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

Phase 3, Multi-Center, Double-Blind, Randomized, Parallel Group, Coronary Artery Intravascular Ultrasound Evaluation of the Anti-Atherosclerotic Efficacy, Safety, and Tolerability of Fixed Combination CP-529,414/Atorvastatin, Administered Orally, Once Daily (QD) for 24 Months, Compared With Atorvastatin Alone, in Subjects With Angiographically Documented Coronary Heart Disease.

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

Study Overview

• Status: Completed
• Conditions: Coronary Disease; Coronary Arteriosclerosis; Hyperlipidemia
• Intervention / Treatment: Drug: atorvastatin; Drug: torcetrapib/atorvastatin

Detailed Description

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

• Study Type: Interventional
• Enrollment: 1100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium
    • Pfizer Investigational Site
  • Bruxelles, Belgium
    • Pfizer Investigational Site
  • Genk, Belgium
    • Pfizer Investigational Site
• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Pfizer Investigational Site
  • British Columbia
    • Victoria, British Columbia, Canada
      • Pfizer Investigational Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • Pfizer Investigational Site
  • Ontario
    • Ottawa, Ontario, Canada
      • Pfizer Investigational Site
    • Torono, Ontario, Canada
      • Pfizer Investigational Site
  • Quebec
    • Montreal, Quebec, Canada
      • Pfizer Investigational Site
    • Montréal, Quebec, Canada
      • Pfizer Investigational Site
• Netherlands
  • Nijmegen, Netherlands
    • Pfizer Investigational Site
  • Rotterdam, Netherlands
    • Pfizer Investigational Site
• Poland
  • Katowice, Poland
    • Pfizer Investigational Site
  • Krakow, Poland
    • Pfizer Investigational Site
  • Warszawa, Poland
    • Pfizer Investigational Site
• Spain
  • Barcelona, Spain
    • Pfizer Investigational Site
  • Madrid, Spain
    • Pfizer Investigational Site
  • Asturias
    • Oviedo, Asturias, Spain
      • Pfizer Investigational Site
  • Barcelona
    • L´Hospitalet del Llobregat, Barcelona, Spain
      • Pfizer Investigational Site
  • Pontevedra
    • Vigo, Pontevedra, Spain
      • Pfizer Investigational Site
• United States
  • Alabama
    • Birmingham, Alabama, United States
      • Pfizer Investigational Site
    • Mobile, Alabama, United States
      • Pfizer Investigational Site
  • Arkansas
    • Little Rock, Arkansas, United States
      • Pfizer Investigational Site
  • California
    • Fresno, California, United States
      • Pfizer Investigational Site
    • Los Altos, California, United States
      • Pfizer Investigational Site
    • Los Angeles, California, United States
      • Pfizer Investigational Site
    • Mountain View, California, United States
      • Pfizer Investigational Site
    • Sacramento, California, United States
      • Pfizer Investigational Site
    • San Diego, California, United States
      • Pfizer Investigational Site
    • San Francisco, California, United States
      • Pfizer Investigational Site
    • Santa Rosa, California, United States
      • Pfizer Investigational Site
    • Stockton, California, United States
      • Pfizer Investigational Site
  • Colorado
    • Boulder, Colorado, United States
      • Pfizer Investigational Site
    • Denver, Colorado, United States
      • Pfizer Investigational Site
  • Connecticut
    • Brandford, Connecticut, United States
      • Pfizer Investigational Site
    • Farmington, Connecticut, United States
      • Pfizer Investigational Site
    • Guilford, Connecticut, United States
      • Pfizer Investigational Site
    • New Haven, Connecticut, United States
      • Pfizer Investigational Site
  • Florida
    • Atlantis, Florida, United States
      • Pfizer Investigational Site
    • Clearwater, Florida, United States
      • Pfizer Investigational Site
    • Dunedin, Florida, United States
      • Pfizer Investigational Site
    • Fort Lauderdale, Florida, United States
      • Pfizer Investigational Site
    • Jacksonville, Florida, United States
      • Pfizer Investigational Site
    • Largo, Florida, United States
      • Pfizer Investigational Site
    • Melbourne, Florida, United States
      • Pfizer Investigational Site
    • Miami, Florida, United States
      • Pfizer Investigational Site
    • Orlando, Florida, United States
      • Pfizer Investigational Site
    • Pensacola, Florida, United States
      • Pfizer Investigational Site
    • Safety Harbor, Florida, United States
