A Study of the Effect of Dalcetrapib on Artherosclerotic Disease in Patients With Coronary Artery Disease
NCT ID: NCT01059682
Last Updated: 2020-03-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
936 participants
INTERVENTIONAL
2010-01-31
2011-09-30
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
Dalcetrapib
Dalcetrapib 600 mg orally once daily
Placebo
Placebo
Placebo orally once daily
Interventions
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Dalcetrapib
Dalcetrapib 600 mg orally once daily
Placebo
Placebo orally once daily
Eligibility Criteria
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Inclusion Criteria
* Angiographic evidence of coronary artery disease
* Ultrasound evidence of carotid artery disease
* Treated appropriately for dyslipidemia
Exclusion Criteria
* Previous coronary artery bypass graft surgery (CABG) or probable need for CABG in the next 24 months
* Myocardial infarction in the target coronary artery for IVUS between the initial IVUS examination and randomization
* Patients who have symptomatic congestive heart failure at baseline (New York Heart Association class III or IV)
* Severe anemia
* Uncontrolled hypertension
* Poorly controlled diabetes
18 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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Los Angeles, California, United States
Los Angeles, California, United States
Torrance, California, United States
Boulder, Colorado, United States
Greeley, Colorado, United States
Littleton, Colorado, United States
Hartford, Connecticut, United States
Atlantis, Florida, United States
Fort Lauderdale, Florida, United States
Fort Lauderdale, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Sarasota, Florida, United States
Tampa, Florida, United States
Decatur, Georgia, United States
Chicago, Illinois, United States
Elkhart, Indiana, United States
Louisville, Kentucky, United States
Columbia, Maryland, United States
Salisbury, Maryland, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Kalamazoo, Michigan, United States
Midland, Michigan, United States
Muskegon, Michigan, United States
Petoskey, Michigan, United States
Duluth, Minnesota, United States
Rochester, Minnesota, United States
Kansas City, Missouri, United States
Paramus, New Jersey, United States
New York, New York, United States
Rochester, New York, United States
Chapel Hill, North Carolina, United States
Toledo, Ohio, United States
Hershey, Pennsylvania, United States
Providence, Rhode Island, United States
Germantown, Tennessee, United States
Oak Ridge, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
Richmond, Virginia, United States
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Edmonton, Alberta, Canada
Edmonton, Alberta, Canada
New Westminster, British Columbia, Canada
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Saint John, New Brunswick, Canada
St. John's, Newfoundland and Labrador, Canada
Halifax, Nova Scotia, Canada
Brampton, Ontario, Canada
Burlington, Ontario, Canada
Cambridge, Ontario, Canada
Hamilton, Ontario, Canada
Kitchener, Ontario, Canada
London, Ontario, Canada
Mississauga, Ontario, Canada
Newmarket, Ontario, Canada
Oshawa, Ontario, Canada
Ottawa, Ontario, Canada
Scarborough Village, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Chicoutimi, Quebec, Canada
Fleurimont, Quebec, Canada
Gatineau, Quebec, Canada
Greenfield Park, Quebec, Canada
Lachine, Quebec, Canada
Laval, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Saint Georges-de-beauce, Quebec, Canada
Saint-Charles-Borromée, Quebec, Canada
Saint-Jérôme, Quebec, Canada
Saint-Lambert, Quebec, Canada
Ste. Foy, Quebec, Canada
Sudbury, Quebec, Canada
Trois-Rivières, Quebec, Canada
Val-d'Or, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Aachen, , Germany
Berlin, , Germany
Darmstadt, , Germany
Essen, , Germany
Hamburg, , Germany
Hamburg, , Germany
Heidelberg, , Germany
Leipzig, , Germany
München, , Germany
München, , Germany
Regensburg, , Germany
Ulm, , Germany
Elblag, , Poland
Gdansk, , Poland
Krakow, , Poland
Krakow, , Poland
Lublin, , Poland
Poznan, , Poland
Warsaw, , Poland
Warsaw, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Geneva, , Switzerland
Kreuzlingen, , Switzerland
Zurich, , Switzerland
Countries
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References
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Tardif JC, Rhainds D, Brodeur M, Feroz Zada Y, Fouodjio R, Provost S, Boule M, Alem S, Gregoire JC, L'Allier PL, Ibrahim R, Guertin MC, Mongrain I, Olsson AG, Schwartz GG, Rheaume E, Dube MP. Genotype-Dependent Effects of Dalcetrapib on Cholesterol Efflux and Inflammation: Concordance With Clinical Outcomes. Circ Cardiovasc Genet. 2016 Aug;9(4):340-8. doi: 10.1161/CIRCGENETICS.116.001405. Epub 2016 Jul 14.
Tardif JC, Rheaume E, Lemieux Perreault LP, Gregoire JC, Feroz Zada Y, Asselin G, Provost S, Barhdadi A, Rhainds D, L'Allier PL, Ibrahim R, Upmanyu R, Niesor EJ, Benghozi R, Suchankova G, Laghrissi-Thode F, Guertin MC, Olsson AG, Mongrain I, Schwartz GG, Dube MP. Pharmacogenomic determinants of the cardiovascular effects of dalcetrapib. Circ Cardiovasc Genet. 2015 Apr;8(2):372-82. doi: 10.1161/CIRCGENETICS.114.000663. Epub 2015 Jan 11.
Other Identifiers
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NC22703
Identifier Type: -
Identifier Source: org_study_id
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