorvastatin to Atorvastatin Alone in Subjects With Coronary Heart DiseaseCoronary DiseaseCoronary ArteriosclerosisHyperlipidemiaNCT00134173Pfizer1,100
已完成
3 期
Carotid B-Mode Ultrasound Study to Compare Anti-Atherosclerotic Effect of Torcetrpib/Atorvastatin to Atorvastatin Alone.Hypercholesterolemia, FamilialHyperlipidemiaNCT00136981Pfizer800