A Study of Dalcetrapib in Patients With Stable Coronary Heart Disease, With Coronary Heart Disease Risk Equivalents or at Elevated Risk for Cardiovascular Disease
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).
2 other identifiers
interventional
2,220
13 countries
241
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2012
Shorter than P25 for phase_3
241 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 13, 2012
CompletedFirst Posted
Study publicly available on registry
January 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedNovember 2, 2016
November 1, 2016
6 months
January 13, 2012
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Time to first occurrence of any component of the composite cardiovascular event (cardiovascular mortality and morbidity)
approximately 4 years
Secondary Outcomes (3)
All cause mortality
approximately 4 years
Safety: Incidence of adverse events
approximately 4 years
Change in blood lipid and lipoprotein levels
from baseline to 12 months
Study Arms (2)
Dalcetrapib
EXPERIMENTALDalcetrapib 600 mg orally daily on a background of contemporary, guidelines-based medical care.
Placebo
PLACEBO COMPARATORPlacebo orally daily, on a background of contemporary, guidelines-based medical care.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 cholesteryl ester transfer protein (CETP)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (241)
Unknown Facility
Birmingham, Alabama, 35294-0007, United States
Unknown Facility
Huntsville, Alabama, 35801, United States
Unknown Facility
Anaheim, California, 92801, United States
Unknown Facility
Fullerton, California, 92835, United States
Unknown Facility
San Diego, California, 92103, United States
Unknown Facility
Santa Ana, California, 92704, United States
Unknown Facility
Santa Rosa, California, 95405, United States
Unknown Facility
Torrance, California, 90503, United States
Unknown Facility
Torrance, California, 90509, United States
Unknown Facility
Colorado Springs, Colorado, 80909, United States
Unknown Facility
Denver, Colorado, 80218, United States
Unknown Facility
Lonetree, Colorado, 80124, United States
Unknown Facility
Bridgeport, Connecticut, 06606, United States
Unknown Facility
Hartford, Connecticut, 06102, United States
Unknown Facility
Boynton Beach, Florida, 33472, United States
Unknown Facility
Daytona Beach, Florida, 32114, United States
Unknown Facility
Daytona Beach, Florida, 32117, United States
Unknown Facility
Fort Myers, Florida, 33907, United States
Unknown Facility
Jacksonville, Florida, 32216, United States
Unknown Facility
Panama City, Florida, 32401, United States
Unknown Facility
Plantation, Florida, 33317, United States
Unknown Facility
Port Charlotte, Florida, 33952, United States
Unknown Facility
Tallahassee, Florida, 32308, United States
Unknown Facility
Tampa, Florida, 33613, United States
Unknown Facility
West Palm Beach, Florida, 33401, United States
Unknown Facility
Covington, Georgia, 30014, United States
Unknown Facility
Cumming, Georgia, 30041, United States
Unknown Facility
Decatur, Georgia, 30033, United States
Unknown Facility
Aurora, Illinois, 60504, United States
Unknown Facility
Rock Island, Illinois, 61201, United States
Unknown Facility
Winfield, Illinois, 60190, United States
Unknown Facility
Elkhart, Indiana, 46617, United States
Unknown Facility
Hammond, Indiana, 46320-1942, United States
Unknown Facility
Indianapolis, Indiana, 46237, United States
Unknown Facility
Indianapolis, Indiana, 46250, United States
Unknown Facility
Muncie, Indiana, 47303, United States
Unknown Facility
South Bend, Indiana, 46601, United States
Unknown Facility
