Status:
COMPLETED
Safety of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke
Lead Sponsor:
AstraZeneca
Conditions:
Intracerebral Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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-0...
Eligibility Criteria
Inclusion
- Males and females
- Intracerebral Hemorrhage as the cause of stroke symptoms
- Onset of symptoms within 6 hours
- Full functional independence prior to the present stroke
Exclusion
- Unconsciousness
- 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 7 days.
- Meets all other exclusion criteria
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00075959
Start Date
August 1 2004
End Date
January 1 2006
Last Update
January 4 2013
Active Locations (64)
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1
Research Site
Birmingham, Alabama, United States
2
Research Site
Scottsdale, Arizona, United States
3
Research Site
Fort Smith, Arkansas, United States
4
Research Site
Carmichael, California, United States