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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00075959
First received: January 12, 2004
Last updated: January 3, 2013
Last verified: January 2013
History of Changes

January 12, 2004
January 3, 2013
August 2004
January 2006   (final data collection date for primary outcome measure)
Global disability on modified Rankin scale at 90 days
Not Provided
Complete list of historical versions of study NCT00075959 on ClinicalTrials.gov Archive Site
  • NIH stroke scale
  • Barthel Index
  • Stroke Impact Scale
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Safety of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke
CHANT (Cerebral Hemorrhage And NXY Treatment) A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter, Phase IIb Study to Assess the Safety and Tolerability of Intravenous Infusion of NXY-059 in Adult Patients With Acute Intracerebral Hemorrhage (ICH)

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Intracerebral Hemorrhage
Drug: NXY-059
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
January 2006
January 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00075959
SA-NXY-0012, 0012, CHANT
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: AstraZeneca NXY-059 Medical Science Director, MD AstraZeneca
AstraZeneca
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP