Safety of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

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-059 compared to placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Disufenton sodium

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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