NCT00134264

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15,067

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2004

Typical duration for phase_3

Geographic Reach
7 countries

221 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

February 3, 2012

Status Verified

January 1, 2012

Enrollment Period

2.9 years

First QC Date

August 22, 2005

Last Update Submit

January 30, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • The time to first occurrence of a major cardiovascular disease event

Secondary Outcomes (1)

  • Various composites of major cardiovascular disease events and other lipid parameters

Interventions

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of coronary heart disease or risk equivalents that place the patient at high risk for cardiovascular disease events

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (221)

Pfizer Investigational Site

Alabaster, Alabama, United States

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Pfizer Investigational Site

Birmingham, Alabama, United States

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Gilbert, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Fresno, California, United States

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Los Angeles, California, United States

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Modesto, California, United States

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San Diego, California, United States

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Santa Rosa, California, United States

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Tustin, California, United States

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Walnut Creek, California, United States

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Denver, Colorado, United States

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Longmont, Colorado, United States

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Guilford, Connecticut, United States

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Hartford, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Clearwater, Florida, United States

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Coral Gables, Florida, United States

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Fort Meyers, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville Beach, Florida, United States

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Lakeland, Florida, United States

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Orlando, Florida, United States

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Pensacola, Florida, United States

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Port Charlotte, Florida, United States

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Sarasota, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Aurora, Illinois, United States

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Blue Island, Illinois, United States

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Chicago, Illinois, United States

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Evansville, Indiana, United States

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Fort Wayne, Indiana, United States

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Davenport, Iowa, United States

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Des Moines, Iowa, United States

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Iowa City, Iowa, United States

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Wichita, Kansas, United States

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Witchita, Kansas, United States

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Louisville, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Covington, Louisiana, United States

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Marrero, Louisiana, United States

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Scarborough, Maine, United States

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Baltimore, Maryland, United States

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Bel Air, Maryland, United States

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Columbia, Maryland, United States

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Towson, Maryland, United States

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Westminster, Maryland, United States

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Abington, Massachusetts, United States

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Haverhill, Massachusetts, United States

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Natick, Massachusetts, United States

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Grand Rapids, Michigan, United States

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Minneapolis, Minnesota, United States

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Saint Paul, Minnesota, United States

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St Louis, Missouri, United States

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Billings, Montana, United States

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Butte, Montana, United States

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Omaha, Nebraska, United States

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Papillon, Nebraska, United States

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Las Vegas, Nevada, United States

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Concord, New Hampshire, United States

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Lebanon, New Hampshire, United States

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Manchester, New Hampshire, United States

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Elmer, New Jersey, United States

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Haddon Heights, New Jersey, United States

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New Brunswick, New Jersey, United States

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Garden City, New York, United States

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New Hyde Park, New York, United States

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Rochester, New York, United States

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Durham, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Mansfield, Ohio, United States

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Sandusky, Ohio, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Beaver, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Kingsport, Tennessee, United States

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Nashville, Tennessee, United States

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Beaumont, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Plano, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Burlington, Vermont, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Burien, Washington, United States

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Tacoma, Washington, United States

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Concord, New South Wales, Australia

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East Gosford, New South Wales, Australia

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St Leonards, New South Wales, Australia

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Wollongong, New South Wales, Australia

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Chermside, Queensland, Australia

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Herston, Queensland, Australia

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Woolloongabba, Queensland, Australia

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Adelaide, South Australia, Australia

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Bedford Park, South Australia, Australia

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Woodville, South Australia, Australia

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Clayton, Victoria, Australia

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Fitzroy, Victoria, Australia

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Footscray, Victoria, Australia

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Heidelberg, Victoria, Australia

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Prahran, Victoria, Australia

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Fremantle, Western Australia, Australia

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Joondalup, Western Australia, Australia

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Camperdown, Australia

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Darlinghurst, Australia

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Geelong, Australia

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Launceston, Tas, Australia

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Melbourne, Australia

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Nedlands, Australia

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Perth, Australia

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Southport, Australia

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Calgary, Alberta, Canada

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Halifax, Nova Scotia, Canada

