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

AstraZeneca

Status and phase

Completed

Phase 2

Conditions

Intracerebral Hemorrhage

Treatments

Drug: NXY-059

Study type

Interventional

Funder types

Industry

Identifiers

NCT00075959

0012

CHANT

SA-NXY-0012

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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