Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism

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NCT00643201

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FOR MORE INFORMATION
Study Location
Alabama Clinical Therapeutics, Llc
Birmingham, Alabama, 35235, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Venous Thrombosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Men and women ≥ 18 years of age

- Clinical diagnosis of DVT or PE

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Contraindications for enoxaparin or warfarin


- Active bleeding or high risk for serious bleeding


- Short life expectancy


- Uncontrolled high blood pressure


- Significantly impaired kidney or liver function

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Venous ThrombosisEfficacy and Safety Study of Apixaban for Extended Treatment of Deep Vein Thrombosis or Pulmonary Embolism
NCT00633893
  1. Birmingham, Alabama
  2. Phoenix, Arizona
  3. Tempe, Arizona
  4. Fort Smith, Arkansas
  5. Banning, California
  6. La Jolla, California
  7. Los Angeles, California
  8. Mission Viejo, California
  9. Palm Springs, California
  10. Pomona, California
  11. San Francisco, California
  12. Stanford, California
  13. Torrance, California
  14. Vista, California
  15. Aurora, Colorado
  16. Golden, Colorado
  17. Newark, Delaware
  18. Bay Pines, Florida
  19. Clearwater, Florida
  20. Clearwater, Florida
  21. Fort Lauderdale, Florida
  22. Hollywood, Florida
  23. Loxahatchee, Florida
  24. Miami, Florida
  25. Naples, Florida
  26. Plantation, Florida
  27. Tampa, Florida
  28. Vero Beach, Florida
  29. Weston, Florida
  30. Austell, Georgia
  31. Decatur, Georgia
  32. Lawrenceville, Georgia
  33. Boise, Idaho
  34. Nampa, Idaho
  35. Carmel, Indiana
  36. New Albany, Indiana
  37. Windsor Heights, Iowa
  38. Hazard, Kentucky
  39. Owensboro, Kentucky
  40. Rockport, Maine
  41. Annapolis, Maryland
  42. Hyannis, Massachusetts
  43. Detroit, Michigan
  44. Royal Oak, Michigan
  45. Kansas City, Missouri
  46. Butte, Montana
  47. Great Falls, Montana
  48. Grand Island, Nebraska
  49. Omaha, Nebraska
  50. Buffalo, New York
  51. Goshen, New York
  52. Liverpool, New York
  53. Staten Island, New York
  54. Valhalla, New York
  55. Durham, North Carolina
  56. Fayetteville, North Carolina
  57. Raleigh, North Carolina
  58. Statesville, North Carolina
  59. Whiteville, North Carolina
  60. Wilmington, North Carolina
  61. Akron, Ohio
  62. Canal Fulton, Ohio
  63. Centerville, Ohio
  64. Columbus, Ohio
  65. Columbus, Ohio
  66. Toledo, Ohio
  67. Oklahoma City, Oklahoma
  68. Phoenixville, Pennsylvania
  69. Providence, Rhode Island
  70. Charleston, South Carolina
  71. Greenville, South Carolina
  72. Irmo, South Carolina
  73. Murrells Inlet, South Carolina
  74. Summerville, South Carolina
  75. Bristol, Tennessee
  76. Kingsport, Tennessee
  77. Amarillo, Texas
  78. Corsicana, Texas
  79. Houston, Texas
  80. Tomball, Texas
  81. Layton, Utah
  82. Salt Lake City, Utah
  83. Charlottesville, Virginia
  84. Norfolk, Virginia
  85. Bellevue, Washington
  86. Tacoma, Washington
