At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 409 enrolled
Drug / intervention
Clazosentan +1 moredrug
Likely dose
Clazosentan 15 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase 3 Study to Assess the Efficacy and Safety of Clazosentan in Preventing Clinical Deterioration Due to Delayed Cerebral Ischemia (DCI), in Adult Subjects With Aneurysmal Subarachnoid Hemorrhage (aSAH)
In Brief
A Phase 3 clinical trial evaluating Clazosentan and Placebo for Aneurysmal Subarachnoid Hemorrhage. Completed, enrolled 409 participants across 80 sites in 15 countries.
Detailed Summary
This study will evaluate if clazosentan (on top of normal routine medical care) can reduce the risk of developing complications related to cerebral vasospasm and permanent brain damage as compared to normal routine medical care alone.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAneurysmal Subarachnoid Hemorrhage
CountriesAustria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Poland, Spain, Sweden, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJul 2018
Enrollment StartFeb 2019
Primary CompletionJun 2022
Study CompletionNov 2022
TodayJul 2026
First PostedJul 12, 2018
Enrollment StartFeb 3, 2019
Primary CompletionJun 13, 2022
Study CompletionNov 18, 2022
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 8.0 years ago
Interventions
Clazosentandrug
Clazosentan will be administered as a continuous intravenous infusion at the dose of 15 mg/hour for up to 14 days.
Placebodrug
Placebo will be administered at the same infusion rate as clazosentan for up to 14 days.