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A Study of Torcetrapib/Atorvastatin vs Atorvastatin Alone or Placebo in Patients With High Cholesterol

Primary Purpose

Hyperlipidemia

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

About this trial

This is an interventional treatment trial for Hyperlipidemia

Eligibility Criteria

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

Inclusion Criteria: subjects with elevated cholesterol Exclusion Criteria: Women who are pregnant or lactating, or planning to become pregnant. Intolerance to statin therapy resulting in withdrawal 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
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Outcomes

Primary Outcome Measures

LDL and HDL levels

Secondary Outcome Measures

other lipid parameters

Full Information

First Posted
August 26, 2005
Last Updated
February 15, 2012
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00138762
Brief Title
A Study of Torcetrapib/Atorvastatin vs Atorvastatin Alone or Placebo in Patients With High Cholesterol
Official Title
A Phase 3, Double Blind, Placebo-Controlled, Randomized, Parallel Group, Multicenter Study of the Efficacy, Safety and Tolerability of Fixed Combination Torcetrapib/Atorvastatin Administered Orally Once Daily for 6 Months, Compared to Atorvastatin Alone or Placebo in Subjects With Mixed Dyslipidemia (Fredrickson Types IIa and IIb).
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (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. A study to look at lipid levels in subjects taking the study drug, Atorvastatin alone or placebo.
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
Hyperlipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
3800 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
torcetrapib/atorvastatin
Intervention Type
Drug
Intervention Name(s)
atorvastatin
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
LDL and HDL levels
Secondary Outcome Measure Information:
Title
other lipid parameters