Overland Park, Kansas, 66215, United States
Unknown Facility
Louisville, Kentucky, 40205, United States
Unknown Facility
Alexandria, Louisiana, 71301, United States
Unknown Facility
Bangor, Maine, 04401, United States
Unknown Facility
Beltsville, Maryland, 20705, United States
Unknown Facility
Salisbury, Maryland, 21804, United States
Unknown Facility
Boston, Massachusetts, 02111, United States
Unknown Facility
Haverhill, Massachusetts, 01830, United States
Unknown Facility
Hyannis, Massachusetts, 02601, United States
Unknown Facility
North Dartmouth, Massachusetts, 02747, United States
Unknown Facility
Jackson, Michigan, 49201, United States
Unknown Facility
Kalamazoo, Michigan, 49048, United States
Unknown Facility
Marquette, Michigan, 49855, United States
Unknown Facility
Midland, Michigan, 48670, United States
Unknown Facility
Rochester Hills, Michigan, 48307, United States
Unknown Facility
Saginaw, Michigan, 48602, United States
Unknown Facility
Ypsilanti, Michigan, 48197, United States
Unknown Facility
Rochester, Minnesota, 55905-0001, United States
Unknown Facility
Saint Cloud, Minnesota, 56303, United States
Unknown Facility
Chesterfield, Missouri, 63017, United States
Unknown Facility
Columbia, Missouri, 65201, United States
Unknown Facility
Kansas City, Missouri, 64111, United States
Unknown Facility
Kalispell, Montana, 59901, United States
Unknown Facility
Nashua, New Hampshire, 03060, United States
Unknown Facility
Camden, New Jersey, 08103, United States
Unknown Facility
Haddon Heights, New Jersey, 08035, United States
Unknown Facility
Mine Hill, New Jersey, 07803, United States
Unknown Facility
Wayne, New Jersey, 07470, United States
Unknown Facility
Westwood, New Jersey, 07675, United States
Unknown Facility
Albany, New York, 12206-1098, United States
Unknown Facility
Albany, New York, 12211, United States
Unknown Facility
Buffalo, New York, 14215, United States
Unknown Facility
Cortlandt Manor, New York, 10567, United States
Unknown Facility
Poughkeepsi, New York, 12601, United States
Unknown Facility
Saratoga Springs, New York, 12866, United States
Unknown Facility
Smithtown, New York, 11787, United States
Unknown Facility
Syracuse, New York, 13202, United States
Unknown Facility
The Bronx, New York, 10461, United States
Unknown Facility
Troy, New York, 12180, United States
Unknown Facility
Asheville, North Carolina, 28803, United States
Unknown Facility
Durham, North Carolina, 27710, United States
Unknown Facility
Elizabeth City, North Carolina, 27909, United States
Unknown Facility
Hickory, North Carolina, 28602, United States
Unknown Facility
Morehead City, North Carolina, 28557, United States
Unknown Facility
Rocky Mount, North Carolina, 27804, United States
Unknown Facility
Statesville, North Carolina, 28625, United States
Unknown Facility
Wilmington, North Carolina, 28401, United States
Unknown Facility
Fargo, North Dakota, 58103, United States
Unknown Facility
Cincinnati, Ohio, 45227, United States
Unknown Facility
Cleveland, Ohio, 44195, United States
Unknown Facility
Mansfield, Ohio, 44827, United States
Unknown Facility
Mentor, Ohio, 44060, United States
Unknown Facility
Thornville, Ohio, 43076, United States
Unknown Facility
Toledo, Ohio, 43623, United States
Unknown Facility
Zanesville, Ohio, 43701, United States
Unknown Facility
Allentowm, Pennsylvania, 18105, United States
Unknown Facility
Altoona, Pennsylvania, 16602, United States
Unknown Facility
Camp Hill, Pennsylvania, 17011, United States
Unknown Facility
Doylestown, Pennsylvania, 18901, United States
Unknown Facility
Erie, Pennsylvania, 16502, United States
Unknown Facility
