Safety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke
NCT ID: NCT00119626
Last Updated: 2010-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1700 participants
INTERVENTIONAL
2003-06-30
2005-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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NXY-059
Eligibility Criteria
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Inclusion Criteria
* Acute ischemic stroke with limb weakness, onset of symptoms within 6 hours
* Full functional independence prior to the present stroke
Exclusion Criteria
* Subjects who are unlikely to complete the infusion of investigational product and/or are unlikely to undergo active medical management during that period due to a severe clinical condition
* Severe illness with life expectancy less than 6 months
* Known severe kidney disorder
* Current known alcohol or illicit drug abuse or dependence
* Pregnant or breast-feeding
* Treatment with acetazolamide and methotrexate is not permitted during the infusion
* Participation in a previous clinical study within 30 days
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Principal Investigators
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AstraZeneca NXY-059 Medical Science Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Södertälje, , Sweden
Research Site
Glasgow, , United Kingdom
Countries
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References
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Lees KR, Zivin JA, Ashwood T, Davalos A, Davis SM, Diener HC, Grotta J, Lyden P, Shuaib A, Hardemark HG, Wasiewski WW; Stroke-Acute Ischemic NXY Treatment (SAINT I) Trial Investigators. NXY-059 for acute ischemic stroke. N Engl J Med. 2006 Feb 9;354(6):588-600. doi: 10.1056/NEJMoa052980.
Other Identifiers
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0006
Identifier Type: -
Identifier Source: secondary_id
SAINT I
Identifier Type: -
Identifier Source: secondary_id
SA-NXY-0006
Identifier Type: -
Identifier Source: org_study_id