Study To Evaluate The Effect Of Torcetrapib/Atorvastatin In Subjects With A Genetic Cholesterol Disorder.

• Status: Terminated
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

To evaluate the efficacy and safety of the lipid drug torcetrapib/atorvastatin in subjects with a rare genetically known disorder of high cholesterol and triglyceride levels.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Atorvastatin; Atorvastatin Calcium; Fenofibrate; Torcetrapib

Criteria

Inclusion Criteria:

• Diagnosis of Familial Dysbetalipoproteinemia (Fredrickson Type III hyperlipoproteinemia)

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