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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-004691-20 | EudraCT Number |
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The purpose of this study is to assess if 10 mg BAY 59-7939, taken once daily as a tablet, is safe and can help prevent blood clots forming after a hip replacement operation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (BAY59-7939) | Drug | 10 mg rivaroxaban (tablet) once daily administered for 35 +/- 4 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causes | Treatment period: up to day 35+/-6 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE) | Treatment period: up to day 35+/-6 | |
| Incidence of symptomatic VTE (DVT, PE) | Treatment period: up to day 35+/-6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35205 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18582928 | Derived | Kakkar AK, Brenner B, Dahl OE, Eriksson BI, Mouret P, Muntz J, Soglian AG, Pap AF, Misselwitz F, Haas S; RECORD2 Investigators. Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial. Lancet. 2008 Jul 5;372(9632):31-9. doi: 10.1016/S0140-6736(08)60880-6. Epub 2008 Jun 24. |
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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| Enoxaparin | Drug | 40 mg enoxaparin syringe administered for 12 +/- 2 days |
|
| Incidence of DVT (total, proximal, distal) | Treatment period: up to day 35+/-6 |
| Incidence of symptomatic VTE during follow-up | Follow-up period: following 35+/-6 days |
| The composite endpoint comprising major VTE and treatment-emergent major bleeding | For major VTE, treatment period: up to Day 35+/-6 ; for major bleeding, from first dose of double-blind study medication to up to two days after last dose of double-blind study medication |
| Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all death | Treatment period: up to day 35+/-6 |
| Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE-related death | Treatment period: up to day 35+/-6 |
| Treatment-emergent major bleedings | From first dose of double-blind study medication to up to two days after last dose of double-blind study medication |
| Denver |
| Colorado |
| 80222 |
| United States |
| Bay Pines | Florida | 33744 | United States |
| Miami | Florida | 33186 | United States |
| Oklahoma City | Oklahoma | 73103 | United States |
| Canberra | Australian Capital Territory | 2605 | Australia |
| Lismore | New South Wales | 2480 | Australia |
| Sydney | New South Wales | 2065 | Australia |
| Southport | Queensland | 4215 | Australia |
| Geelong | Victoria | 3220 | Australia |
| Melbourne | Victoria | 3128 | Australia |
| Belo Horizonte | Minas Gerais | 30170-132 | Brazil |
| Belo Horizonte | Minas Gerais | 30380 090 | Brazil |
| Curitiba | Paraná | 80050-350 | Brazil |
| Passo Fundo | Rio Grande do Sul | 99010-100 | Brazil |
| Batatais | São Paulo | 14300 000 | Brazil |
| Marília | São Paulo | 17515-900 | Brazil |
| São Paulo | São Paulo | 0122-1020 | Brazil |
| São Paulo | São Paulo | 04023-900 | Brazil |
| São Paulo | São Paulo | 04262-000 | Brazil |
| Rio de Janeiro | Brazil |
| Red Deer | Alberta | T4N 4E7 | Canada |
| Penticton | British Columbia | V2A 5C8 | Canada |
| Winnipeg | Manitoba | R3J 3M7 | Canada |
| Saint John | New Brunswick | E2L 4L2 | Canada |
| Oshawa | Ontario | L1G 2B9 | Canada |
| Ottawa | Ontario | K1H 8L6 | Canada |
| Ottawa | Ontario | K1Y 4E9 | Canada |
| Scarborough Village | Ontario | M1M 3W3 | Canada |
