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A Study of Torcetrapib/Atorvastatin vs Atorvastatin Alone or Placebo in Patients With High Cholesterol

Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hyperlipidemia

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

Summary

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

A study to look at lipid levels in subjects taking the study drug, Atorvastatin alone or placebo.

Clinical Details

Official title: A Phase 3, Double Blind, Placebo-Controlled, Randomized, Parallel Group, Multicenter Study of the Efficacy, Safety and Tolerability of Fixed Combination Torcetrapib/Atorvastatin Administered Orally Once Daily for 6 Months, Compared to Atorvastatin Alone or Placebo in Subjects With Mixed Dyslipidemia (Fredrickson Types IIa and IIb).

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

Primary outcome: LDL and HDL levels

Secondary outcome: other lipid parameters

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

Eligibility

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

Criteria:

Inclusion Criteria:

- subjects with elevated cholesterol

Exclusion Criteria:

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

- Intolerance to statin therapy resulting in withdrawal

- 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

Locations and Contacts

Pfizer Investigational Site, Ham, Belgium

Pfizer Investigational Site, Hoeilaart, Belgium

Pfizer Investigational Site, Leuven, Belgium

Pfizer Investigational Site, Wilsele, Belgium

Pfizer Investigational Site, Hasselt, Belgium

Pfizer Investigational Site, Bruxelles, Belgium

Pfizer Investigational Site, La Louviere, Belgium

Pfizer Investigational Site, Dottignies, Belgium

Pfizer Investigational Site, Homburg/Saar, Germany

Pfizer Investigational Site, Erlangen, Germany

Pfizer Investigational Site, Berlin, Germany

Pfizer Investigational Site, Heidelberg, Germany

Pfizer Investigational Site, Essen, Germany

Pfizer Investigational Site, Rodgau, Germany

Pfizer Investigational Site, Nuernberg, Germany

Pfizer Investigational Site, Offenbach, Germany

Pfizer Investigational Site, Kuenzing, Germany

Pfizer Investigational Site, Karlsruhe, Germany

Pfizer Investigational Site, Beckum, Germany

Pfizer Investigational Site, Hamburg, Germany

Pfizer Investigational Site, Feldafing, Germany

Pfizer Investigational Site, Schwerin, Germany

Pfizer Investigational Site, Bochum, Germany

Pfizer Investigational Site, Seoul, Korea, Republic of

Pfizer Investigational Site, Suwon, Korea, Republic of

Pfizer Investigational Site, Puebla, Mexico

Pfizer Investigational Site, Oslo, Norway

Pfizer Investigational Site, Skedsmokorset, Norway

Pfizer Investigational Site, Honefoss, Norway

Pfizer Investigational Site, Elverum, Norway

Pfizer Investigational Site, Lena, Norway

Pfizer Investigational Site, Tromso, Norway

Pfizer Investigational Site, Jessheim, Norway

Pfizer Investigational Site, Moss, Norway

Pfizer Investigational Site, Kongsberg, Norway

Pfizer Investigational Site, Molde, Norway

Pfizer Investigational Site, Roverud, Norway

Pfizer Investigational Site, Bekkestua, Norway

Pfizer Investigational Site, Lierskogen, Norway

Pfizer Investigational Site, Linkoping, Sweden

Pfizer Investigational Site, Umea, Sweden

Pfizer Investigational Site, Orebro, Sweden

Pfizer Investigational Site, GOTEBORG, Sweden

Pfizer Investigational Site, Strangnas, Sweden

Pfizer Investigational Site, Jarfalla, Sweden

Pfizer Investigational Site, Mobile, Alabama, United States

Pfizer Investigational Site, Phoenix, Arizona, United States

Pfizer Investigational Site, Mesa, Arizona, United States

Pfizer Investigational Site, Oro Valley, Arizona, United States

Pfizer Investigational Site, Sun City, Arizona, United States

Pfizer Investigational Site, Little Rock, Arkansas, United States

Pfizer Investigational Site, Penzance, CORNWALL, United Kingdom

Pfizer Investigational Site, Greenbrae, California, United States

Pfizer Investigational Site, Santa Ana, California, United States

Pfizer Investigational Site, Mission Viejo, California, United States

Pfizer Investigational Site, Los Angeles, California, United States

Pfizer Investigational Site, Stockton, California, United States

Pfizer Investigational Site, Upland, California, United States

Pfizer Investigational Site, Anaheim, California, United States

Pfizer Investigational Site, Concord, California, United States

Pfizer Investigational Site, Thouasand Oaks, California, United States

Pfizer Investigational Site, Tustin, California, United States

Pfizer Investigational Site, Tustin, California, United States

Pfizer Investigational Site, Sacramento, California, United States

Pfizer Investigational Site, Walnut Creek, California, United States

Pfizer Investigational Site, Westlake Village, California, United States

Pfizer Investigational Site, Carmichael, California, United States

Pfizer Investigational Site, Boulder, Colorado, United States

Pfizer Investigational Site, Waterbury, Connecticut, United States

Pfizer Investigational Site, Tlalpan, D.F., Mexico

Pfizer Investigational Site, Mexico, D.F., Mexico

Pfizer Investigational Site, Woolwell, Plymouth, DEVON, United Kingdom

Pfizer Investigational Site, Mexico, DF, Mexico

Pfizer Investigational Site, Newark, Delaware, United States

Pfizer Investigational Site, Jupiter, Florida, United States