  87. Menomonee Falls, Wisconsin
  88. Capital Federal, Buenos Aires
  89. Ciudad Autonoma De Buenos Aire, Buenos Aires
  90. Ciudad Autonoma De Buenos Aire, Buenos Aires
  91. Ciudad Autonoma De Buenos Aire, Buenos Aires
  92. Ciudad De Buenos Aires, Buenos Aires
  93. Ciudad De Buenos Aires, Buenos Aires
  94. Coronel Suarez, Buenos Aires
  95. La Plata, Buenos Aires
  96. La Plata, Buenos Aires
  97. Mar Del Plata, Buenos Aires
  98. San Martin, Buenos Aires
  99. Rosario, Santa Fe
  100. Rosario, Santa Fe
  101. Rosario, Santa Fe
  102. Buenos Aires,
  103. Buenos Aires,
  104. Buenos Aires,
  105. Cordoba,
  106. Cordoba,
  107. Corrientes,
  108. Garran, Australian Capital Territory
  109. Kogarah, New South Wales
  110. Lismore, New South Wales
  111. St Leonards, New South Wales
  112. Herston, Queensland
  113. Kippa Ring, Queensland
  114. Woolloongabba, Queensland
  115. Adelaide, South Australia
  116. Bedford Park, South Australia
  117. Launceston, Tasmania
  118. Box Hill, Victoria
  119. Clayton, Victoria
  120. Footscray, Victoria
  121. Parkville, Victoria
  122. Richmond, Victoria
  123. Ringwood East, Victoria
  124. Windsor, Victoria
  125. Perth, Western Australia
  126. Graz,
  127. Innsbruck,
  128. Vienna,
  129. Vienna,
  130. Wien,
  131. Wien,
  132. Salvador, Bahia
  133. Brasilia, Distrito Federal
  134. Belo Horizonte - Mg, Minas Gerais
  135. Belo Horizonte - Mg, Minas Gerais
  136. Curitiba, Parana
  137. Curitiba, Parana
  138. Curitiba, Parana
  139. Curitiba, Parana
  140. Rio Janeiro, Rio De Janeiro
  141. Port Alegre, Rio Grande Do Sul
  142. Porto Alegre, Rio Grande Do Sul
  143. Porto Alegre, Rio Grande Do Sul
  144. Porto Alegre, Rio Grande Do Sul
  145. Botucatu, Sao Paulo
  146. Campinas, Sao Paulo
  147. Santo Andre - Sp, Sao Paulo
  148. Sao Jose Do Rio Preto, Sao Paulo
  149. Sao Jose Do Rio Preto, Sao Paulo
  150. Rio De Janeiro,
  151. Sao Paulo,
  152. Sao Paulo,
  153. Sao Paulo,
  154. Sao Paulo,
  155. Edmonton, Alberta
  156. Edmonton, Alberta
  157. Edmonton, Alberta
  158. Kelowna, British Columbia
  159. Victoria, British Columbia
  160. Hamilton, Ontario
  161. Hamilton, Ontario
  162. Toronto, Ontario
  163. Waterloo, Ontario
  164. Windsor, Ontario
  165. Montreal, Quebec
  166. Montreal, Quebec
  167. Montreal, Quebec
  168. Pointe- Claire, Quebec
  169. St. Jerome, Quebec
  170. Quebec,
  171. Temuco, Araucania
  172. Punta Arenas, Magallanes Antartica
  173. Independencia, Metropolitana
  174. Santiago, Metropolitana
  175. Santiago, Metropolitana
  176. Santiago, Metropolitana
  177. Santiago, Metropolitana
  178. Vina Del Mar, Valparaiso
  179. Kladno,
  180. Litomysl,
  181. Mestec Kralove,
  182. Ostrava Vitkovice,
  183. Plzen,
  184. Praha 13,
  185. Praha 1,
  186. Praha 1,
  187. Praha 2,
  188. Praha 2,
  189. Praha 2,
  190. Praha 4,
  191. Usti Nad Orlici,
  192. Arhus C,
  193. Braedstrup,
  194. Esbjerg,
  195. Frederiksberg,
  196. Hellerup,
  197. Herning,
  198. Hilleroed,
  199. Naestved,
  200. Silkeborg,
  201. Arras,
  202. Besancon,
  203. Brest Cedex,
  204. Clamart,
  205. Clermont-Ferrand Cedex 01,
  206. Dijon,
  207. Grenoble,
