A double-blind study to assess the efficacy and safety of clazosentan in reducing cerebral vasospasm in patients with aneurysmal subarachnoid hemorrhage treated by surgical clipping
Phase 3
Completed
- Conditions
- Aneurysmal subarachnoid hemorrhage (aSAH)
- Registration Number
- JPRN-jRCT2080223313
- 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 surgical clipping
WFNS GradeI - IV
Fisher group 3
Exclusion Criteria
Presence of cerebral vasospasm seen prior to the clipping procedure etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie clazosentan's effect on cerebral vasospasm in aneurysmal subarachnoid hemorrhage?
How does clazosentan compare to nimodipine in preventing delayed cerebral ischemia after surgical clipping for aSAH?
Are there specific biomarkers that predict response to endothelin receptor antagonists like clazosentan in aSAH patients?
What are the long-term management strategies for fluid retention and anemia associated with clazosentan therapy in aSAH?
How do endothelin receptor antagonists like clazosentan fit into the broader therapeutic landscape for aneurysmal subarachnoid hemorrhage management?