Efficacy and Safety Study of Apixaban for Extended Treatment of Deep Vein Thrombosis or Pulmonary Embolism
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Collaborator:
Pfizer
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00633893
First received: March 5, 2008
Last updated: November 6, 2012
Last verified: November 2012
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Purpose
The purpose is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients who have completed their intended treatment for deep vein thrombosis (DVT) or pulmonary embolism (PE)
| Condition | Intervention | Phase |
|---|---|---|
|
Venous Thrombosis |
Drug: Apixaban Drug: Placebo |
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 Safety and Efficacy Trial Evaluating the Use of Apixaban for the Extended Treatment of Deep Vein Thrombosis and Pulmonary Embolism |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Venous Thromboembolic Recurrence or Death [ Time Frame: upon occurrence during study treatment ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Bleeding [ Time Frame: upon occurrence during study treatment ] [ Designated as safety issue: Yes ]
| Enrollment: | 316 |
| Study Start Date: | May 2008 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
2.5 mg
|
Drug: Apixaban
Tablets, Oral, twice daily, 12 months
Other Name: BMS-562247
|
|
Experimental: 2
5.0 mg
|
Drug: Apixaban
Tablets, Oral, twice daily, 12 months
Other Name: BMS-562247
|
|
Active Comparator: 3
0 mg
|
Drug: Placebo
Tablets, Oral, twice daily, 12 months
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Men and women ≥ 18 years of age;
- Clinical diagnosis of DVT or PE;
- Anticoagulant treatment completed
- No recurrence of VTE
Exclusion Criteria:
- Subjects with indications for long-term treatment with a vitamin K antagonist
- Active bleeding or high risk for serious bleeding
- Short life expectancy
- Uncontrolled high blood pressure
- Impaired kidney or liver function
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00633893
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| United States, Alabama | |
| Alabama Clinical Therapeutics, Llc | |
| Birmingham, Alabama, United States, 35235 | |
| United States, Arizona | |
| Cardiovascular Consultants, Ltd. | |
| Phoenix, Arizona, United States, 85032 | |
| Robert J. Bloomberg, Md, Pc | |
| Tempe, Arizona, United States, 85283 | |
| United States, Arkansas | |
| Fort Smith Lung Center | |
| Fort Smith, Arkansas, United States, 72901 | |
| United States, California | |
| Beaver Medical Group | |
| Banning, California, United States, 92220 | |
| Scripps Clinic/Scripps Health And Green Hospital | |
| La Jolla, California, United States, 92037 | |
| Healthcare Partners Medical Group | |
| Los Angeles, California, United States, 90015 | |
| Mission Internal Medical Group | |
| Mission Viejo, California, United States, 92691 | |
| Desert Med Grp Inc, Dba Desert Oasis Healthcare Med Group | |
| Palm Springs, California, United States, 92262 | |
| Indus Clinical Research Institute, Inc. | |
| Pomona, California, United States, 91767 | |
| Kaiser Permanente Medical Center | |
| San Francisco, California, United States, 94118 | |
| Stanford University Medical Center | |
| Stanford, California, United States, 94305 | |
| Harbor Ucla Medical Center | |
| Torrance, California, United States, 90509 | |
| Progressive Clinical Research | |
| Vista, California, United States, 92083 | |
| United States, Colorado | |
| Rocky Mountain Internal Medicine | |
| Aurora, Colorado, United States, 80012 | |
| New West Physicians | |
| Golden, Colorado, United States, 80401 | |
| United States, Delaware | |
| Alfieri Cardiology | |
| Newark, Delaware, United States, 19713 | |
| United States, Florida | |
| Bay Pines Va Healthcare Systems | |
| Bay Pines, Florida, United States, 33744 | |
| St. Francis Sleep Allergy & Lung Institute | |
| Clearwater, Florida, United States, 33765 | |
| Research Alliance, Inc. | |
| Clearwater, Florida, United States, 33756 | |
| Berma Research Group | |
| Fort Lauderdale, Florida, United States, 33316 | |
| Healthworx | |
| Hollywood, Florida, United States, 33021 | |
| Hematology Oncology Associates | |
| Loxahatchee, Florida, United States, 33470 | |
| South Miami Heart Center | |
| Miami, Florida, United States, 33143 | |