| Scarborough Village | Ontario | M1P 2V5 | Canada |
| Thunder Bay | Ontario | P7B 6V4 | Canada |
| Windsor | Ontario | N9A 1E1 | Canada |
| Guangzhou | Guangdong | 510405 | China |
| Jinan | Shandong | 250014 | China |
| Qingdao | Shandong | 266003 | China |
| Xi’an | Shanxi | 710004 | China |
| Beijing | 100035 | China |
| Beijing | 100044 | China |
| Beijing | 100853 | China |
| Shanghai | 200025 | China |
| Shanghai | 200032 | China |
| Shanghai | 200233 | China |
| Shanghai | 200433 | China |
| Barranquilla | Colombia |
| Bogotá | Colombia |
| Cali | Colombia |
| Medellín | Colombia |
| Copenhagen | 2300 | Denmark |
| Copenhagen | 2400 | Denmark |
| Frederiksberg | 2000 | Denmark |
| Glostrup Municipality | 2600 | Denmark |
| Herlev | 2730 | Denmark |
| Holbæk | 4300 | Denmark |
| Hvidovre | 2650 | Denmark |
| Silkeborg | 8600 | Denmark |
| Viborg | 8800 | Denmark |
| Tallinn | 10138 | Estonia |
| Tartu | 51014 | Estonia |
| Hyderabad | Andhra Pradesh | 500034 | India |
| Secundrabad | Andhra Pradesh | 500003 | India |
| Bangalore | Bangalore | 560034 | India |
| Ludhiana | Punjab | 141001 | India |
| Bangalore | 560001 | India |
| Mumbai | 400012 | India |
| Surabaya | Surabaya | Indonesia |
| Bandung | West Java | 40161 | Indonesia |
| Genova | 16132 | Italy |
| Lecco | 23900 | Italy |
| Modena | 41100 | Italy |
| Naples | 80131 | Italy |
| Parma | 43100 | Italy |
| Siena | 53100 | Italy |
| Udine | 33100 | Italy |
| Liepāja | 3402 | Latvia |
| Riga | Latvia |
| Kaunas | 44320 | Lithuania |
| Klaipėda | 92288 | Lithuania |
| Panevezys | 35144 | Lithuania |
| Šiauliai | 76231 | Lithuania |
| Chihuahua, Chih. | Chihuahua | 31000 | Mexico |
| Guadalajara | Jalisco | 44280 | Mexico |
| Auckland | 0622 | New Zealand |
| Auckland | 1023 | New Zealand |
| Kongsvinger | 2212 | Norway |
| Namsos | 7800 | Norway |
| Oslo | 0264 | Norway |
| Oslo | 0440 | Norway |
| Tynset | 2501 | Norway |
| Callao | CALLAO 2 | Peru |
| Lima | 01 | Peru |
| Lima | 31 | Peru |
| Lima | LIMA 11 | Peru |
| Lima | LIMA 1 | Peru |
| Lima Cercado | LIMA 1 | Peru |
| Lisbon | Lisbon District | 1069-166 | Portugal |
| Setúbal | Setúbal District | 299-182 | Portugal |
| Torres Vedras | Torres Vedras | 2560-324 | Portugal |
| Porto | 4200-319 | Portugal |
| Bloemfontein | Freestate | 9300 | South Africa |
| Johannesburg | Gauteng | 2132 | South Africa |
| Randburg | Gauteng | 2125 | South Africa |
| Newcastle | KwaZulu-Natal | 2940 | South Africa |
| Cape Town | Western Cape | 7505 | South Africa |
| Kyunggido | Kyunggido | 471710 | South Korea |
| Daegu | 700721 | South Korea |
| Seoul | 135-710 | South Korea |
| Seoul | 138-736 | South Korea |
| Falköping | 521 85 | Sweden |
| Hässleholm | 281 25 | Sweden |
| Kungälv | 442 83 | Sweden |
| Lidköping | 531 85 | Sweden |
| Örebro | 701 85 | Sweden |
| Stockholm | 112 81 | Sweden |
| Sundsvall | 851 86 | Sweden |
| Varberg | 432 81 | Sweden |
| Vaxjo | 351 85 | Sweden |
| Kaohsiung City | 833 | Taiwan |
| Taoyuan | 333 | Taiwan |
| Chesterfield | Derbyshire | S44 5BL | United Kingdom |
| Dumfries | Dumfries and Galloway | DG1 4EP | United Kingdom |
| Kirkcaldy | Fife | KY2 5AH | United Kingdom |
| London | Greater London | SE5 9RS | United Kingdom |
| Liverpool | Merseyside | L14 3LB | United Kingdom |
| Great Yarmouth | Norfolk | NR31 6LA | United Kingdom |
| Northampton | Northamptonshire | NN1 5BD | United Kingdom |
| Epsom | Surrey | KT18 7EG | United Kingdom |
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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