Coronary Disease, Diabetes Mellitus
Conditions
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
Interventions
DRUGatorvastatin
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time to first occurrence of a major cardiovascular disease event | — |
Secondary
| Measure | Time frame |
|---|---|
| Various composites of major cardiovascular disease events and other lipid parameters | — |
Countries
Australia, Canada, Netherlands, Spain, Sweden, United Kingdom, United States
Outcome results
None listed