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| Sponsor: | Actelion |
|---|---|
| Information provided by: | Actelion |
| ClinicalTrials.gov Identifier: | NCT00558311 |
Purpose
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:
An independent Critical Events Committee (CEC) will adjudicate whether or not patients meet the primary endpoint and its individual morbidity components.
| Condition | Intervention | Phase |
|---|---|---|
|
Aneurysmal Subarachnoid Hemorrhage |
Drug: clazosentan Drug: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Prospective, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Clazosentan in Reducing Vasospasm-related Morbidity and All-cause Mortality in Adult Patients With Aneurysmal Subarachnoid Hemorrhage Treated by Surgical Clipping. |
| Estimated Enrollment: | 1146 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1 A: Experimental
clazosentan
|
Drug: clazosentan
Intravenous clazosentan administered by continuous infusion at 5 mg/h for the duration of the treatment
|
|
2 B: Placebo Comparator
placebo
|
Drug: placebo
Placebo administered by continuous infusion at 5 mg/h for the duration of the treatment.
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Written informed consent to participate in the study must be obtained from the patient or a legal representative prior to initiation of any study-mandated procedure and randomization.
Exclusion Criteria:
Patients with current alcohol or drug abuse or dependence.
Further detail on exclusion criterion number 4:
Contacts and Locations
Show 121 Study Locations| Study Director: | Sebastien Roux, MD | Actelion |
More Information
| Responsible Party: | Actelion ( Sebastien Roux, MD ) |
| Study ID Numbers: | AC-054-301 |
| Study First Received: | November 13, 2007 |
| Last Updated: | September 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00558311 History of Changes |
| Health Authority: | Austria: Agency for Health and Food Safety; Belgium: Federal Agency for Medicinal Products and Health Products; Czech Republic: State Institute for Drug Control; Denmark: Danish Medicines Agency; Finland: Finnish Medicines Agency; France: Afssaps - French Health Products Safety Agency; Germany: German Institute of Medical Documentation and Information; Italy: The Italian Medicines Agency; Norway: Norwegian Medicines Agency; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; Australia: Department of Health and Ageing Therapeutic Goods Administration; Switzerland: Swissmedic; Canada: Health Canada; China: State Food and Drug Administration; Colombia: Institutional Review Board |
|
Aneurysmal Subarachnoid Hemorrhage vasospasm |
clazosentan PIVLAZ Actelion surgical clipping |
|
Pathologic Processes Nervous System Diseases Vascular Diseases Subarachnoid Hemorrhage Central Nervous System Diseases |
Cardiovascular Diseases Intracranial Hemorrhages Brain Diseases Hemorrhage Cerebrovascular Disorders |