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NCT00940095 · ClinicalTrials.gov registry record · Phase 3
Clazosentan in Aneurysmal Subarachnoid Hemorrhage
A Phase 3 study, sponsored by Idorsia Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 577
- Enrollment target
NCT00940095 is a Phase 3 study that was terminated before completion, run by Idorsia Pharmaceuticals. The registered enrollment target is 577 participants.
The verdict
NCT00940095, a Phase 3 study, was terminated before completion, sponsored by Idorsia Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 577 participants
- Enrollment target
Study Summary
The aim of this study is to demonstrate that clazosentan, administered as a continuous intravenous infusion at either 5 mg/h or 15 mg/h until Day 14 post aneurysmal subarachnoid hemorrhage (aSAH), reduces the incidence of cerebral vasospasm-related morbidity and all-cause mortality within 6 weeks post-aSAH treated by endovascular coiling. The primary endpoint of the study is the occurrence of cerebral vasospasm-related morbidity, and mortality of all-causes within 6 weeks post-aSAH, defined by at least one of the following: 1. Death (all causes). 2. New cerebral infarct(s) due to cerebral vasospasm as either the primary or relevant contributing cause, or not adjudicated to be entirely due to causes other than vasospasm. 3. Delayed ischemic neurological deficit (DIND) due to cerebral vasospasm as either the primary or relevant contributing cause, or not adjudicated to be entirely due to causes other than vasospasm. 4. Administration of a valid rescue therapy in the presence of confirmed cerebral vasospasm on angiography (DSA or CTA). An independent Critical Events Committee (CEC) will adjudicate whether or not patients meet the primary endpoint and its individual morbidity components.
Interventions
- DRUG Placebo
- DRUG Clazosentan 15 mg/h
- DRUG Clazosentan 5 m/h
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 577 participants |
| Start Date | 2009-07-01 |
| Est. Completion | 2011-01-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00940095
The ClinicalTrials.gov registry entry for NCT00940095 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 577 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Idorsia Pharmaceuticals, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00940095 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00940095 about?
NCT00940095 is a clinical study titled "Clazosentan in Aneurysmal Subarachnoid Hemorrhage". The aim of this study is to demonstrate that clazosentan, administered as a continuous intravenous infusion at either 5 mg/h or 15 mg/h until Day 14 post aneurysmal subarachnoid hemorrhage (aSAH), reduces the incidence of cerebral vasospasm-related morbidity and all-cause mortality within 6 weeks po...
What is the current status of trial NCT00940095?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 577 participants. The study started on 2009-07-01. Estimated completion is 2011-01-01.
What interventions are being tested in trial NCT00940095?
The interventions under investigation include: Placebo (DRUG), Clazosentan 15 mg/h (DRUG), Clazosentan 5 m/h (DRUG).
Who is sponsoring clinical trial NCT00940095?
This trial is sponsored by Idorsia Pharmaceuticals, which has 34 total clinical trials registered on ClinicalTrials.gov.
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