Coronary Arteriosclerosis, Coronary Disease, Hyperlipidemia
Conditions
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
Interventions
DRUGatorvastatin
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change coronary artery atheroma volume as measured by intravascular ultrasound. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in levels of lipids and other biomarkers. | — |
Countries
Belgium, Canada, Netherlands, Poland, Spain, United States
Outcome results
None listed