A Study of Dalcetrapib in Patients With Stable Coronary Heart Disease, With Coronary Heart Disease Risk Equivalents or at Elevated Risk for Cardiovascular Disease
NCT ID: NCT01516541
Last Updated: 2016-11-02
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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COMPLETED
PHASE3
2220 participants
INTERVENTIONAL
2012-01-31
2012-07-31
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 600 mg orally daily on a background of contemporary, guidelines-based medical care.
Background care
Guidelines-based medical care
dalcetrapib
600 mg orally daily
Placebo
Placebo orally daily, on a background of contemporary, guidelines-based medical care.
Background care
Guidelines-based medical care
Placebo
Matching dalcetrapib placebo orally daily
Interventions
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Background care
Guidelines-based medical care
Placebo
Matching dalcetrapib placebo orally daily
dalcetrapib
600 mg orally daily
Eligibility Criteria
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Inclusion Criteria
* Established cardiovascular disease A stable coronary disease B cerebrovascular disease C peripheral artery disease
* Without established coronary disease D pharmacologically treated type 2 diabetes mellitus and one or more risk factor(s) for cardiovascular disease E 3 or more risk factors for cardiovascular disease
* Receiving evidence-based medical and dietary management of dyslipidemia
Exclusion Criteria
* Uncontrolled hypertension
* Uncontrolled diabetes
* Concomitant treatment with any other drug raising HDL-C
* Previous treatment with compounds targeting cholesteryl ester transfer protein (CETP)
45 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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Birmingham, Alabama, United States
Huntsville, Alabama, United States
Anaheim, California, United States
Fullerton, California, United States
San Diego, California, United States
Santa Ana, California, United States
Santa Rosa, California, United States
Torrance, California, United States
Torrance, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Lonetree, Colorado, United States
Bridgeport, Connecticut, United States
Hartford, Connecticut, United States
Boynton Beach, Florida, United States
Daytona Beach, Florida, United States
Daytona Beach, Florida, United States
Fort Myers, Florida, United States
Jacksonville, Florida, United States
Panama City, Florida, United States
Plantation, Florida, United States
Port Charlotte, Florida, United States
Tallahassee, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Covington, Georgia, United States
Cumming, Georgia, United States
Decatur, Georgia, United States
Aurora, Illinois, United States
Rock Island, Illinois, United States
Winfield, Illinois, United States
Elkhart, Indiana, United States
Hammond, Indiana, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Muncie, Indiana, United States
South Bend, Indiana, United States
Overland Park, Kansas, United States
Louisville, Kentucky, United States
Alexandria, Louisiana, United States
Bangor, Maine, United States
Beltsville, Maryland, United States
Salisbury, Maryland, United States
Boston, Massachusetts, United States
Haverhill, Massachusetts, United States
Hyannis, Massachusetts, United States
North Dartmouth, Massachusetts, United States
Jackson, Michigan, United States
Kalamazoo, Michigan, United States
Marquette, Michigan, United States
Midland, Michigan, United States
Rochester Hills, Michigan, United States
Saginaw, Michigan, United States
Ypsilanti, Michigan, United States
Rochester, Minnesota, United States
Saint Cloud, Minnesota, United States
Chesterfield, Missouri, United States
Columbia, Missouri, United States
Kansas City, Missouri, United States
Kalispell, Montana, United States
Nashua, New Hampshire, United States
Camden, New Jersey, United States
Haddon Heights, New Jersey, United States
Mine Hill, New Jersey, United States
Wayne, New Jersey, United States
Westwood, New Jersey, United States
Albany, New York, United States
Albany, New York, United States
Buffalo, New York, United States
Cortlandt Manor, New York, United States
Poughkeepsi, New York, United States
Saratoga Springs, New York, United States
Smithtown, New York, United States
Syracuse, New York, United States
The Bronx, New York, United States
Troy, New York, United States
Asheville, North Carolina, United States
Durham, North Carolina, United States
Elizabeth City, North Carolina, United States
Hickory, North Carolina, United States
Morehead City, North Carolina, United States
Rocky Mount, North Carolina, United States
Statesville, North Carolina, United States
Wilmington, North Carolina, United States
Fargo, North Dakota, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Mansfield, Ohio, United States
Mentor, Ohio, United States
Thornville, Ohio, United States
Toledo, Ohio, United States
Zanesville, Ohio, United States
Allentowm, Pennsylvania, United States
Altoona, Pennsylvania, United States
Camp Hill, Pennsylvania, United States
Doylestown, Pennsylvania, United States
Erie, Pennsylvania, United States
Erie, Pennsylvania, United States
Langhorne, Pennsylvania, United States
Lansdale, Pennsylvania, United States
North Wales, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pottstown, Pennsylvania, United States
Tipton, Pennsylvania, United States
West Chester, Pennsylvania, United States
Anderson, South Carolina, United States
Greer, South Carolina, United States
Rapid City, South Dakota, United States
Johnson City, Tennessee, United States
Dallas, Texas, United States
Humble, Texas, United States
Odessa, Texas, United States
Tyler, Texas, United States
Provo, Utah, United States
Charlottesville, Virginia, United States
Danville, Virginia, United States
Lynchburg, Virginia, United States
Manassas, Virginia, United States
Richmond, Virginia, United States
Winchester, Virginia, United States
Milton, Queensland, Australia
Geelong, Victoria, Australia
Joondalup, Western Australia, Australia
Coquitlam, British Columbia, Canada
Kelowna, British Columbia, Canada
Vancouver, British Columbia, Canada
Moncton, New Brunswick, Canada
Ajax, Ontario, Canada
Barrie, Ontario, Canada
Burlington, Ontario, Canada
Cambridge, Ontario, Canada
Greater Sudbury, Ontario, Canada
Greater Sudbury, Ontario, Canada
London, Ontario, Canada
Oakville, Ontario, Canada
Oshawa, Ontario, Canada
Oshawa, Ontario, Canada
Thunder Bay, Ontario, Canada
Toronto, Ontario, Canada
Granby, Quebec, Canada
Greenfield Park, Quebec, Canada
Lachine, Quebec, Canada
Longueuil, Quebec, Canada
Longueuil, Quebec, Canada
Mirabel, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Québec, Quebec, Canada
Saint-Lambert, Quebec, Canada
Trois-Rivières, Quebec, Canada
Val-d'Or, Quebec, Canada
Beijing, , China
Nanchang, , China
Shijiazhuang, , China
Benátky nad Jizerou, , Czechia
Jindřichův Hradec, , Czechia
Ostrava, , Czechia
Pardubice, , Czechia
Prague, , Czechia
Slaný, , Czechia
Trutnov, , Czechia
Århus N, , Denmark
Ballerup Municipality, , Denmark
Hvidovre, , Denmark
Vejle, , Denmark
Pessac, , France
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Kisvárda, , Hungary
Komárom, , Hungary
Nagykanizsa, , Hungary
Pécs, , Hungary
Úrhida, , Hungary
Aguascalientes, , Mexico
Aguascaliente, , Mexico
Celaya, , Mexico
Chihuahua City, , Mexico
Cuernavaca, , Mexico
D. F., , Mexico
Durango, , Mexico
Guadalajara, , Mexico
Guadalajara, , Mexico
Guadalajara, , Mexico
Mexico City, , Mexico
Monterrey, , Mexico
Monterrey, , Mexico
Pachuca, , Mexico
Querétaro, , Mexico
San Luis Potosi S.l.p., , Mexico
San Luis Potosí City, , Mexico
San Luís Potosí, , Mexico
Tampico, , Mexico
Alkmaar, , Netherlands
Amsterdam, , Netherlands
Apeldoorn, , Netherlands
Breda, , Netherlands
Delft, , Netherlands
Eindhoven, , Netherlands
Eindhoven, , Netherlands
Gouda, , Netherlands
Groningen, , Netherlands
Heerlen, , Netherlands
Hoorn, , Netherlands
Leiden, , Netherlands
Rotterdam, , Netherlands
Rotterdam, , Netherlands
Utrecht, , Netherlands
Velp, , Netherlands
Venlo, , Netherlands
Zoetermeer, , Netherlands
Bialystok, , Poland
Gdansk, , Poland
Gdynia, , Poland
Katowice, , Poland
Krakow, , Poland
Lodz, , Poland
Lodz, , Poland
Lublin, , Poland
Lublin, , Poland
Lublin, , Poland
Poznan, , Poland
Pulway, , Poland
Ruda Śląska, , Poland
Warsaw, , Poland
Warsaw, , Poland
Almería, Almeria, Spain
Barcelona, Barcelona, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Málaga, Malaga, Spain
Birmingham, , United Kingdom
Cardiff, , United Kingdom
Glasgow, , United Kingdom
Liverpool, , United Kingdom
Manchester, , United Kingdom
Reading, , United Kingdom
Countries
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Other Identifiers
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2011-001891-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NC25608
Identifier Type: -
Identifier Source: org_study_id