A Study of Dalcetrapib in Patients With Stable Coronary Heart Disease, With Coronary Heart Disease Risk Equivalents or at Elevated Risk for Cardiovascular Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01516541
First received: January 13, 2012
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality in patients with stable coronary heart disease (CHD), with CHD risk equivalents or at elevated risk for cardiovascular disease. Eligible patients will be randomized to receive either dalcetrapib 600 mg orally daily or placebo orally daily, on a background of contemporary, guidelines-based medical care. Anticipated time on study treatment is 4 years.


Condition Intervention Phase
Cardiovascular Disease, Coronary Heart Disease, Dyslipidemia, Peripheral Arterial Disease (PAD)
Drug: dalcetrapib
Drug: Placebo
Other: Background care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3b, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Study to Evaluate the Effect of Dalcetrapib 600 mg on Cardiovascular (CV) Events in Adult Patients With Stable Coronary Heart Disease (CHD), CHD Risk Equivalents or at Elevated Risk for Cardiovascular Disease (CVD).

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Time to first occurrence of any component of the composite cardiovascular event (cardiovascular mortality and morbidity) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All cause mortality [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Change in blood lipid and lipoprotein levels [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: No ]

Enrollment: 2220
Study Start Date: January 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dalcetrapib Drug: dalcetrapib
600 mg orally daily
Other: Background care
Guidelines-based medical care
Placebo Comparator: Placebo Drug: Placebo
Matching dalcetrapib placebo orally daily
Other: Background care
Guidelines-based medical care

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, >/= 45 years of age
  • 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:

  • Occurrence of myocardial infarction, hospitalization for unstable angina, stroke or revascularization (coronary, carotid or peripheral) within three months prior to randomization
  • Uncontrolled hypertension
  • Uncontrolled diabetes
  • Concomitant treatment with any other drug raising HDL-C
  • Previous treatment with compounds targeting CETP
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01516541

