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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00119626 |
This study will determine if NXY-059 will reduce functional disability from an acute stroke. The study is designed to look at both overall recovery and recovery of motor function, for example muscle strength and coordination.
Condition | Intervention | Phase |
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Cerebral Stroke Ischemic Attack, Transient |
Drug: NXY-059 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | SAINT I (Stroke – Acute Ischemic – NXY Treatment) A Double Blind, Randomized, Placebo Controlled, Parallel Group, Multicenter, Phase IIb/III Study to Assess the Efficacy and Safety of Intravenous NXY-059 in Acute Ischemic Stroke. |
Estimated Enrollment: | 1700 |
Study Start Date: | June 2003 |
Estimated Study Completion Date: | January 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Sweden | |
Research Site | |
Södertälje, Sweden | |
United Kingdom | |
Research Site | |
Glasgow, United Kingdom |
Study Director: | AstraZeneca NXY-059 Medical Science Director, MD | AstraZeneca |
Study ID Numbers: | SA-NXY-0006, 0006, SAINT I |
Study First Received: | July 6, 2005 |
Last Updated: | May 3, 2006 |
ClinicalTrials.gov Identifier: | NCT00119626 |
Health Authority: | United States: Food and Drug Administration |
Stroke, Acute Cerebrovascular Stroke |
Ischemic Attack, Transient Cerebral Infarction Stroke Vascular Diseases Disufenton sodium Central Nervous System Diseases |
Brain Ischemia Brain Infarction Ischemia Brain Diseases Infarction 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 |