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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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080223314
Enrollment
220
Registered
2016-09-05
Start date
2016-12-09
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysmal subarachnoid hemorrhage (aSAH)

Interventions

Sponsors

Idorsia Pharmaceuticals Japan Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: patients treated by endovascular coiling WFNS GradeI - IV Fisher group 3

Exclusion criteria

Exclusion criteria: Presence of cerebral vasospasm seen prior to the endovascular coiling etc.

Design outcomes

Primary

MeasureTime frame
efficacy The occurrence of the morbidity/mortality event. DSA and CT image will be taken. The relationship between each event and cerebral vasospasm will be finally judged by Event Review Committee and Image Review Comittee.

Secondary

MeasureTime frame
safety efficacy The occurrence of each component of the morbidy/mortality events GOSE, mRS, MMSE morbidity/mortality event: The appropriateness of the events will be confirmed by Event Review Committee and Image Review Comittee. GOSE, mRS, MMSE: Assessed by investigators.

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026