A Coronary IVUS Study to Compare Torcetrapib/Atorvastatin to Atorvastatin Alone in Subjects With Coronary Heart Disease
Phase 3
Completed
- Conditions
- Coronary DiseaseHyperlipidemiaCoronary Arteriosclerosis
- Registration Number
- NCT00134173
- Lead Sponsor
- Pfizer
- Brief Summary
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
- Detailed Description
For additional information please call: 1-800-718-1021
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1100
Inclusion Criteria
- angiographic evidence of coronary atherosclerosis
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change coronary artery atheroma volume as measured by intravascular ultrasound.
- Secondary Outcome Measures
Name Time Method Changes in levels of lipids and other biomarkers.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇪🇸Madrid, Spain