  208. Le Kremlin-Bicetre,
  209. Lille Cedex,
  210. Limoges Cedex,
  211. Lyon Cedex 03,
  212. Nantes,
  213. Saint-Priest En Jarez,
  214. Toulouse Cedex 9,
  215. Vernon,
  216. Berlin,
  217. Berlin,
  218. Berlin,
  219. Bochum,
  220. Bonn,
  221. Cologne,
  222. Dortmund,
  223. Dresden,
  224. Dresden,
  225. Erfurt,
  226. Frankfurt,
  227. Gottingen,
  228. Karlsbad,
  229. Krefeld,
  230. Ludwigshafen,
  231. Mannheim,
  232. Mannheim,
  233. Mannheim,
  234. Munchen,
  235. Munich,
  236. Hong Kong,
  237. Shatin, N.T,
  238. Hyderabad, Andhra Pradesh
  239. Hyderabad, Andhra Pradesh
  240. Ahmedabad, Gujarat
  241. Gurgaon, Haryana
  242. Bangalore, Karnataka
  243. Bengaluru, Karnataka
  244. Kochi, Kerala
  245. Pune, Maharashtra
  246. Mohali, Punjab
  247. Ludhiana, Tagore Nagar
  248. Chennai, Tamil Nadu
  249. Ahmedabad,
  250. Bangalore, Karnataka,
  251. Bangalore,
  252. Chennai,
  253. Chennai,
  254. New Dehli,
  255. Afula,
  256. Givataim,
  257. Hadera,
  258. Haifa,
  259. Haifa,
  260. Holon,
  261. Jerusalem,
  262. Kfar Saba,
  263. Kiryat Hadassah,
  264. Nahariya,
  265. Petach-Tikva,
  266. Safed,
  267. Tel Aviv,
  268. Tel Hashomer,
  269. Bollate,
  270. Bologna,
  271. Chieti Scalo,
  272. Cosenza,
  273. Ferrara,
  274. Firenze,
  275. Genova,
  276. Milano,
  277. Padova,
  278. Palermo,
  279. Pavia,
  280. Perugia,
  281. Piacenza,
  282. Pisa,
  283. Roma,
  284. Rozzano (Mi),
  285. San Daniele Del Friuli (Ud),
  286. Udine,
  287. Venezia,
  288. Vicenza,
  289. Vittorio Veneto (Tv),
  290. Busan,
  291. Jongno-Gu,
  292. Seoul,
  293. Seoul,
  294. Seoul,
  295. Seoul,
  296. Tijuana, Baja California
  297. Mexico, Distrito Federal
  298. Leon, Guanajuato
  299. Guadalajara, Jalisco
  300. Guadalajara, Jalisco
  301. Guadalajara, Jalisco
  302. Zapopan, Jalisco
  303. Monterrey, Nuevo Leon
  304. Monterrey, Nuevo Leon
  305. Culiacan, Sinaloa
  306. Culiacan, Sinaloa
  307. Xalapa, Veracruz
  308. Aguascalientes,
  309. Chihuahua,
  310. Durango,
  311. Puebla,
  312. Queretaro,
  313. San Luis Potosi,
  314. San Luis Potosi,
  315. Alesund,
  316. Fredrikstad,
  317. Gjettum,
  318. Gjovik,
  319. Hamar,
  320. Oslo,
  321. Cavite,
  322. Davao City,
  323. Pasig City,
  324. Quezon City,
  325. Arkonska 4,
  326. Bialystok,
  327. Bydgoszcz,
  328. Bydgoszcz,
  329. Bydgoszcz,
  330. Gdansk,
  331. Gdynia,
  332. Gdynia,
  333. Lodz,
  334. Lublin,
  335. Lublin,
  336. Poznan,
  337. Przeworsk,
  338. Szczecin,
  339. Tarnobrzeg,
  340. Warsawa,
  341. Warsaw,
  342. Warsaw,
  343. Warszawa,
  344. Warszawa,
  345. Wroclaw,
  346. Wroclaw,
  347. Guarda,
  348. Lisboa,
  349. San Juan,
  350. San Juan,
  351. Baia Mare,
  352. Bucharest,
  353. Bucharest,
  354. Bucharest,
  355. Targu Mures,
  356. Arkhangelsk,
  357. Kemerovo,
  358. Moscow,
  359. Moscow,
  360. Moscow,
  361. Moscow,
  362. Novosibirsk,
  363. Novosibirsk,
  364. Rostov-On Don,
  365. Ryazan,
  366. Saint Petersburg,
  367. Saint-Petersburg,
  368. Saint-Petersburg,
  369. Samara,
  370. Saratov,
  371. Saratov,
  372. St Petersburg,
  373. Tomsk,
  374. Yaroslavl,
  375. Singapore,
