A Study Examining Torcetrapib/Atorvastatin And Atorvastatin Effects On Clinical CV Events In Patients With Heart Disease

Condition(s) targeted: Coronary Disease; Diabetes Mellitus

Intervention: torcetrapib/atorvastatin (Drug); atorvastatin (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 demonstrate if torcetrapib/atorvastatin can reduce the risk for major cardiovascular disease events, when compared to atorvastatin alone, in patients with coronary heart disease or risk equivalents

Official title: Phase 3 Multi Center, Double Blind, Randomized, Parallel Group Evaluation Of The Fixed Combination Torcetrapib/Atorvastatin, Administered Orally, Once Daily (Qd), Compared With Atorvastatin Alone, On The Occurrence Of Major Cardiovascular Events In Subjects With Coronary Heart Disease Or Risk Equivalents

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

Primary outcome: The time to first occurrence of a major cardiovascular disease event

Secondary outcome: Various composites of major cardiovascular disease events and other lipid parameters

Minimum age: 45 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of coronary heart disease or risk equivalents that place the patient at high

risk for cardiovascular disease events

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 evaluationof response, or render unlikely that the subject would complete the study

Pfizer Investigational Site, SOUTHPORT, Australia

Pfizer Investigational Site, Melbourne, Australia

Pfizer Investigational Site, Geelong, Australia

Pfizer Investigational Site, LAUNCESTON, TAS, Australia

Pfizer Investigational Site, Camperdown, Australia

Pfizer Investigational Site, NEDLANDS, Australia

Pfizer Investigational Site, Perth, Australia

Pfizer Investigational Site, Darlinghurst, Australia

Pfizer Investigational Site, Saint John's, Canada

Pfizer Investigational Site, MAASTRICHT, Netherlands

Pfizer Investigational Site, BREDA, Netherlands

Pfizer Investigational Site, ROTTERDAM, Netherlands

Pfizer Investigational Site, Venlo, Netherlands

Pfizer Investigational Site, Rotterdam, Netherlands

Pfizer Investigational Site, Nijmegen, Netherlands

Pfizer Investigational Site, Amsterdam, Netherlands

Pfizer Investigational Site, Delft, Netherlands

Pfizer Investigational Site, Arnhem, Netherlands

Pfizer Investigational Site, Zoetermeer, Netherlands

Pfizer Investigational Site, Eindhoven, Netherlands

Pfizer Investigational Site, Leiden, Netherlands

Pfizer Investigational Site, Goes, Netherlands

Pfizer Investigational Site, Hertogenbosch, Netherlands

Pfizer Investigational Site, Gouda, Netherlands

Pfizer Investigational Site, Heerlen, Netherlands

Pfizer Investigational Site, Sittard, Netherlands

Pfizer Investigational Site, HOORN, Netherlands

Pfizer Investigational Site, AN Rotterdam, Netherlands

Pfizer Investigational Site, Utrecht, Netherlands

Pfizer Investigational Site, Apeldoorn, Netherlands

Pfizer Investigational Site, Velp, Netherlands

Pfizer Investigational Site, Groningen, Netherlands

Pfizer Investigational Site, Cappelle aan den IJssel, Netherlands

Pfizer Investigational Site, Salamanca, Spain

Pfizer Investigational Site, Madrid, Spain

Pfizer Investigational Site, Almeria, Spain

Pfizer Investigational Site, Barcelona, Spain

Pfizer Investigational Site, Ciudad Real, Spain

Pfizer Investigational Site, GRANADA, Spain

Pfizer Investigational Site, Malaga, Spain

Pfizer Investigational Site, Sevilla, Spain

Pfizer Investigational Site, Valencia, Spain

Pfizer Investigational Site, ZARAGOZA, Spain

Pfizer Investigational Site, Zaragoza, Spain

Pfizer Investigational Site, Göteborg, Sweden

Pfizer Investigational Site, Malmo, Sweden

Pfizer Investigational Site, Skelleftea, Sweden

Pfizer Investigational Site, Karlshamn, Sweden

Pfizer Investigational Site, Västervik, Sweden

Pfizer Investigational Site, Uppsala, Sweden

Pfizer Investigational Site, Koping, Sweden

Pfizer Investigational Site, Uddevalla, Sweden

Pfizer Investigational Site, HELSINGBORG, Sweden

Pfizer Investigational Site, Hässleholm, Sweden

Pfizer Investigational Site, Borås, Sweden

Pfizer Investigational Site, Stockholm, Sweden

Pfizer Investigational Site, Goteborg, Sweden

Pfizer Investigational Site, Ostersund, Sweden

Pfizer Investigational Site, Molndal, Sweden

Pfizer Investigational Site, Vaxjo, Sweden

Pfizer Investigational Site, Linköping, Sweden

Pfizer Investigational Site, Eskilstuna, Sweden

Pfizer Investigational Site, Norrkoping, Sweden

Pfizer Investigational Site, Lund, Sweden

Pfizer Investigational Site, Lulea, Sweden

Pfizer Investigational Site, London, United Kingdom

Pfizer Investigational Site, Birmingham, United Kingdom

Pfizer Investigational Site, Brighton, East Sussex, United Kingdom

Pfizer Investigational Site, Leicester, United Kingdom

Pfizer Investigational Site, Bournemouth, United Kingdom

