Study To Evaluate The Safety And Efficacy Of Torcetrapib/Atorvastatin In Subjects With Familial Hypercholerolemia
Phase 3
Completed
- Conditions
- Hypercholesterolemia, FamilialHyperlipidemia
- Registration Number
- NCT00134485
- Lead Sponsor
- Pfizer
- Brief Summary
The Torcetrapib project was terminated on December 2, 2006 due to safety findings.
To evaluate the efficacy and safety of torcetrapib/atorvastatin compared to atorvastatin alone in patients with heterozygous familial hypercholesterolemia
- Detailed Description
For additional information please call: 1-800-718-1021
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
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 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 in HDL-C and LDL-C
- Secondary Outcome Measures
Name Time Method Changes in other lipid parameters
Trial Locations
- Locations (1)
Pfizer Investigational Site