Erie, Pennsylvania, 16550, United States
Unknown Facility
Langhorne, Pennsylvania, 19047, United States
Unknown Facility
Lansdale, Pennsylvania, 19446, United States
Unknown Facility
North Wales, Pennsylvania, 19454-2053, United States
Unknown Facility
Philadelphia, Pennsylvania, 19114, United States
Unknown Facility
Philadelphia, Pennsylvania, 19153, United States
Unknown Facility
Pottstown, Pennsylvania, 19464, United States
Unknown Facility
Tipton, Pennsylvania, 16684, United States
Unknown Facility
West Chester, Pennsylvania, 19380, United States
Unknown Facility
Anderson, South Carolina, 29621, United States
Unknown Facility
Greer, South Carolina, 29651, United States
Unknown Facility
Rapid City, South Dakota, 57701, United States
Unknown Facility
Johnson City, Tennessee, 37604, United States
Unknown Facility
Dallas, Texas, 75251, United States
Unknown Facility
Humble, Texas, 77338, United States
Unknown Facility
Odessa, Texas, 79761, United States
Unknown Facility
Tyler, Texas, 75701, United States
Unknown Facility
Provo, Utah, 84004, United States
Unknown Facility
Charlottesville, Virginia, 22908, United States
Unknown Facility
Danville, Virginia, 24541-4160, United States
Unknown Facility
Lynchburg, Virginia, 24501, United States
Unknown Facility
Manassas, Virginia, 20109, United States
Unknown Facility
Richmond, Virginia, 23249, United States
Unknown Facility
Winchester, Virginia, 22601, United States
Unknown Facility
Milton, Queensland, 4064, Australia
Unknown Facility
Geelong, Victoria, 3220, Australia
Unknown Facility
Joondalup, Western Australia, 6027, Australia
Unknown Facility
Coquitlam, British Columbia, V3K 3P4, Canada
Unknown Facility
Kelowna, British Columbia, V1Y 1T2, Canada
Unknown Facility
Vancouver, British Columbia, V5Z 1M9, Canada
Unknown Facility
Moncton, New Brunswick, E1C 4B7, Canada
Unknown Facility
Ajax, Ontario, L1S 7K8, Canada
Unknown Facility
Barrie, Ontario, L4M 7G1, Canada
Unknown Facility
Burlington, Ontario, L7M 4Y1, Canada
Unknown Facility
Cambridge, Ontario, N1R 7R1, Canada
Unknown Facility
Greater Sudbury, Ontario, P3E 2N8, Canada
Unknown Facility
Greater Sudbury, Ontario, P3E 3B8, Canada
Unknown Facility
London, Ontario, N6A 5G6, Canada
Unknown Facility
Oakville, Ontario, L6K 3W7, Canada
Unknown Facility
Oshawa, Ontario, L1H 1B9, Canada
Unknown Facility
Oshawa, Ontario, L1J 2K1, Canada
Unknown Facility
Thunder Bay, Ontario, P7B 6V4, Canada
Unknown Facility
Toronto, Ontario, M4G 3E8, Canada
Unknown Facility
Granby, Quebec, J2G 8Z9, Canada
Unknown Facility
Greenfield Park, Quebec, J4V 3G8, Canada
Unknown Facility
Lachine, Quebec, H8S 2E4, Canada
Unknown Facility
Longueuil, Quebec, J4M 2X1, Canada
Unknown Facility
Longueuil, Quebec, J4N 1C2, Canada
Unknown Facility
Mirabel, Quebec, J7J 2K8, Canada
Unknown Facility
Montreal, Quebec, H1T 1C8, Canada
Unknown Facility
Montreal, Quebec, H1T 3Y7, Canada
Unknown Facility
Montreal, Quebec, H2K 4L5, Canada
Unknown Facility
Montreal, Quebec, H3J 2V5, Canada
Unknown Facility
Québec, Quebec, G1J 1Z4, Canada
Unknown Facility
Québec, Quebec, G1V 4M6, Canada
Unknown Facility
Saint-Lambert, Quebec, J4P 2H4, Canada
Unknown Facility
Trois-Rivières, Quebec, G8T 7A1, Canada
Unknown Facility
Val-d'Or, Quebec, J9P 3Y1, Canada
Unknown Facility
Beijing, 100050, China
Unknown Facility
Nanchang, 330006, China
Unknown Facility
Shijiazhuang, 050035, China
Unknown Facility
Benátky nad Jizerou, 29471, Czechia
Unknown Facility
Jindřichův Hradec, 377 01, Czechia
Unknown Facility
Ostrava, 722 00, Czechia
Unknown Facility
Pardubice, 530 02, Czechia
Unknown Facility
Prague, 140 00, Czechia
Unknown Facility