Pfizer Investigational Site, Dundee, United Kingdom

Pfizer Investigational Site, Shrewsbury, United Kingdom

Pfizer Investigational Site, Coventry, United Kingdom

Pfizer Investigational Site, Bath, United Kingdom

Pfizer Investigational Site, Cardiff, United Kingdom

Pfizer Investigational Site, Edinburgh, United Kingdom

Pfizer Investigational Site, ABERDEEN, United Kingdom

Pfizer Investigational Site, Liverpool, United Kingdom

Pfizer Investigational Site, Newcastle-upon-Tyne, United Kingdom

Pfizer Investigational Site, Exeter, United Kingdom

Pfizer Investigational Site, Bristol, United Kingdom

Pfizer Investigational Site, CARDIFF, United Kingdom

Pfizer Investigational Site, Harrow, United Kingdom

Pfizer Investigational Site, Chichester, United Kingdom

Pfizer Investigational Site, Glasgow, United Kingdom

Pfizer Investigational Site, Romford, United Kingdom

Pfizer Investigational Site, Warwick, United Kingdom

Pfizer Investigational Site, Birmingham, Alabama, United States

Pfizer Investigational Site, Alabaster, Alabama, United States

Pfizer Investigational Site, Calgary, Alberta, Canada

Pfizer Investigational Site, Phoenix, Arizona, United States

Pfizer Investigational Site, Gilbert, Arizona, United States

Pfizer Investigational Site, Tucson, Arizona, United States

Pfizer Investigational Site, Sant Coloma de Gramenet, Barcelona, Spain

Pfizer Investigational Site, Terrasa, Barcelona, Spain

Pfizer Investigational Site, Vancouver, British Columbia, Canada

Pfizer Investigational Site, Wrexham, CLWYD, United Kingdom

Pfizer Investigational Site, Jerez de La Frontera, Cadiz, Spain

Pfizer Investigational Site, Santa Rosa, California, United States

Pfizer Investigational Site, Tustin, California, United States

Pfizer Investigational Site, San Diego, California, United States

Pfizer Investigational Site, Los Angeles, California, United States

Pfizer Investigational Site, Walnut Creek, California, United States

Pfizer Investigational Site, Modesto, California, United States

Pfizer Investigational Site, Fresno, California, United States

Pfizer Investigational Site, Santander, Cantabria, Spain

Pfizer Investigational Site, Denver, Colorado, United States

Pfizer Investigational Site, Longmont, Colorado, United States

Pfizer Investigational Site, Hartford, Connecticut, United States

Pfizer Investigational Site, Guilford, Connecticut, United States

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

Pfizer Investigational Site, Jacksonville, Florida, United States

Pfizer Investigational Site, Clearwater, Florida, United States

Pfizer Investigational Site, Coral Gables, Florida, United States

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

Pfizer Investigational Site, Fort Meyers, Florida, United States

Pfizer Investigational Site, Orlando, Florida, United States

Pfizer Investigational Site, Sarasota, Florida, United States

Pfizer Investigational Site, Jacksonville Beach, Florida, United States

Pfizer Investigational Site, Lakeland, Florida, United States

Pfizer Investigational Site, Pensacola, Florida, United States

Pfizer Investigational Site, Port Charlotte, Florida, United States

Pfizer Investigational Site, Atlanta, Georgia, United States

Pfizer Investigational Site, San Sebastian, Guipuzcoa, Spain

Pfizer Investigational Site, Chicago, Illinois, United States

Pfizer Investigational Site, Blue Island, Illinois, United States

Pfizer Investigational Site, Aurora, Illinois, United States

Pfizer Investigational Site, Fort Wayne, Indiana, United States

Pfizer Investigational Site, Evansville, Indiana, United States

Pfizer Investigational Site, des Moines, Iowa, United States

Pfizer Investigational Site, Davenport, Iowa, United States

Pfizer Investigational Site, Iowa City, Iowa, United States

Pfizer Investigational Site, Witchita, Kansas, United States

Pfizer Investigational Site, Wichita, Kansas, United States

Pfizer Investigational Site, Louisville, Kentucky, United States

Pfizer Investigational Site, WOOLWICH, LONDON, United Kingdom

Pfizer Investigational Site, Ferrol, La Coruna, Spain

Pfizer Investigational Site, Santiago De Compostela, La Coruña, Spain

Pfizer Investigational Site, Marrero, Louisiana, United States

Pfizer Investigational Site, Baton Rouge, Louisiana, United States

Pfizer Investigational Site, Covington, Louisiana, United States

Pfizer Investigational Site, Scarborough, Maine, United States

Pfizer Investigational Site, Winnipeg, Manitoba, Canada

Pfizer Investigational Site, Baltimore, Maryland, United States

Pfizer Investigational Site, Westminster, Maryland, United States

Pfizer Investigational Site, Towson, Maryland, United States

Pfizer Investigational Site, Bel Air, Maryland, United States

Pfizer Investigational Site, Columbia, Maryland, United States

Pfizer Investigational Site, Haverhill, Massachusetts, United States

