Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001891-21 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dalcetrapib | Experimental | Dalcetrapib 600 mg orally daily on a background of contemporary, guidelines-based medical care. |
|
| Placebo | Placebo Comparator | Placebo orally daily, on a background of contemporary, guidelines-based medical care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Background care | Other | Guidelines-based medical care |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first occurrence of any component of the composite cardiovascular event (cardiovascular mortality and morbidity) | approximately 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | approximately 4 years | |
| Safety: Incidence of adverse events | approximately 4 years | |
| Change in blood lipid and lipoprotein levels |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35294-0007 | United States | |||
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Matching dalcetrapib placebo orally daily |
|
| dalcetrapib | Drug | 600 mg orally daily |
|
| from baseline to 12 months |
| Huntsville |
| Alabama |
| 35801 |
| United States |
| Anaheim | California | 92801 | United States |
| Fullerton | California | 92835 | United States |
| San Diego | California | 92103 | United States |
| Santa Ana | California | 92704 | United States |
| Santa Rosa | California | 95405 | United States |
| Torrance | California | 90503 | United States |
| Torrance | California | 90509 | United States |
| Colorado Springs | Colorado | 80909 | United States |
| Denver | Colorado | 80218 | United States |
| Lonetree | Colorado | 80124 | United States |
| Bridgeport | Connecticut | 06606 | United States |
| Hartford | Connecticut | 06102 | United States |
| Boynton Beach | Florida | 33472 | United States |
| Daytona Beach | Florida | 32114 | United States |
| Daytona Beach | Florida | 32117 | United States |
| Fort Myers | Florida | 33907 | United States |
| Jacksonville | Florida | 32216 | United States |
| Panama City | Florida | 32401 | United States |
| Plantation | Florida | 33317 | United States |
| Port Charlotte | Florida | 33952 | United States |
| Tallahassee | Florida | 32308 | United States |
| Tampa | Florida | 33613 | United States |
| West Palm Beach | Florida | 33401 | United States |
| Covington | Georgia | 30014 | United States |
| Cumming | Georgia | 30041 | United States |
| Decatur | Georgia | 30033 | United States |
| Aurora | Illinois | 60504 | United States |
| Rock Island | Illinois | 61201 | United States |
| Winfield | Illinois | 60190 | United States |
| Elkhart | Indiana | 46617 | United States |
| Hammond | Indiana | 46320-1942 | United States |
| Indianapolis | Indiana | 46237 | United States |
| Indianapolis | Indiana | 46250 | United States |
| Muncie | Indiana | 47303 | United States |
| South Bend | Indiana | 46601 | United States |
| Overland Park | Kansas | 66215 | United States |
| Louisville | Kentucky | 40205 | United States |
| Alexandria | Louisiana | 71301 | United States |
| Bangor | Maine | 04401 | United States |
| Beltsville | Maryland | 20705 | United States |
| Salisbury | Maryland | 21804 | United States |
| Boston | Massachusetts | 02111 | United States |
| Haverhill | Massachusetts | 01830 | United States |
| Hyannis | Massachusetts | 02601 | United States |
| North Dartmouth | Massachusetts | 02747 | United States |
| Jackson | Michigan | 49201 | United States |
| Kalamazoo | Michigan | 49048 | United States |
| Marquette | Michigan | 49855 | United States |
| Midland | Michigan | 48670 | United States |
| Rochester Hills | Michigan | 48307 | United States |
| Saginaw | Michigan | 48602 | United States |
| Ypsilanti | Michigan | 48197 | United States |
| Rochester | Minnesota | 55905-0001 | United States |
| Saint Cloud | Minnesota | 56303 | United States |
| Chesterfield | Missouri | 63017 | United States |