| Physicians Regional Medical Group | |
| Naples, Florida, United States, 34119 | |
| Richard A. Mclean M.D., P.A. | |
| Plantation, Florida, United States, 33317 | |
| Tampa Clinical Research | |
| Tampa, Florida, United States, 33624 | |
| Primary Care Of The Treasure Coast, Inc. | |
| Vero Beach, Florida, United States, 32960 | |
| Cleveland Clinic Florida | |
| Weston, Florida, United States, 33331 | |
| United States, Georgia | |
| Vascular Surgical Associates, Pc | |
| Austell, Georgia, United States, 30106 | |
| Atlanta Institute For Medical Research, Inc | |
| Decatur, Georgia, United States, 30030 | |
| Gwinnett Biomedical Research | |
| Lawrenceville, Georgia, United States, 30046 | |
| United States, Idaho | |
| Boise Orthopedic Clinic | |
| Boise, Idaho, United States, 83706 | |
| Saltzer Medical Group | |
| Nampa, Idaho, United States, 83686 | |
| United States, Indiana | |
| Infectious Disease Of Indiana Psc | |
| Carmel, Indiana, United States, 46032 | |
| Office Of:Eugene C. Fletcher, Md | |
| New Albany, Indiana, United States, 47150 | |
| United States, Iowa | |
| Heartland Vascular Medicine And Surgery | |
| Windsor Heights, Iowa, United States, 50324 | |
| United States, Kentucky | |
| Kentucky Lung Clinic | |
| Hazard, Kentucky, United States, 41701 | |
| Owensboro Heart & Vascular | |
| Owensboro, Kentucky, United States, 42303 | |
| United States, Maine | |
| Pen Bay Medical Center | |
| Rockport, Maine, United States, 04856 | |
| United States, Maryland | |
| Anne Arundel Health System Research Institute, Inc. | |
| Annapolis, Maryland, United States, 21401 | |
| United States, Massachusetts | |
| Cape Cod Research Institute | |
| Hyannis, Massachusetts, United States, 02601 | |
| United States, Michigan | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| William Beaumont Hospital | |
| Royal Oak, Michigan, United States, 48073 | |
| United States, Missouri | |
| Veterans Affairs Medical Center | |
| Kansas City, Missouri, United States, 64128 | |
| United States, Montana | |
| Mercury Street Medical Group, Pllc | |
| Butte, Montana, United States, 59701 | |
| Great Falls Clinic, Llp | |
| Great Falls, Montana, United States, 59405 | |
| United States, Nebraska | |
| Internal Medical Associates Of Grand Island, P.C | |
| Grand Island, Nebraska, United States, 68803 | |
| Creighton University Medical Center | |
| Omaha, Nebraska, United States, 68131 | |
| United States, New York | |
| Kaleida Health System | |
| Buffalo, New York, United States, 14209 | |
| Goshen Medical Associates | |
| Goshen, New York, United States, 10924 | |
| Sjh Cardiology Associates | |
| Liverpool, New York, United States, 13088 | |
| Richmond University Medical Center | |
| Staten Island, New York, United States, 10310 | |
| New York Medical College | |
| Valhalla, New York, United States, 10595 | |
| United States, North Carolina | |
| Thomas L. Ortel, Md, Phd | |
| Durham, North Carolina, United States, 27710 | |
| Valley Internal Medicine | |
| Fayetteville, North Carolina, United States, 28304 | |
| Rex Healthcare | |
| Raleigh, North Carolina, United States, 27607 | |
| Piedmont Healthcare/Research | |
| Statesville, North Carolina, United States, 28625 | |
| Whiteville Medical Associates, P.A. | |
| Whiteville, North Carolina, United States, 28472 | |
| Wilmington Medical Research | |
| Wilmington, North Carolina, United States, 28401 | |
| United States, Ohio | |
| Akron General Medical Center | |
| Akron, Ohio, United States, 44307 | |
| Community Health Care, Inc. | |
| Canal Fulton, Ohio, United States, 44614 | |
| Valley Medical Research | |
| Centerville, Ohio, United States, 45459 | |
| Ohio State University Medical Center | |
| Columbus, Ohio, United States, 43210 | |
| Remington Davis Inc. | |
| Columbus, Ohio, United States, 43215 | |
| Jobst Vascular Center At The Toledo Hospital | |
| Toledo, Ohio, United States, 43606 | |
| United States, Oklahoma | |
| Cor Clinical Research, Llc | |
| Oklahoma City, Oklahoma, United States, 73103 | |
| United States, Pennsylvania | |
| Pma Medical Specialists | |
| Phoenixville, Pennsylvania, United States, 19460 | |
| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| United States, South Carolina | |
| Charleston Hematology Oncology Associates, Pa | |
| Charleston, South Carolina, United States, 29414 | |
