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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00075959
Recruitment Status : Completed
First Posted : January 14, 2004
Last Update Posted : January 4, 2013
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Brief 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.

Condition or disease Intervention/treatment Phase
Intracerebral Hemorrhage Drug: NXY-059 Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
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)
Study Start Date : August 2004
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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

Secondary Outcome Measures :
  1. NIH stroke scale
  2. Barthel Index
  3. Stroke Impact Scale

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00075959

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Sponsors and Collaborators
Study Director: AstraZeneca NXY-059 Medical Science Director, MD AstraZeneca Identifier: NCT00075959     History of Changes
Other Study ID Numbers: SA-NXY-0012
First Posted: January 14, 2004    Key Record Dates
Last Update Posted: January 4, 2013
Last Verified: January 2013

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

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