A Study Examining Torcetrapib/Atorvastatin And Atorvastatin Effects On Clinical CV Events In Patients With Heart Disease
Phase 3
Terminated
- Conditions
- Diabetes MellitusCoronary Disease
- Registration Number
- NCT00134264
- Lead Sponsor
- Pfizer
- Brief Summary
The Torcetrapib project was terminated on December 2, 2006 due to safety findings.
To demonstrate if torcetrapib/atorvastatin can reduce the risk for major cardiovascular disease events, when compared to atorvastatin alone, in patients with coronary heart disease or risk equivalents
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 15067
Inclusion Criteria
- Diagnosis of coronary heart disease or risk equivalents that place the patient at high risk for cardiovascular disease events
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 evaluationof 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 The time to first occurrence of a major cardiovascular disease event
- Secondary Outcome Measures
Name Time Method Various composites of major cardiovascular disease events and other lipid parameters
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇬🇧Warwick, United Kingdom