A Clinical Trial Comparing Torcetrapib/Atorvastatin To Simvastatin In Subjects With High Cholesterol (A5091031).
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)
1 other identifier
interventional
640
1 country
51
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2006
Shorter than P25 for phase_3
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2005
CompletedFirst Posted
Study publicly available on registry
December 20, 2005
CompletedStudy Start
First participant enrolled
January 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedFebruary 17, 2012
February 1, 2012
11 months
December 19, 2005
February 15, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Percent change in LDL-C and HDL-C from baseline, after six weeks of treatment.
Secondary Outcomes (1)
Changes in other lipid parameters and other biomarkers.
Interventions
Eligibility Criteria
You may qualify if:
- eligible for statin treatment for LDL cholesterol by NCEP guidelines
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (51)
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Mesa, Arizona, United States
Pfizer Investigational Site
Alhambra, California, United States
Pfizer Investigational Site
Inglewood, California, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Santa Ana, California, United States
Pfizer Investigational Site
Wilmington, Delaware, United States
Pfizer Investigational Site
Fort Lauderdale, Florida, United States
Pfizer Investigational Site
Hollywood, Florida, United States
Pfizer Investigational Site
Jacksonville, Florida, United States
Pfizer Investigational Site
Merritt Island, Florida, United States
Pfizer Investigational Site
Pensacola, Florida, United States
Pfizer Investigational Site
Vero Beach, Florida, United States
Pfizer Investigational Site
Winter Park, Florida, United States
Pfizer Investigational Site
Atlanta, Georgia, United States
Pfizer Investigational Site
Conyers, Georgia, United States
Pfizer Investigational Site
Woodstock, Georgia, United States
Pfizer Investigational Site
Hinsdale, Illinois, United States
Pfizer Investigational Site
La Grange, Illinois, United States
Pfizer Investigational Site
Park Ridge, Illinois, United States
Pfizer Investigational Site
Springfield, Illinois, United States
Pfizer Investigational Site
Kansas City, Kansas, United States
Pfizer Investigational Site
Lexington, Kentucky, United States
Pfizer Investigational Site
Baltimore, Maryland, United States
Pfizer Investigational Site
Bethesda, Maryland, United States
Pfizer Investigational Site
Elkton, Maryland, United States
Pfizer Investigational Site
Flint, Michigan, United States
Pfizer Investigational Site
Springfield, Missouri, United States
Pfizer Investigational Site
Lawrenceville, New Jersey, United States
Pfizer Investigational Site
Albany, New York, United States
Pfizer Investigational Site
Seaford, New York, United States
Pfizer Investigational Site
Charlotte, North Carolina, United States
Pfizer Investigational Site
Cincinnati, Ohio, United States
Pfizer Investigational Site
Mansfield, Ohio, United States
Pfizer Investigational Site
Hillsboro, Oregon, United States
Pfizer Investigational Site
Beaver, Pennsylvania, United States
Pfizer Investigational Site
Flourtown, Pennsylvania, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States
Pfizer Investigational Site
Yardley, Pennsylvania, United States
Pfizer Investigational Site
Greenville, South Carolina, United States
Pfizer Investigational Site
Collierville, Tennessee, United States
Pfizer Investigational Site
Kingsport, Tennessee, United States
Pfizer Investigational Site
Knoxville, Tennessee, United States
Pfizer Investigational Site
North Richland Hills, Texas, United States
Pfizer Investigational Site
Spring, Texas, United States
Pfizer Investigational Site
Salt Lake City, Utah, United States
Pfizer Investigational Site
West Jordan, Utah, United States
Pfizer Investigational Site
Richmond, Virginia, United States
Pfizer Investigational Site
Bellevue, Washington, United States
Pfizer Investigational Site
Puyallup, Washington, United States
Pfizer Investigational Site
Tacoma, Washington, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2005
First Posted
December 20, 2005
Study Start
January 1, 2006
Primary Completion
December 1, 2006
Study Completion
December 1, 2006
Last Updated
February 17, 2012
Record last verified: 2012-02