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

Primary Purpose

Coronary Disease, Coronary Arteriosclerosis, Hyperlipidemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
torcetrapib/atorvastatin
atorvastatin
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
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Outcomes

Primary Outcome Measures

Change coronary artery atheroma volume as measured by intravascular ultrasound.

Secondary Outcome Measures

Changes in levels of lipids and other biomarkers.

Full Information

First Posted
August 22, 2005
Last Updated
December 6, 2007
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00134173
Brief Title
A Coronary IVUS Study to Compare Torcetrapib/Atorvastatin to Atorvastatin Alone in Subjects With Coronary Heart Disease
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease, Coronary Arteriosclerosis, Hyperlipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
torcetrapib/atorvastatin
Intervention Type
Drug
Intervention Name(s)
atorvastatin
Primary Outcome Measure Information:
Title
Change coronary artery atheroma volume as measured by intravascular ultrasound.
Secondary Outcome Measure Information:
Title
Changes in levels of lipids and other biomarkers.

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
19029466
Citation
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.
Results Reference
derived
PubMed Identifier
17387129
Citation
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].
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5091005&StudyName=A+Coronary+IVUS+Study+to+Compare+Torcetrapib%2FAtorvastatin+to+Atorvastatin+Alone+in+Subjects+with+Coronary+Heart+Disease
Description
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Learn more about this trial

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

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