- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00134498
A Study Comparing The Efficacy & Safety Of Torcetrapib/Atorvastatin And Atorvastatin In Subjects With High Triglycerides
November 15, 2007 updated by: Pfizer
Phase 3, Multi-Site, Double-Blind, Randomized, Forced Titration, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Fixed Combination Torcetrapib (CP 529,414)/Atorvastatin Administered Orally, Once Daily (Qd) For Eighteen Weeks, Compared With Atorvastatin Alone, In Subjects With Fredrickson Type IV Hypertriglyceridemia
The Torcetrapib project was terminated on December 2, 2006 due to safety findings.
To assess the safety and efficacy of the fixed combination torcetrapib/atorvastatin in subjects with Fredrickson Type IV Hypertriglyceridemia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
For additional information please call: 1-800-718-1021
Study Type
Interventional
Enrollment
160
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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Nova Scotia
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Halifax, Nova Scotia, Canada
- Pfizer Investigational Site
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Ontario
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London, Ontario, Canada
- Pfizer Investigational Site
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Quebec
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Chicoutimi, Quebec, Canada
- Pfizer Investigational Site
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Montreal, Quebec, Canada
- Pfizer Investigational Site
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Ste-Foy, Quebec, Canada
- Pfizer Investigational Site
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California
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Anaheim, California, United States
- Pfizer Investigational Site
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Huntington Beach, California, United States
- Pfizer Investigational Site
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Los Angeles, California, United States
- Pfizer Investigational Site
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Orange, California, United States
- Pfizer Investigational Site
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Orangevale, California, United States
- Pfizer Investigational Site
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Pacific Palisades, California, United States
- Pfizer Investigational Site
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Studio City, California, United States
- Pfizer Investigational Site
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Tustin, California, United States
- Pfizer Investigational Site
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Walnut Creek, California, United States
- Pfizer Investigational Site
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Connecticut
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Farmington, Connecticut, United States
- Pfizer Investigational Site
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District of Columbia
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Washington, District of Columbia, United States
- Pfizer Investigational Site
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Florida
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Hollywood, Florida, United States
- Pfizer Investigational Site
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Longwood, Florida, United States
- Pfizer Investigational Site
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West Palm Beach, Florida, United States
- Pfizer Investigational Site
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Hawaii
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Tripler AMC, Hawaii, 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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Indiana
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Indianapolis, Indiana, United States
- Pfizer Investigational Site
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Kansas
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Overland Park, Kansas, United States
- Pfizer Investigational Site
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Louisiana
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Baton Rouge, Louisiana, United States
- Pfizer Investigational Site
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Maine
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Scarborough, Maine, United States
- Pfizer Investigational Site
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Maryland
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Bethesda, Maryland, 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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Richland, Michigan, United States
- Pfizer Investigational Site
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Minnesota
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St. Cloud, Minnesota, United States
- Pfizer Investigational Site
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Mississippi
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Olive Branch, Mississippi, United States
- Pfizer Investigational Site
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Missouri
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Jefferson City, Missouri, United States
- Pfizer Investigational Site
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St. Louis, Missouri, 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 York
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Rochester, New York, United States
- Pfizer Investigational Site
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Syracuse, New York, United States
- Pfizer Investigational Site
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West Seneca, New York, United States
- Pfizer Investigational Site
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North Carolina
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Statesville, North Carolina, United States
- Pfizer Investigational Site
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Pennsylvania
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Sellersville, Pennsylvania, United States
- Pfizer Investigational Site
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Rhode Island
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Warwick, Rhode Island, United States
- Pfizer Investigational Site
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Texas
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San Antonio, Texas, United States
- Pfizer Investigational Site
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Virginia
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Richmond, Virginia, United States
- Pfizer Investigational Site
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Wisconsin
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Madison, 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:
- Diagnosis of Fredrickson Type IV Hypertriglyceridemia
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 evaluation of response, or render unlikely that the subject would complete the study
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: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Change in HDL-C and non-HDL-C levels
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Secondary Outcome Measures
Outcome Measure |
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Changes in levels of other lipid and 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
February 1, 2005
Study Completion
November 1, 2006
Study Registration Dates
First Submitted
August 22, 2005
First Submitted That Met QC Criteria
August 22, 2005
First Posted (Estimate)
August 24, 2005
Study Record Updates
Last Update Posted (Estimate)
November 16, 2007
Last Update Submitted That Met QC Criteria
November 15, 2007
Last Verified
March 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Genetic Diseases, Inborn
- Metabolism, Inborn Errors
- Lipid Metabolism Disorders
- Dyslipidemias
- Lipid Metabolism, Inborn Errors
- Hyperlipidemias
- Hypertriglyceridemia
- Hyperlipoproteinemias
- Hyperlipoproteinemia Type IV
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Atorvastatin
- Torcetrapib
Other Study ID Numbers
- A5091025
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.
Clinical Trials on Hypertriglyceridemia
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