| Greenville Hospital System | |
| Greenville, South Carolina, United States, 29615 | |
| Three Rivers Medical Associates, Pa | |
| Irmo, South Carolina, United States, 29063 | |
| Clinical Research Authority, Llc | |
| Murrells Inlet, South Carolina, United States, 29576 | |
| Palmetto Clinical Research | |
| Summerville, South Carolina, United States, 29485 | |
| United States, Tennessee | |
| Holston Medical Group | |
| Bristol, Tennessee, United States, 37620 | |
| Holston Medical Group | |
| Kingsport, Tennessee, United States, 37660 | |
| United States, Texas | |
| Amarillo Heart Clinical Research Institute Inc. | |
| Amarillo, Texas, United States, 79106 | |
| Corsicana Medical Research | |
| Corsicana, Texas, United States, 75110 | |
| Ankur Doshi, Md | |
| Houston, Texas, United States, 77024 | |
| Northwest Heart Center | |
| Tomball, Texas, United States, 77375 | |
| United States, Utah | |
| Tanner Clinic | |
| Layton, Utah, United States, 84041 | |
| University Of Utah Hospital | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Virginia | |
| University Of Virginia Health System | |
| Charlottesville, Virginia, United States, 22908 | |
| Sentara York Clinical Research | |
| Norfolk, Virginia, United States, 23510 | |
| United States, Washington | |
| Lake Washington Vascular, Pllc | |
| Bellevue, Washington, United States, 98004 | |
| Franciscan Research Center | |
| Tacoma, Washington, United States, 98405 | |
| United States, Wisconsin | |
| Medical Assoicates Inc. | |
| Menomonee Falls, Wisconsin, United States, 53051 | |
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| Capital Federal, Buenos Aires, Argentina, C1426ANZ | |
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| Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina, 1093 AAS | |
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| Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina, C1437JCP | |
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| Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina, C1180AAX | |
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| Ciudad De Buenos Aires, Buenos Aires, Argentina, C1181ACH | |
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| Ciudad De Buenos Aires, Buenos Aires, Argentina, C1034ACO | |
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| Coronel Suarez, Buenos Aires, Argentina, B7540GHD | |
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| La Plata, Buenos Aires, Argentina, 1900 | |
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| La Plata, Buenos Aires, Argentina, B1902COI | |
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| Mar Del Plata, Buenos Aires, Argentina, 7600 | |
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| San Martin, Buenos Aires, Argentina, B1650CSQ | |
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| Rosario, Santa Fe, Argentina, S2000DSV | |
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| Buenos Aires, Argentina, C1280AEB | |
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| Cordoba, Argentina, 5000 | |
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| Cordoba, Argentina, X5000JHQ | |
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| Corrientes, Argentina, 3400 | |
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| Garran, Australian Capital Territory, Australia, 2605 | |
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| Kogarah, New South Wales, Australia, 2217 | |
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| Lismore, New South Wales, Australia, 2480 | |
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| St Leonards, New South Wales, Australia, 2065 | |
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| Adelaide, South Australia, Australia, 5000 | |
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| Bedford Park, South Australia, Australia, 5042 | |
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| Launceston, Tasmania, Australia, 7250 | |
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| Box Hill, Victoria, Australia, 3128 | |
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| Salvador, Bahia, Brazil, 40144 900 | |
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| Brasilia, Distrito Federal, Brazil, 70335 | |
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| Belo Horizonte - Mg, Minas Gerais, Brazil, 30150 | |
