A Clinical Trial Comparing Torcetrapib/Atorvastatin To Simvastatin In Subjects With High Cholesterol (A5091031).
Primary Purpose
Hyperlipidemia, Dyslipidemia, Hypercholesterolemia
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
torcetrapib/atorvastatin
simvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Hyperlipidemia
Eligibility Criteria
Inclusion Criteria: eligible for statin treatment for LDL cholesterol by NCEP guidelines Exclusion Criteria: Women who are pregnant or lactating, or planning to become pregnant. Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors. Subjects with significant liver or kidney disease or significant heart failure.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Outcomes
Primary Outcome Measures
Percent change in LDL-C and HDL-C from baseline, after six weeks of treatment.
Secondary Outcome Measures
Changes in other lipid parameters and other biomarkers.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00267280
Brief Title
A Clinical Trial Comparing Torcetrapib/Atorvastatin To Simvastatin In Subjects With High Cholesterol (A5091031).
Official Title
A Phase 3, Open-Label, Multisite, Randomized, Parallel Group Study of the Efficacy and Safety of Fixed Combination Torcetrapib/Atorvastatin Administered Once Daily (QD) Compared to Simvastatin for 6 Weeks in Subjects With Hypercholesterolemia (A5091031)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Terminated
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 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.
Cholesterol levels will be measured over six weeks in subjects being treated with two different kinds of cholesterol medications to see how the different treatments compare to one another.
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, Dyslipidemia, Hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
640 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
torcetrapib/atorvastatin
Intervention Type
Drug
Intervention Name(s)
simvastatin
Primary Outcome Measure Information:
Title
Percent change in LDL-C and HDL-C from baseline, after six weeks of treatment.
Secondary Outcome Measure Information:
Title
Changes in other lipid parameters and other biomarkers.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
eligible for statin treatment for LDL cholesterol by NCEP guidelines
Exclusion Criteria:
Women who are pregnant or lactating, or planning to become pregnant.
Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors.
Subjects with significant liver or kidney disease or significant heart failure.
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
Mesa
State/Province
Arizona
Country
United States
Facility Name
Pfizer Investigational Site
City
Alhambra
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Inglewood
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
Santa Ana
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Wilmington
State/Province
Delaware
Country
United States
Facility Name
Pfizer Investigational Site
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Hollywood
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Merritt Island
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Pensacola
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Vero Beach
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Winter Park
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Pfizer Investigational Site
City
Conyers
State/Province
Georgia
Country
United States
Facility Name
Pfizer Investigational Site
City
Woodstock
State/Province
Georgia
Country
United States
Facility Name
Pfizer Investigational Site
City
Hinsdale
State/Province
Illinois
Country
United States
Facility Name
Pfizer Investigational Site
City
La Grange
State/Province
Illinois
Country
United States
Facility Name
Pfizer Investigational Site
City
Park Ridge
State/Province
Illinois
Country
United States
Facility Name
Pfizer Investigational Site
City
Springfield
State/Province
Illinois
Country
United States
Facility Name
Pfizer Investigational Site
City
Kansas City
State/Province
Kansas
Country
United States
Facility Name
Pfizer Investigational Site
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
Pfizer Investigational Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Pfizer Investigational Site
City
Bethesda
State/Province
Maryland
Country
United States
Facility Name
Pfizer Investigational Site
City
Elkton
State/Province
Maryland
Country
United States
Facility Name
Pfizer Investigational Site
City
Flint
State/Province
Michigan
Country
United States
Facility Name
Pfizer Investigational Site
City
Springfield
State/Province
Missouri
Country
United States
Facility Name
Pfizer Investigational Site
City
Lawrenceville
State/Province
New Jersey
Country
United States
Facility Name
Pfizer Investigational Site
City
Albany
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
Seaford
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Pfizer Investigational Site
City
Mansfield
State/Province
Ohio
Country
United States
Facility Name
Pfizer Investigational Site
City
Hillsboro
State/Province
Oregon
Country
United States
Facility Name
Pfizer Investigational Site
City
Beaver
State/Province
Pennsylvania
Country
United States
Facility Name
Pfizer Investigational Site
City
Flourtown
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
Yardley
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
Collierville
State/Province
Tennessee
Country
United States
Facility Name
Pfizer Investigational Site
City
Kingsport
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
North Richland Hills
State/Province
Texas
Country
United States
Facility Name
Pfizer Investigational Site
City
Spring
State/Province
Texas
Country
United States
Facility Name
Pfizer Investigational Site
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Pfizer Investigational Site
City
West Jordan
State/Province
Utah
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
Puyallup
State/Province
Washington
Country
United States
Facility Name
Pfizer Investigational Site
City
Tacoma
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial Comparing Torcetrapib/Atorvastatin To Simvastatin In Subjects With High Cholesterol (A5091031).
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