Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Knee 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 knee replacement surgery and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied. |
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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 | NCT00452530 |
First Received | March 23, 2007 |
Last Updated | February 28, 2012 |
Last verified | February 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | March 23, 2007 |
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Last Updated Date | February 28, 2012 |
Start Date | June 2007 |
Estimated Primary Completion Date | January 2009 |
Current Primary Outcome Measures | A combination of adjudicated asymptomatic and symptomatic DVT, non-fatal PE and all-cause death [Time Frame: after 12 days of treatment] [Designated as safety issue: No] |
Current Secondary Outcome Measures | A combination of adjudicated asymptomatic and symptomatic proximal DVT, non-fatal PE, & VTE-related death [Time Frame: after 12 days of treatment] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
Brief Title | Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery |
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Official Title | A Phase 3, Randomized, Double-blind, Active-controlled (Enoxaparin 40 mg QD), Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery (The ADVANCE - 2 Study) |
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 knee 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: Treatment |
Condition |
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Intervention | Drug: Enoxaparin + Placebo Syringes + tablets, Subcutaneous + Oral, 40 mg, once daily, 12 days Other Names: Lovenox®Drug: Apixaban + Placebo Tablet + Syringes, Oral + subcutaneous, 2.5mg, twice daily, 12 days Other Names: BMS-562247 |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 3054 |
Estimated Completion Date | January 2009 |
Estimated Primary Completion Date | January 2009 |
Eligibility Criteria | Inclusion Criteria: - men and non-pregnant, non-breastfeeding women - 18 years or older - scheduled for total knee 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 | Austria, Belgium, Brazil, Chile, China, Colombia, Czech Republic, Denmark, France, Germany, Hungary, India, Israel, Italy, Korea, Republic of, Malaysia, Mexico, Norway, Philippines, Poland, Russian Federation, Singapore, South Africa, Spain, Sweden, Ukraine, United Kingdom |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00452530 |
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Other Study ID Numbers | CV185-047 |
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 | February 2012 |
Locations[ + expand ][ + ]
Local Institution | Graz, Austria, 8036 |
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Local Institution | Innsbruck, Austria, 6020 |
Local Institution | Linz, Austria, 4010 |
Local Institution | Wels, Austria, 4600 |
Local Institution | Wien, Austria, 1090 |
Local Institution | Wien, Austria, 1130 |
Local Institution | Wiener Neustadt, Austria, 2700 |
Local Institution | Antwerpen, Belgium, 2020 |
Local Institution | Hasselt, Belgium, 3500 |
Local Institution | Belo Horizonte - Mg, Minas Gerais, Brazil, 30130 |
Local Institution | Sao Paulo, Brazil, 04023 |
Local Institution | Santiago, Metropolitana, Chile, 7500922 |
Local Institution | Santiago, Metropolitana, Chile, 8330033 |
Local Institution | Beijing, Beijing, China, 100035 |
Local Institution | Beijing, Beijing, China, 100835 |
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 | Bogota, Colombia |
Local Institution | Bogota, Colombia, XXXXX |
Local Institution | Cali, Colombia, - - - - - |
Local Institution | Medelin, Colombia, ----- |
Local Institution | Brno, Czech Republic, 662 50 |
Local Institution | Chomutov, Czech Republic, 430 12 |
Local Institution | Pardubice, Czech Republic, 532 03 |
Local Institution | Prague 8, Czech Republic, 180 81 |
Local Institution | Uherske Hradiste, Czech Republic, 686 68 |
Local Institution | Hellerup, Denmark, 2900 |
Local Institution | Hvidovre, Denmark, 2650 |
Local Institution | Kolding, Denmark, 6000 |
Local Institution | Viborg, Denmark, 8800 |
Local Institution | Monaco, France, 98000 |
Local Institution | Nice, France, 06200 |