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| Belo Horizonte - Mg, Minas Gerais, Brazil, 30130 | |
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| Curitiba, Parana, Brazil, 81520 | |
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| Rio Janeiro, Rio De Janeiro, Brazil, 22280 | |
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| Port Alegre, Rio Grande Do Sul, Brazil, 90020 | |
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| Porto Alegre, Rio Grande Do Sul, Brazil, 90035 | |
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| Porto Alegre, Rio Grande Do Sul, Brazil, 9110270 | |
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| Botucatu, Sao Paulo, Brazil, 18618 | |
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| Santo Andre - Sp, Sao Paulo, Brazil, 09060 | |
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| Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015 | |
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| Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15090 | |
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| Rio De Janeiro, Brazil, 20551 | |
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| Edmonton, Alberta, Canada, T5H 4B9 | |
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| Edmonton, Alberta, Canada, Tsa 4l8 | |
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| Edmonton, Alberta, Canada, T5X 3N5 | |
| Canada, British Columbia | |
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| Kelowna, British Columbia, Canada, V1Y 9L8 | |
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| Victoria, British Columbia, Canada, V8R 4R2 | |
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| Hamilton, Ontario, Canada, L8S 4K1 | |
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| Hamilton, Ontario, Canada, L8L 2X2 | |
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| Waterloo, Ontario, Canada, N2J 1C4 | |
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| Windsor, Ontario, Canada, N8X 5A6 | |
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| Independencia, Metropolitana, Chile, XXXXX | |
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| Vina Del Mar, Valparaiso, Chile, 2520000 | |
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| Ostrava Vitkovice, Czech Republic, 703 00 | |
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| Plzen, Czech Republic, 323 33 | |
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| Frederiksberg, Denmark, 2000 | |
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| Seoul, Korea, Republic of, 138736 | |
| Local Institution | |
| Seoul, Korea, Republic of, 137-040 | |
| Local Institution | |
| Seoul, Korea, Republic of, 120752 | |
| Mexico | |
| Local Institution | |
| Tijuana, Baja California, Mexico, 22500 | |
| Local Institution | |
| Mexico, Distrito Federal, Mexico, 06726 | |
| Local Institution | |
| Leon, Guanajuato, Mexico, 37320 | |
| Local Institution | |
| Guadalajara, Jalisco, Mexico, 44130 | |
| Local Institution | |
| Guadalajara, Jalisco, Mexico, 44280 | |
| Local Institution | |
| Guadalajara, Jalisco, Mexico, 44200 | |
| Local Institution | |
| Zapopan, Jalisco, Mexico, 45200 | |
| Local Institution | |
| Monterrey, Nuevo Leon, Mexico, 64000 | |
| Local Institution | |
| Monterrey, Nuevo Leon, Mexico, 64710 | |
| Local Institution | |
| Culiacan, Sinaloa, Mexico, 80020 | |
| Local Institution | |
| Culiacan, Sinaloa, Mexico, 80230 | |
| Local Institution | |
| Xalapa, Veracruz, Mexico, 91020 | |
| Local Institution | |
| Aguascalientes, Mexico, 20230 | |
| Local Institution | |
| Chihuahua, Mexico, 31203 | |
| Local Institution | |
| Durango, Mexico, 34080 | |
| Local Institution | |
| Puebla, Mexico, 72000 | |
| Local Institution | |
| Queretaro, Mexico, 76000 | |
| Local Institution | |
| San Luis Potosi, Mexico, 78200 | |
| Local Institution | |
| San Luis Potosi, Mexico, 78240 | |
| Norway | |
| Local Institution | |
| Alesund, Norway, 6026 | |
| Local Institution | |
| Fredrikstad, Norway, 1606 | |
| Local Institution | |
| Gjettum, Norway, 1346 | |
| Local Institution | |
| Gjovik, Norway, 2819 | |
| Local Institution | |
| Hamar, Norway, 2318 | |
| Local Institution | |
| Oslo, Norway, 0407 | |
| Philippines | |
| Local Institution | |
| Cavite, Philippines, 4114 | |
