- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00137462
Lipitor Trial To Study The Effect Of Torcetrpib/Atorvastatin To Atorvastatin Alone.
November 15, 2007 updated by: Pfizer
A Phase 3, Double-Blind, Randomized, Multisite Trial Of The Efficacy, Safety, And Tolerability Of The Fixed Combination Torcetrapib/Atorvastatin Administered Orally, Once Daily For 12 Months, Compared To Atorvastatin Alone, Titrated Based On NCEP ATP-III LDL-C Goals In Subjects With Fredrickson Types IIa And IIb Dyslipidemias
The Torcetrapib project was terminated on December 2, 2006 due to safety findings.
To look at various lipids in the blood of people with Fredrickson Type IIa and Type IIb mixed dyslipidemias
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
For additional information please call: 1-800-718-1021
Study Type
Interventional
Enrollment
900
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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Alberta
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Edmonton, Alberta, Canada, T6G 2B7
- Pfizer Investigational Site
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British Columbia
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Coquitlam, British Columbia, Canada, V3K 3P4
- Pfizer Investigational Site
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Ontario
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London, Ontario, Canada, N6C 5J1
- Pfizer Investigational Site
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London, Ontario, Canada, N6G 2M3
- Pfizer Investigational Site
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Ottawa, Ontario, Canada, K1H 8K7
- Pfizer Investigational Site
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Sarnia, Ontario, Canada, N7T 4X3
- Pfizer Investigational Site
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Toronto, Ontario, Canada, M9W 4L6
- Pfizer Investigational Site
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Prince Edward Island
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Charlottetown, Prince Edward Island, Canada, C1A 1L2
- Pfizer Investigational Site
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Quebec
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Mirabel, Quebec, Canada, J7J 2K8
- Pfizer Investigational Site
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Pointe-Claire, Quebec, Canada, H9R 4S3
- Pfizer Investigational Site
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St. Georges de Beauce, Quebec, Canada, G5Y 4W1
- Pfizer Investigational Site
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Alabama
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Huntsville, Alabama, United States, 35802
- Pfizer Investigational Site
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Union Grove, Alabama, United States, 35175
- Pfizer Investigational Site
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California
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Fresno, California, United States, 93720
- Pfizer Investigational Site
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Los Angeles, California, United States, 90057
- Pfizer Investigational Site
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Orange, California, United States, 92868
- Pfizer Investigational Site
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San Diego, California, United States, 92128
- Pfizer Investigational Site
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Colorado
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Denver, Colorado, United States, 80220
- Pfizer Investigational Site
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Denver, Colorado, United States, 80262
- Pfizer Investigational Site
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Golden, Colorado, United States, 80401
- Pfizer Investigational Site
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Connecticut
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Bridgeport, Connecticut, United States, 06610
- Pfizer Investigational Site
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Fairfield, Connecticut, United States, 06824
- Pfizer Investigational Site
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Trumbull, Connecticut, United States, 06611
- Pfizer Investigational Site
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Waterbury, Connecticut, United States, 06708
- Pfizer Investigational Site
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District of Columbia
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Washington, District of Columbia, United States, 20037
- Pfizer Investigational Site
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Florida
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Boynton Beach, Florida, United States, 33437
- Pfizer Investigational Site
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Fort Lauderdale, Florida, United States, 33308
- Pfizer Investigational Site
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Gainesville, Florida, United States, 32610
- Pfizer Investigational Site
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Gainesville, Florida, United States, 32605
- Pfizer Investigational Site
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Gainsville, Florida, United States, 32610
- Pfizer Investigational Site
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Sebastian, Florida, United States, 32958
- Pfizer Investigational Site
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Vero Beach, Florida, United States, 32960
- Pfizer Investigational Site
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Illinois
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Rockford, Illinois, United States, 61108
- Pfizer Investigational Site
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Springfield, Illinois, United States, 62704
- Pfizer Investigational Site
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Kansas
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Olathe, Kansas, United States, 66061
- Pfizer Investigational Site
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Overland Park, Kansas, United States, 66210
- Pfizer Investigational Site
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Kentucky
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Madisonville, Kentucky, United States, 42431
- Pfizer Investigational Site
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Massachusetts
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Burlington, Massachusetts, United States, 01805
- Pfizer Investigational Site
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Michigan
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Grand Rapids, Michigan, United States, 49525
- Pfizer Investigational Site
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Troy, Michigan, United States, 48098
- Pfizer Investigational Site
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New Mexico
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Albuquerque, New Mexico, United States, 87102
- Pfizer Investigational Site
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Albuquerque, New Mexico, United States, 87106
- Pfizer Investigational Site
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New York
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Orchard Park, New York, United States, 14127
- Pfizer Investigational Site
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Syracuse, New York, United States, 13202
- Pfizer Investigational Site
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Syracuse, New York, United States, 13210
- Pfizer Investigational Site
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Williamsville, New York, United States, 14221
- Pfizer Investigational Site
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North Carolina
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Charlotte, North Carolina, United States, 28262
- Pfizer Investigational Site
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Ohio
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Cleveland, Ohio, United States, 44126
- Pfizer Investigational Site
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Columbus, Ohio, United States, 43214
- Pfizer Investigational Site
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Oregon
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Keizer, Oregon, United States, 97303
- Pfizer Investigational Site
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Salem, Oregon, United States, 97302
- Pfizer Investigational Site
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Pennsylvania
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Doylestown, Pennsylvania, United States, 18901
- Pfizer Investigational Site
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South Carolina
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Charleston, South Carolina, United States, 29425
- Pfizer Investigational Site
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Mt. Pleasant, South Carolina, United States, 29464
- Pfizer Investigational Site
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Mt. Pleasant, South Carolina, United States, 83464
- Pfizer Investigational Site
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Tennessee
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Kingsport, Tennessee, United States, 37660
- Pfizer Investigational Site
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Morristown, Tennessee, United States, 37813
- Pfizer Investigational Site
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Texas
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Dallas, Texas, United States, 75230
- Pfizer Investigational Site
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McKinney, Texas, United States, 75069
- 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:
- Statin eligible per NCEP ATP-III guidelines
- At least 18 years of age
Exclusion Criteria:
- Women who are pregnant or lactating, or planning to become pregnant
- Intolerance to statin therapy
- 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 lipid parameters (HDL, LDL) at various timepoints over 12 months.
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Secondary Outcome Measures
Outcome Measure |
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Changes in levels of lipids and other biomarkers.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
November 1, 2004
Study Completion
September 1, 2006
Study Registration Dates
First Submitted
August 26, 2005
First Submitted That Met QC Criteria
August 26, 2005
First Posted (Estimate)
August 29, 2005
Study Record Updates
Last Update Posted (Estimate)
November 16, 2007
Last Update Submitted That Met QC Criteria
November 15, 2007
Last Verified
December 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A5091019
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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