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The purpose of this study is to assess the safety and tolerability of E5555 in Japanese patients with acute coronary syndrome.
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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 | Drug | E5555, 50 mg (tablet), taken orally, once a day. |
| |
| E5555 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability: Adverse events, bleeding events, clinical laboratory tests, Coagulation tests, vital signs and 12-lead ECG. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Major cardiac adverse events, biomarkers, platelet aggregation inhibition, plasma concentration. | 3 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 |
|---|---|---|---|---|---|---|
| Toyoake | Aichi-ken | Japan | ||||
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| Drug |
E5555, 100 mg (tablet), taken orally, once a day. |
|
| E5555 | Drug | E5555, 200 mg (tablet), taken orally, once a day. |
|
| Placebo | Drug | Placebo tablet taken orally, once a day. |
|
| Fukuoka |
| Fukuoka |
| Japan |
| Kasuga | Fukuoka | Japan |
| Kitakyushu | Fukuoka | Japan |
| Kurume | Fukuoka | Japan |
| Gifu | Gifu | Japan |
| Ōgaki | Gifu | Japan |
| Fukuyama | Hiroshima | Japan |
| Higashi-Hiroshima | Hiroshima | Japan |
| Hiroshima | Hiroshima | Japan |
| Sapporo | Hokkaido | Japan |
| Amagasaki | Hyōgo | Japan |
| Himaji | Hyōgo | Japan |
| Kobe | Hyōgo | Japan |
| Nishinomiya | Hyōgo | Japan |
| Kagoshima | Kagoshima-ken | Japan |
| Yokohama | Kanagawa | Japan |
| Ōmura | Nakasaki | Japan |
| Beppu | Oita Prefecture | Japan |
| Urazoe | Okinawa | Japan |
| Osaka | Osaka | Japan |
| Wako | Saitama | Japan |
| Komatsushimachō | Tokushima | Japan |
| Bunkyo | Tokyo | Japan |
| Fuchū | Tokyo | Japan |
| Hachiōji | Tokyo | Japan |
| Kodaira | Tokyo | Japan |
| Nerima City | Tokyo | Japan |
| Shinagawa-ku | Tokyo | Japan |
| Shinagawa | Tokyo | Japan |
| Shinjuku | Tokyo | Japan |
| tabashi City | Tokyo | Japan |
| Tanabe | Wakayama | Japan |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D023921 | Coronary Stenosis |
| D003328 | Coronary Thrombosis |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D003327 | Coronary Disease |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
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| ID | Term |
|---|---|
| C540445 | E 5555 |
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