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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-004416-13 | EudraCT Number |
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The purpose of this study is to evaluate the efficacy and safety of various doses of YM150 (the experimental drug) compared to enoxaparin in the prevention of venous thromboembolism in patients that are undergoing elective hip replacement surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. YM150, Dose X, twice daily | Experimental |
| |
| 2, YM150, Dose X, once daily | Experimental |
| |
| 3. YM150, Dose Y, twice daily | Experimental |
| |
| 4. YM150, Dose Y, once daily | Experimental |
| |
| 5. Enoxaparin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YM150 | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of symptomatic Venous Thromboembolisms and death from all causes | 12 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of all Venous Thromboembolic events | Until day 12, during the treatment period, follow-up period and entire study period | |
| Incidence of Bleeding events | During the treatment period, follow-up period and entire study period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Europe B.V. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85023 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24136153 | Derived | Eriksson BI, Agnelli G, Gallus AS, Lassen MR, Prins MH, Renfurm RW, Kashiwa M, Turpie AG. Darexaban (YM150) versus enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a randomised phase IIb dose confirmation study (ONYX-3). Thromb Haemost. 2014 Feb;111(2):213-25. doi: 10.1160/TH13-04-0296. Epub 2013 Oct 17. |
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| enoxaparin | Drug | SC injection |
|
| Phoenix |
| Arizona |
| 85050 |
| United States |
| Tuscon | Arizona | 85712 | United States |
| Little Rock | Arkansas | 72205 | United States |
| Long Beach | California | 90806 | United States |
| Torrance | California | 90507 | United States |
| Aurora | Colorado | 80015 | United States |
| DeLand | Florida | 32720 | United States |
| Pinellas Park | Florida | 33781 | United States |
| Sarasota | Florida | 34239 | United States |
| Tamarac | Florida | 33321 | United States |
| Meridian | Idaho | 83642 | United States |
| Lexington | Kentucky | 40509 | United States |
| Baltimore | Maryland | 21215 | United States |
| Charleston | South Carolina | 29414 | United States |
| Austin | Texas | 78745 | United States |
| Dallas | Texas | 75231 | United States |
| Houston | Texas | 77024 | United States |
| Box Hill | Victoria | 3128 | Australia |
| Ringwood East | Victoria | 3135 | Australia |
| Windsor | Victoria | 3181 | Australia |
| Perth | Western Australia | 6000 | Australia |
| Kogarah | 2217 | Australia |
| Graz | 8036 | Austria |
| Innsbruck | A-6020 | Austria |
| Linz | 4010 | Austria |
| Vienna | 1090 | Austria |
| Vienna | 1130 | Austria |
| Foca | 73300 | Bosnia and Herzegovina |
| Curitiba | Puerto Rico | 80060-900 | Brazil |
| Porto Alegre | Rio Grande do Sul | 30130-100 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| São Paulo | So Paulo | 04262-000 | Brazil |
| Red Deer | Alberta | T4N 6V7 | Canada |
| Burlington | Ontario | L7R 4B7 | Canada |
| Guelph | Ontario | N1E 6L9 | Canada |
| Newmarket | Ontario | L3Y 2P9 | Canada |
| Thunder Bay | Ontario | P7B 6V4 | Canada |
| Waterloo | Ontario | N2J 1CA | Canada |
| Medellín | Antioquia | Colombia |
| Bogota | Cundinamarca | Colombia |
| Floridablanca | Santander Department | Colombia |
| Barranquilla | Colombia |
| Brno | 66250 | Czechia |
| Chomutov | 43001 | Czechia |
| Havlíčkův Brod | 580 22 | Czechia |
| Jihlava | 58633 | Czechia |
| Jindřichův Hradec | 37738 | Czechia |
| Klatovy | 33938 | Czechia |
| Liberec | 46001 | Czechia |
| Prague | 18081 | Czechia |
| Třebíč | 67401 | Czechia |
| Copenhagen | 2300 | Denmark |
| Copenhagen | 2400 | Denmark |
| Frederiksberg | 2000 | Denmark |
| Herlev | 2730 | Denmark |
| Hørsholm | 2970 | Denmark |
| Silkeborg | 8600 | Denmark |
| Kohtla-Järve | 30322 | Estonia |
| Tallinn | 10611 | Estonia |
| Tartu | 51014 | Estonia |
| Jyväskylä | 40620 | Finland |
| Oulu | 90029 | Finland |
| Mainz | 55101 | Germany |
| Marburg | 35033 | Germany |
| Budapest | 1113 | Hungary |
| Debrecen | 4012 | Hungary |
| Győr | 9023 | Hungary |
| Kecskemét | 6000 | Hungary |
| Szeged | 6725 | Hungary |
| Szekszárd | 7100 | Hungary |
| Székesfehérvár | 8000 | Hungary |
| Szolnok | 5000 | Hungary |
| Hyderabaad | Andhra Pradesh | 500034 | India |
| Secunderabad | Andhra Pradesh | 500003 | India |
| Secunderabad | Andhra Prasdesh | 500003 | India |
| Vadodara | Gujarat | 390007 | India |
| Gurgaon | Haryana | 122001 | India |
| Jamshedpur | Jharkhand | 831004 | India |
| Bangalore | Karnataka | 560054 | India |
| Kormangala | Karnataka | 5600034 | India |
| Mangalore | Karnataka | 575001 | India |
| Bhopal | Madhya Pradesh | 462010 | India |
| Jaipur | Rajasthan | 302004 | India |
| Afula | 18101 | Israel |
| Haifa | 31096 | Israel |
| Kfar Saba | 44281 | Israel |
| Petah Tikva | 49100 | Israel |
| Rehovot | 76100 | Israel |
| Bologna | 40136 | Italy |
| Milan | 20132 | Italy |
| Daugavpils | LV4317 | Latvia |
| Liepāja | LV 3400 | Latvia |
| Riga | LV 1005 | Latvia |
| Riga | LV1004 | Latvia |
| Valmiera | LV4201 | Latvia |
| Kaunas | LT-44320 | Lithuania |
| Klaipėda | 92288 | Lithuania |
| Vilnius | 04130 | Lithuania |
| Gjøvik | 2819 | Norway |
| Kongsvinger | 2226 | Norway |
| Lillehammer | 2629 | Norway |
| Tynset | 2500 | Norway |
| Tønsberg | 3116 | Norway |
| Gmina Końskie | 26-200 | Poland |
| Głogów Małopolski | 36-060 | Poland |
| Krakow | 31-913 | Poland |
| Lodz | 91-002 | Poland |
| Lodz | 93-513 | Poland |
| Lublin | 20-718 | Poland |
| Opole | 45-372 | Poland |
| Otwock | 05-400 | Poland |
| Poznan | 61-485 | Poland |
| Warsaw | 00-909 | Poland |
| Warsaw | 02-005 | Poland |
| Timișoara | Timiș County | 300736 | Romania |
| Bucharest | 021382 | Romania |
| Bucharest | 021659 | Romania |
| Bucharest | 042122 | Romania |
| Cluj-Napoca | 0400132 | Romania |
| Craiova | 20116 | Romania |
| Iași | 0700483 | Romania |
| Kazan' | 420012 | Russia |
| Moscow | 119049 | Russia |
| Nizhny Novgorod | 603155 | Russia |
| Novosibirsk | 630091 | Russia |
| Omsk | 644043 | Russia |
| Saint Petersburg | 194291 | Russia |
| Saint Petersburg | 194354 | Russia |
| Samara | 443095 | Russia |
| Yaroslavl | 150003 | Russia |
| Banska Bysterica | 975 01 | Slovakia |
| Kosice Saca | 04015 | Slovakia |
| Prešov | 08181 | Slovakia |
| Worcester | Cape Town | 6850 | South Africa |
| Benoni | 1501 | South Africa |
| Bryanston | 2021 | South Africa |
| Port Elizabeth | 6014 | South Africa |
| Pretoria | 0001 | South Africa |
| Pretoria | 0083 | South Africa |
| Barcelona | 08036 | Spain |
| Castelló | 12004 | Spain |
| Madrid | 28006 | Spain |
| Palma Mallorca | 07014 | Spain |
| Kalmar | 391 85 | Sweden |
| Motala | 591 85 | Sweden |
| Mölndal | 41685 | Sweden |
| Stockholm | 182 88 | Sweden |
| Varberg | 43281 | Sweden |
| Cherkassy | 18009 | Ukraine |
| Ivano-Frankivsk | 76008 | Ukraine |
| Lviv | 79495 | Ukraine |
| Sevastopol | 99018 | Ukraine |
| Epsom | Surrey | KT18 7EG | United Kingdom |
| London | SE5 9RS | United Kingdom |
| Northampton | NN1 5 BD | United Kingdom |
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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