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Evaluate the safety and tolerability of escalating oral doses of YM150 in patients undergoing elective primary total knee replacement surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Dose regimen 1 |
|
| 2 | Active Comparator |
| |
| 3 | Experimental | Dose regimen 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YM150 | Drug | Oral |
| |
| enoxaparin |
| Measure | Description | Time Frame |
|---|---|---|
| All clinically relevant bleeds during treatment rated as major or clinically relevant non-major, and/or incidence of death due to any cause during study treatment | 2 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Venous thromboembolism and/or bleeds | 2 Weeks | |
| Other safety assessments | 2 Weeks | |
| PK, PD variables |
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Inclusion Criteria:
Exclusion Criteria:
Documented history or considered to be at increased risk of venous thromboembolism
Subjects considered to be at increased risk of bleeding:
Acute bacterial endocarditis
Severe hypertension
Retinopathy
Concomitant use of anticoagulants / antiplatelet agents (including homeopathic drugs) and/or anticipated postoperative need for other reasons than prevention of DVT during the study period.
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| Name | Affiliation | Role |
|---|---|---|
| Central Contact | Astellas Pharma Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jakarta | 14460 | Indonesia | ||||
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| Drug |
Sub cutaneous |
|
| 2 Weeks |
| Chubu Region |
| Japan |
| Chugoku Region | Japan |
| Kansai Region | Japan |
| Kanto Region | Japan |
| Kyushyu Region | Japan |
| Shikoku Region | Japan |
| Tohoku Region | Japan |
| Kelantan | 16150 | Malaysia |
| Kuala Lumpur | 59100 | Malaysia |
| Manila | 1008 | Philippines |
| Quezon City | 1114 | Philippines |
| Singapore | Singapore |
| Incheon | 405-760 | South Korea |
| Jeonnam | 519-809 | South Korea |
| Seoul | 110-744 | South Korea |
| Kaohsiung City | 833 | Taiwan |
| Bangkok | Thailand |
| Chiang Mai | 50200 | Thailand |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| 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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