| Local Institution | |
| Davao City, Philippines, 8000 | |
| Local Institution | |
| Pasig City, Philippines, 1600 | |
| Local Institution | |
| Quezon City, Philippines, 1102 | |
| Poland | |
| Local Institution | |
| Arkonska 4, Poland, 71455 | |
| Local Institution | |
| Bialystok, Poland, 15-276 | |
| Local Institution | |
| Bydgoszcz, Poland, 85-681 | |
| Local Institution | |
| Bydgoszcz, Poland, 85-650 | |
| Local Institution | |
| Bydgoszcz, Poland, 85-168 | |
| Local Institution | |
| Gdansk, Poland, 80-803 | |
| Local Institution | |
| Gdynia, Poland, 81-423 | |
| Local Institution | |
| Gdynia, Poland, 81-348 | |
| Local Institution | |
| Lodz, Poland, 90-153 | |
| Local Institution | |
| Lublin, Poland, 20-718 | |
| Local Institution | |
| Lublin, Poland, 20-081 | |
| Local Institution | |
| Poznan, Poland, 61-848 | |
| Local Institution | |
| Przeworsk, Poland, 37-200 | |
| Local Institution | |
| Szczecin, Poland, 70-111 | |
| Local Institution | |
| Tarnobrzeg, Poland, 39-400 | |
| Local Institution | |
| Warsaw, Poland, 01-809 | |
| Local Institution | |
| Warsaw, Poland, 02-005 | |
| Local Institution | |
| Warsawa, Poland, 02-776 | |
| Local Institution | |
| Warszawa, Poland, 01-138 | |
| Local Institution | |
| Warszawa, Poland, 02-018 | |
| Local Institution | |
| Wroclaw, Poland, 53-114 | |
| Local Institution | |
| Wroclaw, Poland, 51-124 | |
| Portugal | |
| Local Institution | |
| Guarda, Portugal, 6301-857 | |
| Local Institution | |
| Lisboa, Portugal, 1769-001 | |
| Puerto Rico | |
| Local Institution | |
| San Juan, Puerto Rico, 00921 | |
| Local Institution | |
| San Juan, Puerto Rico, 00909 | |
| Romania | |
| Local Institution | |
| Baia Mare, Romania, 430031 | |
| Local Institution | |
| Bucharest, Romania, 050098 | |
| Local Institution | |
| Bucharest, Romania, 022328 | |
| Local Institution | |
| Bucharest, Romania, 030171 | |
| Local Institution | |
| Targu Mures, Romania, 540136 | |
| Russian Federation | |
| Local Institution | |
| Arkhangelsk, Russian Federation, 163045 | |
| Local Institution | |
| Kemerovo, Russian Federation, 650002 | |
| Local Institution | |
| Moscow, Russian Federation, 111539 | |
| Local Institution | |
| Moscow, Russian Federation, 105077 | |
| Local Institution | |
| Moscow, Russian Federation, 119049 | |
| Local Institution | |
| Moscow, Russian Federation, 127473 | |
| Local Institution | |
| Novosibirsk, Russian Federation, 630055 | |
| Local Institution | |
| Novosibirsk, Russian Federation, 630090 | |
| Local Institution | |
| Rostov-On Don, Russian Federation, 344022 | |
| Local Institution | |
| Ryazan, Russian Federation, 390026 | |
| Local Institution | |
| Saint Petersburg, Russian Federation, 192242 | |
| Local Institution | |
| Saint-Petersburg, Russian Federation, 196247 | |
| Local Institution | |
| Saint-Petersburg, Russian Federation, 199106 | |
| Local Institution | |
| Samara, Russian Federation, 443010 | |
| Local Institution | |
| Saratov, Russian Federation, 410028 | |
| Local Institution | |
| Saratov, Russian Federation, 410012 | |
| Local Institution | |
| St Petersburg, Russian Federation, 194044 | |
| Local Institution | |
| Tomsk, Russian Federation, 634012 | |
| Local Institution | |
| Yaroslavl, Russian Federation, 150062 | |
| Singapore | |
| Local Institution | |
| Singapore, Singapore, 308433 | |
| Local Institution | |
| Singapore, Singapore, 169608 | |
| South Africa | |
| Local Institution | |
| Bloemfontein, Free State, South Africa, 9301 | |
| Local Institution | |
| Centurion, Gauteng, South Africa, 0157 | |
| Local Institution | |
| Parktown, Gauteng, South Africa, 2193 | |
| Local Institution | |
| Pretoria, Gauteng, South Africa, 0083 | |
| Local Institution | |
| Pretoria, Gauteng, South Africa, 0084 | |
| Local Institution | |
| Durban, Kwa Zulu Natal, South Africa, 4001 | |
| Local Institution | |
| Pietermaritzburg, Kwa Zulu Natal, South Africa, 3201 | |
| Local Institution | |
| Bellville, Western Cape, South Africa, 7530 | |
| Local Institution | |
| George, Western Cape, South Africa, 6529 | |
| Local Institution | |
| Somerset West, Western Cape, South Africa, 7130 | |
| Local Institution | |
| Worcester, Western Cape, South Africa, 6850 | |
| Spain | |
| Local Institution | |
| Torrevieja, Alicante, Spain, 03186 | |
| Local Institution | |
