Edaravone Dexborneol for Treatment of Hypertensive Intracerebral Hemorrhage
NCT ID: NCT04714177
Last Updated: 2021-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
390 participants
INTERVENTIONAL
2021-03-01
2023-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Edaravone Dexborneol
Edaravone Dexborneol injection
Edaravone Dexborneol
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
Placebo
Edaravone Dexborneol matching injection
Placebo
Edaravone Dexborneol matching injection, addition to standard of care of Intracerebral Hemorrhage
Interventions
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Edaravone Dexborneol
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
Placebo
Edaravone Dexborneol matching injection, addition to standard of care of Intracerebral Hemorrhage
Eligibility Criteria
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Inclusion Criteria
* Males and females
* Diagnose as hypertensive intracerebral hemorrhage
* Onset of symptoms within 6\~48 hours
* Position of bleeding major in basal ganglia
* The sum of scores on items 5 and 6 on the NIHSS were \>= 2 at baseline and the total score (items 1-11) was \>=6 and \<=20
* Volume of Hematoma \<= 30 ml
* Premorbid mRS score of 0 or 1
Exclusion Criteria
* Experienced stroke in latest 3 month
* Volume of Hematoma \> 5 ml in other bleeding position
* Obstructive hydrocephalus
* Any diagnosis as other than hypertensive ICH
* Unconsciousness
* Severe concurrent illness with life expectancy less than 90 days
* Pregnancy or breast-feeding
18 Years
80 Years
ALL
No
Sponsors
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Jiangsu Simcere Pharmaceutical Co., Ltd.
INDUSTRY
First Affiliated Hospital, Sun Yat-Sen University
OTHER
Responsible Party
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Jinsheng Zeng, MD, PhD
Principal Investigator
Central Contacts
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Xiaofei Feng, MD
Role: CONTACT
Other Identifiers
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SIM23-ICH-201
Identifier Type: -
Identifier Source: org_study_id
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