A Coronary IVUS Study to Compare Torcetrapib/Atorvastatin to Atorvastatin Alone in Subjects With Coronary Heart Disease

Condition(s) targeted: Coronary Disease; Coronary Arteriosclerosis; 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 ultrasound images taken in the blood vessels of the heart and to look at various lipids in the blood of people with known coronary heart disease

Official title: Phase 3, Multi-Center, Double-Blind, Randomized, Parallel Group, Coronary Artery Intravascular Ultrasound Evaluation of the Anti-Atherosclerotic Efficacy, Safety, and Tolerability of Fixed Combination CP-529,414/Atorvastatin, Administered Orally, Once Daily (QD) for 24 Months, Compared With Atorvastatin Alone, in Subjects With Angiographically Documented Coronary Heart Disease.

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

Primary outcome: Change coronary artery atheroma volume as measured by intravascular ultrasound.

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: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- angiographic evidence of coronary atherosclerosis

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, Genk, Belgium

Pfizer Investigational Site, Aalst, Belgium

Pfizer Investigational Site, Bruxelles, Belgium

Pfizer Investigational Site, Rotterdam, Netherlands

Pfizer Investigational Site, Nijmegen, Netherlands

Pfizer Investigational Site, Katowice, Poland

Pfizer Investigational Site, Krakow, Poland

Pfizer Investigational Site, Warszawa, Poland

Pfizer Investigational Site, Barcelona, Spain

Pfizer Investigational Site, Madrid, Spain

Pfizer Investigational Site, Birmingham, Alabama, United States

Pfizer Investigational Site, Mobile, Alabama, United States

Pfizer Investigational Site, Calgary, Alberta, Canada

Pfizer Investigational Site, Little Rock, Arkansas, United States

Pfizer Investigational Site, Oviedo, Asturias, Spain

Pfizer Investigational Site, L´Hospitalet del Llobregat, Barcelona, Spain

Pfizer Investigational Site, Victoria, British Columbia, Canada

Pfizer Investigational Site, Santa Rosa, California, United States

Pfizer Investigational Site, Los Altos, California, United States

Pfizer Investigational Site, Mountain View, California, United States

Pfizer Investigational Site, Los Angeles, California, United States

Pfizer Investigational Site, San Diego, California, United States

Pfizer Investigational Site, Stockton, California, United States

Pfizer Investigational Site, Fresno, California, United States

Pfizer Investigational Site, Sacramento, California, United States

Pfizer Investigational Site, San Francisco, California, United States

Pfizer Investigational Site, Denver, Colorado, United States

Pfizer Investigational Site, Boulder, Colorado, United States

Pfizer Investigational Site, Farmington, Connecticut, United States

Pfizer Investigational Site, Brandford, Connecticut, United States

Pfizer Investigational Site, Guilford, Connecticut, United States

Pfizer Investigational Site, New Haven, Connecticut, United States

Pfizer Investigational Site, Fort Lauderdale, Florida, United States

Pfizer Investigational Site, Jacksonville, Florida, United States

Pfizer Investigational Site, Miami, Florida, United States

Pfizer Investigational Site, Atlantis, Florida, United States

Pfizer Investigational Site, Clearwater, Florida, United States

Pfizer Investigational Site, Safety Harbor, Florida, United States

Pfizer Investigational Site, Melbourne, Florida, United States

Pfizer Investigational Site, Jacksonville, Florida, United States

Pfizer Investigational Site, Pensacola, Florida, United States

Pfizer Investigational Site, Tampa, Florida, United States

Pfizer Investigational Site, Dunedin, Florida, United States

Pfizer Investigational Site, Largo, Florida, United States

Pfizer Investigational Site, Orlando, Florida, United States

Pfizer Investigational Site, Sarasota, Florida, United States

Pfizer Investigational Site, Rockford, Illinois, United States

Pfizer Investigational Site, Blue Island, Illinois, United States

Pfizer Investigational Site, Merrionette Park, Illinois, United States

Pfizer Investigational Site, Hobart, Indiana, United States

Pfizer Investigational Site, Merrillville, Indiana, United States

Pfizer Investigational Site, Elkhart, Indiana, United States

Pfizer Investigational Site, Goshen, Indiana, United States

Pfizer Investigational Site, Davenport, Iowa, United States

Pfizer Investigational Site, Des Moines, Iowa, United States

Pfizer Investigational Site, West Des Moines, Iowa, United States

Pfizer Investigational Site, Shawnee Mission, Kansas, United States

Pfizer Investigational Site, Louisville, Kentucky, United States

Pfizer Investigational Site, New Orleans, Louisiana, United States

Pfizer Investigational Site, Bogalusa, Louisiana, United States

Pfizer Investigational Site, Covington, Louisiana, United States

Pfizer Investigational Site, Auburn, Maine, United States

Pfizer Investigational Site, Lewiston, Maine, United States

Pfizer Investigational Site, Portland, Maine, United States

Pfizer Investigational Site, Scarborough, Maine, United States

Pfizer Investigational Site, Salisbury, Maryland, United States

Pfizer Investigational Site, Baltimore, Maryland, United States

Pfizer Investigational Site, Columbia, Maryland, United States

