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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
  Purpose

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.


Condition Intervention Phase
Intracerebral Hemorrhage
 Drug: NXY-059
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Global disability on modified Rankin scale at 90 days

Secondary Outcome Measures:
  • NIH stroke scale
  • Barthel Index
  • Stroke Impact Scale

Estimated Enrollment: 600
Study Start Date: August 2004
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075959

  Show 64 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca NXY-059 Medical Science Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00075959     History of Changes
Other Study ID Numbers: SA-NXY-0012, 0012, CHANT
Study First Received: January 12, 2004
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Stroke
cerebral vascular accident
CVA
Hemorrhage
 Intracerebral Hemorrhage (ICH)
Brain Attack
Cataplexy

Additional relevant MeSH terms:
Hemorrhage
Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
 Cardiovascular Diseases
Disufenton sodium
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013