Carotid B-Mode Ultrasound Study to Compare Anti-Atherosclerotic Effect of Torcetrpib/Atorvastatin to Atorvastatin Alone.
Phase 3
Completed
- Conditions
- Hypercholesterolemia, FamilialHyperlipidemia
- Registration Number
- NCT00136981
- 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 carotid arteries and to look at various lipids in the blood of people with heterozygous familial hypercholesterolemia
- Detailed Description
For additional information please call: 1-800-718-1021
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 800
Inclusion Criteria
- Diagnosis of Heterozygous Familial Hypercholesterolemia
- At least 18 years of age
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 (high doses)
- 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 Change in intima media thickness as measures by carotid ultrasound
- Secondary Outcome Measures
Name Time Method Changes in levels of lipids and other biomarkers.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇿🇦Cape Town, South Africa