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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00075959 |
This study will determine if NXY-059 is safe in patients with an acute stroke caused by bleeding in the central nervous system. The primary objective was to assess the safety and tolerability of NXY-059 compared to placebo.
Condition | Intervention | Phase |
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Intracerebral Hemorrhage |
Drug: NXY-059 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | CHANT (Cerebral Hemorrhage And NXY Treatment) A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter, Phase IIb Study to Assess the Safety and Tolerability of Intravenous Infusion of NXY-059 in Adult Patients With Acute Intracerebral Hemorrhage (ICH) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | AstraZeneca NXY-059 Medical Science Director, MD | AstraZeneca |
Study ID Numbers: | SA-NXY-0012, 0012, CHANT |
Study First Received: | January 12, 2004 |
Last Updated: | April 5, 2006 |
ClinicalTrials.gov Identifier: | NCT00075959 |
Health Authority: | United States: Food and Drug Administration |
Stroke cerebral vascular accident CVA Hemorrhage |
Intracerebral Hemorrhage (ICH) Brain Attack Cataplexy |
Cerebral Hemorrhage Cataplexy Cerebral Infarction Stroke Vascular Diseases Disufenton sodium |
Central Nervous System Diseases Intracranial Hemorrhages Brain Diseases Hemorrhage Cerebrovascular Disorders |
Antioxidants Pathologic Processes Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Nervous System Diseases Cardiovascular Diseases Cardiovascular Agents Protective Agents Pharmacologic Actions |