- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00134238
Carotid B-mode Ultrasound Study to Compare Anti-Atherosclerotic Effect of Torcetrapib/Atorvastatin to Atorvastatin. (RADIANCE 2)
February 15, 2012 updated by: Pfizer
Phase 3 Multi-Center, Double-Blind, Randomized, Parallel Group, Carotid B-mode Ultrasound Evaluation of the Anti-Atherosclerotic Efficacy, Safety, and Tolerability of Fixed Combination CP-529,414/Atorvastatin, Administered Orally, Once Daily (QD) for 24 Months, Compared With Atorvastatin Alone, in Subjects With Mixed Hyperlipidemia
The Torcetrapib project was terminated on December 2, 2006 due to safety findings.
To look at ultrasound images taken in the carotid arteries and to look at various lipids in the blood of people with mixed hyperlipidemia
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
For additional information please call: 1-800-718-1021
Study Type
Interventional
Enrollment (Actual)
755
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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Quebec, Canada
- Pfizer Investigational Site
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British Columbia
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Vancouver, British Columbia, Canada
- Pfizer Investigational Site
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Manitoba
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Winnipeg, Manitoba, 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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Prague 4, Czech Republic
- Pfizer Investigational Site
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Kuopio, Finland
- Pfizer Investigational Site
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Paris Cedex, France
- Pfizer Investigational Site
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Nijmegen, Netherlands
- Pfizer Investigational Site
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Rotterdam, Netherlands
- Pfizer Investigational Site
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Utrecht, Netherlands
- Pfizer Investigational Site
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Arizona
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Gilbert, Arizona, United States
- Pfizer Investigational Site
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Phoenix, Arizona, United States
- Pfizer Investigational Site
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Scottsdale, Arizona, United States
- Pfizer Investigational Site
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California
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Alhambra, California, United States
- Pfizer Investigational Site
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Encinitas, California, United States
- Pfizer Investigational Site
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La Jolla, California, United States
- Pfizer Investigational Site
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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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Connecticut
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Hartford, Connecticut, United States
- Pfizer Investigational Site
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Florida
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Melbourne, Florida, United States
- Pfizer Investigational Site
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Palm Bay, Florida, United States
- Pfizer Investigational Site
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Sebastian, Florida, United States
- Pfizer Investigational Site
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Stuart, Florida, United States
- Pfizer Investigational Site
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Vero Beach, Florida, 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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Massachusetts
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Boston, Massachusetts, United States
- Pfizer Investigational Site
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Cambridge, Massachusetts, United States
- Pfizer Investigational Site
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Minnesota
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Edina, Minnesota, United States
- Pfizer Investigational Site
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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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New Hampshire
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Concord, New Hampshire, United States
- Pfizer Investigational Site
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New York
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Bronxville, New York, United States
- Pfizer Investigational Site
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Buffalo, New York, United States
- Pfizer Investigational Site
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Mount Vernon, New York, United States
- Pfizer Investigational Site
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New York, New York, United States
- Pfizer Investigational Site
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Williamsville, New York, United States
- Pfizer Investigational Site
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North Carolina
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Durham, North Carolina, United States
- Pfizer Investigational Site
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Raleigh, North Carolina, United States
- Pfizer Investigational Site
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Winston-Salem, 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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Texas
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Houston, 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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Salt Lake City, Utah, United States
- Pfizer Investigational Site
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Virginia
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Newport News, Virginia, United States
- Pfizer Investigational Site
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Norfolk, Virginia, United States
- Pfizer Investigational Site
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Richmond, Virginia, United States
- Pfizer Investigational Site
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Washington
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Bothell, Washington, United States
- Pfizer Investigational Site
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Kirkland, Washington, United States
- Pfizer Investigational Site
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Renton, Washington, United States
- Pfizer Investigational Site
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Seattle, Washington, 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 to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of mixed hyperlipidemia
- At least 18 years of age
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 (high doses)
- 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 evaluationof 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
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Change in intima media thickness as measured by carotid ultrasound
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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
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.
General Publications
- Tajik P, Meijer R, Duivenvoorden R, Peters SA, Kastelein JJ, Visseren FJ, Crouse JR 3rd, Palmer MK, Raichlen JS, Grobbee DE, Bots ML. Asymmetrical distribution of atherosclerosis in the carotid artery: identical patterns across age, race, and gender. Eur J Prev Cardiol. 2012 Aug;19(4):687-97. doi: 10.1177/1741826711410821. Epub 2011 May 25.
- Vergeer M, Bots ML, van Leuven SI, Basart DC, Sijbrands EJ, Evans GW, Grobbee DE, Visseren FL, Stalenhoef AF, Stroes ES, Kastelein JJ. Cholesteryl ester transfer protein inhibitor torcetrapib and off-target toxicity: a pooled analysis of the rating atherosclerotic disease change by imaging with a new CETP inhibitor (RADIANCE) trials. Circulation. 2008 Dec 9;118(24):2515-22. doi: 10.1161/CIRCULATIONAHA.108.772665. Epub 2008 Nov 24. Erratum In: Circulation. 2009 Feb 10;119(5):e197.
- Bots ML, Visseren FL, Evans GW, Riley WA, Revkin JH, Tegeler CH, Shear CL, Duggan WT, Vicari RM, Grobbee DE, Kastelein JJ; RADIANCE 2 Investigators. Torcetrapib and carotid intima-media thickness in mixed dyslipidaemia (RADIANCE 2 study): a randomised, double-blind trial. Lancet. 2007 Jul 14;370(9582):153-160. doi: 10.1016/S0140-6736(07)61088-5.
- Kastelein JJ, van Leuven SI, Evans GW, Riley WA, Revkin JH, Shear CL, Bots ML; RADIANCE 1 and 2 Study Investigators. Designs of RADIANCE 1 and 2: carotid ultrasound studies comparing the effects of torcetrapib/atorvastatin with atorvastatin alone on atherosclerosis. Curr Med Res Opin. 2007 Apr;23(4):885-94. doi: 10.1185/030079907x182121.
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, 2003
Primary Completion (ACTUAL)
December 1, 2006
Study Completion (ACTUAL)
December 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)
February 17, 2012
Last Update Submitted That Met QC Criteria
February 15, 2012
Last Verified
February 1, 2012
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
- Hypertriglyceridemia
- Hyperlipidemias
- Hyperlipoproteinemias
- Hyperlipidemia, Familial Combined
- Lipidoses
- Hyperlipoproteinemia Type V
- 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
- A5091004
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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