Carotid B-mode Ultrasound Study to Compare Anti-Atherosclerotic Effect of Torcetrapib/Atorvastatin to Atorvastatin.
NCT ID: NCT00134238
Last Updated: 2012-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
755 participants
INTERVENTIONAL
2003-11-30
2006-12-31
Brief Summary
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To look at ultrasound images taken in the carotid arteries and to look at various lipids in the blood of people with mixed hyperlipidemia
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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torcetrapib/atorvastatin
atorvastatin
Eligibility Criteria
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Inclusion Criteria
* At least 18 years of age
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Gilbert, Arizona, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Scottsdale, Arizona, United States
Pfizer Investigational Site
Alhambra, California, United States
Pfizer Investigational Site
Encinitas, California, United States
Pfizer Investigational Site
La Jolla, California, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
Hartford, Connecticut, United States
Pfizer Investigational Site
Melbourne, Florida, United States
Pfizer Investigational Site
Palm Bay, Florida, United States
Pfizer Investigational Site
Sebastian, Florida, United States
Pfizer Investigational Site
Stuart, Florida, United States
Pfizer Investigational Site
Vero Beach, Florida, United States
Pfizer Investigational Site
Overland Park, Kansas, United States
Pfizer Investigational Site
Boston, Massachusetts, United States
Pfizer Investigational Site
Cambridge, Massachusetts, United States
Pfizer Investigational Site
Edina, Minnesota, United States
Pfizer Investigational Site
Minneapolis, Minnesota, United States
Pfizer Investigational Site
Kansas City, Missouri, United States
Pfizer Investigational Site
Concord, New Hampshire, United States
Pfizer Investigational Site
Bronxville, New York, United States
Pfizer Investigational Site
Buffalo, New York, United States
Pfizer Investigational Site
Mount Vernon, New York, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Williamsville, New York, United States
Pfizer Investigational Site
Durham, North Carolina, United States
Pfizer Investigational Site
Raleigh, North Carolina, United States
Pfizer Investigational Site
Winston-Salem, North Carolina, United States
Pfizer Investigational Site
Cincinnati, Ohio, United States
Pfizer Investigational Site
Houston, Texas, United States
Pfizer Investigational Site
San Antonio, Texas, United States
Pfizer Investigational Site
Salt Lake City, Utah, United States
Pfizer Investigational Site
Newport News, Virginia, United States
Pfizer Investigational Site
Norfolk, Virginia, United States
Pfizer Investigational Site
Richmond, Virginia, United States
Pfizer Investigational Site
Bothell, Washington, United States
Pfizer Investigational Site
Kirkland, Washington, United States
Pfizer Investigational Site
Renton, Washington, United States
Pfizer Investigational Site
Seattle, Washington, United States
Pfizer Investigational Site
Vancouver, British Columbia, Canada
Pfizer Investigational Site
Winnipeg, Manitoba, Canada
Pfizer Investigational Site
Chicoutimi, Quebec, Canada
Pfizer Investigational Site
Montreal, Quebec, Canada
Pfizer Investigational Site
Québec, Quebec, Canada
Pfizer Investigational Site
Prague, , Czechia
Pfizer Investigational Site
Kuopio, , Finland
Pfizer Investigational Site
Paris, , France
Pfizer Investigational Site
Nijmegen, , Netherlands
Pfizer Investigational Site
Rotterdam, , Netherlands
Pfizer Investigational Site
Utrecht, , Netherlands
Countries
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References
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Clezar CN, Flumignan CD, Cassola N, Nakano LC, Trevisani VF, Flumignan RL. Pharmacological interventions for asymptomatic carotid stenosis. Cochrane Database Syst Rev. 2023 Aug 4;8(8):CD013573. doi: 10.1002/14651858.CD013573.pub2.
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.
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.
Other Identifiers
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A5091004
Identifier Type: -
Identifier Source: org_study_id
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