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To evaluate the safety and efficacy of twice daily dosing and once daily dosing of YM150 in subjects undergoing primary elective knee replacement surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. YM150 Dose X, twice daily | Experimental |
| |
| 2. YM150 Dose Y, once daily | Experimental |
| |
| 3. YM150 Dose Y, twice daily | Experimental |
| |
| 4. YM150 Dose Z, once daily | Experimental |
| |
| 5. Warfarin | Active Comparator | various doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YM150 | Drug | Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of total venous thromboembolisms (VTE). | 6 Weeks | |
| The incidence of bleeding events classified as major by the Adjudication Committee | 6 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of efficacy variables including: Proximal VTE, Distal VTE, Confirmed symptomatic VTE, death due to any cause | 6 Weeks | |
| Incidence of the bleeding types: major, clinically relevant nonmajor, minor | 6 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Central Contact | Astellas Pharma Global Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile | Alabama | 36608 | United States | |||
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| Warfarin | Drug | Oral |
|
| Phoenix |
| Arizona |
| 85023 |
| United States |
| Tuscon | Arizona | 85712 | United States |
| Little Rock | Arkansas | 72205 | United States |
| Fountain Valley | California | 92708 | United States |
| La Mesa | California | 91942 | United States |
| Long Beach | California | 90806 | United States |
| Long Beach | California | 90822 | United States |
| San Diego | California | 92128 | United States |
| Santa Ana | California | 92074 | United States |
| Torrance | California | 90502 | United States |
| Yuba City | California | 95991 | United States |
| Aurora | Colorado | 80012 | United States |
| Denver | Colorado | 80230 | United States |
| Lone Tree | Colorado | 80124 | United States |
| Washington D.C. | District of Columbia | 20017 | United States |
| Bay Pines | Florida | 33744 | United States |
| Bradenton | Florida | 34209 | United States |
| Gulf Breeze | Florida | 32561 | United States |
| Hollywood | Florida | 33021 | United States |
| St. Petersburg | Florida | 33703 | United States |
| St. Petersburg | Florida | 33713 | United States |
| Decatur | Georgia | 30033 | United States |
| Savannah | Georgia | 31405 | United States |
| Boise | Idaho | 83702 | United States |
| Idaho Falls | Idaho | 83404 | United States |
| Springfield | Illinois | 62703 | United States |
| Springfield | Illinois | 62794 | United States |
| Baltimore | Maryland | 21218 | United States |
| Cincinnati | Ohio | 45242 | United States |
| Cleveland | Ohio | 44195 | United States |
| Tulsa | Oklahoma | 74146 | United States |
| Charleston | South Carolina | 29414 | United States |
| Austin | Texas | 78745 | United States |
| Dallas | Texas | 75231 | United States |
| Grapevine | Texas | 76051 | United States |
| Houston | Texas | 77030 | United States |
| Lubbock | Texas | 79410 | United States |
| Lubbock | Texas | 79412 | United States |
| Odessa | Texas | 79761 | United States |
| San Antonio | Texas | 78217 | United States |
| San Antonio | Texas | 78229 | United States |
| Richmond | Virginia | 23249 | United States |
| Richmond | Virginia | 23294 | United States |
| Red Deer | Alberta | T4N 4E7 | Canada |
| Ajax | Ontario | L1S 2J5 | Canada |
| Burlington | Ontario | L7R 4B7 | Canada |
| Montreal | Ontario | H1T 2M4 | Canada |
| Newmarket | Ontario | L3Y 2P9 | Canada |
| Saint Catherines | Ontario | L2R 7P3 | Canada |
| Scarborough Village | Ontario | M1E 5E9 | Canada |
| Thunder Bay | Ontario | P7B 6V4 | Canada |
| Waterloo | Ontario | N2J 1CA | Canada |
| Charlottetown | Prince Edward Island | C1A 1L2 | Canada |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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