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A Study Examining Torcetrapib/Atorvastatin And Atorvastatin Effects On Clinical CV Events In Patients With Heart Disease (ILLUMINATE)

Primary Purpose

Coronary Disease, Diabetes Mellitus

Status
Terminated
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

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

Inclusion Criteria: Diagnosis of coronary heart disease or risk equivalents that place the patient at high risk for cardiovascular disease events 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 evaluationof response, or render unlikely that the subject would complete the study

Sites / Locations

  • Pfizer Investigational Site
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Outcomes

Primary Outcome Measures

The time to first occurrence of a major cardiovascular disease event

Secondary Outcome Measures

Various composites of major cardiovascular disease events and other lipid parameters

Full Information

First Posted
August 22, 2005
Last Updated
January 30, 2012
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00134264
Brief Title
A Study Examining Torcetrapib/Atorvastatin And Atorvastatin Effects On Clinical CV Events In Patients With Heart Disease
Acronym
ILLUMINATE
Official Title
Phase 3 Multi Center, Double Blind, Randomized, Parallel Group Evaluation Of The Fixed Combination Torcetrapib/Atorvastatin, Administered Orally, Once Daily (Qd), Compared With Atorvastatin Alone, On The Occurrence Of Major Cardiovascular Events In Subjects With Coronary Heart Disease Or Risk Equivalents
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Terminated
Study Start Date
July 2004 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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 demonstrate if torcetrapib/atorvastatin can reduce the risk for major cardiovascular disease events, when compared to atorvastatin alone, in patients with coronary heart disease or risk equivalents

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease, Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
15067 (Actual)

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
The time to first occurrence of a major cardiovascular disease event
Secondary Outcome Measure Information:
Title
Various composites of major cardiovascular disease events and other lipid parameters

