A Study of the Effect of RO4607381 on Atherosclerotic Plaque in Patients With Coronary Heart Disease
NCT ID: NCT00655473
Last Updated: 2020-01-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
130 participants
INTERVENTIONAL
2008-03-31
2010-11-30
Brief Summary
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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
Study Groups
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Dalcetrapib (RO4607381)
Dalcetrapib (RO4607381)
600mg po daily for 24 months
Placebo
Placebo
po daily for 24 months
Interventions
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Dalcetrapib (RO4607381)
600mg po daily for 24 months
Placebo
po daily for 24 months
Eligibility Criteria
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Inclusion Criteria
* CHD, including patients with other CHD risk factors;
* treated appropriately for dyslipidemia;
* clinically stable.
Exclusion Criteria
* recent (within 3 months) clinically significant coronary events, transient ischemic attacks or cerebrovascular accident;
* severe anemia;
* uncontrolled hypertension;
* poorly controlled diabetes.
18 Years
75 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Jacksonville, Florida, United States
Royal Oak, Michigan, United States
Minneapolis, Minnesota, United States
Kansas City, Missouri, United States
New York, New York, United States
Statesville, North Carolina, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Houston, Texas, United States
Seattle, Washington, United States
Montreal, Quebec, Canada
Countries
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References
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Duivenvoorden R, Mani V, Woodward M, Kallend D, Suchankova G, Fuster V, Rudd JHF, Tawakol A, Farkouh ME, Fayad ZA. Relationship of serum inflammatory biomarkers with plaque inflammation assessed by FDG PET/CT: the dal-PLAQUE study. JACC Cardiovasc Imaging. 2013 Oct;6(10):1087-1094. doi: 10.1016/j.jcmg.2013.03.009.
Calcagno C, Ramachandran S, Izquierdo-Garcia D, Mani V, Millon A, Rosenbaum D, Tawakol A, Woodward M, Bucerius J, Moshier E, Godbold J, Kallend D, Farkouh ME, Fuster V, Rudd JH, Fayad ZA. The complementary roles of dynamic contrast-enhanced MRI and 18F-fluorodeoxyglucose PET/CT for imaging of carotid atherosclerosis. Eur J Nucl Med Mol Imaging. 2013 Dec;40(12):1884-93. doi: 10.1007/s00259-013-2518-4. Epub 2013 Aug 14.
Fayad ZA, Mani V, Woodward M, Kallend D, Abt M, Burgess T, Fuster V, Ballantyne CM, Stein EA, Tardif JC, Rudd JH, Farkouh ME, Tawakol A; dal-PLAQUE Investigators. Safety and efficacy of dalcetrapib on atherosclerotic disease using novel non-invasive multimodality imaging (dal-PLAQUE): a randomised clinical trial. Lancet. 2011 Oct 29;378(9802):1547-59. doi: 10.1016/S0140-6736(11)61383-4. Epub 2011 Sep 9.
Other Identifiers
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NC21153
Identifier Type: -
Identifier Source: org_study_id
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