- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00267254
A Clinical Trial Comparing Torcetrapib/Atorvastatin To Simvastatin In Subjects With High Cholesterol.
November 20, 2007 updated by: Pfizer
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 (A5091030)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
For additional information please call: 1-800-718-1021
Study Type
Interventional
Enrollment
640
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States
- Pfizer Investigational Site
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Mobile, Alabama, United States
- Pfizer Investigational Site
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Arizona
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Mesa, Arizona, United States
- Pfizer Investigational Site
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Phoenix, Arizona, United States
- Pfizer Investigational Site
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Tempe, Arizona, United States
- Pfizer Investigational Site
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Arkansas
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Little Rock, Arkansas, United States
- Pfizer Investigational Site
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California
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Los Angeles, California, United States
- Pfizer Investigational Site
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San Diego, California, United States
- Pfizer Investigational Site
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Santa Rosa, California, United States
- Pfizer Investigational Site
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Florida
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Boynton Beach, Florida, United States
- Pfizer Investigational Site
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Melbourne, Florida, United States
- Pfizer Investigational Site
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Merritt Island, Florida, United States
- Pfizer Investigational Site
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Palm Bay, Florida, United States
- Pfizer Investigational Site
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Safety Harbor, Florida, United States
- Pfizer Investigational Site
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Tampa, Florida, United States
- Pfizer Investigational Site
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Illinois
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Chicago, Illinois, United States
- Pfizer Investigational Site
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Kansas
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Newton, Kansas, United States
- Pfizer Investigational Site
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Topeka, Kansas, United States
- Pfizer Investigational Site
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Wichita, Kansas, United States
- Pfizer Investigational Site
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Kentucky
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Madisonville, Kentucky, United States
- Pfizer Investigational Site
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Massachusetts
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Boston, Massachusetts, United States
- Pfizer Investigational Site
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Michigan
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Ann Arbor, Michigan, United States
- Pfizer Investigational Site
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Canton, Michigan, United States
- Pfizer Investigational Site
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Portage, Michigan, United States
- Pfizer Investigational Site
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Troy, Michigan, United States
- Pfizer Investigational Site
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Minnesota
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Minneapolis, Minnesota, United States
- Pfizer Investigational Site
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Missouri
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Kansas City, Missouri, United States
- Pfizer Investigational Site
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St. Louis, Missouri, United States
- Pfizer Investigational Site
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Montana
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Butte, Montana, United States
- Pfizer Investigational Site
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Nebraska
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Lincoln, Nebraska, United States
- Pfizer Investigational Site
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Nevada
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Las Vegas, Nevada, United States
- Pfizer Investigational Site
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New Hampshire
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Concord, New Hampshire, United States
- Pfizer Investigational Site
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New Jersey
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Trenton, New Jersey, United States
- Pfizer Investigational Site
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New York
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Cooperstown, New York, United States
- Pfizer Investigational Site
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East Syracuse, New York, United States
- Pfizer Investigational Site
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Rochester, New York, United States
- Pfizer Investigational Site
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North Carolina
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Charlotte, North Carolina, United States
- Pfizer Investigational Site
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Ohio
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Cincinnati, Ohio, United States
- Pfizer Investigational Site
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South Carolina
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Clinton, South Carolina, United States
- Pfizer Investigational Site
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Tennessee
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Cordova, Tennessee, United States
- Pfizer Investigational Site
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Memphis, Tennessee, United States
- Pfizer Investigational Site
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Milan, Tennessee, United States
- Pfizer Investigational Site
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Texas
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Dallas, Texas, United States
- Pfizer Investigational Site
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Fort Worth, Texas, United States
- Pfizer Investigational Site
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San Antonio, Texas, United States
- Pfizer Investigational Site
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Utah
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Payson, Utah, United States
- Pfizer Investigational Site
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Salt Lake City, Utah, United States
- Pfizer Investigational Site
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Virginia
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Norfolk, Virginia, United States
- Pfizer Investigational Site
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Wisconsin
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Milwaukee, Wisconsin, United States
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Percent change in LDL-C and HDL-C from baseline, after six weeks of treatment.
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Secondary Outcome Measures
Outcome Measure |
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Changes in other lipid parameters and other biomarkers.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Study Completion (Actual)
August 1, 2006
Study Registration Dates
First Submitted
December 19, 2005
First Submitted That Met QC Criteria
December 19, 2005
First Posted (Estimate)
December 20, 2005
Study Record Updates
Last Update Posted (Estimate)
November 21, 2007
Last Update Submitted That Met QC Criteria
November 20, 2007
Last Verified
April 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Lipid Metabolism Disorders
- Dyslipidemias
- Hypercholesterolemia
- Hyperlipidemias
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Atorvastatin
- Simvastatin
- Torcetrapib
Other Study ID Numbers
- A5091030
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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