Pfizer Investigational Site, Natick, Massachusetts, United States

Pfizer Investigational Site, Abington, Massachusetts, United States

Pfizer Investigational Site, Grand Rapids, Michigan, United States

Pfizer Investigational Site, Minneapolis, Minnesota, United States

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

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

Pfizer Investigational Site, Butte, Montana, United States

Pfizer Investigational Site, Billings, Montana, United States

Pfizer Investigational Site, Omaha, Nebraska, United States

Pfizer Investigational Site, Papillon, Nebraska, United States

Pfizer Investigational Site, Las Vegas, Nevada, United States

Pfizer Investigational Site, Concord, New Hampshire, United States

Pfizer Investigational Site, Manchester, New Hampshire, United States

Pfizer Investigational Site, Lebanon, New Hampshire, United States

Pfizer Investigational Site, New Brunswick, New Jersey, United States

Pfizer Investigational Site, Haddon Heights, New Jersey, United States

Pfizer Investigational Site, Elmer, New Jersey, United States

Pfizer Investigational Site, East Gosford, New South Wales, Australia

Pfizer Investigational Site, St. Leonards, New South Wales, Australia

Pfizer Investigational Site, Concord, New South Wales, Australia

Pfizer Investigational Site, Wollongong, New South Wales, Australia

Pfizer Investigational Site, Rochester, New York, United States

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

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

Pfizer Investigational Site, Durham, North Carolina, United States

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

Pfizer Investigational Site, Halifax, Nova Scotia, Canada

Pfizer Investigational Site, Toledo, Ohio, United States

Pfizer Investigational Site, Cleveland, Ohio, United States

Pfizer Investigational Site, Cincinnati, Ohio, United States

Pfizer Investigational Site, Sandusky, Ohio, United States

Pfizer Investigational Site, Mansfield, Ohio, United States

Pfizer Investigational Site, Columbus, Ohio, United States

Pfizer Investigational Site, Oklahoma City, Oklahoma, United States

Pfizer Investigational Site, Oshawa, Ontario, Canada

Pfizer Investigational Site, Toronto, Ontario, Canada

Pfizer Investigational Site, Sarnia, Ontario, Canada

Pfizer Investigational Site, Scarborough, Ontario, Canada

Pfizer Investigational Site, Cornwall, Ontario, Canada

Pfizer Investigational Site, Newmarket, Ontario, Canada

Pfizer Investigational Site, Portland, Oregon, United States

Pfizer Investigational Site, Beaver, Pennsylvania, United States

Pfizer Investigational Site, Philadelphia, Pennsylvania, United States

Pfizer Investigational Site, Sainte-foy, Quebec, Canada

Pfizer Investigational Site, Sherbrooke, Quebec, Canada

Pfizer Investigational Site, Laval, Quebec, Canada

Pfizer Investigational Site, Montreal, Quebec, Canada

Pfizer Investigational Site, Ste-foy, Quebec, Canada

Pfizer Investigational Site, Chermside, Queensland, Australia

Pfizer Investigational Site, HERSTON, Queensland, Australia

Pfizer Investigational Site, Woolloongabba, Queensland, Australia

Pfizer Investigational Site, Glasgow, Scotland, United Kingdom

Pfizer Investigational Site, Woodville, South Australia, Australia

Pfizer Investigational Site, Adelaide, South Australia, Australia

Pfizer Investigational Site, Bedford Park, South Australia, Australia

Pfizer Investigational Site, Kingsport, Tennessee, United States

Pfizer Investigational Site, Nashville, Tennessee, United States

Pfizer Investigational Site, Plano, Texas, United States

Pfizer Investigational Site, Dallas, Texas, United States

Pfizer Investigational Site, San Antonio, Texas, United States

Pfizer Investigational Site, Beaumont, Texas, United States

Pfizer Investigational Site, Houston, Texas, United States

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

Pfizer Investigational Site, Burlington, Vermont, United States

Pfizer Investigational Site, Fitzroy, Victoria, Australia

Pfizer Investigational Site, PRAHRAN, Victoria, Australia

Pfizer Investigational Site, Heidelberg, Victoria, Australia

Pfizer Investigational Site, Clayton, Victoria, Australia

Pfizer Investigational Site, Footscray, Victoria, Australia

Pfizer Investigational Site, Richmond, Virginia, United States

Pfizer Investigational Site, Norfolk, Virginia, United States

Pfizer Investigational Site, Burien, Washington, United States

Pfizer Investigational Site, Tacoma, Washington, United States

Pfizer Investigational Site, Fremantle, Western Australia, Australia

Pfizer Investigational Site, Joondalup, Western Australia, Australia

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

Link to ClinicalStudyResults.org Posting:

Starting date: March 2004
Last updated: November 9, 2007