NCT00134173

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

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

Enrollment
1,100

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2003

Typical duration for phase_3

Geographic Reach
6 countries

146 active sites

Status
completed

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

October 1, 2003

Completed
1.9 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 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

December 10, 2007

Status Verified

April 1, 2007

First QC Date

August 22, 2005

Last Update Submit

December 6, 2007

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change coronary artery atheroma volume as measured by intravascular ultrasound.

Secondary Outcomes (1)

  • Changes in levels of lipids and other biomarkers.

Interventions

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • angiographic evidence of coronary atherosclerosis

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 evaluation of response, or render unlikely that the subject would complete the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (146)

Pfizer Investigational Site

Birmingham, Alabama, United States

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Pfizer Investigational Site

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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Pfizer Investigational Site

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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Pfizer Investigational Site

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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Pfizer Investigational Site

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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Pfizer Investigational Site

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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Pfizer Investigational Site

Barcelona, Barcelona, Spain

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Pfizer Investigational Site

L´Hospitalet Del Llobregat, Barcelona, Spain

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Pfizer Investigational Site

Madrid, Madrid, Spain

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Pfizer Investigational Site

Vigo, Pontevedra, Spain

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Pfizer Investigational Site

Oviedo, Principality of Asturias, Spain

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Related Publications (2)

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Coronary DiseaseCoronary Artery DiseaseHyperlipidemias

Interventions

torcetrapibAtorvastatin

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesArteriosclerosisArterial Occlusive DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic 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

Study Record Dates

First Submitted

August 22, 2005

First Posted

August 24, 2005

Study Start

October 1, 2003

Study Completion

September 1, 2006

Last Updated

December 10, 2007

Record last verified: 2007-04

Locations