| Columbia | Missouri | 65201 | United States |
| Kansas City | Missouri | 64111 | United States |
| Kalispell | Montana | 59901 | United States |
| Nashua | New Hampshire | 03060 | United States |
| Camden | New Jersey | 08103 | United States |
| Haddon Heights | New Jersey | 08035 | United States |
| Mine Hill | New Jersey | 07803 | United States |
| Wayne | New Jersey | 07470 | United States |
| Westwood | New Jersey | 07675 | United States |
| Albany | New York | 12206-1098 | United States |
| Albany | New York | 12211 | United States |
| Buffalo | New York | 14215 | United States |
| Cortlandt Manor | New York | 10567 | United States |
| Poughkeepsi | New York | 12601 | United States |
| Saratoga Springs | New York | 12866 | United States |
| Smithtown | New York | 11787 | United States |
| Syracuse | New York | 13202 | United States |
| The Bronx | New York | 10461 | United States |
| Troy | New York | 12180 | United States |
| Asheville | North Carolina | 28803 | United States |
| Durham | North Carolina | 27710 | United States |
| Elizabeth City | North Carolina | 27909 | United States |
| Hickory | North Carolina | 28602 | United States |
| Morehead City | North Carolina | 28557 | United States |
| Rocky Mount | North Carolina | 27804 | United States |
| Statesville | North Carolina | 28625 | United States |
| Wilmington | North Carolina | 28401 | United States |
| Fargo | North Dakota | 58103 | United States |
| Cincinnati | Ohio | 45227 | United States |
| Cleveland | Ohio | 44195 | United States |
| Mansfield | Ohio | 44827 | United States |
| Mentor | Ohio | 44060 | United States |
| Thornville | Ohio | 43076 | United States |
| Toledo | Ohio | 43623 | United States |
| Zanesville | Ohio | 43701 | United States |
| Allentowm | Pennsylvania | 18105 | United States |
| Altoona | Pennsylvania | 16602 | United States |
| Camp Hill | Pennsylvania | 17011 | United States |
| Doylestown | Pennsylvania | 18901 | United States |
| Erie | Pennsylvania | 16502 | United States |
| Erie | Pennsylvania | 16550 | United States |
| Langhorne | Pennsylvania | 19047 | United States |
| Lansdale | Pennsylvania | 19446 | United States |
| North Wales | Pennsylvania | 19454-2053 | United States |
| Philadelphia | Pennsylvania | 19114 | United States |
| Philadelphia | Pennsylvania | 19153 | United States |
| Pottstown | Pennsylvania | 19464 | United States |
| Tipton | Pennsylvania | 16684 | United States |
| West Chester | Pennsylvania | 19380 | United States |
| Anderson | South Carolina | 29621 | United States |
| Greer | South Carolina | 29651 | United States |
| Rapid City | South Dakota | 57701 | United States |
| Johnson City | Tennessee | 37604 | United States |
| Dallas | Texas | 75251 | United States |
| Humble | Texas | 77338 | United States |
| Odessa | Texas | 79761 | United States |
| Tyler | Texas | 75701 | United States |
| Provo | Utah | 84004 | United States |
| Charlottesville | Virginia | 22908 | United States |
| Danville | Virginia | 24541-4160 | United States |
| Lynchburg | Virginia | 24501 | United States |
| Manassas | Virginia | 20109 | United States |
| Richmond | Virginia | 23249 | United States |
| Winchester | Virginia | 22601 | United States |
| Milton | Queensland | 4064 | Australia |
| Geelong | Victoria | 3220 | Australia |
| Joondalup | Western Australia | 6027 | Australia |
| Coquitlam | British Columbia | V3K 3P4 | Canada |
| Kelowna | British Columbia | V1Y 1T2 | Canada |
| Vancouver | British Columbia | V5Z 1M9 | Canada |
| Moncton | New Brunswick | E1C 4B7 | Canada |
| Ajax | Ontario | L1S 7K8 | Canada |
| Barrie | Ontario | L4M 7G1 | Canada |
| Burlington | Ontario | L7M 4Y1 | Canada |
| Cambridge | Ontario | N1R 7R1 | Canada |
| Greater Sudbury | Ontario | P3E 2N8 | Canada |
| Greater Sudbury | Ontario | P3E 3B8 | Canada |
| London | Ontario | N6A 5G6 | Canada |
| Oakville | Ontario | L6K 3W7 | Canada |
