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Sponsored by: |
Actelion |
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Information provided by: | Actelion |
ClinicalTrials.gov Identifier: | NCT00111085 |
The purpose of the study is to measure how effective and safe three different doses of the drug clazosentan are in preventing vasospasm after subarachnoid hemorrhage.
Condition | Intervention | Phase |
---|---|---|
Vasospasm Following Subarachnoid Hemorrhage Aneurysmal Subarachnoid Hemorrhage Intracranial Vasospasm |
Drug: clazosentan |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase IIb, Multi-Center, International, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Dose-Finding Study for the Prevention of Cerebral Vasospasm After aSAH by Intravenous Administration of Clazosentan, a Selective ETA Receptor Antagonist |
Estimated Enrollment: | 400 |
Study Start Date: | December 2004 |
Estimated Study Completion Date: | March 2006 |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Illinois | |
Dr. Giuseppe Lanzino | |
Peoria, Illinois, United States | |
United States, Indiana | |
Dr. Horner | |
Indianapolis, Indiana, United States | |
United States, Maryland | |
Dr. Aldrich | |
Baltimore, Maryland, United States | |
United States, Massachusetts | |
Dr. Ogilvy | |
Boston, Massachusetts, United States | |
United States, Ohio | |
Dr. Woo | |
Cleveland, Ohio, United States | |
Dr. Zuccarello | |
Cincinnati, Ohio, United States | |
United States, Pennsylvania | |
Dr. Zager | |
Philadelphia, Pennsylvania, United States | |
Dr. Rosenwasser | |
Philadelphia, Pennsylvania, United States | |
United States, Texas | |
Dr. George A. Lopez | |
Houston, Texas, United States | |
United States, Virginia | |
Dr. Bullock | |
Richmond, Virginia, United States | |
Canada | |
Dr. Fleetwood | |
Halifax, Nova Scotia, Canada | |
Canada, Alberta | |
Dr. Findlay | |
Edmonton, Alberta, Canada | |
Dr. Wong | |
Calgary, Alberta, Canada | |
Canada, British Columbia | |
Dr. Redekop | |
Vancouver, British Columbia, Canada | |
Canada, Ontario | |
Dr. Ferguson | |
Toronto, Ontario, Canada | |
Canada, Quebec | |
Dr. Bojanowski | |
Montreal, Quebec, Canada |
Study ID Numbers: | CONSCIOUS-1/ AC-054-201 |
Study First Received: | May 17, 2005 |
Last Updated: | April 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00111085 |
Health Authority: | United States: Food and Drug Administration |
aneurysmal subarachnoid hemorrhage (aSAH) vasospasm delayed ischemic neurological deficits (DIND) computer tomography scan (CT scan) |
digital subtraction angiography (DSA) endothelin A receptor clazosentan |
Signs and Symptoms Vascular Diseases Subarachnoid Hemorrhage Central Nervous System Diseases Intracranial Hemorrhages |
Ischemia Brain Diseases Hemorrhage Cerebrovascular Disorders Vasospasm, Intracranial |
Pathologic Processes Nervous System Diseases Cardiovascular Diseases |