A double-blind study to assess the efficacy and safety of clazosentan in reducing cerebral vasospasm in patients with aneurysmal subarachnoid hemorrhage treated by endovascular coiling
Phase 3
Completed
- Conditions
- Aneurysmal subarachnoid hemorrhage (aSAH)
- Registration Number
- JPRN-jRCT2080223314
- Lead Sponsor
- Idorsia Pharmaceuticals Japan Ltd.
- Brief Summary
The incidence of Morbidity/Mortality events was significantly decreased in the clazosentan 10 mg/h group compared with the placebo group. The incidence of adverse events in the clazosentan 10 mg/h group differed from the placebo group in terms of fluid retention events and anemia, but there were no new safety concerns.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 220
Inclusion Criteria
patients treated by endovascular coiling
WFNS GradeI - IV
Fisher group 3
Exclusion Criteria
Presence of cerebral vasospasm seen prior to the endovascular coiling etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>The occurrence of the morbidity/mortality event.<br>DSA and CT image will be taken.<br>The relationship between each event and cerebral vasospasm will be finally judged by Event Review Committee and Image Review Comittee.
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>The occurrence of each component of the morbidy/mortality events<br>GOSE, mRS, MMSE<br>morbidity/mortality event: The appropriateness of the events will be confirmed by Event Review Committee and Image Review Comittee.<br>GOSE, mRS, MMSE: Assessed by investigators.