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

Coronary Disease Clinical Trial

— ILLUSTRATE  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00134173
• Other study ID #: A5091005
• Status: Completed
• Phase: Phase 3
• First received: August 22, 2005
• Last updated: December 6, 2007
• Start date: October 2003
• Est. completion date: September 2006

Study information

• Verified date: April 2007
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1100
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Hyperlipidemia
• Hyperlipidemias
• Myocardial Ischemia

Intervention

Drug:
• torcetrapib/atorvastatin

• atorvastatin

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Netherlands,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change coronary artery atheroma volume as measured by intravascular ultrasound.
Secondary	Changes in levels of lipids and other biomarkers.

External Links

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