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:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01516541
First received: January 13, 2012
Last updated: September 1, 2016
Last verified: September 2016
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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) |
Other: Background care Drug: Placebo Drug: dalcetrapib |
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
Dalcetrapib 600 mg orally daily on a background of contemporary, guidelines-based medical care.
|
Other: Background care
Guidelines-based medical care
Drug: dalcetrapib
600 mg orally daily
|
|
Placebo Comparator: Placebo
Placebo orally daily, on a background of contemporary, guidelines-based medical care.
|
Other: Background care
Guidelines-based medical care
Drug: Placebo
Matching dalcetrapib placebo orally daily
|
Eligibility| Ages Eligible for Study: | 45 Years and older (Adult, Senior) |
| 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 cholesteryl ester transfer protein (CETP)
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01516541
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01516541
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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 | |
| Lonetree, Colorado, United States, 80124 | |
| 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, 32114 | |
| Daytona Beach, Florida, United States, 32117 | |
| 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 | |
| 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 1C8 | |
| Montreal, Quebec, Canada, H1T 3Y7 | |
| 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, China, 330006 | |
| Shijiazhuang, China, 050035 | |
| 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, 1036 | |
| Budapest, Hungary, 1133 | |
| Debrecen, Hungary, 4025 | |
| Kisvarda, Hungary, 4600 | |
| Komarom, Hungary, 2900 | |
| Nagykanizsa, Hungary, 8800 | |
| Pecs, Hungary, 7621 | |
| Urhida, Hungary, 8142 | |
| Mexico | |
| Aguascalientes, Mexico, 20230 | |
| Aguascaliente, Mexico, 20230 | |
| Celaya, Mexico, 38000 | |
| Chihuahua, Mexico, 31217 | |
| Cuernavaca, Mexico, 62250 | |
| D. F., Mexico, 14380 | |
| Durango, Mexico, 34080 | |
| Guadalajara, Mexico, 44600 | |
| Guadalajara, Mexico, 44650 | |
| Guadalajara, Mexico, 44670 | |
| 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, 5611 NJ | |
| Eindhoven, Netherlands, 5632 EJ | |
| Gouda, Netherlands, 2803 HH | |
| Groningen, Netherlands, 9711 SG | |
| Heerlen, Netherlands, 6419 PC | |
| Hoorn, Netherlands, 1624 NP | |
| Leiden, Netherlands, 2300 RC | |
| 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, 90-302 | |
| Lodz, Poland, 91-425 | |
| Lublin, Poland, 20-015 | |
| Lublin, Poland, 20-044 | |
| Lublin, Poland, 20-538 | |
| 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
| 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: | September 1, 2016 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Heart Diseases Dyslipidemias Coronary Disease Coronary Artery Disease Myocardial Ischemia Peripheral Arterial Disease Peripheral Vascular Diseases Lipid Metabolism Disorders Metabolic Diseases |
Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases Atherosclerosis Dalcetrapib Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents |
ClinicalTrials.gov processed this record on September 26, 2016