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NCT03585270 · ClinicalTrials.gov registry record · Phase 3
Clinical Research Study With Clazosentan to Evaluate Its Effects on Preventing Complications Due to the Narrowing of the Blood Vessels (Vasospasm) in the Brain, Caused by Bleeding Onto the Surface of the Brain
A Phase 3 study, sponsored by Idorsia Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 409
- Enrollment target
NCT03585270: Completed Phase 3 study, sponsored by Idorsia Pharmaceuticals.
NCT03585270 is a Phase 3 study that has completed, run by Idorsia Pharmaceuticals. The registered enrollment target is 409 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03585270, a Phase 3 study, has completed, sponsored by Idorsia Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 409 participants
- Enrollment target
Study 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.
Primary Outcome
Clinical deterioration due to delayed cerebral ischemia is defined as a worsening of at least 2 points compared to the reference score, on the modified Glasgow Coma Scale or the abbreviated National Institutes of Health Stroke Scale (aNIHSS), lasting for at least 2 hours, which cannot be entirely attributed to causes other than cerebral vasospasm. It is centrally adjudicated by the Clinical Event Committee (CEC) based on a written charter and review of clinical data, case narratives, angiograms
Interventions
- DRUG Placebo
- DRUG Clazosentan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 409 participants |
| Start Date | 2019-02-03 |
| Est. Completion | 2022-11-18 |
| Phase | Phase 3 |
What the finished NCT03585270 record still lists
NCT03585270 is an interventional study that assigns participants to a tested intervention. The registered 409 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03585270 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03585270 about?
NCT03585270 is a clinical study titled "Clinical Research Study With Clazosentan to Evaluate Its Effects on Preventing Complications Due to the Narrowing of the Blood Vessels (Vasospasm) in the Brain, Caused by Bleeding Onto the Surface of the Brain". 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.
What is the current status of trial NCT03585270?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 409 participants. The study started on 2019-02-03. Estimated completion is 2022-11-18.
What interventions are being tested in trial NCT03585270?
The interventions under investigation include: Placebo (DRUG), Clazosentan (DRUG).
Who is sponsoring clinical trial NCT03585270?
This trial is sponsored by Idorsia Pharmaceuticals, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03585270's enrollment target sits among peer trials
409 911th of 2000 higher than 1,090 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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