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

NCT ID: NCT00134173

Last Updated: 2007-12-10

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2006-09-30

Brief Summary

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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

Detailed Description

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

Conditions

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Coronary Disease Coronary Arteriosclerosis Hyperlipidemia

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

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Little Rock, Arkansas, United States

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Fresno, California, United States

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Los Altos, California, United States

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Los Angeles, California, United States

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Mountain View, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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Santa Rosa, California, United States

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Stockton, California, United States

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Boulder, Colorado, United States

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Denver, Colorado, United States

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Brandford, Connecticut, United States

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Farmington, Connecticut, United States

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Guilford, Connecticut, United States

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New Haven, Connecticut, United States

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Atlantis, Florida, United States

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Clearwater, Florida, United States

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Dunedin, Florida, United States

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Fort Lauderdale, Florida, United States

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Jacksonville, Florida, United States

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Largo, Florida, United States

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Melbourne, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Pensacola, Florida, United States

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Safety Harbor, Florida, United States

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Sarasota, Florida, United States

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Tampa, Florida, United States

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Blue Island, Illinois, United States

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Merrionette Park, Illinois, United States

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Rockford, Illinois, United States

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Elkhart, Indiana, United States

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Goshen, Indiana, United States

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Hobart, Indiana, United States

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Merrillville, Indiana, United States

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Davenport, Iowa, United States

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Des Moines, Iowa, United States

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West Des Moines, Iowa, United States

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Shawnee Mission, Kansas, United States

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Louisville, Kentucky, United States

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Bogalusa, Louisiana, United States

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Covington, Louisiana, United States

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New Orleans, Louisiana, United States

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Auburn, Maine, United States

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Lewiston, Maine, United States

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Portland, Maine, United States

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Scarborough, Maine, United States

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Baltimore, Maryland, United States

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Columbia, Maryland, United States

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Salisbury, Maryland, United States

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Takoma Park, Maryland, United States

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Ann Arbor, Michigan, United States

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Flint, Michigan, United States

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Kalamazoo, Michigan, United States

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Lapeer, Michigan, United States

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Petoskey, Michigan, United States

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Royal Oak, Michigan, United States

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Saginaw, Michigan, United States

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Ypsilanti, Michigan, United States

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Duluth, Minnesota, United States

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Maplewood, Minnesota, United States

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Minneapolis, Minnesota, United States

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Saint Cloud, Minnesota, United States

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Saint Paul, Minnesota, United States

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Southaven, Mississippi, United States

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Kansas City, Missouri, United States

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Omaha, Nebraska, United States

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Ridgewood, New Jersey, United States

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Albuquerque, New Mexico, United States

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Carlsbad, New Mexico, United States

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Albany, New York, United States

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Bay Shore, New York, United States

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Buffalo, New York, United States

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Flushing, New York, United States

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Johnson City, New York, United States

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New York, New York, United States

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Oneonta, New York, United States

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Poughkeepsie, New York, United States

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Rochester, New York, United States

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Troy, New York, United States

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Williamsville, New York, United States

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Eden, North Carolina, United States

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Greensboro, North Carolina, United States

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Greenville, North Carolina, United States

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Raleigh, North Carolina, United States

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Reidsville, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Bellevue, Ohio, United States

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Cleveland, Ohio, United States

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Clyde, Ohio, United States

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Defiance, Ohio, United States

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Fostoria, Ohio, United States

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Middleburg Heights, Ohio, United States

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Orange, Ohio, United States

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Toledo, Ohio, United States

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Wauseon, Ohio, United States

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Westlake, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Eugene, Oregon, United States

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Florence, Oregon, United States

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Hillsboro, Oregon, United States

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Doylestown, Pennsylvania, United States

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Harrisburg, Pennsylvania, United States

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Hershey, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Wormleysburg, Pennsylvania, United States

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Greenville, South Carolina, United States

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Chattanooga, Tennessee, United States

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Knoxville, Tennessee, United States

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Memphis, Tennessee, United States

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Oak Ridge, Tennessee, United States

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San Antonio, Texas, United States

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Annandale, Virginia, United States

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Charlottesville, Virginia, United States

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Falls Church, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Bellevue, Washington, United States

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Seattle, Washington, United States

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Huntington, West Virginia, United States

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Milwaukee, Wisconsin, United States

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Aalst, , Belgium

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Brussels, , Belgium

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Genk, , Belgium

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Calgary, Alberta, Canada

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Victoria, British Columbia, Canada

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Halifax, Nova Scotia, Canada

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Ottawa, Ontario, Canada

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Torono, Ontario, Canada

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Montreal, Quebec, Canada

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Nijmegen, , Netherlands

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Rotterdam, , Netherlands

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Katowice, , Poland

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Krakow, , Poland

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Warsaw, , Poland

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Barcelona, Barcelona, Spain

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L“Hospitalet Del Llobregat, Barcelona, Spain

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Madrid, Madrid, Spain

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Vigo, Pontevedra, Spain

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Oviedo, Principality of Asturias, Spain

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Countries

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United States Belgium Canada Netherlands Poland Spain

References

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Nicholls SJ, Tuzcu EM, Brennan DM, Tardif JC, Nissen SE. Cholesteryl ester transfer protein inhibition, high-density lipoprotein raising, and progression of coronary atherosclerosis: insights from ILLUSTRATE (Investigation of Lipid Level Management Using Coronary Ultrasound to Assess Reduction of Atherosclerosis by CETP Inhibition and HDL Elevation). Circulation. 2008 Dec 9;118(24):2506-14. doi: 10.1161/CIRCULATIONAHA.108.790733. Epub 2008 Nov 24.

Reference Type DERIVED
PMID: 19029466 (View on PubMed)

Nissen SE, Tardif JC, Nicholls SJ, Revkin JH, Shear CL, Duggan WT, Ruzyllo W, Bachinsky WB, Lasala GP, Tuzcu EM; ILLUSTRATE Investigators. Effect of torcetrapib on the progression of coronary atherosclerosis. N Engl J Med. 2007 Mar 29;356(13):1304-16. doi: 10.1056/NEJMoa070635. Epub 2007 Mar 26.

Reference Type DERIVED
PMID: 17387129 (View on PubMed)

Related Links

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Other Identifiers

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A5091005

Identifier Type: -

Identifier Source: org_study_id