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The purpose of this study is to examine the superiority of YM150 to the placebo and to evaluate the dose-dependent response of YM150 in patients undergoing elective total knee replacement surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YM150 group-1 | Experimental | YM150 low dose group |
|
| YM150 group-2 | Experimental | YM150 high dose group |
|
| Placebo group | Placebo Comparator |
| |
| Enoxaparin group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YM150 | Drug | oral |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Overall incidence of venous thromboembolism | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of individual venous thromboembolism | 2 weeks | |
| Incidence of bleeding events | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chugoku | Japan | |||||
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| Drug |
oral |
|
| Enoxaparin | Drug | injection |
|
| Chūbu |
| Japan |
| Hokkaido | Japan |
| Kansai | Japan |
| Kantou | Japan |
| Kyusyu | Japan |
| Tōhoku | Japan |
| Changhua | Taiwan |
| Chiayi City | Taiwan |
| Kaohsiung City | Taiwan |
| Taichung | Taiwan |
| Bangkok | Thailand |
| Chiang Mai | Thailand |
| 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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