Lipitor Trial To Study The Effect Of Torcetrpib/Atorvastatin To Atorvastatin Alone.

Condition(s) targeted: Hyperlipidemia

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 look at various lipids in the blood of people with Fredrickson Type IIa and Type IIb mixed dyslipidemias

Official title: A Phase 3, Double-Blind, Randomized, Multisite Trial Of The Efficacy, Safety, And Tolerability Of The Fixed Combination Torcetrapib/Atorvastatin Administered Orally, Once Daily For 12 Months, Compared To Atorvastatin Alone, Titrated Based On NCEP ATP-III LDL-C Goals In Subjects With Fredrickson Types IIa And IIb Dyslipidemias

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

Primary outcome: Change in lipid parameters (HDL, LDL) at various timepoints over 12 months.

Secondary outcome: Changes in levels of lipids and other 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:

- Statin eligible per NCEP ATP-III guidelines

- At least 18 years of age

Exclusion Criteria:

- Women who are pregnant or lactating, or planning to become pregnant

- Intolerance to statin therapy

- 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, Huntsville, Alabama 35802, United States

Pfizer Investigational Site, Union Grove, Alabama 35175, United States

Pfizer Investigational Site, Edmonton, Alberta T6G 2B7, Canada

Pfizer Investigational Site, Coquitlam, British Columbia V3K 3P4, Canada

Pfizer Investigational Site, San Diego, California 92128, United States

Pfizer Investigational Site, Los Angeles, California 90057, United States

Pfizer Investigational Site, Fresno, California 93720, United States

Pfizer Investigational Site, ORANGE, California 92868, United States

Pfizer Investigational Site, Golden, Colorado 80401, United States

Pfizer Investigational Site, Denver, Colorado 80220, United States

Pfizer Investigational Site, Denver, Colorado 80262, United States

Pfizer Investigational Site, Bridgeport, Connecticut 06610, United States

Pfizer Investigational Site, Fairfield, Connecticut 06824, United States

Pfizer Investigational Site, Trumbull, Connecticut 06611, United States

Pfizer Investigational Site, Waterbury, Connecticut 06708, United States

Pfizer Investigational Site, Washington, District of Columbia 20037, United States

Pfizer Investigational Site, Sebastian, Florida 32958, United States

Pfizer Investigational Site, Vero Beach, Florida 32960, United States

Pfizer Investigational Site, Boynton Beach, Florida 33437, United States

Pfizer Investigational Site, Fort Lauderdale, Florida 33308, United States

Pfizer Investigational Site, Gainesville, Florida 32605, United States

Pfizer Investigational Site, Gainesville, Florida 32610, United States

Pfizer Investigational Site, Gainsville, Florida 32610, United States

Pfizer Investigational Site, Springfield, Illinois 62704, United States

Pfizer Investigational Site, Rockford, Illinois 61108, United States

Pfizer Investigational Site, Olathe, Kansas 66061, United States

Pfizer Investigational Site, Overland Park, Kansas 66210, United States

Pfizer Investigational Site, Madisonville, Kentucky 42431, United States

Pfizer Investigational Site, Burlington, Massachusetts 01805, United States

Pfizer Investigational Site, Troy, Michigan 48098, United States

Pfizer Investigational Site, Grand Rapids, Michigan 49525, United States

Pfizer Investigational Site, Albuquerque, New Mexico 87106, United States

Pfizer Investigational Site, Albuquerque, New Mexico 87102, United States

Pfizer Investigational Site, Orchard Park, New York 14127, United States

Pfizer Investigational Site, Williamsville, New York 14221, United States

Pfizer Investigational Site, Syracuse, New York 13202, United States

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

Pfizer Investigational Site, Charlotte, North Carolina 28262, United States

Pfizer Investigational Site, Columbus, Ohio 43214, United States

Pfizer Investigational Site, Cleveland, Ohio 44126, United States

Pfizer Investigational Site, London, Ontario N6C 5J1, Canada

Pfizer Investigational Site, London, Ontario N6G 2M3, Canada

Pfizer Investigational Site, Sarnia, Ontario N7T 4X3, Canada

Pfizer Investigational Site, Toronto, Ontario M9W 4L6, Canada

Pfizer Investigational Site, Ottawa, Ontario K1H 8K7, Canada

Pfizer Investigational Site, Keizer, Oregon 97303, United States

Pfizer Investigational Site, Salem, Oregon 97302, United States

Pfizer Investigational Site, Doylestown, Pennsylvania 18901, United States

Pfizer Investigational Site, Charlottetown, Prince Edward Island C1A 1L2, Canada

Pfizer Investigational Site, Pointe-Claire, Quebec H9R 4S3, Canada

Pfizer Investigational Site, Mirabel, Quebec J7J 2K8, Canada

Pfizer Investigational Site, St. Georges de Beauce, Quebec G5Y 4W1, Canada

Pfizer Investigational Site, Charleston, South Carolina 29425, United States

Pfizer Investigational Site, Mt. Pleasant, South Carolina 29464, United States

Pfizer Investigational Site, Mt. Pleasant, South Carolina 83464, United States

Pfizer Investigational Site, Morristown, Tennessee 37813, United States

Pfizer Investigational Site, Kingsport, Tennessee 37660, United States

Pfizer Investigational Site, Dallas, Texas 75230, United States

Pfizer Investigational Site, McKinney, Texas 75069, United States

Link to ClinicalStudyResults.org Posting:

Starting date: November 2004
Ending date: September 2006
Last updated: November 15, 2007