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To evaluate the safety and tolerability of YM150 in subjects with non-valvular atrial fibrillation (NVAF)and to obtain information on pharmacokinetics and pharmacodynamics (anti-thrombotic potential) in the target population
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Low dose |
|
| 2 | Experimental | Middle dose |
|
| 3 | Experimental | High dose |
|
| 4 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YM150 | Drug | Oral |
| |
| warfarin |
| Measure | Description | Time Frame |
|---|---|---|
| All clinically relevant bleeds during the treatment period rated as "major" or "clinically relevant non-major(CRNM)" | 16 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of symptomatic stroke | 16 Weeks | |
| Incidence of transient ischemic attack (TIA) | 16 Weeks | |
| Incidence of systemic thromboembolic event |
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Inclusion Criteria:
Subjects are eligible for the study if all of the following apply:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Central Contact | Astellas Pharma Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Launceston | Australia | |||||
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| Drug |
Oral |
|
| 16 Weeks |
| Incidence of the bleeding rates | 16 Weeks |
| Other safety assessments | 16 Weeks |
| PK, PD variables | 16 Weeks |
| Pok Fu Lam |
| Hong Kong |
| Shatin | Hong Kong |
| Hokkaido | Japan |
| Kansai | Japan |
| Kanto | Japan |
| Kyusyu | Japan |
| Shikoku | Japan |
| TÅhoku | Japan |
| Kuala Lumpur | Malaysia |
| Hastings | New Zealand |
| Singapore | Singapore |
| Bloemfontein | South Africa |
| Seoul | South Korea |
| Taipei | Taiwan |
| Bangkok | Thailand |
| Chiang Mai | Thailand |
| Nakhon Ratchasima | Thailand |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D016769 | Embolism and Thrombosis |
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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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