Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Hip Replacement Surgery
Overview[ - collapse ][ - ]
| Purpose | The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein thrombosis [DVT]) and lung (pulmonary embolism [PE] that sometimes occur after hip replacement surgery and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied |
|---|---|
| Condition | Deep Vein Thrombosis Pulmonary Embolism |
| Intervention | Drug: Enoxaparin + Placebo Drug: Apixaban + Placebo |
| Phase | Phase 3 |
| Sponsor | Bristol-Myers Squibb |
| Responsible Party | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier | NCT00423319 |
| First Received | January 17, 2007 |
| Last Updated | March 18, 2014 |
| Last verified | March 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | January 17, 2007 |
|---|---|
| Last Updated Date | March 18, 2014 |
| Start Date | March 2007 |
| Estimated Primary Completion Date | September 2009 |
| Current Primary Outcome Measures | A combination of asymptomatic and symptomatic DVT, non-fatal PE and all-cause death [Time Frame: after 35 days of treatment] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Hip Replacement Surgery |
|---|---|
| Official Title | A Phase 3 Randomized, Double-Blind, Active-Controlled, Parallel-Group, Multi-Center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Hip Replacement Surgery |
| Brief Summary | The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein thrombosis [DVT]) and lung (pulmonary embolism [PE] that sometimes occur after hip replacement surgery and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention |
| Condition |
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| Intervention | Drug: Enoxaparin + Placebo Syringes + tablets, Subcutaneous + Oral, 40 mg, once daily, 5 weeks Other Names: Lovenox®Drug: Apixaban + Placebo Tablet + Syringes, Oral + Subcutaneous, 2.5 mg, twice daily, 5weeks Other Names:
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| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 5407 |
| Estimated Completion Date | September 2009 |
| Estimated Primary Completion Date | September 2009 |
| Eligibility Criteria | Inclusion Criteria: - men and non-pregnant, non breastfeeding women - 18 years or older - scheduled for hip replacement surgery Exclusion Criteria: - hereditary or acquired bleeding disorders - clotting disorders - bleeding or high risk for bleeding - drugs that affect bleeding or coagulation |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States, Argentina, Australia, Belgium, Canada, China, Denmark, France, Germany, Hungary, India, Israel, Mexico, Norway, Poland, Romania, Russian Federation, Spain, Sweden, Ukraine, United Kingdom |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00423319 |
|---|---|
| Other Study ID Numbers | CV185-035 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Bristol-Myers Squibb |
| Study Sponsor | Bristol-Myers Squibb |
| Collaborators | Not Provided |
| Investigators | Study Director: Bristol-Myers Squibb Bristol-Myers Squibb |
| Verification Date | March 2014 |
Locations[ + expand ][ + ]
| Capstone Clinical Trials, Inc | Birmingham, Alabama, United States, 35209 |
|---|---|
| West Alabama Research, Llc | Birmingham, Alabama, United States, 35209 |
| Martin Bowen Hefley Orthopedics | Little Rock, Arkansas, United States, 72205 |
| Orthoarkansas, P.A. | Little Rock, Arkansas, United States, 72205 |
| Uc Davis Medical Center | Sacramento, California, United States, 95817 |
| Colorado Orthopedic Consultants, Pc | Aurora, Colorado, United States, 80012 |
| Advanced Orthopedic And Sports Medicine Specilists | Denver, Colorado, United States, 80230 |
| Denver-Vail Orthopedics, P.C. | Denver, Colorado, United States, 80230 |
| Pab Clinical Research | Brandon, Florida, United States, 33511 |