| Oshawa | Ontario | L1H 1B9 | Canada |
| Oshawa | Ontario | L1J 2K1 | Canada |
| Thunder Bay | Ontario | P7B 6V4 | Canada |
| Toronto | Ontario | M4G 3E8 | Canada |
| Granby | Quebec | J2G 8Z9 | Canada |
| Greenfield Park | Quebec | J4V 3G8 | Canada |
| Lachine | Quebec | H8S 2E4 | Canada |
| Longueuil | Quebec | J4M 2X1 | Canada |
| Longueuil | Quebec | J4N 1C2 | Canada |
| Mirabel | Quebec | J7J 2K8 | Canada |
| Montreal | Quebec | H1T 1C8 | Canada |
| Montreal | Quebec | H1T 3Y7 | Canada |
| Montreal | Quebec | H2K 4L5 | Canada |
| Montreal | Quebec | H3J 2V5 | Canada |
| Québec | Quebec | G1J 1Z4 | Canada |
| Québec | Quebec | G1V 4M6 | Canada |
| Saint-Lambert | Quebec | J4P 2H4 | Canada |
| Trois-Rivières | Quebec | G8T 7A1 | Canada |
| Val-d'Or | Quebec | J9P 3Y1 | Canada |
| Beijing | 100050 | China |
| Nanchang | 330006 | China |
| Shijiazhuang | 050035 | China |
| Benátky nad Jizerou | 29471 | Czechia |
| Jindřichův Hradec | 377 01 | Czechia |
| Ostrava | 722 00 | Czechia |
| Pardubice | 530 02 | Czechia |
| Prague | 140 00 | Czechia |
| Slaný | 274 01 | Czechia |
| Trutnov | 541 01 | Czechia |
| Århus N | 8200 | Denmark |
| Ballerup Municipality | 2750 | Denmark |
| Hvidovre | 2650 | Denmark |
| Vejle | 7100 | Denmark |
| Pessac | 33604 | France |
| Budapest | 1036 | Hungary |
| Budapest | 1133 | Hungary |
| Debrecen | 4025 | Hungary |
| Kisvárda | 4600 | Hungary |
| Komárom | 2900 | Hungary |
| Nagykanizsa | 8800 | Hungary |
| Pécs | 7621 | Hungary |
| Úrhida | 8142 | Hungary |
| Aguascalientes | 20230 | Mexico |
| Aguascaliente | 20230 | Mexico |
| Celaya | 38000 | Mexico |
| Chihuahua City | 31217 | Mexico |
| Cuernavaca | 62250 | Mexico |
| D. F. | 14380 | Mexico |
| Durango | 34080 | Mexico |
| Guadalajara | 44600 | Mexico |
| Guadalajara | 44650 | Mexico |
| Guadalajara | 44670 | Mexico |
| Mexico City | 11650 | Mexico |
| Monterrey | 64020 | Mexico |
| Monterrey | 64060 | Mexico |
| Pachuca | 42086 | Mexico |
| Querétaro | 76000 | Mexico |
| San Luis Potosi S.l.p. | 78240 | Mexico |
| San Luis Potosí City | 78200 | Mexico |
| San Luís Potosí | 78200 | Mexico |
| Tampico | 89000 | Mexico |
| Alkmaar | 1815 JD | Netherlands |
| Amsterdam | 1105 AZ | Netherlands |
| Apeldoorn | 7334 DZ | Netherlands |
| Breda | 4818 CK | Netherlands |
| Delft | 2625 AD | Netherlands |
| Eindhoven | 5611 NJ | Netherlands |
| Eindhoven | 5632 EJ | Netherlands |
| Gouda | 2803 HH | Netherlands |
| Groningen | 9711 SG | Netherlands |
| Heerlen | 6419 PC | Netherlands |
| Hoorn | 1624 NP | Netherlands |
| Leiden | 2300 RC | Netherlands |
| Rotterdam | 3021 HC | Netherlands |
| Rotterdam | 3045 PM | Netherlands |
| Utrecht | 3584 CX | Netherlands |
| Velp | 6883 ES | Netherlands |
| Venlo | 5912 BL | Netherlands |
| Zoetermeer | 2724 EK | Netherlands |
| Bialystok | 15-879 | Poland |
| Gdansk | 80-286 | Poland |
| Gdynia | 81-384 | Poland |
| Katowice | 40-748 | Poland |
| Krakow | 30-069 | Poland |
| Lodz | 90-302 | Poland |
| Lodz | 91-425 | Poland |
| Lublin | 20-015 | Poland |
| Lublin | 20-044 | Poland |
| Lublin | 20-538 | Poland |
| Poznan | 61-655 | Poland |
| Pulway | 24-100 | Poland |
| Ruda Śląska | 41-709 | Poland |
| Warsaw | 01-192 | Poland |
| Warsaw | 02-097 | Poland |
| Almería | Almeria | 04009 | Spain |
| Barcelona | Barcelona | 08003 | Spain |
| Madrid | Madrid | 28009 | Spain |
| Madrid | Madrid | 280146 | Spain |
| Málaga | Malaga | 29010 | Spain |
| Birmingham | B15 2SQ | United Kingdom |
| Cardiff | CF14 5GJ | United Kingdom |
| Glasgow | G20 0SP | United Kingdom |
| Liverpool | L22 0LG | United Kingdom |
| Manchester | M15 6SX | United Kingdom |
| Reading | RG2 0TG | United Kingdom |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
| D050171 | Dyslipidemias |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D016491 | Peripheral Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C411602 | dalcetrapib |
Not provided
Not provided
Not provided