Slaný, 274 01, Czechia
Unknown Facility
Trutnov, 541 01, Czechia
Unknown Facility
Århus N, 8200, Denmark
Unknown Facility
Ballerup Municipality, 2750, Denmark
Unknown Facility
Hvidovre, 2650, Denmark
Unknown Facility
Vejle, 7100, Denmark
Unknown Facility
Pessac, 33604, France
Unknown Facility
Budapest, 1036, Hungary
Unknown Facility
Budapest, 1133, Hungary
Unknown Facility
Debrecen, 4025, Hungary
Unknown Facility
Kisvárda, 4600, Hungary
Unknown Facility
Komárom, 2900, Hungary
Unknown Facility
Nagykanizsa, 8800, Hungary
Unknown Facility
Pécs, 7621, Hungary
Unknown Facility
Úrhida, 8142, Hungary
Unknown Facility
Aguascalientes, 20230, Mexico
Unknown Facility
Aguascaliente, 20230, Mexico
Unknown Facility
Celaya, 38000, Mexico
Unknown Facility
Chihuahua City, 31217, Mexico
Unknown Facility
Cuernavaca, 62250, Mexico
Unknown Facility
D. F., 14380, Mexico
Unknown Facility
Durango, 34080, Mexico
Unknown Facility
Guadalajara, 44600, Mexico
Unknown Facility
Guadalajara, 44650, Mexico
Unknown Facility
Guadalajara, 44670, Mexico
Unknown Facility
Mexico City, 11650, Mexico
Unknown Facility
Monterrey, 64020, Mexico
Unknown Facility
Monterrey, 64060, Mexico
Unknown Facility
Pachuca, 42086, Mexico
Unknown Facility
Querétaro, 76000, Mexico
Unknown Facility
San Luis Potosi S.l.p., 78240, Mexico
Unknown Facility
San Luis Potosí City, 78200, Mexico
Unknown Facility
San Luís Potosí, 78200, Mexico
Unknown Facility
Tampico, 89000, Mexico
Unknown Facility
Alkmaar, 1815 JD, Netherlands
Unknown Facility
Amsterdam, 1105 AZ, Netherlands
Unknown Facility
Apeldoorn, 7334 DZ, Netherlands
Unknown Facility
Breda, 4818 CK, Netherlands
Unknown Facility
Delft, 2625 AD, Netherlands
Unknown Facility
Eindhoven, 5611 NJ, Netherlands
Unknown Facility
Eindhoven, 5632 EJ, Netherlands
Unknown Facility
Gouda, 2803 HH, Netherlands
Unknown Facility
Groningen, 9711 SG, Netherlands
Unknown Facility
Heerlen, 6419 PC, Netherlands
Unknown Facility
Hoorn, 1624 NP, Netherlands
Unknown Facility
Leiden, 2300 RC, Netherlands
Unknown Facility
Rotterdam, 3021 HC, Netherlands
Unknown Facility
Rotterdam, 3045 PM, Netherlands
Unknown Facility
Utrecht, 3584 CX, Netherlands
Unknown Facility
Velp, 6883 ES, Netherlands
Unknown Facility
Venlo, 5912 BL, Netherlands
Unknown Facility
Zoetermeer, 2724 EK, Netherlands
Unknown Facility
Bialystok, 15-879, Poland
Unknown Facility
Gdansk, 80-286, Poland
Unknown Facility
Gdynia, 81-384, Poland
Unknown Facility
Katowice, 40-748, Poland
Unknown Facility
Krakow, 30-069, Poland
Unknown Facility
Lodz, 90-302, Poland
Unknown Facility
Lodz, 91-425, Poland
Unknown Facility
Lublin, 20-015, Poland
Unknown Facility
Lublin, 20-044, Poland
Unknown Facility
Lublin, 20-538, Poland
Unknown Facility
Poznan, 61-655, Poland
Unknown Facility
Pulway, 24-100, Poland
Unknown Facility
Ruda Śląska, 41-709, Poland
Unknown Facility
Warsaw, 01-192, Poland
Unknown Facility
Warsaw, 02-097, Poland
Unknown Facility
Almería, Almeria, 04009, Spain
Unknown Facility
Barcelona, Barcelona, 08003, Spain
Unknown Facility
Madrid, Madrid, 28009, Spain
Unknown Facility
Madrid, Madrid, 280146, Spain
Unknown Facility
Málaga, Malaga, 29010, Spain
Unknown Facility
Birmingham, B15 2SQ, United Kingdom
Unknown Facility
Cardiff, CF14 5GJ, United Kingdom
Unknown Facility
Glasgow, G20 0SP, United Kingdom
Unknown Facility
Liverpool, L22 0LG, United Kingdom
Unknown Facility
Manchester, M15 6SX, United Kingdom
Unknown Facility
Reading, RG2 0TG, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2012
First Posted
January 25, 2012
Study Start
January 1, 2012
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
November 2, 2016
Record last verified: 2016-11