| Research Alliance, Inc. | Clearwater, Florida, United States, 33756 |
| Shrock Orthopedic Research | Ft. Lauderdale, Florida, United States, 33316 |
| Phoenix Clinical Research, Llc | Tamarac, Florida, United States, 33321 |
| Atlanta Knee And Sports Medicine | Decatur, Georgia, United States, 30033 |
| Americana Orthopedics | Boise, Idaho, United States, 83702 |
| Bosie Orthopedic Clinic | Meridian, Idaho, United States, 83642 |
| University Orthopedic Center | Altoona, Pennsylvania, United States, 16602 |
| Robert R. King, Md | Lubbock, Texas, United States, 79410 |
| Gill Orthopedic Center | Lubbock, Texas, United States, 79410 |
| Unlimited Research | San Antonio, Texas, United States, 78217 |
| Local Institution | Capital Federal, Buenos Aires, Argentina, C1280AEB |
| Local Institution | Capital Federal, Buenos Aires, Argentina, C1425AGP |
| Local Institution | Capital Federal, Buenos Aires, Argentina, C1199ACK |
| Local Institution | Ciudad De Buenos Aires, Buenos Aires, Argentina, C1426BOS |
| Local Institution | Coronel Suarez, Buenos Aires, Argentina, B7540GHD |
| Local Institution | Monte Grande, Buenos Aires, Argentina, B1842DID |
| Local Institution | Camperdown, New South Wales, Australia, 2050 |
| Local Institution | Kogarah, New South Wales, Australia, 2217 |
| Local Institution | Lismore, New South Wales, Australia, 2480 |
| Local Institution | Southport, Queensland, Australia, 4215 |
| Local Institution | Bedford Park, South Australia, Australia, 5042 |
| Local Institution | Box Hill, Victoria, Australia, 3128 |
| Local Institution | Malvern, Victoria, Australia, 3144 |
| Local Institution | Windsor, Victoria, Australia, 3181 |
| Local Institution | Perth, Western Australia, Australia, 6000 |
| Local Institution | Antwerp, Belgium, 2020 |
| Local Institution | Brasschaat, Belgium, 2930 |
| Local Institution | Genk, Belgium, 3600 |
| Local Institution | Hasselt, Belgium, 3500 |
| Local Institution | Leuven, Belgium, 3000 |
| Local Institution | Edmonton, Alberta, Canada, T6G 2B7 |
| Local Institution | Ajax, Ontario, Canada, L1S 2J5 |
| Local Institution | Cambridge, Ontario, Canada, N1R 7L7 |
| Local Institution | Chatham, Ontario, Canada, N7L 4T1 |
| Local Institution | Guelph, Ontario, Canada, N1E 6L9 |
| Local Institution | Newmarket, Ontario, Canada, L3Y 5G8 |
| Local Institution | Oshawa, Ontario, Canada, L1J 2J2 |
| Local Institution | Sarnia, Ontario, Canada, N7T 6H3 |
| Local Institution | Scarborough, Ontario, Canada, M1S 4T7 |
| Local Institution | St. Catharines, Ontario, Canada, L2R 7P3 |
| Local Institution | Stratford, Ontario, Canada, N5A 2N4 |
| Local Institution | Waterloo, Ontario, Canada, N2J 1C4 |
| Local Institution | Windsor, Ontario, Canada, N8W 1E6 |
| Local Institution | Montreal, Quebec, Canada, H3G 1A4 |
| Local Institution | Quebec, Canada, G1L 3L5 |
| Local Institution | Beijing, Beijing, China, 100853 |
| Local Institution | Beijing, Beijing, China, 100035 |
| Local Institution | Guangzhou, Guangdong, China, 510405 |
| Local Institution | Qingdao, Shandong, China, 266003 |
| Local Institution | Shanghai, Shanghai, China, 200025 |
| Local Institution | Shanghai, Shanghai, China, 200233 |
| Local Institution | Shanghai, Shanghai, China, 200011 |
| Local Institution | Amager, Denmark, 2300 |
| Local Institution | Frederiksberg, Denmark, 2000 |
| Local Institution | Herlev, Denmark, 2730 |
| Local Institution | Horsholm, Denmark, 2970 |
| Local Institution | Hvidovre, Denmark, 2650 |
| Local Institution | Kobenhavn Nv, Denmark, 2400 |
| Local Institution | Silkeborg, Denmark, 8600 |
| Local Institution | Nice, France, 06200 |
| Local Institution | Paris, France, 75019 |
| Local Institution | Paris, France, 75679 |
| Local Institution | Paris, France, 75014 |
| Local Institution | Saint Etienne, France, 42100 |