  376. Singapore,
  377. Bloemfontein, Free State
  378. Centurion, Gauteng
  379. Parktown, Gauteng
  380. Pretoria, Gauteng
  381. Pretoria, Gauteng
  382. Durban, Kwa Zulu Natal
  383. Pietermaritzburg, Kwa Zulu Natal
  384. Bellville, Western Cape
  385. George, Western Cape
  386. Somerset West, Western Cape
  387. Worcester, Western Cape
  388. Torrevieja, Alicante
  389. Badalona, Barcelona
  390. Majadahonda, Madrid
  391. San Sebastian De Los Reyes, Madrid
  392. Cadiz,
  393. Getafe,
  394. Girona,
  395. L'Hospitalet De Llobregat,
  396. Leon,
  397. Madrid,
  398. Madrid,
  399. Madrid,
  400. Madrid,
  401. Mourente,
  402. Pamplona,
  403. Salamanca,
  404. Sant Boi De Llobregat,
  405. Tarragona,
  406. Toledo,
  407. Valencia,
  408. Chernihiv,
  409. Dnipropetrovsk,
  410. Donetsk,
  411. Ivano-Frankivsk,
  412. Ivano-Frankivsk,
  413. Kharkiv,
  414. Kyiv,
  415. Lviv,
  416. Odesa,
  417. Ternopil,
  418. Vinnytsia,
  419. Zaporizhzhia,
  420. Aberdeen, Aberdeenshire
  421. Romford, Essex
  422. London, Greater London
  423. London, Greater London
  424. Manchester, Greater Manchester
  425. Hull, Humberside
  426. Nottingham, Nottinghamshire
  427. Bury St. Edmunds, Suffolk
  428. Coventry, West Midlands
  429. Dudley, West Midlands
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Venous ThrombosisEfficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism
NCT00643201
  1. Birmingham, Alabama
  2. Mobile, Alabama
  3. Fort Smith, Arkansas
  4. Little Rock, Arkansas
  5. Banning, California
  6. Fresno, California
  7. Sacramento, California
  8. San Diego, California
  9. Stanford, California
  10. Torrance, California
  11. Golden, Colorado
  12. Wheat Ridge, Colorado
  13. Bridgeport, Connecticut
  14. New Haven, Connecticut
  15. Washington, District of Columbia
  16. Bay Pines, Florida
  17. Brandon, Florida
  18. Clearwater, Florida
  19. Jacksonville, Florida
  20. St. Petersburg, Florida
  21. Tampa, Florida
  22. Vero Beach, Florida
  23. Weston, Florida
  24. Atlanta, Georgia
  25. Decatur, Georgia
  26. Savannah, Georgia
  27. Jerseyville, Illinois
  28. Oak Park, Illinois
  29. Carmel, Indiana
  30. Windsor Heights, Iowa
  31. Hazard, Kentucky
  32. Lexington, Kentucky
  33. Owensboro, Kentucky
  34. Rockport, Maine
  35. Annapolis, Maryland
  36. Baltimore, Maryland
  37. Baltimore, Maryland
  38. Detroit, Michigan
  39. Flint, Michigan
  40. Picayune, Mississippi
  41. Columbia, Missouri
  42. Kansas City, Missouri
  43. St Louis, Missouri
  44. St. Louis, Missouri
  45. Butte, Montana
  46. Great Falls, Montana
  47. Grand Island, Nebraska
  48. Omaha, Nebraska
  49. Morristown, New Jersey
  50. Albany, New York
  51. Buffalo, New York
  52. Staten Island, New York
  53. Valhalla, New York
  54. Charlotte, North Carolina
  55. Durham, North Carolina
  56. Raleigh, North Carolina
  57. Statesville, North Carolina
  58. Wilmington, North Carolina
  59. Winston Salem, North Carolina
  60. Grand Forks, North Dakota
  61. Cleveland, Ohio
  62. Columbus, Ohio
  63. Portland, Oregon
  64. Hershey, Pennsylvania
  65. Greenville, South Carolina
  66. Summerville, South Carolina
