A Clinical Trial Comparing Torcetrapib/Atorvastatin To Simvastatin In Subjects With High Cholesterol (A5091031).

Phase 3

Terminated

• Conditions: Hyperlipidemia; Dyslipidemia; Hypercholesterolemia

• Registration Number: NCT00267280
• Lead Sponsor: Pfizer

Brief Summary

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

Cholesterol levels will be measured over six weeks in subjects being treated with two different kinds of cholesterol medications to see how the different treatments compare to one another.

Detailed Description

For additional information please call: 1-800-718-1021

Study Timeline

• Study First Submitted: 2005-12-19
• Study First Submitted QC: 2005-12-19
• Study First Posted: 2005-12-20
• Study Start: 2006-01
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2012-02
• Disposition First Submitted: 2012-02-15
• Disposition First Submitted QC: 2012-02-15
• Last Update Submitted: 2012-02-15
• Disposition First Posted: 2012-02-17
• Last Update Posted: 2012-02-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 640

Inclusion Criteria

• eligible for statin treatment for LDL cholesterol by NCEP guidelines

Exclusion Criteria

• Women who are pregnant or lactating, or planning to become pregnant.
• Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors.
• Subjects with significant liver or kidney disease or significant heart failure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percent change in LDL-C and HDL-C from baseline, after six weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
Changes in other lipid parameters and other biomarkers.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Tacoma, Washington, United States