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

Condition(s) targeted: Hyperlipoproteinemia Type III

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

Phase: Phase 3

Status: Terminated

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 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.

Official title: Phase 3, Multi-Center, Double-Blind, Randomized, Crossover Study Of The Efficacy, Safety, And Tolerability Of Fixed Combination Torcetrapib (Cp-529,414)/Atorvastatin, Compared With Atorvastatin Therapy Alone, And Fenofibrate Alone, In Subjects With Fredrickson Type III Hyperlipoproteinemia (Familial Dysbetalipoproteinemia).

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

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

Secondary outcome: Changes in other lipid and biomarker variable levels.

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 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

Pfizer Investigational Site, Quebec G1V 4M6, Canada

Pfizer Investigational Site, Anaheim, California 92804, United States

Pfizer Investigational Site, Tustin, California 92780, United States

Pfizer Investigational Site, Orange, California 92868, United States

Pfizer Investigational Site, Pacific Palisades, California 90272, United States

Pfizer Investigational Site, Studio City, California 91604, United States

Pfizer Investigational Site, Huntington Beach, California 92648, United States

Pfizer Investigational Site, Hollywood, Florida 33021, United States

Pfizer Investigational Site, Longwood, Florida 32779, United States

Pfizer Investigational Site, Tripler Army Medical Center, Hawaii 96859-5000, United States

Pfizer Investigational Site, Scarborough, Maine 04074, United States

Pfizer Investigational Site, Portage, Michigan 49002, United States

Pfizer Investigational Site, Portage, Michigan 49024, United States

Pfizer Investigational Site, Olive Branch, Mississippi 38654, United States

Pfizer Investigational Site, Syracuse, New York 13210, United States

Pfizer Investigational Site, Rochester, New York 14618, United States

Pfizer Investigational Site, West Seneca, New York 14224, United States

Pfizer Investigational Site, London, Ontario N6A 5K8, Canada

Pfizer Investigational Site, Sellersville, Pennsylvania 18960, United States

Pfizer Investigational Site, Montreal, Quebec H2W 1R7, Canada

Pfizer Investigational Site, Chicoutimi, Quebec G7H 5H6, Canada

Pfizer Investigational Site, Montreal, Quebec H1T 1C8, Canada

Pfizer Investigational Site, Greer, South Carolina 29651, United States

Pfizer Investigational Site, Memphis, Tennessee 38105, United States

Pfizer Investigational Site, Salt Lake City, Utah 84108, United States

Pfizer Investigational Site, Seattle, Washington 98104, United States

Pfizer Investigational Site, Madison, Wisconsin 53719, United States

Link to ClinicalStudyResults.org Posting:

Starting date: March 2005
Last updated: November 28, 2007