  67. Bristol, Tennessee
  68. Jackson, Tennessee
  69. Houston, Texas
  70. San Antonio, Texas
  71. Salt Lake City, Utah
  72. Bellevue, Washington
  73. Tacoma, Washington
  74. Ciudad Autonoma De Buenos Aire, Buenos Aires
  75. Rosario, Santa Fe
  76. Rosario, Santa Fe
  77. Rosario, Santa Fe
  78. Buenos Aires,
  79. Cordoba,
  80. Corrientes,
  81. Garran, Australian Capital Territory
  82. Concord, New South Wales
  83. Kogarah, New South Wales
  84. Lismore, New South Wales
  85. Randwick, New South Wales
  86. Herston, Queensland
  87. Adelaide, South Australia
  88. Bedford Park, South Australia
  89. Hobart, Tasmania
  90. Box Hill, Victoria
  91. Clayton, Victoria
  92. Ringwood East, Victoria
  93. Windsor, Victoria
  94. Perth, Western Australia
  95. Graz,
  96. Innsbruck,
  97. Vienna,
  98. Vienna,
  99. Vienna,
  100. Vienna,
  101. Wien,
  102. Belo Horizonte - Mg, Minas Gerais
  103. Curitiba, Parana
  104. Curitiba, Parana
  105. Curitiba, Parana
  106. Curitiba, Parana
  107. Rio Janeiro, Rio De Janeiro
  108. Port Alegre, Rio Grande Do Sul
  109. Porto Alegre, Rio Grande Do Sul
  110. Porto Alegre, Rio Grande Do Sul
  111. Porto Alegre, Rio Grande Do Sul
  112. Botucatu, Sao Paulo
  113. Liberdade, Sao Paulo
  114. Sao Jose Do Rio Preto, Sao Paulo
  115. Sao Bernardo do Campo, SP
  116. Rio De Janeiro,
  117. Sao Paulo,
  118. Sao Paulo,
  119. Sao Paulo,
  120. Sao Paulo,
  121. Edmonton, Alberta
  122. Edmonton, Alberta
  123. Vancouver, British Columbia
  124. Vancouver, British Columbia
  125. Victoria, British Columbia
  126. Winnipeg, Manitoba
  127. Saint John, New Brunswick
  128. Hamilton, Ontario
  129. Hamilton, Ontario
  130. Hamilton, Ontario
  131. Ottawa, Ontario
  132. Toronto, Ontario
  133. Waterloo, Ontario
  134. Windsor, Ontario
  135. Greenfield Park, Quebec
  136. Montreal, Quebec
  137. St. Jerome, Quebec
  138. Punta Arenas, Magallanes Antartica
  139. Independencia, Metropolitana
  140. Santiago, Metropolitana
  141. Santiago, Metropolitana
  142. Vina Del Mar, Valparaiso
  143. Beijing, Beijing
  144. Beijing, Beijing
  145. Beijing, Beijing
  146. Beijing, Beijing
  147. Beijing, Beijing
  148. Beijing, Beijing
  149. Beijing, Beijing
  150. Beijing, Beijing
  151. Guangzhou, Guangdong
  152. Wuhan, Hubei
  153. Shengyang, Liaoning
  154. Shanghai, Shanghai
  155. Shanghai, Shanghai
  156. Hangzhou, Zhejiang
  157. Hangzhou, Zhejiang
  158. Xian,
  159. Hradec Kralove,
  160. Kladno,
  161. Litomysl,
  162. Mestec Kralove,
  163. Ostrava Vitkovice,
  164. Ostrava,
  165. Praha 10,
  166. Praha 1,
  167. Praha 1,
  168. Praha 2,
  169. Usti Nad Labem,
  170. Usti Nad Orlici,
  171. Arhus C,
  172. Hellerup,
  173. Herning,
  174. Hilleroed,
  175. Horsens,
  176. Naestved,
  177. Silkeborg,
  178. Angers,
  179. Arras,
  180. Besancon,
  181. Clamart,
  182. Clermont-Ferrand Cedex 01,
  183. Dijon,
  184. Grenoble Cedex 9,
  185. Langres Cedex,
  186. Le Kremlin-Bicetre,
  187. Lille Cedex,
  188. Limoges Cedex,
  189. Nantes,
  190. Paris,
  191. Paris,
  192. Pierre Benite,
  193. Saint-Priest En Jarez,
  194. Toulouse cedex 9,
  195. Vernon,