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of coronary heart disease or risk equivalents that place the patient at high risk for cardiovascular disease events 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 evaluationof 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
Alabaster
State/Province
Alabama
Country
United States
Facility Name
Pfizer Investigational Site
City
Birmingham
State/Province
Alabama
Country
United States
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Pfizer Investigational Site
City
Gilbert
State/Province
Arizona
Country
United States
Facility Name
Pfizer Investigational Site
City
Phoenix
State/Province
Arizona
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United States
Facility Name
Pfizer Investigational Site
City
Tucson
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Arizona
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United States
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Pfizer Investigational Site
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Fresno
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California
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United States
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Pfizer Investigational Site
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Los Angeles
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California
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United States
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Pfizer Investigational Site
City
Modesto
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California
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United States
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Pfizer Investigational Site
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San Diego
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California
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United States
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Pfizer Investigational Site
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Santa Rosa
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California
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United States
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Tustin
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California
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United States
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Pfizer Investigational Site
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Walnut Creek
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California
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Denver
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Colorado
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Longmont
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Colorado
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Pfizer Investigational Site
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Guilford
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Connecticut
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United States
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Pfizer Investigational Site
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Hartford
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Connecticut
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United States
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Pfizer Investigational Site
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Washington
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District of Columbia
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United States
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Pfizer Investigational Site
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Clearwater
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Florida
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United States
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Pfizer Investigational Site
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Coral Gables
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Florida
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United States
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Fort Meyers
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Jacksonville Beach
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Jacksonville
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Lakeland
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Orlando
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Pensacola
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Port Charlotte
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Sarasota
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West Palm Beach
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Atlanta
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Aurora
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Blue Island
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Chicago
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Evansville
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Fort Wayne
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Davenport
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des Moines
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Iowa City
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Wichita
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Witchita
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Louisville
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Baton Rouge
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Covington
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Marrero
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Bel Air
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Columbia
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Towson
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Westminster
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Abington
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Haverhill
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Natick
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Grand Rapids
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Minneapolis
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Billings
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Butte
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Omaha
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Papillon
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Las Vegas
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Concord
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Lebanon
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Manchester
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Elmer
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Haddon Heights
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New Brunswick
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Garden City
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New Hyde Park
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Rochester
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Durham
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Winston-salem
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Cincinnati
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Cleveland
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Columbus
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Mansfield
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Sandusky
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Toledo
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Oklahoma City
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Portland
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Oregon
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United States
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Beaver
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Philadelphia
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United States
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Kingsport
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Nashville
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United States
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Beaumont
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Dallas
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Houston
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Plano
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San Antonio
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Salt Lake City
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Burlington
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Norfolk
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Richmond
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Burien
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Tacoma
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Concord
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Australia
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Pfizer Investigational Site
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East Gosford
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New South Wales
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Australia
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Pfizer Investigational Site
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St. Leonards
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New South Wales
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Australia
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Wollongong
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New South Wales
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Australia
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Pfizer Investigational Site
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Chermside
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Queensland
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Australia
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Pfizer Investigational Site
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Herston
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Queensland
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Australia
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Pfizer Investigational Site
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Woolloongabba
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Queensland
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Australia
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Pfizer Investigational Site
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Adelaide
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South Australia
Country
Australia
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Pfizer Investigational Site
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Bedford Park
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South Australia
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Australia
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Pfizer Investigational Site
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Woodville
State/Province
South Australia
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Australia
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Pfizer Investigational Site
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Clayton
State/Province
Victoria
Country
Australia
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Pfizer Investigational Site
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Fitzroy
State/Province
Victoria
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Australia
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Pfizer Investigational Site
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Footscray
State/Province
Victoria
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Australia
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Pfizer Investigational Site
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Heidelberg
State/Province
Victoria
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Australia
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Pfizer Investigational Site
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Prahran
State/Province
Victoria
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Australia
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Pfizer Investigational Site
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Fremantle
State/Province
Western Australia
Country
Australia
Facility Name
Pfizer Investigational Site
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Joondalup
State/Province
Western Australia
Country
Australia
Facility Name
Pfizer Investigational Site
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Camperdown
Country
Australia
Facility Name
Pfizer Investigational Site
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Darlinghurst
Country
Australia
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Pfizer Investigational Site
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Geelong
Country
Australia
Facility Name
Pfizer Investigational Site
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Launceston, Tas
Country
Australia
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Pfizer Investigational Site
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Melbourne
Country
Australia
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Pfizer Investigational Site
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Nedlands
Country
Australia
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Pfizer Investigational Site
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Perth
Country
Australia
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Pfizer Investigational Site
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Southport
Country
Australia
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Pfizer Investigational Site
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Calgary
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Alberta
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Canada
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Pfizer Investigational Site
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Vancouver
State/Province
British Columbia
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Canada
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Pfizer Investigational Site
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Winnipeg
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Manitoba
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Canada
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Pfizer Investigational Site
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Halifax
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Nova Scotia
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Canada
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Pfizer Investigational Site
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Cornwall
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Ontario
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Canada
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Pfizer Investigational Site
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Newmarket
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Ontario
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Canada
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Pfizer Investigational Site
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Oshawa
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Ontario
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Canada
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Pfizer Investigational Site
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Sarnia
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Ontario
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Canada
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Pfizer Investigational Site
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Scarborough
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Ontario
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Canada
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Pfizer Investigational Site
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Toronto
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Ontario
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Canada
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Laval
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Quebec
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Canada
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Pfizer Investigational Site
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Montreal
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Quebec
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Canada
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Pfizer Investigational Site
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Sainte-foy
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Quebec
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Canada
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Pfizer Investigational Site
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Sherbrooke
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Quebec
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Canada
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Pfizer Investigational Site
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Ste-foy
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Quebec
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Canada
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Saint John's
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Canada
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Amsterdam
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Netherlands
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Pfizer Investigational Site
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AN Rotterdam
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Netherlands
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Pfizer Investigational Site
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Apeldoorn
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Netherlands
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Arnhem
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Netherlands
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Breda
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Netherlands
Facility Name
Pfizer Investigational Site
City
Cappelle aan den IJssel
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Delft
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Eindhoven
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Goes
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Gouda
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Groningen
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Heerlen
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Hertogenbosch
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Hoorn
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Leiden
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Maastricht
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Nijmegen
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Rotterdam
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Sittard
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Utrecht
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Velp
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Venlo
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Zoetermeer
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Sant Coloma de Gramenet
State/Province
Barcelona
Country
Spain
Facility Name
Pfizer Investigational Site
City
Terrasa
State/Province
Barcelona
Country
Spain
Facility Name
Pfizer Investigational Site
City
Jerez de La Frontera
State/Province
Cadiz
Country
Spain
Facility Name
Pfizer Investigational Site
City
Santander
State/Province
Cantabria
Country
Spain
Facility Name
Pfizer Investigational Site
City
San Sebastian
State/Province
Guipuzcoa
Country
Spain
Facility Name
Pfizer Investigational Site
City
Ferrol
State/Province
La Coruna
Country
Spain
Facility Name
Pfizer Investigational Site
City
Santiago De Compostela
State/Province
La Coruña
Country
Spain
Facility Name
Pfizer Investigational Site
City
Almeria
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
Country
Spain
Facility Name
Pfizer Investigational Site
City
Ciudad Real
Country
Spain
Facility Name
Pfizer Investigational Site
City
Granada
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
Country
Spain
Facility Name
Pfizer Investigational Site
City
Malaga
Country
Spain
Facility Name
Pfizer Investigational Site
City
Salamanca
Country
Spain
Facility Name
Pfizer Investigational Site
City
Sevilla
Country
Spain
Facility Name
Pfizer Investigational Site
City
Valencia
Country
Spain
Facility Name
Pfizer Investigational Site
City
Zaragoza
Country
Spain
Facility Name
Pfizer Investigational Site
City
Borås
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Eskilstuna
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Goteborg
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Göteborg
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Helsingborg
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Hässleholm
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Karlshamn
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Koping
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Linköping
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Lulea
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Lund
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Malmo
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Molndal
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Norrkoping
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Ostersund
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Skelleftea
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Uddevalla
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Uppsala
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Vaxjo
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Västervik
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Wrexham
State/Province
Clwyd
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Woolwich
State/Province
London
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Glasgow
State/Province
Scotland
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Aberdeen
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bath
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Birmingham
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bournemouth
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Brighton, East Sussex
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bristol
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Cardiff
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Chichester
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Coventry
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Dundee
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Edinburgh
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Exeter
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Glasgow
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Harrow
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Leicester
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Liverpool
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Newcastle-upon-Tyne
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Romford
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Shrewsbury
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Warwick
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29103916
Citation
Arsenault BJ, Petrides F, Tabet F, Bao W, Hovingh GK, Boekholdt SM, Ramin-Mangata S, Meilhac O, DeMicco D, Rye KA, Waters DD, Kastelein JJP, Barter P, Lambert G. Effect of atorvastatin, cholesterol ester transfer protein inhibition, and diabetes mellitus on circulating proprotein subtilisin kexin type 9 and lipoprotein(a) levels in patients at high cardiovascular risk. J Clin Lipidol. 2018 Jan-Feb;12(1):130-136. doi: 10.1016/j.jacl.2017.10.001. Epub 2017 Oct 12.
Results Reference
derived
PubMed Identifier
28974520
Citation
Williams SA, Murthy AC, DeLisle RK, Hyde C, Malarstig A, Ostroff R, Weiss SJ, Segal MR, Ganz P. Improving Assessment of Drug Safety Through Proteomics: Early Detection and Mechanistic Characterization of the Unforeseen Harmful Effects of Torcetrapib. Circulation. 2018 Mar 6;137(10):999-1010. doi: 10.1161/CIRCULATIONAHA.117.028213. Epub 2017 Oct 3.
Results Reference
derived
PubMed Identifier
28431663
Citation
Bagdade J, Barter P, Quiroga C, Alaupovic P. Effects of Torcetrapib and Statin Treatment on ApoC-III and Apoprotein-Defined Lipoprotein Subclasses (from the ILLUMINATE Trial). Am J Cardiol. 2017 Jun 1;119(11):1753-1756. doi: 10.1016/j.amjcard.2017.02.049. Epub 2017 Mar 18.
Results Reference
derived
PubMed Identifier
21804130
Citation
Barter PJ, Rye KA, Tardif JC, Waters DD, Boekholdt SM, Breazna A, Kastelein JJ. Effect of torcetrapib on glucose, insulin, and hemoglobin A1c in subjects in the Investigation of Lipid Level Management to Understand its Impact in Atherosclerotic Events (ILLUMINATE) trial. Circulation. 2011 Aug 2;124(5):555-62. doi: 10.1161/CIRCULATIONAHA.111.018259. Epub 2011 Jul 18.
Results Reference
derived
PubMed Identifier
20645885
Citation
Dogan S, Duivenvoorden R, Grobbee DE, Kastelein JJ, Shear CL, Evans GW, Visseren FL, Bots ML; Radiance 1 and Radiance 2 Study Groups. Ultrasound protocols to measure carotid intima-media thickness in trials; comparison of reproducibility, rate of progression, and effect of intervention in subjects with familial hypercholesterolemia and subjects with mixed dyslipidemia. Ann Med. 2010 Sep;42(6):447-64. doi: 10.3109/07853890.2010.499132.
Results Reference
derived
PubMed Identifier
20228610
Citation
Dogan S, Duivenvoorden R, Grobbee DE, Kastelein JJ, Shear CL, Evans GW, Visseren FL, Bots ML; Radiance 1 and 2 Study Groups. Completeness of carotid intima media thickness measurements depends on body composition: the RADIANCE 1 and 2 trials. J Atheroscler Thromb. 2010 May;17(5):526-35. doi: 10.5551/jat.3269. Epub 2010 Mar 13.
Results Reference
derived
PubMed Identifier
19029469
Citation
Vergeer M, Bots ML, van Leuven SI, Basart DC, Sijbrands EJ, Evans GW, Grobbee DE, Visseren FL, Stalenhoef AF, Stroes ES, Kastelein JJ. Cholesteryl ester transfer protein inhibitor torcetrapib and off-target toxicity: a pooled analysis of the rating atherosclerotic disease change by imaging with a new CETP inhibitor (RADIANCE) trials. Circulation. 2008 Dec 9;118(24):2515-22. doi: 10.1161/CIRCULATIONAHA.108.772665. Epub 2008 Nov 24. Erratum In: Circulation. 2009 Feb 10;119(5):e197.
Results Reference
derived
PubMed Identifier
17984165
Citation
Barter PJ, Caulfield M, Eriksson M, Grundy SM, Kastelein JJ, Komajda M, Lopez-Sendon J, Mosca L, Tardif JC, Waters DD, Shear CL, Revkin JH, Buhr KA, Fisher MR, Tall AR, Brewer B; ILLUMINATE Investigators. Effects of torcetrapib in patients at high risk for coronary events. N Engl J Med. 2007 Nov 22;357(21):2109-22. doi: 10.1056/NEJMoa0706628. Epub 2007 Nov 5.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5091043&StudyName=A+Study+Examining+Torcetrapib%2FAtorvastatin+And+Atorvastatin+Effects+On+Clinical+CV+Events+In+Patients+With+Heart+Disease
Description
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A Study Examining Torcetrapib/Atorvastatin And Atorvastatin Effects On Clinical CV Events In Patients With Heart Disease

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