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| Name | Class |
|---|---|
| Jiangsu Simcere Pharmaceutical Co., Ltd. | INDUSTRY |
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pending
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Edaravone Dexborneol | Experimental | Edaravone Dexborneol injection |
|
| Placebo | Placebo Comparator | Edaravone Dexborneol matching injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edaravone Dexborneol | Drug | Edaravone Dexborneol 37.5 mg, containing Edaravone 30 mg and Dexborneol 7.5 mg, Edaravone Dexborneol 37.5 mg BID, 14 days, addition to standard of care of Intracerebral Hemorrhage |
| Measure | Description | Time Frame |
|---|---|---|
| The proportionof Participants With modified Rankin Scale (mRS) 0 ~ 1 | 90 days after the first dose of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of death | 90 days after the first dose of study treatment | |
| The proportionof Participants With modified Rankin Scale (mRS) | 14, 30 and 90 days after the first dose of study treatment |
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaofei Feng, MD | Contact | +86 18601203770 | xiaofeimed@163.com | |
| Xiaofei Feng, MD | Contact | +86(25)8556 6366 |
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| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Placebo | Drug | Edaravone Dexborneol matching injection, addition to standard of care of Intracerebral Hemorrhage |
|
| The change in the NIH stroke scale (NIHSS) from the baseline | 14, 30 and 90 days after the first dose of study treatment |
| The proportionof Participants With Glasgow Outcome Score (GOS) | 14, 30 and 90 days after the first dose of study treatment |
| Barthel Index (BI) | 90 days after the first dose of study treatment |
| Stroke Specific Quality of Life Scale (SS-QOL) | 90 days after the first dose of study treatment |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |