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NCT00558311 · ClinicalTrials.gov registry record · Phase 3
Clazosentan in Reducing Vasospasm-related Morbidity and All-cause Mortality in Adult Patients With Aneurysmal Subarachnoid Hemorrhage Treated by Surgical Clipping
A Phase 3 study of Aneurysmal Subarachnoid Hemorrhage, sponsored by Idorsia Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,157
- Enrollment target
- 20
- Study locations
NCT00558311 is a Phase 3 study of Aneurysmal Subarachnoid Hemorrhage that has completed, run by Idorsia Pharmaceuticals. The registered enrollment target is 1,157 participants, above the 60-participant average among 4 other Aneurysmal Subarachnoid Hemorrhage trials with a reported enrollment target (1828% higher). The trial reports 20 study locations across 9 states.
The verdict
NCT00558311, a Phase 3 study of Aneurysmal Subarachnoid Hemorrhage, has completed, sponsored by Idorsia Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,157 participants
- Enrollment target
- 20
- Study locations
Study Summary
The aim of this study is to demonstrate that clazosentan, administered as a continuous intravenous infusion at 5 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 surgical clipping. 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. Neurological signs or symptoms (depending on state of consciousness), in the presence of confirmed cerebral vasospasm on angiography (DSA or CTA), leading to the administration of a valid rescue therapy. An independent Critical Events Committee (CEC) will adjudicate whether or not patients meet the primary endpoint and its individual morbidity components.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Clazosentan
Study Locations (20)
Other
- Royal Brisbane Hospital - Herston
- The Alfred Hospital - Melbourne
- Landeskrankenhaus - Feldkirch
- Landeskrankenhaus und Medizinische Universitat Graz - Graz
- Medizinsche Universitat - Innsbruck
- University Fur Neurochirurgie, SALK, Christian Doppler Hospital - Salzburg
- AKH University of Vienna, Medical University - Vienna
- Sozialmedizinisches Zentrum Ost (ZMZ-Ost) Donauspital Vienna - Vienna
- Cliniques Universitaires Saint-Luc, Universite Catholique de - Brussels
New York
- Columbia University Medical Center - New York
- State University of New York at Stony Brook-Health Sciences Center - Stony Brook
Ohio
- University of Cincinnati-Department of Neurosurgery - Cincinnati
- University Hospitals Case Medical Center-Department of Neurosurgery - Cleveland
Virginia
- University of Virginia Health System-Department of Neurosurgery - Charlottesville
- Virginia Commonwealth University-Department of Neurosurgery - Richmond
Arizona
- Barrow Neurosurgical Associates - Phoenix
Colorado
- Colorado Neurological Institute - Englewood
Massachusetts
- Massachusetts General Hospital - Boston
Oregon
- Oregon Health & Science University-Oregon Stroke Center - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,157 participants |
| Start Date | 2007-12-14 |
| Est. Completion | 2010-07-13 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00558311
The ClinicalTrials.gov registry entry for NCT00558311 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,157 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 60-participant average among 4 other Aneurysmal Subarachnoid Hemorrhage trials with a reported enrollment target (1828% higher). The listed sponsor is Idorsia Pharmaceuticals, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Aneurysmal Subarachnoid Hemorrhage appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00558311 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, New York, Ohio.
Frequently Asked Questions
What is clinical trial NCT00558311 about?
NCT00558311 is a clinical study titled "Clazosentan in Reducing Vasospasm-related Morbidity and All-cause Mortality in Adult Patients With Aneurysmal Subarachnoid Hemorrhage Treated by Surgical Clipping". The aim of this study is to demonstrate that clazosentan, administered as a continuous intravenous infusion at 5 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 b...
What is the current status of trial NCT00558311?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,157 participants. The study started on 2007-12-14. Estimated completion is 2010-07-13.
What conditions does trial NCT00558311 study?
This clinical trial studies the following conditions: Aneurysmal Subarachnoid Hemorrhage.
What interventions are being tested in trial NCT00558311?
The interventions under investigation include: Placebo (DRUG), Clazosentan (DRUG).
Who is sponsoring clinical trial NCT00558311?
This trial is sponsored by Idorsia Pharmaceuticals, which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00558311 being conducted?
This trial has 20 study locations across Arizona, Colorado, Massachusetts, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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