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Clazosentan in Reducing Vasospasm-related Morbidity and All-cause Mortality in Adult Patients With Aneurysmal Subarachnoid Hemorrhage Treated by Surgical Clipping
NCT00558311 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,157 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Idorsia Pharmaceuticals, which has 38 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00558311 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, New York, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00558311?
The interventions under investigation include: Placebo (DRUG), Clazosentan (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00558311?
This trial is sponsored by Idorsia Pharmaceuticals, which has 38 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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