| Local Institution | Saint-Saulve, France, 59880 |
| Local Institution | Frankfurt, Germany, 60528 |
| Local Institution | Frankfurt / Main, Germany, 65929 |
| Local Institution | Rheinfelden, Germany, 79618 |
| Local Institution | Budapest, Hungary, 1081 |
| Local Institution | Kecskemet, Hungary, 6000 |
| Local Institution | Szeged, Hungary, 6720 |
| Local Institution | Szolnok, Hungary, 5000 |
| Local Institution | Ahmedabad, Gujarat, India, 380015 |
| Local Institution | Ludhiana, Punjab, India, 141001 |
| Local Institution | Lucknow, Uttar Prsdesh, India, 226003 |
| Local Institution | Bangalore, India, 560034 |
| Local Institution | Mangalore, India, 575001 |
| Local Institution | Beer Sheva, Israel, 84101 |
| Local Institution | Haifa, Israel, 31096 |
| Local Institution | Holon, Israel, 58100 |
| Local Institution | Kfar-Saba, Israel, 44281 |
| Local Institution | Zerifin, Israel, 70300 |
| Local Institution | Tijuana, Baja California, Mexico, 22010 |
| Local Institution | Mexico City, Distrito Federal, Mexico, 07760 |
| Local Institution | Mexico City, Distrito Federal, Mexico, 06726 |
| Local Institution | Guadalajara, Jalisco, Mexico, 45235 |
| Local Institution | Monterrey, Nuevo Leon, Mexico, 64460 |
| Local Institution | Cd. Madero, Tamaulipas, Mexico, 89240 |
| Local Institution | Aguascalientes, Mexico, 20010 |
| Local Institution | Chihuahua, Mexico, 31020 |
| Local Institution | Gjettum, Norway, 1346 |
| Local Institution | Kongsvinger, Norway, 2212 |
| Local Institution | Lillehammer, Norway, 2629 |
| Local Institution | Tonsberg, Norway, 3116 |
| Local Institution | Tynset, Norway, 2500 |
| Local Institution | Gdansk, Poland, 80-803 |
| Local Institution | Lodz, Poland, 91-002 |
| Local Institution | Szczecin, Poland, 71-252 |
| Local Institution | Warszawa, Poland, 03-242 |
| Local Institution | Warszawa, Poland, 02-005 |
| Local Institution | Wroclaw, Poland, 50-556 |
| Local Institution | Bucharest, Romania, 021659 |
| Local Institution | Cluj Napoca, Romania, 400132 |
| Local Institution | Chelyabinsk, Russian Federation, 454021 |
| Local Institution | Kazan, Russian Federation, 420029 |
| Local Institution | Moscow, Russian Federation, 119415 |
| Local Institution | Moscow, Russian Federation, 115522 |
| Local Institution | Moscow, Russian Federation, 117292 |
| Local Institution | Moscow, Russian Federation, 111539 |
| Local Institution | Saint Petersburg, Russian Federation, 194354 |
| Local Institution | Saint Petersburg, Russian Federation, 195427 |
| Local Institution | Saint Petersburg, Russian Federation, 196247 |
| Local Institution | Saint Petersburg, Russian Federation, 193312 |
| Local Institution | Saint Petersburg, Russian Federation, 199106 |
| Local Institution | Samara, Russian Federation, 443095 |
| Local Institution | St.Petersburg, Russian Federation, 192242 |
| Local Institution | Yaroslavl, Russian Federation, 150003 |
| Local Institution | Badalona-Barcelone, Spain, 08916 |
| Local Institution | Barcelona, Spain, 08036 |
| Local Institution | Barcelona, Spain, 08035 |
| Local Institution | Barcelona, Spain, 08024 |
| Local Institution | Barcelona, Spain, 08006 |
| Local Institution | Gothenburg, Sweden, 416 85 |
| Local Institution | Stockholm, Sweden, 182 88 |
| Local Institution | Cherkassy, Ukraine, 18009 |
| Local Institution | Chernivtsy, Ukraine, 58013 |
| Local Institution | Dnipropetrovsk, Ukraine, 49005 |
| Local Institution | Ivano-Frankivsk, Ukraine, 76008 |
| Local Institution | Kyiv, Ukraine, 01601 |
| Local Institution | Kyiv, Ukraine, 04107 |
| Local Institution | Sevastopol, Ukraine, 99018 |
| Local Institution | London, Greater London, United Kingdom, SE5 9RS |
| Local Institution | Wigan, Lancashire, United Kingdom, WN6 9EP |
| Local Institution | Epsom, Surrey, United Kingdom, KT18 7EG |