      • Pfizer Investigational Site
    • Sarasota, Florida, United States
      • Pfizer Investigational Site
    • Tampa, Florida, United States
      • Pfizer Investigational Site
  • Illinois
    • Blue Island, Illinois, United States
      • Pfizer Investigational Site
    • Merrionette Park, Illinois, United States
      • Pfizer Investigational Site
    • Rockford, Illinois, United States
      • Pfizer Investigational Site
  • Indiana
    • Elkhart, Indiana, United States
      • Pfizer Investigational Site
    • Goshen, Indiana, United States
      • Pfizer Investigational Site
    • Hobart, Indiana, United States
      • Pfizer Investigational Site
    • Merrillville, Indiana, United States
      • Pfizer Investigational Site
  • Iowa
    • Davenport, Iowa, United States
      • Pfizer Investigational Site
    • Des Moines, Iowa, United States
      • Pfizer Investigational Site
    • West Des Moines, Iowa, United States
      • Pfizer Investigational Site
  • Kansas
    • Shawnee Mission, Kansas, United States
      • Pfizer Investigational Site
  • Kentucky
    • Louisville, Kentucky, United States
      • Pfizer Investigational Site
  • Louisiana
    • Bogalusa, Louisiana, United States
      • Pfizer Investigational Site
    • Covington, Louisiana, United States
      • Pfizer Investigational Site
    • New Orleans, Louisiana, United States
      • Pfizer Investigational Site
  • Maine
    • Auburn, Maine, United States
      • Pfizer Investigational Site
    • Lewiston, Maine, United States
      • Pfizer Investigational Site
    • Portland, Maine, United States
      • Pfizer Investigational Site
    • Scarborough, Maine, United States
      • Pfizer Investigational Site
  • Maryland
    • Baltimore, Maryland, United States
      • Pfizer Investigational Site
    • Columbia, Maryland, United States
      • Pfizer Investigational Site
    • Salisbury, Maryland, United States
      • Pfizer Investigational Site
    • Takoma Park, Maryland, United States
      • Pfizer Investigational Site
  • Michigan
    • Ann Arbor, Michigan, United States
      • Pfizer Investigational Site
    • Flint, Michigan, United States
      • Pfizer Investigational Site
    • Kalamazoo, Michigan, United States
      • Pfizer Investigational Site
    • Lapeer, Michigan, United States
      • Pfizer Investigational Site
    • Petoskey, Michigan, United States
      • Pfizer Investigational Site
    • Royal Oak, Michigan, United States
      • Pfizer Investigational Site
    • Saginaw, Michigan, United States
      • Pfizer Investigational Site
    • Ypsilanti, Michigan, United States
      • Pfizer Investigational Site
  • Minnesota
    • Duluth, Minnesota, United States
      • Pfizer Investigational Site
    • Maplewood, Minnesota, United States
      • Pfizer Investigational Site
    • Minneapolis, Minnesota, United States
      • Pfizer Investigational Site
    • St. Cloud, Minnesota, United States
      • Pfizer Investigational Site
    • St. Paul, Minnesota, United States
      • Pfizer Investigational Site
  • Mississippi
    • Southaven, Mississippi, United States
      • Pfizer Investigational Site
  • Missouri
    • Kansas City, Missouri, United States
      • Pfizer Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States
      • Pfizer Investigational Site
  • New Jersey
    • Ridgewood, New Jersey, United States
      • Pfizer Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States
      • Pfizer Investigational Site
    • Carlsbad, New Mexico, United States
      • Pfizer Investigational Site
  • New York
    • Albany, New York, United States
      • Pfizer Investigational Site
    • Bay Shore, New York, United States
      • Pfizer Investigational Site
    • Buffalo, New York, United States
      • Pfizer Investigational Site
    • Flushing, New York, United States
      • Pfizer Investigational Site
    • Johnson City, New York, United States
      • Pfizer Investigational Site
    • New York, New York, United States
      • Pfizer Investigational Site
    • Oneonta, New York, United States
      • Pfizer Investigational Site
    • Poughkeepsie, New York, United States
      • Pfizer Investigational Site
    • Rochester, New York, United States
      • Pfizer Investigational Site
    • Troy, New York, United States
      • Pfizer Investigational Site
    • Williamsville, New York, United States
      • Pfizer Investigational Site
  • North Carolina
    • Eden, North Carolina, United States
      • Pfizer Investigational Site
    • Greensboro, North Carolina, United States
      • Pfizer Investigational Site
    • Greenville, North Carolina, United States
      • Pfizer Investigational Site
    • Raleigh, North Carolina, United States
      • Pfizer Investigational Site
    • Reidsville, North Carolina, United States
      • Pfizer Investigational Site
    • Winston-Salem, North Carolina, United States
      • Pfizer Investigational Site
  • Ohio
    • Bellevue, Ohio, United States
      • Pfizer Investigational Site
    • Cleveland, Ohio, United States
      • Pfizer Investigational Site
    • Clyde, Ohio, United States
      • Pfizer Investigational Site
    • Defiance, Ohio, United States
      • Pfizer Investigational Site
    • Fostoria, Ohio, United States
      • Pfizer Investigational Site
    • Middleburg Heights, Ohio, United States
      • Pfizer Investigational Site
    • Orange Village, Ohio, United States
      • Pfizer Investigational Site
    • Toledo, Ohio, United States
      • Pfizer Investigational Site
    • Wauseon, Ohio, United States
      • Pfizer Investigational Site
    • Westlake, Ohio, United States
      • Pfizer Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
      • Pfizer Investigational Site
    • Tulsa, Oklahoma, United States
      • Pfizer Investigational Site
  • Oregon
    • Eugene, Oregon, United States
      • Pfizer Investigational Site
    • Florence, Oregon, United States
      • Pfizer Investigational Site
    • Hillsboro, Oregon, United States
      • Pfizer Investigational Site
  • Pennsylvania
    • Doylestown, Pennsylvania, United States
      • Pfizer Investigational Site
    • Harrisburg, Pennsylvania, United States
      • Pfizer Investigational Site
    • Hershey, Pennsylvania, United States
      • Pfizer Investigational Site
    • Lancaster, Pennsylvania, United States
      • Pfizer Investigational Site
    • Philadelphia, Pennsylvania, United States
      • Pfizer Investigational Site
    • Pittsburgh, Pennsylvania, United States
      • Pfizer Investigational Site
    • Wormleysburg, Pennsylvania, United States
      • Pfizer Investigational Site
  • South Carolina
    • Greenville, South Carolina, United States
      • Pfizer Investigational Site
  • Tennessee
    • Chattanooga, Tennessee, United States
      • Pfizer Investigational Site
    • Knoxville, Tennessee, United States
      • Pfizer Investigational Site
    • Memphis, Tennessee, United States
      • Pfizer Investigational Site
    • Oak Ridge, Tennessee, United States
      • Pfizer Investigational Site
  • Texas
    • San Antonio, Texas, United States
      • Pfizer Investigational Site
  • Virginia
    • Annandale, Virginia, United States
      • Pfizer Investigational Site
    • Charlottesville, Virginia, United States
      • Pfizer Investigational Site
    • Falls Church, Virginia, United States
      • Pfizer Investigational Site
    • Norfolk, Virginia, United States
      • Pfizer Investigational Site
    • Richmond, Virginia, United States
      • Pfizer Investigational Site
  • Washington
    • Bellevue, Washington, United States
      • Pfizer Investigational Site
    • Seattle, Washington, United States
      • Pfizer Investigational Site
  • West Virginia
    • Huntington, West Virginia, United States
      • Pfizer Investigational Site
  • Wisconsin
    • Milwaukee, Wisconsin, United States
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change coronary artery atheroma volume as measured by intravascular ultrasound.

Secondary Outcome Measures

Outcome Measure
Changes in levels of lipids and other biomarkers.

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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. Erratum In: N Engl J Med. 2007 Aug 23;357(8):835. Lasala, Gregory P [corrected to Lasala, Gabriel P].

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: October 1, 2003
• Study Completion (Actual): September 1, 2006

Study Registration Dates

• First Submitted: August 22, 2005
• First Submitted That Met QC Criteria: August 22, 2005
• First Posted (Estimate): August 24, 2005

Study Record Updates

• Last Update Posted (Estimate): December 10, 2007
• Last Update Submitted That Met QC Criteria: December 6, 2007
• Last Verified: April 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Arterial Occlusive Diseases; Lipid Metabolism Disorders; Dyslipidemias; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Arteriosclerosis; Hyperlipidemias; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Torcetrapib
• Other Study ID Numbers: A5091005