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The purpose of this study is to assess the safety and tolerability of E5555 in Japanese subjects with coronary artery disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E5555 50 mg | Drug | E5555 50 mg (tablet) taken orally, once a day. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability: Adverse events, bleeding events, clinical laboratory tests, Coagulation tests, vital signs and 12-lead ECG | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Major cardiac adverse events, biomarkers, platelet aggregation inhibition, plasma concentration. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Masaru Takeuchi | New Product Development, Clinical Research Center, Eisai Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ichinomiya | Aichi-ken | Japan | ||||
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| E5555 100 mg |
| Drug |
E5555 100 mg (tablet) taken orally, once a day. |
|
| E5555 200 mg | Drug | E5555 200 mg (tablet) taken orally, once a day. |
|
| Placebo | Drug | Placebo (tablet) taken orally, once a day. |
|
| Gifu |
| Gifu |
| Japan |
| Ōgaki | Gifu | Japan |
| Asahikawa | Hokkaido | Japan |
| Chitose | Hokkaido | Japan |
| Sapporo | Hokkaido | Japan |
| Tomakomai | Hokkaido | Japan |
| Himeji | Hyōgo | Japan |
| Nishinomiya | Hyōgo | Japan |
| Tsuchiura | Ibaraki | Japan |
| Kanazawa | Ishikawa-ken | Japan |
| Yokohama | Kanagawa | Japan |
| Kumamoto | Kumamoto | Japan |
| Matsusaka | Mie-ken | Japan |
| Tsu | Mie-ken | Japan |
| Osaka | Osaka | Japan |
| Sayama | Osaka | Japan |
| Kitamoto | Saitama | Japan |
| Saitama | Saitama | Japan |
| Shizuoka | Shizuoka | Japan |
| Bunkyo-ku | Tokyo | Japan |
| Musashino | Tokyo | Japan |
| Ōta-ku | Tokyo | Japan |
| Shinjuku-ku | Tokyo | Japan |
| Tachikawa | Tokyo | Japan |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C540445 | E 5555 |
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