SAINT (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

CompletadoFase 3ClinicalTrials.gov

ID: NCT00061022Tipo: INTERVENTIONALInicio: 1 de may de 2003Fin estimado: 1 de sept de 2006

Traducción no disponible, mostrando original

Resumen

This study will determine if NXY-059 will improve recovery from an acute stroke. The study is designed to look at both overall recovery and recovery of motor function, for example muscle strengthen and coordination.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Males and females
Acute ischemic stroke with limb weakness
Onset of symptoms within 6 hours
Full functional independence prior to the present stroke

Criterios de exclusión

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 30 days.

Intervenciones

drug

NXY-059

Ubicaciones

Research Site

Boulogne Sur Mer, Argentina

Research Site

Buenos Aires, Argentina

Research Site

Capital Federal, Argentina

Research Site

Ciudad de Buenos Aires, Argentina

Research Site

Córdoba, Argentina

Research Site

Mar del Plata, Argentina

Patrocinadores

PrincipalAstraZeneca

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