A Study Comparing The Efficacy & Safety Of Torcetrapib/Atorvastatin And Atorvastatin In Subjects With High Triglycerides

Condition(s) targeted: Hypertriglyceridemia; Hyperlipoproteinemia Type IV

Intervention: torcetrapib/atorvastatin (Drug); atorvastatin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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

To assess the safety and efficacy of the fixed combination torcetrapib/atorvastatin in subjects with Fredrickson Type IV Hypertriglyceridemia.

Official title: Phase 3, Multi-Site, Double-Blind, Randomized, Forced Titration, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Fixed Combination Torcetrapib (CP 529,414)/Atorvastatin Administered Orally, Once Daily (Qd) For Eighteen Weeks, Compared With Atorvastatin Alone, In Subjects With Fredrickson Type IV Hypertriglyceridemia

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change in HDL-C and non-HDL-C levels

Secondary outcome: Changes in levels of other lipid and biomarkers.

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of Fredrickson Type IV Hypertriglyceridemia

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

Pfizer Investigational Site, Anaheim, California, United States

Pfizer Investigational Site, Los Angeles, California, United States

Pfizer Investigational Site, Orange, California, United States

Pfizer Investigational Site, Pacific Palisades, California, United States

Pfizer Investigational Site, Studio City, California, United States

Pfizer Investigational Site, Huntington Beach, California, United States

Pfizer Investigational Site, Tustin, California, United States

Pfizer Investigational Site, Walnut Creek, California, United States

Pfizer Investigational Site, Orangevale, California, United States

Pfizer Investigational Site, Farmington, Connecticut, United States

Pfizer Investigational Site, Washington, District of Columbia, United States

Pfizer Investigational Site, West Palm Beach, Florida, United States

Pfizer Investigational Site, Longwood, Florida, United States

Pfizer Investigational Site, Hollywood, Florida, United States

Pfizer Investigational Site, Tripler AMC, Hawaii, United States

Pfizer Investigational Site, Chicago, Illinois, United States

Pfizer Investigational Site, Indianapolis, Indiana, United States

Pfizer Investigational Site, Overland Park, Kansas, United States

Pfizer Investigational Site, Baton Rouge, Louisiana, United States

Pfizer Investigational Site, Scarborough, Maine, United States

Pfizer Investigational Site, Bethesda, Maryland, United States

Pfizer Investigational Site, Portage, Michigan, United States

Pfizer Investigational Site, Richland, Michigan, United States

Pfizer Investigational Site, Ann Arbor, Michigan, United States

Pfizer Investigational Site, Canton, Michigan, United States

Pfizer Investigational Site, St. Cloud, Minnesota, United States

Pfizer Investigational Site, Olive Branch, Mississippi, United States

Pfizer Investigational Site, Jefferson City, Missouri, United States

Pfizer Investigational Site, St. Louis, Missouri, United States

Pfizer Investigational Site, Las Vegas, Nevada, United States

Pfizer Investigational Site, Syracuse, New York, United States

Pfizer Investigational Site, West Seneca, New York, United States

Pfizer Investigational Site, Rochester, New York, United States

Pfizer Investigational Site, Statesville, North Carolina, United States

Pfizer Investigational Site, Halifax, Nova Scotia, Canada

Pfizer Investigational Site, London, Ontario, Canada

Pfizer Investigational Site, Sellersville, Pennsylvania, United States

Pfizer Investigational Site, Montreal, Quebec, Canada

Pfizer Investigational Site, Ste-Foy, Quebec, Canada

Pfizer Investigational Site, Chicoutimi, Quebec, Canada

Pfizer Investigational Site, Warwick, Rhode Island, United States

Pfizer Investigational Site, San Antonio, Texas, United States

Pfizer Investigational Site, Richmond, Virginia, United States

Pfizer Investigational Site, Madison, Wisconsin, United States

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org Posting:

Starting date: February 2005
Ending date: November 2006
Last updated: November 15, 2007