Pfizer Investigational Site, Takoma Park, Maryland, United States

Pfizer Investigational Site, Petoskey, Michigan, United States

Pfizer Investigational Site, Saginaw, Michigan, United States

Pfizer Investigational Site, Flint, Michigan, United States

Pfizer Investigational Site, Lapeer, Michigan, United States

Pfizer Investigational Site, Kalamazoo, Michigan, United States

Pfizer Investigational Site, Ann Arbor, Michigan, United States

Pfizer Investigational Site, Ypsilanti, Michigan, United States

Pfizer Investigational Site, Royal Oak, Michigan, United States

Pfizer Investigational Site, Maplewood, Minnesota, United States

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

Pfizer Investigational Site, Minneapolis, Minnesota, United States

Pfizer Investigational Site, Duluth, Minnesota, United States

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

Pfizer Investigational Site, Southaven, Mississippi, United States

Pfizer Investigational Site, Kansas City, Missouri, United States

Pfizer Investigational Site, Omaha, Nebraska, United States

Pfizer Investigational Site, Ridgewood, New Jersey, United States

Pfizer Investigational Site, Albuquerque, New Mexico, United States

Pfizer Investigational Site, Carlsbad, New Mexico, United States

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

Pfizer Investigational Site, Buffalo, New York, United States

Pfizer Investigational Site, Rochester, New York, United States

Pfizer Investigational Site, Albany, New York, United States

Pfizer Investigational Site, Oneonta, New York, United States

Pfizer Investigational Site, Troy, New York, United States

Pfizer Investigational Site, Johnson City, New York, United States

Pfizer Investigational Site, Flushing, New York, United States

Pfizer Investigational Site, Williamsville, New York, United States

Pfizer Investigational Site, Poughkeepsie, New York, United States

Pfizer Investigational Site, Bay Shore, New York, United States

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

Pfizer Investigational Site, Eden, North Carolina, United States

Pfizer Investigational Site, Greensboro, North Carolina, United States

Pfizer Investigational Site, Reidsville, North Carolina, United States

Pfizer Investigational Site, Raleigh, North Carolina, United States

Pfizer Investigational Site, Greenville, North Carolina, United States

Pfizer Investigational Site, Halifax, Nova Scotia, Canada

Pfizer Investigational Site, Cleveland, Ohio, United States

Pfizer Investigational Site, Orange Village, Ohio, United States

Pfizer Investigational Site, Westlake, Ohio, United States

Pfizer Investigational Site, Middleburg Heights, Ohio, United States

Pfizer Investigational Site, Bellevue, Ohio, United States

Pfizer Investigational Site, Clyde, Ohio, United States

Pfizer Investigational Site, Defiance, Ohio, United States

Pfizer Investigational Site, Fostoria, Ohio, United States

Pfizer Investigational Site, Toledo, Ohio, United States

Pfizer Investigational Site, Wauseon, Ohio, United States

Pfizer Investigational Site, Tulsa, Oklahoma, United States

Pfizer Investigational Site, Oklahoma City, Oklahoma, United States

Pfizer Investigational Site, Torono, Ontario, Canada

Pfizer Investigational Site, Ottawa, Ontario, Canada

Pfizer Investigational Site, Eugene, Oregon, United States

Pfizer Investigational Site, Florence, Oregon, United States

Pfizer Investigational Site, Hillsboro, Oregon, United States

Pfizer Investigational Site, Harrisburg, Pennsylvania, United States

Pfizer Investigational Site, Wormleysburg, Pennsylvania, United States

Pfizer Investigational Site, Hershey, Pennsylvania, United States

Pfizer Investigational Site, Philadelphia, Pennsylvania, United States

Pfizer Investigational Site, Doylestown, Pennsylvania, United States

Pfizer Investigational Site, Lancaster, Pennsylvania, United States

Pfizer Investigational Site, Pittsburgh, Pennsylvania, United States

Pfizer Investigational Site, Vigo, Pontevedra, Spain

Pfizer Investigational Site, Montreal, Quebec, Canada

Pfizer Investigational Site, Montréal, Quebec, Canada

Pfizer Investigational Site, Greenville, South Carolina, United States

Pfizer Investigational Site, Chattanooga, Tennessee, United States

Pfizer Investigational Site, Knoxville, Tennessee, United States

Pfizer Investigational Site, Oak Ridge, Tennessee, United States

Pfizer Investigational Site, Memphis, Tennessee, United States

Pfizer Investigational Site, San Antonio, Texas, United States

Pfizer Investigational Site, Charlottesville, Virginia, United States

Pfizer Investigational Site, Norfolk, Virginia, United States

Pfizer Investigational Site, Annandale, Virginia, United States

Pfizer Investigational Site, Falls Church, Virginia, United States

Pfizer Investigational Site, Richmond, Virginia, United States

Pfizer Investigational Site, Seattle, Washington, United States

Pfizer Investigational Site, Bellevue, Washington, United States

Pfizer Investigational Site, Huntington, West Virginia, United States

Pfizer Investigational Site, Milwaukee, Wisconsin, United States

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

Link to ClinicalStudyResults.org Posting:

Starting date: October 2003
Ending date: September 2006
Last updated: December 6, 2007