  196. Berlin,
  197. Berlin,
  198. Berlin,
  199. Berlin,
  200. Bochum,
  201. Cologne,
  202. Dortmund,
  203. Dresden,
  204. Dresden,
  205. Frankfurt,
  206. Gottingen,
  207. Karlsbad,
  208. Ludwigshafen,
  209. Mannheim,
  210. Mannheim,
  211. Munchen,
  212. Munich,
  213. Pokfulman,
  214. Shatin, N.T,
  215. Budapest,
  216. Budapest,
  217. Budapest,
  218. Gyula,
  219. Kecskemet,
  220. Miskolc,
  221. Mosonmagyarovar,
  222. Szekesfehervar,
  223. Zalaegerszeg,
  224. Hyderabad, Andhra Pradesh
  225. Hyderabad, Andhra Pradesh
  226. Ahmedabad, Gujarat
  227. Gurgaon, Haryana
  228. Bangalore, Karnataka
  229. Bengaluru, Karnataka
  230. Manipal, Karnataka
  231. Pune, Maharashtra
  232. Mohali, Punjab
  233. Ludhiana, Tagore Nagar
  234. Chennai, Tamil Nadu
  235. Bangalore,
  236. Bangalore,
  237. Pune,
  238. Tiberias, Lower Galillee
  239. Afula,
  240. Ashkelon,
  241. Hadera,
  242. Haifa,
  243. Haifa,
  244. Holon,
  245. Jerusalem,
  246. Jerusalem,
  247. Kfar Saba,
  248. Nahariya,
  249. Petach-Tikva,
  250. Rehovot,
  251. Safed,
  252. Tel Aviv,
  253. Tel Hashomer,
  254. Bologna,
  255. Castelfranco Veneto (Tv),
  256. Chieti Scalo,
  257. Cosenza,
  258. Milano,
  259. Padova,
  260. Palermo,
  261. Pavia,
  262. Piacenza,
  263. Pisa,
  264. Reggio Emilia,
  265. Rome,
  266. Rozzano (Mi),
  267. San Daniele Del Friuli (Ud),
  268. Vicenza,
  269. Vittorio Veneto (Tv),
  270. Busan,
  271. Seoul,
  272. Seoul,
  273. Seoul,
  274. Georgetown, Penang
  275. Ipoh, Perak
  276. Kuala Lumpur,
  277. Melaka,
  278. Tijuana, Baja California
  279. Leon, Guanajuato
  280. Guadalajara, Jalisco
  281. Zapopan, Jalisco
  282. Zapopan, Jalisco
  283. Monterrey, Nuevo Leon
  284. Monterrey, Nuevo Leon
  285. Xalapa, Veracruz
  286. Aguascalientes,
  287. Durango,
  288. Alesund,
  289. Fredrikstad,
  290. Gjettum,
  291. Gjovik,
  292. Hamar,
  293. Oslo,
  294. Oslo,
  295. Oslo,
  296. Trondheim,
  297. Tynset,
  298. Bialystok,
  299. Bydgoszcz,
  300. Bydgoszcz,
  301. Gdansk,
  302. Gdynia,
  303. Lodz,
  304. Lublin,
  305. Lublin,
  306. Poznan,
  307. Przeworsk,
  308. Szczecin,
  309. Warsawa,
  310. Warsaw,
  311. Warszawa,
  312. Wroclaw,
  313. Wroclaw,
  314. Coimbra,
  315. Guarda,
  316. Lisboa,
  317. Lisboa,
  318. San Juan,
  319. Baia Mare,
  320. Bucharest,
  321. Bucharest,
  322. Bucharest,
  323. Targu Mures,
  324. Arkhangelsk,
  325. Chelyabinsk,
  326. Kazan,
  327. Moscow,
  328. Moscow,
  329. Moscow,
  330. Moscow,
  331. Moscow,
  332. Moscow,
  333. Moscow,
  334. Moscow,
  335. Moscow,
  336. Novosibirsk,
  337. Rostov-On Don,
  338. Ryazan,
  339. Saint Petersburg,
  340. Saint Petersburg,
  341. Saint-Petersburg,
  342. Saint-Petersburg,
  343. Saint-Petersburg,
  344. Saratov,
  345. St Petersburg,
  346. Yaroslavl,
  347. Singapore,
  348. Singapore,
  349. Singapore,
  350. Bioemfontein, Free State
  351. Centurion, Gauteng
  352. Parktown, Gauteng
  353. Pretoria, Gauteng
  354. Durban, Kwa Zulu Natal
  355. Pietermaritzburg, Kwa Zulu Natal
  356. Bellville, Western Cape
  357. George, Western Cape
  358. Somerset West, Western Cape