Local Institution | Paris, France, 75019 |
Local Institution | Paris, France, 75679 |
Local Institution | Paris, France, 75014 |
Local Institution | Saint-Saulve, France, 59880 |
Local Institution | Bad Mergentheim, Germany, 97980 |
Local Institution | Bochum, Germany, 44791 |
Local Institution | Brandenburg, Germany, 14770 |
Local Institution | Dresden, Germany, 01307 |
Local Institution | Frankfurt, Germany, 65929 |
Local Institution | Frankfurt Am Main, Germany, 60528 |
Local Institution | Halle/S, Germany, 06112 |
Local Institution | Kremmen Ot Sommerfeld, Germany, 16766 |
Local Institution | Rheinfelden, Germany, 79618 |
Local Institution | Witten, Germany, 58455 |
Local Institution | Szeged, Hungary, 6725 |
Local Institution | Szekszard, Hungary, 7100 |
Local Institution | Ahmedabad, Gujarat, India, 380054 |
Local Institution | Ludhiana, Punjab, India, 141001 |
Local Institution | Bangalore, India, 560034 |
Local Institution | Baroda, India, 390007 |
Local Institution | Mangalore, India, 575001 |
Local Institution | Jeruselem, Israel, 91031 |
Local Institution | Petach-Tikva, Israel, 49372 |
Local Institution | Safed, Israel, 13110 |
Local Institution | Tel Aviv, Israel, 64239 |
Local Institution | Tel Hashomer, Israel, 52621 |
Local Institution | Abano Terme (Pd), Italy, 35031 |
Local Institution | Bologna, Italy, 40136 |
Local Institution | Pordenone, Italy, 33170 |
Local Institution | Roma, Italy, 00168 |
Local Institution | San Donato Milanese (Mi), Italy, 20097 |
Local Institution | Jeonnam, Korea, Republic of, 519-809 |
Local Institution | Seoul, Korea, Republic of, 110-744 |
Local Institution | Seoul, Korea, Republic of, 138-736 |
Local Institution | Seoul, Korea, Republic of, 136-705 |
Local Institution | Kuala Lumpur, Malaysia, 56000 |
Local Institution | Kuala Lumpur, Malaysia, 50586 |
Local Institution | Zapopan, Jalisco, Mexico, 45200 |
Local Institution | Hermosillo, Sonora, Mexico, 83190 |
Local Institution | Aguascalientes, Mexico, 20010 |
Local Institution | San Luis Potosi, Mexico, 78340 |
Local Institution | Veracruz, Mexico, 91700 |
Local Institution | Alesund, Norway, 6026 |
Local Institution | Gjettum, Norway, 1346 |
Local Institution | Kongsvinger, Norway, 2212 |
Local Institution | Manila, Philippines, 1000 |
Local Institution | Quezon City, Philippines, 1114 |
Local Institution | Quezon City, Philippines, 1102 |
Local Institution | Bytom, Poland, 41-902 |
Local Institution | Gdansk, Poland, 80-803 |
Local Institution | Warszawa, Poland, 03-242 |
Local Institution | Wroclaw, Poland, 50-556 |
Local Institution | Chelyabinsk, Russian Federation, 454021 |
Local Institution | Kazan, Russian Federation, 420029 |
Local Institution | Lipetsk, Russian Federation, 398035 |
Local Institution | Moscow, Russian Federation, 115522 |
Local Institution | Rostov-Na-Donu, Russian Federation, 344010 |
Local Institution | Saint Petersburg, Russian Federation, 199106 |
Local Institution | Saint Petersburg, Russian Federation, 194354 |
Local Institution | Saint Petersburg, Russian Federation, 195427 |
Local Institution | Saint Petersburg, Russian Federation, 193312 |
Local Institution | Samara, Russian Federation, 443095 |
Local Institution | Singapore, Singapore, 169608 |
Local Institution | Singapore, Singapore, 529889 |
Local Institution | Randburg, Free State, South Africa, 2194 |
Local Institution | Johannesburg, Gauteng, South Africa, 2193 |
Local Institution | Johannesburg, Gauteng, South Africa, 2031 |
Local Institution | Pretoria, Gauteng, South Africa, 0083 |
Local Institution | Somerset West, Western Cape, South Africa, 7130 |
Local Institution | Tygerberg, Western Cape, South Africa, 7505 |
Local Institution | Worcester, Western Cape, South Africa, 6850 |
Local Institution | Badalona-Barcelona, Spain, 08916 |
Local Institution | Barcelona, Spain, 08035 |
Local Institution | Barcelona, Spain, 08006 |
Local Institution | Barcelona, Spain, 08024 |
Local Institution | Madrid, Spain, 28034 |
Local Institution | Santiago De Compostela, Spain, 15706 |
Local Institution | Valencia, Spain, 46010 |
Local Institution | Boras, Sweden, 501 82 |
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 9PJ |
Local Institution | Epsom, Surrey, United Kingdom, KT18 7EG |