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: subjects with elevated cholesterol Exclusion Criteria: Women who are pregnant or lactating, or planning to become pregnant. Intolerance to statin therapy resulting in withdrawal 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
Mobile
State/Province
Alabama
Country
United States
Facility Name
Pfizer Investigational Site
City
Mesa
State/Province
Arizona
Country
United States
Facility Name
Pfizer Investigational Site
City
Oro Valley
State/Province
Arizona
Country
United States
Facility Name
Pfizer Investigational Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Pfizer Investigational Site
City
Sun City
State/Province
Arizona
Country
United States
Facility Name
Pfizer Investigational Site
City
Little Rock
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Arkansas
Country
United States
Facility Name
Pfizer Investigational Site
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Anaheim
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Carmichael
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Concord
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Greenbrae
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
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Mission Viejo
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California
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United States
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Pfizer Investigational Site
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Sacramento
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California
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United States
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Pfizer Investigational Site
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Santa Ana
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California
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United States
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Pfizer Investigational Site
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Stockton
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California
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United States
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Pfizer Investigational Site
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Thouasand Oaks
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California
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United States
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Pfizer Investigational Site
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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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Upland
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California
Country
United States
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Pfizer Investigational Site
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Walnut Creek
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California
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United States
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Pfizer Investigational Site
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Westlake Village
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California
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United States
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Pfizer Investigational Site
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Boulder
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Colorado
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United States
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Pfizer Investigational Site
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Waterbury
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Connecticut
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United States
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Newark
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Delaware
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United States
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Pfizer Investigational Site
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Coral Gables
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United States
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Pfizer Investigational Site
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Ft. Pierce
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United States
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Jacksonville
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Jupiter
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Lake Worth
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Melbourne
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Palm Bay
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United States
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Sebastian
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United States
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Pfizer Investigational Site
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Stuart
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United States
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Pfizer Investigational Site
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Vero Beach
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United States
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Wellington
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United States
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West Palm Beach
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United States
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Chicago
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Illinois
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United States
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Pfizer Investigational Site
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Creve Coevr
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Illinois
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United States
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Pfizer Investigational Site
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Peoria
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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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Iowa City
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Iowa
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United States
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Pfizer Investigational Site
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Kansas City
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Kansas
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United States
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Overland Park
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United States
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Wichita
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Erlanger
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United States
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Louisville
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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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Slidell
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Louisiana
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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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Bethesda
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United States
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Pfizer Investigational Site
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Elkton
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Jackson
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United States
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Jefferson City
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United States
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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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Billings
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United States
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Pfizer Investigational Site
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Lincoln
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Omaha
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Las Vegas
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Endwell
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Lake Success
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Pfizer Investigational Site
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Rochester
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Williamsville
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Charlotte
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Concord
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United States
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Fayetteville
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Monroe
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United States
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Pfizer Investigational Site
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Raleigh
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United States
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Pfizer Investigational Site
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Winston-Salem
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United States
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Pfizer Investigational Site
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Cincinnati
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United States
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Pfizer Investigational Site
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Elyria
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United States
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Pfizer Investigational Site
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Olmsted Township
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United States
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Pfizer Investigational Site
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Westlake
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Tulsa
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United States
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Pfizer Investigational Site
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Beaverton
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United States
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Pfizer Investigational Site
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Hillsboro
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Pfizer Investigational Site
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Portland
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United States
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Pfizer Investigational Site
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Warwick
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United States
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Pfizer Investigational Site
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Greer
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United States
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Pfizer Investigational Site
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Spartanburg
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United States
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Pfizer Investigational Site
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Kingsport
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United States
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Pfizer Investigational Site
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Nashville
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United States
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Pfizer Investigational Site
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Austin
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Pfizer Investigational Site
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Beaumont
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Pfizer Investigational Site
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Bryan
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Pfizer Investigational Site
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Dallas
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Houston
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San Antonio
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The Colony
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United States
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Pfizer Investigational Site
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Salt Lake City
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United States
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Pfizer Investigational Site
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Newport News
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United States
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Pfizer Investigational Site
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Norfolk
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United States
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Pfizer Investigational Site
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Richmond
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United States
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Pfizer Investigational Site
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Renton
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United States
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Pfizer Investigational Site
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Yakima
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United States
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Pfizer Investigational Site
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Milwaukee
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United States
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Pfizer Investigational Site
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Oregon
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Wisconsin
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United States
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Pfizer Investigational Site
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Bruxelles
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Belgium
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Pfizer Investigational Site
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Dottignies
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Belgium
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Pfizer Investigational Site
City
Ham
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Belgium
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Pfizer Investigational Site
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Hasselt
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Belgium
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Pfizer Investigational Site
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Hoeilaart
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Belgium
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Pfizer Investigational Site
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La Louviere
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Belgium
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Pfizer Investigational Site
City
Leuven
Country
Belgium
Facility Name
Pfizer Investigational Site
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Wilsele
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Belgium
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Pfizer Investigational Site
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Beckum
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Germany
Facility Name
Pfizer Investigational Site
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Berlin
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Germany
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Pfizer Investigational Site
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Bochum
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Germany
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Pfizer Investigational Site
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Erlangen
Country
Germany
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Pfizer Investigational Site
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Essen
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Germany
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Pfizer Investigational Site
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Feldafing
Country
Germany
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Pfizer Investigational Site
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Hamburg
Country
Germany
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Pfizer Investigational Site
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Heidelberg
Country
Germany
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Pfizer Investigational Site
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Homburg/Saar
Country
Germany
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Pfizer Investigational Site
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Karlsruhe
Country
Germany
Facility Name
Pfizer Investigational Site
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Kuenzing
Country
Germany
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Pfizer Investigational Site
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Nuernberg
Country
Germany
Facility Name
Pfizer Investigational Site
City
Offenbach
Country
Germany
Facility Name
Pfizer Investigational Site
City
Rodgau
Country
Germany
Facility Name
Pfizer Investigational Site
City
Schwerin
Country
Germany
Facility Name
Pfizer Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Suwon
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Mexico
State/Province
D.f.
Country
Mexico
Facility Name
Pfizer Investigational Site
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Tlalpan
State/Province
D.f.
Country
Mexico
Facility Name
Pfizer Investigational Site
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Mexico
State/Province
DF
Country
Mexico
Facility Name
Pfizer Investigational Site
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Monterrey
State/Province
Nuevo Leon
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Puebla
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Bekkestua
Country
Norway
Facility Name
Pfizer Investigational Site
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Elverum
Country
Norway
Facility Name
Pfizer Investigational Site
City
Honefoss
Country
Norway
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Pfizer Investigational Site
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Jessheim
Country
Norway
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Pfizer Investigational Site
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Kongsberg
Country
Norway
Facility Name
Pfizer Investigational Site
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Lena
Country
Norway
Facility Name
Pfizer Investigational Site
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Lierskogen
Country
Norway
Facility Name
Pfizer Investigational Site
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Molde
Country
Norway
Facility Name
Pfizer Investigational Site
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Moss
Country
Norway
Facility Name
Pfizer Investigational Site
City
Oslo
Country
Norway
Facility Name
Pfizer Investigational Site
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Roverud
Country
Norway
Facility Name
Pfizer Investigational Site
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Skedsmokorset
Country
Norway
Facility Name
Pfizer Investigational Site
City
Tromso
Country
Norway
Facility Name
Pfizer Investigational Site
City
Goteborg
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Jarfalla
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Linkoping
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Orebro
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Strangnas
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Umea
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Penzance
State/Province
Cornwall
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Woolwell, Plymouth
State/Province
Devon
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Middlesex
State/Province
Harrow
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Garston
State/Province
Hertfordshire
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Blackpool
State/Province
Lancashire
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Blackpool
State/Province
Lancs. Fy3 7dq
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Addlestone
State/Province
Surrey
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
East Horsley, Leatherhead
State/Province
Surrey
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Warminster
State/Province
Wiltshire
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Study of Torcetrapib/Atorvastatin vs Atorvastatin Alone or Placebo in Patients With High Cholesterol

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