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Cornwall, Ontario, Canada

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Newmarket, Ontario, Canada

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Oshawa, Ontario, Canada

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Sarnia, Ontario, Canada

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Scarborough Village, Ontario, Canada

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Toronto, Ontario, Canada

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Laval, Quebec, Canada

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Montreal, Quebec, Canada

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Sainte-Foy, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Ste-foy, Quebec, Canada

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St. John's, Canada

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's-Hertogenbosch, Netherlands

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Amsterdam, Netherlands

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AN Rotterdam, Netherlands

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Apeldoorn, Netherlands

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Arnhem, Netherlands

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Breda, Netherlands

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Cappelle Aan Den IJssel, Netherlands

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Delft, Netherlands

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Eindhoven, Netherlands

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Goes, Netherlands

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Gouda, Netherlands

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Groningen, Netherlands

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Heerlen, Netherlands

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Hoorn, Netherlands

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Leiden, Netherlands

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Maastricht, Netherlands

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Nijmegen, Netherlands

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Rotterdam, Netherlands

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Sittard, Netherlands

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Utrecht, Netherlands

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Velp, Netherlands

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Venlo, Netherlands

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Zoetermeer, Netherlands

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Almería, Almeria, Spain

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Barcelona, Barcelona, Spain

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Sant Coloma de Gramenet, Barcelona, Spain

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Terrassa, Barcelona, Spain

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Jerez de la Frontera, Cadiz, Spain

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Santander, Cantabria, Spain

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Ciudad Real, Ciudad Real, Spain

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Granada, Granada, Spain

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Donostia / San Sebastian, Guipuzcoa, Spain

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Ferrol, La Coruna, Spain

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Santiago de Compostela, La Coruña, Spain

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Madrid, Madrid, Spain

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Málaga, Malaga, Spain

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Seville, Sevilla, Spain

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Valencia, Valencia, Spain

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Zaragoza, Zaragoza, Spain

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Madrid, Spain

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Salamanca, Spain

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Borås, Sweden

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Eskilstuna, Sweden

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Gothenburg, Sweden

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Hässleholm, Sweden

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Helsingborg, Sweden

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Karlshamn, Sweden

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Köping, Sweden

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Linköping, Sweden

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Luleå, Sweden

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Lund, Sweden

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Malmo, Sweden

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Mölndal, Sweden

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Norrköping, Sweden

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Östersund, Sweden

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Skellefteå, Sweden

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Stockholm, Sweden

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Uddevalla, Sweden

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Uppsala, Sweden

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Vaxjo, Sweden

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Västervik, Sweden

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Wrexham, Clwyd, United Kingdom

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Woolwich, London, United Kingdom

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Glasgow, Scotland, United Kingdom

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Aberdeen, United Kingdom

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Bath, United Kingdom

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Birmingham, United Kingdom

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Bournemouth, United Kingdom

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Brighton, East Sussex, United Kingdom

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Bristol, United Kingdom

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Cardiff, United Kingdom

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Chichester, United Kingdom

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Coventry, United Kingdom

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Dundee, United Kingdom

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Edinburgh, United Kingdom

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Exeter, United Kingdom

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Glasgow, United Kingdom

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Harrow, United Kingdom

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Leicester, United Kingdom

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Liverpool, United Kingdom

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London, United Kingdom

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Newcastle upon Tyne, United Kingdom

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Romford, United Kingdom

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Shrewsbury, United Kingdom

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Warwick, United Kingdom

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Related Publications (8)

  • Arsenault BJ, Petrides F, Tabet F, Bao W, Hovingh GK, Boekholdt SM, Ramin-Mangata S, Meilhac O, DeMicco D, Rye KA, Waters DD, Kastelein JJP, Barter P, Lambert G. Effect of atorvastatin, cholesterol ester transfer protein inhibition, and diabetes mellitus on circulating proprotein subtilisin kexin type 9 and lipoprotein(a) levels in patients at high cardiovascular risk. J Clin Lipidol. 2018 Jan-Feb;12(1):130-136. doi: 10.1016/j.jacl.2017.10.001. Epub 2017 Oct 12.

  • Williams SA, Murthy AC, DeLisle RK, Hyde C, Malarstig A, Ostroff R, Weiss SJ, Segal MR, Ganz P. Improving Assessment of Drug Safety Through Proteomics: Early Detection and Mechanistic Characterization of the Unforeseen Harmful Effects of Torcetrapib. Circulation. 2018 Mar 6;137(10):999-1010. doi: 10.1161/CIRCULATIONAHA.117.028213. Epub 2017 Oct 3.

  • Bagdade J, Barter P, Quiroga C, Alaupovic P. Effects of Torcetrapib and Statin Treatment on ApoC-III and Apoprotein-Defined Lipoprotein Subclasses (from the ILLUMINATE Trial). Am J Cardiol. 2017 Jun 1;119(11):1753-1756. doi: 10.1016/j.amjcard.2017.02.049. Epub 2017 Mar 18.

  • Barter PJ, Rye KA, Tardif JC, Waters DD, Boekholdt SM, Breazna A, Kastelein JJ. Effect of torcetrapib on glucose, insulin, and hemoglobin A1c in subjects in the Investigation of Lipid Level Management to Understand its Impact in Atherosclerotic Events (ILLUMINATE) trial. Circulation. 2011 Aug 2;124(5):555-62. doi: 10.1161/CIRCULATIONAHA.111.018259. Epub 2011 Jul 18.

  • Dogan S, Duivenvoorden R, Grobbee DE, Kastelein JJ, Shear CL, Evans GW, Visseren FL, Bots ML; Radiance 1 and Radiance 2 Study Groups. Ultrasound protocols to measure carotid intima-media thickness in trials; comparison of reproducibility, rate of progression, and effect of intervention in subjects with familial hypercholesterolemia and subjects with mixed dyslipidemia. Ann Med. 2010 Sep;42(6):447-64. doi: 10.3109/07853890.2010.499132.

  • Dogan S, Duivenvoorden R, Grobbee DE, Kastelein JJ, Shear CL, Evans GW, Visseren FL, Bots ML; Radiance 1 and 2 Study Groups. Completeness of carotid intima media thickness measurements depends on body composition: the RADIANCE 1 and 2 trials. J Atheroscler Thromb. 2010 May;17(5):526-35. doi: 10.5551/jat.3269. Epub 2010 Mar 13.

  • Vergeer M, Bots ML, van Leuven SI, Basart DC, Sijbrands EJ, Evans GW, Grobbee DE, Visseren FL, Stalenhoef AF, Stroes ES, Kastelein JJ. Cholesteryl ester transfer protein inhibitor torcetrapib and off-target toxicity: a pooled analysis of the rating atherosclerotic disease change by imaging with a new CETP inhibitor (RADIANCE) trials. Circulation. 2008 Dec 9;118(24):2515-22. doi: 10.1161/CIRCULATIONAHA.108.772665. Epub 2008 Nov 24.

  • Barter PJ, Caulfield M, Eriksson M, Grundy SM, Kastelein JJ, Komajda M, Lopez-Sendon J, Mosca L, Tardif JC, Waters DD, Shear CL, Revkin JH, Buhr KA, Fisher MR, Tall AR, Brewer B; ILLUMINATE Investigators. Effects of torcetrapib in patients at high risk for coronary events. N Engl J Med. 2007 Nov 22;357(21):2109-22. doi: 10.1056/NEJMoa0706628. Epub 2007 Nov 5.

Related Links

MeSH Terms

Conditions

Coronary DiseaseDiabetes Mellitus

Interventions

torcetrapibAtorvastatin

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2005

First Posted

August 24, 2005

Study Start

July 1, 2004

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

February 3, 2012

Record last verified: 2012-01

Locations