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

NCT ID: NCT00134264

Last Updated: 2012-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

15067 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2007-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Coronary Disease Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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torcetrapib/atorvastatin

Intervention Type DRUG

atorvastatin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Alabaster, Alabama, United States

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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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Countries

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United States Australia Canada Netherlands Spain Sweden United Kingdom

References

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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.

Reference Type DERIVED
PMID: 29103916 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28974520 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28431663 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21804130 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20645885 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20228610 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19029469 (View on PubMed)

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.

Reference Type DERIVED
PMID: 17984165 (View on PubMed)

Related Links

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Other Identifiers

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A5091043

Identifier Type: -

Identifier Source: org_study_id

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