| Badalona, Barcelona, Spain, 08916 | |
| Local Institution | |
| Majadahonda, Madrid, Spain, 28222 | |
| Local Institution | |
| San Sebastian De Los Reyes, Madrid, Spain, 28702 | |
| Local Institution | |
| Cadiz, Spain, 11009 | |
| Local Institution | |
| Getafe, Spain, 28905 | |
| Local Institution | |
| Girona, Spain, 17007 | |
| Local Institution | |
| L'Hospitalet De Llobregat, Spain, 08907 | |
| Local Institution | |
| Leon, Spain, 24008 | |
| Local Institution | |
| Madrid, Spain, 28041 | |
| Local Institution | |
| Madrid, Spain, 28029 | |
| Local Institution | |
| Madrid, Spain, 28007 | |
| Local Institution | |
| Madrid, Spain, 28040 | |
| Local Institution | |
| Mourente, Spain, 36071 | |
| Local Institution | |
| Pamplona, Spain, 31008 | |
| Local Institution | |
| Salamanca, Spain, 37007 | |
| Local Institution | |
| Sant Boi De Llobregat, Spain, 08830 | |
| Local Institution | |
| Tarragona, Spain, 43007 | |
| Local Institution | |
| Toledo, Spain, 45071 | |
| Local Institution | |
| Valencia, Spain, 46026 | |
| Ukraine | |
| Local Institution | |
| Chernihiv, Ukraine, 14034 | |
| Local Institution | |
| Dnipropetrovsk, Ukraine, 49000 | |
| Local Institution | |
| Donetsk, Ukraine, 83045 | |
| Local Institution | |
| Ivano-Frankivsk, Ukraine, 76018 | |
| Local Institution | |
| Ivano-Frankivsk, Ukraine, 76008 | |
| Local Institution | |
| Kharkiv, Ukraine, 61018 | |
| Local Institution | |
| Kyiv, Ukraine, 03680 | |
| Local Institution | |
| Lviv, Ukraine, 79010 | |
| Local Institution | |
| Odesa, Ukraine, 65117 | |
| Local Institution | |
| Ternopil, Ukraine, 46000 | |
| Local Institution | |
| Vinnytsia, Ukraine, 21018 | |
| Local Institution | |
| Zaporizhzhia, Ukraine, 69035 | |
| United Kingdom | |
| Local Institution | |
| Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZN | |
| Local Institution | |
| Romford, Essex, United Kingdom, RM7 0AG | |
| Local Institution | |
| London, Greater London, United Kingdom, SW17 0QT | |
| Local Institution | |
| London, Greater London, United Kingdom, SE5 9RS | |
| Local Institution | |
| Manchester, Greater Manchester, United Kingdom, M23 9LT | |
| Local Institution | |
| Hull, Humberside, United Kingdom, HU3 2JZ | |
| Local Institution | |
| Nottingham, Nottinghamshire, United Kingdom, NG7 2UH | |
| Local Institution | |
| Bury St. Edmunds, Suffolk, United Kingdom, IP30 9QU | |
| Local Institution | |
| Coventry, West Midlands, United Kingdom, CV2 2DX | |
| Local Institution | |
| Dudley, West Midlands, United Kingdom, DY1 2HQ | |
Sponsors and Collaborators
Bristol-Myers Squibb
Pfizer
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided by Bristol-Myers Squibb
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00633893 History of Changes |
| Other Study ID Numbers: | CV185-057, EUDRACT: 2007-004953-27 |
| Study First Received: | March 5, 2008 |
| Last Updated: | November 6, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration Canada: Health Canada Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Brazil: National Health Surveillance Agency Chile: Instituto de Salud Publica de Chile Mexico: Federal Commission for Sanitary Risks Protection Austria: Federal Office for Safety in Health Care Denmark: Danish Medicines Agency France: Ministry of Health Germany: Ministry of Health Israel: Ministry of Health Italy: Ministry of Health Norway: Directorate of Health Spain: Spanish Agency of Medicines South Africa: Department of Health Turkey: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency Czech Republic: Ministry of Health Hungary: Ministry of Health, Social and Family Affairs Poland: Ministry of Health Russia: Ministry of Health of the Russian Federation Ukraine: Ministry of Health Australia: Department of Health and Ageing Therapeutic Goods Administration Hong Kong: Department of Health India: Central Drugs Standard Control Organization Korea: Food and Drug Administration Malaysia: National Pharmaceutical Control Bureau Taiwan: Department of Health Romania: National Medicines Agency Portugal: National Pharmacy and Medicines Institute |
Additional relevant MeSH terms:
|
Embolism Pulmonary Embolism Thrombosis Venous Thrombosis Venous Thromboembolism Embolism and Thrombosis |
Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Thromboembolism |
ClinicalTrials.gov processed this record on May 21, 2013