  359. Worcester, Western Cape
  360. Torrevieja, Alicante
  361. Getafe,
  362. L'Hospitalet De Llobregat,
  363. Leon,
  364. Madrid,
  365. Madrid,
  366. Madrid,
  367. Malaga,
  368. Mourente,
  369. Tarragona,
  370. Chernihiv,
  371. Dnipropetrovsk,
  372. Donetsk,
  373. Ivano-Frankivsk,
  374. Ivano-Frankivsk,
  375. Kharkiv,
  376. Kyiv,
  377. Lviv,
  378. Odesa,
  379. Ternopil,
  380. Vinnytsia,
  381. Zaporizhzhia,
  382. Livingston, West Lothian
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Venous ThrombosisEvaluation of PD 0348292 for Preventing Blood Clots in the Lungs or Deep Leg Veins of Patients After Knee Surgery
NCT00306254
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Little Rock, Arkansas
  4. North Little Rock, Arkansas
  5. Encinitas, California
  6. Fountain Valley, California
  7. Fountain Valley, California
  8. Glendale, California
  9. La Mesa, California
  10. Long Beach, California
  11. Long Beach, California
  12. Long Beach, California
  13. Los Angeles, California
  14. Los Angeles, California
  15. Los Angeles, California
  16. Santa Ana, California
  17. Torrance, California
  18. Aurora, Colorado
  19. Aurora, Colorado
  20. Aurora, Colorado
  21. Denver, Colorado
  22. Englewood, Colorado
  23. Littleton, Colorado
  24. Littleton, Colorado
  25. Lone Tree, Colorado
  26. Lone Tree, Colorado
  27. Parker, Colorado
  28. Coral Gables, Florida
  29. Hollywood, Florida
  30. Miami, Florida
  31. Miami, Florida
  32. Miami, Florida
  33. Miami, Florida
  34. Orlando, Florida
  35. St. Petersburg, Florida
  36. St. Petersburg, Florida
  37. St. Petersburg, Florida
  38. St. Petersburg, Florida
  39. Winter Park, Florida
  40. Winter Park, Florida
  41. Flint, Michigan
  42. Flint, Michigan
  43. Rochester, New York
  44. Hershey, Pennsylvania
  45. Charleston, South Carolina
  46. Charleston, South Carolina
  47. Dallas, Texas
  48. Fort Worth, Texas
  49. Fort Worth, Texas
  50. Houston, Texas
  51. Houston, Texas
  52. Houston, Texas
  53. Lubbock, Texas
  54. San Antonio, Texas
  55. San Antonio, Texas
  56. San Antonio, Texas
  57. San Antonio, Texas
  58. San Antonio, Texas
  59. Caringbah, New South Wales
  60. Kogarah, New South Wales
  61. St Leonards, New South Wales
  62. Bedford Park, South Australia
  63. Daw Park, South Australia
  64. Box Hill, Victoria
  65. Clayton, Victoria
  66. Dandenong, Victoria
  67. East Bentleigh, Victoria
  68. Nedlands, Western Australia
  69. West Perth, Western Australia
  70. Red Deer, Alberta
  71. Kelowna, British Columbia
  72. Guelph, Ontario
  73. Hamilton, Ontario
  74. Kitchener, Ontario
  75. Ottawa, Ontario
  76. Thunder Bay, Ontario
  77. Thunder Bay, Ontario
  78. Weston, Ontario
  79. Montreal, Quebec
  80. Quebec,
  81. Santiago, RM
  82. Medellin, Antioquia
  83. Barranquilla, Atlantico
  84. Floridablanca, Santander
  85. Cali, Valle
  86. Brno,
  87. Chomutov,
  88. Hradec Kralove,
  89. Jihlava,
  90. Kladno,
  91. Pardubice,
  92. Praha 5,
  93. Praha 6,
  94. Praha 8,
  95. Trebic,
  96. Uherske Hradiste,
  97. Hellerup,
  98. Hoersholm,
  99. Hvidovre,
  100. Kjellerup,
  101. Kolding,