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35294-0007
Huntsville, Alabama, United States, 35801
United States, California
Anaheim, California, United States, 92801
Fullerton, California, United States, 92835
San Diego, California, United States, 92103
Santa Ana, California, United States, 92704
Santa Rosa, California, United States, 95405
Torrance, California, United States, 90503
Torrance, California, United States, 90509
United States, Colorado
Colorado Springs, Colorado, United States, 80909
Denver, Colorado, United States, 80218
United States, Connecticut
Bridgeport, Connecticut, United States, 06606
Hartford, Connecticut, United States, 06102
United States, Florida
Boynton Beach, Florida, United States, 33472
Daytona Beach, Florida, United States, 32117
Daytona Beach, Florida, United States, 32114
Fort Myers, Florida, United States, 33907
Jacksonville, Florida, United States, 32216
Panama City, Florida, United States, 32401
Plantation, Florida, United States, 33317
Port Charlotte, Florida, United States, 33952
Tallahassee, Florida, United States, 32308
Tampa, Florida, United States, 33613
West Palm Beach, Florida, United States, 33401
United States, Georgia
Atlanta, Georgia, United States, 30328
Covington, Georgia, United States, 30014
Cumming, Georgia, United States, 30041
Decatur, Georgia, United States, 30033
United States, Illinois
Aurora, Illinois, United States, 60504
Rock Island, Illinois, United States, 61201
Winfield, Illinois, United States, 60190
United States, Indiana
Elkhart, Indiana, United States, 46617
Hammond, Indiana, United States, 46320-1942
Indianapolis, Indiana, United States, 46237
Indianapolis, Indiana, United States, 46250
Muncie, Indiana, United States, 47303
South Bend, Indiana, United States, 46601
United States, Kansas
Overland Park, Kansas, United States, 66215
United States, Kentucky
Louisville, Kentucky, United States, 40205
United States, Louisiana
Alexandria, Louisiana, United States, 71301
United States, Maine
Bangor, Maine, United States, 04401
United States, Maryland
Beltsville, Maryland, United States, 20705
Salisbury, Maryland, United States, 21804
United States, Massachusetts
Boston, Massachusetts, United States, 02111
Haverhill, Massachusetts, United States, 01830
Hyannis, Massachusetts, United States, 02601
North Dartmouth, Massachusetts, United States, 02747
United States, Michigan
Jackson, Michigan, United States, 49201
Kalamazoo, Michigan, United States, 49048
Marquette, Michigan, United States, 49855
Midland, Michigan, United States, 48670
Rochester Hills, Michigan, United States, 48307
Saginaw, Michigan, United States, 48602
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
Rochester, Minnesota, United States, 55905-0001
St. Cloud, Minnesota, United States, 56303
United States, Missouri
Chesterfield, Missouri, United States, 63017
Columbia, Missouri, United States, 65201
Kansas City, Missouri, United States, 64111
United States, Montana
Kalispell, Montana, United States, 59901
United States, New Hampshire
Nashua, New Hampshire, United States, 03060
United States, New Jersey
Camden, New Jersey, United States, 08103
Haddon Heights, New Jersey, United States, 08035
Mine Hill, New Jersey, United States, 07803
Wayne, New Jersey, United States, 07470
Westwood, New Jersey, United States, 07675
United States, New York
Albany, New York, United States, 12206-1098
Albany, New York, United States, 12211
Bronx, New York, United States, 10461
Buffalo, New York, United States, 14215
Cortlandt Manor, New York, United States, 10567
Poughkeepsi, New York, United States, 12601
Saratoga Springs, New York, United States, 12866
Smithtown, New York, United States, 11787
Syracuse, New York, United States, 13202
Troy, New York, United States, 12180
United States, North Carolina
Asheville, North Carolina, United States, 28803
Durham, North Carolina, United States, 27710
Elizabeth City, North Carolina, United States, 27909
Hickory, North Carolina, United States, 28602
Morehead City, North Carolina, United States, 28557
Rocky Mount, North Carolina, United States, 27804
Statesville, North Carolina, United States, 28625
Wilmington, North Carolina, United States, 28401
United States, North Dakota
Fargo, North Dakota, United States, 58103
United States, Ohio
Cincinnati, Ohio, United States, 45227
Cleveland, Ohio, United States, 44195
Mansfield, Ohio, United States, 44827
Mentor, Ohio, United States, 44060
Thornville, Ohio, United States, 43076
Toledo, Ohio, United States, 43623
Zanesville, Ohio, United States, 43701
United States, Pennsylvania
Allentowm, Pennsylvania, United States, 18105
Altoona, Pennsylvania, United States, 16602
Camp Hill, Pennsylvania, United States, 17011
Doylestown, Pennsylvania, United States, 18901
Erie, Pennsylvania, United States, 16502
Erie, Pennsylvania, United States, 16550
Langhorne, Pennsylvania, United States, 19047
Lansdale, Pennsylvania, United States, 19446
North Wales, Pennsylvania, United States, 19454-2053
Philadelphia, Pennsylvania, United States, 19114
Philadelphia, Pennsylvania, United States, 19153
Pottstown, Pennsylvania, United States, 19464
Tipton, Pennsylvania, United States, 16684
West Chester, Pennsylvania, United States, 19380
United States, South Carolina
Anderson, South Carolina, United States, 29621
Greer, South Carolina, United States, 29651
United States, South Dakota
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Johnson City, Tennessee, United States, 37604
United States, Texas
Dallas, Texas, United States, 75251
Humble, Texas, United States, 77338
Odessa, Texas, United States, 79761
Tyler, Texas, United States, 75701
United States, Utah
Provo, Utah, United States, 84004
United States, Virginia
Charlottesville, Virginia, United States, 22908
Danville, Virginia, United States, 24541-4160
Lynchburg, Virginia, United States, 24501
Manassas, Virginia, United States, 20109
Richmond, Virginia, United States, 23249
Winchester, Virginia, United States, 22601
Australia, Queensland
Milton, Queensland, Australia, 4064
Australia, Victoria
Geelong, Victoria, Australia, 3220
Australia, Western Australia
Joondalup, Western Australia, Australia, 6027
Canada, British Columbia
Coquitlam, British Columbia, Canada, V3K 3P4
Kelowna, British Columbia, Canada, V1Y 1T2
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, New Brunswick
Moncton, New Brunswick, Canada, E1C 4B7
Canada, Ontario
Ajax, Ontario, Canada, L1S 7K8
Barrie, Ontario, Canada, L4M 7G1
Burlington, Ontario, Canada, L7M 4Y1
Cambridge, Ontario, Canada, N1R 7R1
London, Ontario, Canada, N6A 5G6
Oakville, Ontario, Canada, L6K 3W7
Oshawa, Ontario, Canada, L1H 1B9
Oshawa, Ontario, Canada, L1J 2K1
Sudbury, Ontario, Canada, P3E 2N8
Sudbury, Ontario, Canada, P3E 3B8
Thunder Bay, Ontario, Canada, P7B 6V4
Toronto, Ontario, Canada, M4G 3E8
Canada, Quebec
Granby, Quebec, Canada, J2G 8Z9
Greenfield Park, Quebec, Canada, J4V 3G8
Lachine, Quebec, Canada, H8S 2E4
Longueuil, Quebec, Canada, J4M 2X1
Longueuil, Quebec, Canada, J4N 1C2
Mirabel, Quebec, Canada, J7J 2K8
Montreal, Quebec, Canada, H1T 3Y7
Montreal, Quebec, Canada, H1T 1C8
Montréal, Quebec, Canada, H2K 4L5
Montréal, Quebec, Canada, H3J 2V5
Québec, Quebec, Canada, G1V 4M6
St-Lambert, Quebec, Canada, J4P 2H4
Trois-Rivières, Quebec, Canada, G8T 7A1
Val D'Or, Quebec, Canada, J9P 3Y1
Canada
Quebec, Canada, G1J 1Z4
China
Beijing, China, 100050
Nanchang City, China, 330006
Shijiazhuang, China, 050011
Czech Republic
Benatky nad Jizerou, Czech Republic, 29471
Jindrichuv Hradec, Czech Republic, 377 01
Ostrava, Czech Republic, 722 00
Pardubice, Czech Republic, 530 02
Praha 4, Czech Republic, 140 00
Slany, Czech Republic, 274 01
Trutnov, Czech Republic, 541 01
Denmark
Ballerup, Denmark, 2750
Hvidovre, Denmark, 2650
Vejle, Denmark, 7100
Århus N, Denmark, 8200
France
Pessac, France, 33604
Hungary
Budapest, Hungary, 1133
Budapest, Hungary, 1036
Debrecen, Hungary, 4025
Kisvarda, Hungary, 4600
Komarom, Hungary, 2900
Nagykanizsa, Hungary, 8800
Pecs, Hungary, 7621
Urhida, Hungary, 8142
Mexico
Aguascaliente, Mexico, 20230
Aguascalientes, Mexico, 20230
Celaya, Mexico, 38000
Chihuahua, Mexico, 31217
Cuernavaca, Mexico, 62250
D. F., Mexico, 14380
Durango, Mexico, 34080
Guadalajara, Mexico, 44670
Guadalajara, Mexico, 44600
Guadalajara, Mexico, 44650
Mexico City, Mexico, 11650
Monterrey, Mexico, 64020
Monterrey, Mexico, 64060
Pachuca, Mexico, 42086
Queretaro, Mexico, 76000
San Luis Potosi S.L.P., Mexico, 78240
San Luis Potosí, Mexico, 78200
San Luís Potosí, Mexico, 78200
Tampico, Mexico, 89000
Netherlands
Alkmaar, Netherlands, 1815 JD
Amsterdam, Netherlands, 1105 AZ
Apeldoorn, Netherlands, 7334 DZ
Breda, Netherlands, 4818 CK
Delft, Netherlands, 2625 AD
Eindhoven, Netherlands, 5632 EJ
Eindhoven, Netherlands, 5611 NJ
Gouda, Netherlands, 2803 HH
Groningen, Netherlands, 9711 SG
Heerlen, Netherlands, 6419 PC
Hoorn, Netherlands, 1624 NP
Leiden, Netherlands, 2333 ZA
Rotterdam, Netherlands, 3021 HC
Rotterdam, Netherlands, 3045 PM
Utrecht, Netherlands, 3584 CX
Velp, Netherlands, 6883 ES
Venlo, Netherlands, 5912 BL
Zoetermeer, Netherlands, 2724 EK
Poland
Bialystok, Poland, 15-879
Gdansk, Poland, 80-286
Gdynia, Poland, 81-384
Katowice, Poland, 40-748
Krakow, Poland, 30-069
Lodz, Poland, 91-425
Lodz, Poland, 90-302
Lublin, Poland, 20-538
Lublin, Poland, 20-015
Lublin, Poland, 20-044
Poznan, Poland, 61-655
Pulway, Poland, 24-100
Ruda Slaska, Poland, 41-709
Warsawa, Poland, 01-192
Warszawa, Poland, 02-097
Spain
Almeria, Spain, 04009
Barcelona, Spain, 08003
Madrid, Spain, 28009
Madrid, Spain, 280146
Malaga, Spain, 29010
United Kingdom
Birmingham, United Kingdom, B15 2SQ
Cardiff, United Kingdom, CF14 5GJ
Glasgow, United Kingdom, G20 0SP
Liverpool, United Kingdom, L22 0LG
Manchester, United Kingdom, M15 6SX
Reading, United Kingdom, RG2 0TG
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01516541     History of Changes
Other Study ID Numbers: NC25608, 2011-001891-21
Study First Received: January 13, 2012
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Cardiovascular Diseases
Heart Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Dyslipidemias
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Atherosclerosis
Lipid Metabolism Disorders
Metabolic Diseases
Dalcetrapib
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014