Pfizer Investigational Site, Melbourne, Florida, United States

Pfizer Investigational Site, Sebastian, Florida, United States

Pfizer Investigational Site, Vero Beach, Florida, United States

Pfizer Investigational Site, Lake Worth, Florida, United States

Pfizer Investigational Site, Wellington, Florida, United States

Pfizer Investigational Site, Ft. Pierce, Florida, United States

Pfizer Investigational Site, Stuart, Florida, United States

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

Pfizer Investigational Site, Coral Gables, Florida, United States

Pfizer Investigational Site, Jacksonville, Florida, United States

Pfizer Investigational Site, Palm Bay, Florida, United States

Pfizer Investigational Site, Middlesex, Harrow, United Kingdom

Pfizer Investigational Site, Garston, Hertfordshire, United Kingdom

Pfizer Investigational Site, Chicago, Illinois, United States

Pfizer Investigational Site, Creve Coevr, Illinois, United States

Pfizer Investigational Site, Peoria, Illinois, United States

Pfizer Investigational Site, Rockford, Illinois, United States

Pfizer Investigational Site, Iowa City, Iowa, United States

Pfizer Investigational Site, Kansas City, Kansas, United States

Pfizer Investigational Site, Overland Park, Kansas, United States

Pfizer Investigational Site, Wichita, Kansas, United States

Pfizer Investigational Site, Louisville, Kentucky, United States

Pfizer Investigational Site, Erlanger, Kentucky, United States

Pfizer Investigational Site, Blackpool, Lancashire, United Kingdom

Pfizer Investigational Site, Blackpool, Lancs. FY3 7DQ, United Kingdom

Pfizer Investigational Site, Covington, Louisiana, United States

Pfizer Investigational Site, Slidell, Louisiana, United States

Pfizer Investigational Site, Scarborough, Maine, United States

Pfizer Investigational Site, Bethesda, Maryland, United States

Pfizer Investigational Site, Baltimore, Maryland, United States

Pfizer Investigational Site, Elkton, Maryland, United States

Pfizer Investigational Site, Jackson, Mississippi, United States

Pfizer Investigational Site, Kansas City, Missouri, United States

Pfizer Investigational Site, Jefferson City, Missouri, United States

Pfizer Investigational Site, Billings, Montana, United States

Pfizer Investigational Site, Omaha, Nebraska, United States

Pfizer Investigational Site, Lincoln, Nebraska, United States

Pfizer Investigational Site, Las Vegas, Nevada, United States

Pfizer Investigational Site, Rochester, New York, United States

Pfizer Investigational Site, Endwell, New York, United States

Pfizer Investigational Site, Williamsville, New York, United States

Pfizer Investigational Site, Lake Success, New York, United States

Pfizer Investigational Site, Winston-Salem, North Carolina, United States

Pfizer Investigational Site, Charlotte, North Carolina, United States

Pfizer Investigational Site, Raleigh, North Carolina, United States

Pfizer Investigational Site, Monroe, North Carolina, United States

Pfizer Investigational Site, Concord, North Carolina, United States

Pfizer Investigational Site, Fayetteville, North Carolina, United States

Pfizer Investigational Site, Monterrey, Nuevo Leon, Mexico

Pfizer Investigational Site, Elyria, Ohio, United States

Pfizer Investigational Site, Olmsted Township, Ohio, United States

Pfizer Investigational Site, Westlake, Ohio, United States

Pfizer Investigational Site, Cincinnati, Ohio, United States

Pfizer Investigational Site, Tulsa, Oklahoma, United States

Pfizer Investigational Site, Portland, Oregon, United States

Pfizer Investigational Site, Hillsboro, Oregon, United States

Pfizer Investigational Site, Beaverton, Oregon, United States

Pfizer Investigational Site, Warwick, Rhode Island, United States

Pfizer Investigational Site, Addlestone, SURREY, United Kingdom

Pfizer Investigational Site, East Horsley, Leatherhead, SURREY, United Kingdom

Pfizer Investigational Site, Spartanburg, South Carolina, United States

Pfizer Investigational Site, Greer, South Carolina, United States

Pfizer Investigational Site, GREER, South Carolina, United States

Pfizer Investigational Site, Kingsport, Tennessee, United States

Pfizer Investigational Site, Nashville, Tennessee, United States

Pfizer Investigational Site, Dallas, Texas, United States

Pfizer Investigational Site, The Colony, Texas, United States

Pfizer Investigational Site, Houston, Texas, United States

Pfizer Investigational Site, Bryan, Texas, United States

Pfizer Investigational Site, Beaumont, Texas, United States

Pfizer Investigational Site, San Antonio, Texas, United States

Pfizer Investigational Site, Austin, Texas, United States

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

Pfizer Investigational Site, Newport News, Virginia, United States

Pfizer Investigational Site, Richmond, Virginia, United States

Pfizer Investigational Site, Norfolk, Virginia, United States

Pfizer Investigational Site, Warminster, WILTSHIRE, United Kingdom

Pfizer Investigational Site, Yakima, Washington, United States

Pfizer Investigational Site, Renton, Washington, United States

Pfizer Investigational Site, Milwaukee, Wisconsin, United States

Pfizer Investigational Site, OREGON, Wisconsin, United States

Additional Information

Link to ClinicalStudyResults.org Posting:

Starting date: July 2004
Last updated: November 15, 2007

Page last updated: June 20, 2008

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