  102. Silkeborg,
  103. Viborg,
  104. Nice,
  105. Paris,
  106. Bologna,
  107. Genova,
  108. Piacenza,
  109. Bialystok,
  110. Bytom,
  111. Piekary Slaskie,
  112. Sosnowiec,
  113. Warszawa,
  114. Warszawa,
  115. Wroclaw,
  116. Coimbra,
  117. Parede,
  118. Setúbal,
  119. Samara,
  120. St. Petersburg,
  121. St. Petersburg,
  122. Yaroslavl,
  123. Kosice,
  124. Cape Town,
  125. Johannesburg,
  126. Johannesburg,
  127. Alcorcon, Madrid
  128. Mirasierra, Madrid
  129. Barcelona,
  130. Barcelona,
  131. Barcelona,
  132. Madrid,
  133. Epsom, Surrey
  134. London,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism
Official Title  ICMJE A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism
Brief Summary The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Venous Thrombosis
Intervention  ICMJE
  • Drug: Enoxaparin
    solution, subcutaneous, 1 mg/kg Q12h until International normalized ratio (INR) ?2.
  • Drug: warfarin
    tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months
    Other Names:
    • Coumadin
    • BMS-565793
  • Drug: Placebo for apixaban
    tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months
  • Drug: Placebo for enoxaparin
    solution, subcutaneous, 1 mg/kg Q12h until sham INR ?2.
  • Drug: Placebo for warfarin
    tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months
  • Drug: apixaban
    tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months
    Other Name: BMS-562247
Study Arms  ICMJE
  • Active Comparator: Apixaban
    apixaban: tablets, oral, 10 milligram (mg) tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months.
    Interventions:
    • Drug: Enoxaparin
    • Drug: warfarin
    • Drug: Placebo for apixaban
  • Experimental: Enoxaparin + Warfarin
    Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until international normalized ratio (INR) ?2.
    Interventions:
    • Drug: Placebo for enoxaparin
    • Drug: Placebo for warfarin
    • Drug: apixaban
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 4, 2014)		5614
Original Estimated Enrollment  ICMJE
 (submitted: March 20, 2008)		5000
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women ? 18 years of age
  • Clinical diagnosis of DVT or PE

Exclusion Criteria:

  • Contraindications for enoxaparin or warfarin
  • Active bleeding or high risk for serious bleeding
  • Short life expectancy
  • Uncontrolled high blood pressure
  • Significantly impaired kidney or liver function
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Brazil,   Canada,   Chile,   China,   Czech Republic,   Denmark,   France,   Germany,   Hong Kong,   Hungary,   India,   Israel,   Italy,   Korea, Republic of,   Malaysia,   Mexico,   Norway,   Poland,   Portugal,   Puerto Rico,   Romania,   Russian Federation,   Singapore,   South Africa,   Spain,   Ukraine,   United Kingdom,   United States
Removed Location Countries Taiwan,   Turkey
 
Administrative Information
NCT Number  ICMJE NCT00643201
Other Study ID Numbers  ICMJE CV185-056
EUDRACT: 2007-007867-25
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Bristol-Myers SquibbBristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP