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)
3 other identifiers
interventional
600
1 country
64
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2004
Shorter than P25 for phase_2
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2004
CompletedFirst Posted
Study publicly available on registry
January 14, 2004
CompletedStudy Start
First participant enrolled
August 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedJanuary 4, 2013
January 1, 2013
1.4 years
January 12, 2004
January 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Global disability on modified Rankin scale at 90 days
Secondary Outcomes (3)
NIH stroke scale
Barthel Index
Stroke Impact Scale
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (64)
Research Site
Birmingham, Alabama, United States
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Scottsdale, Arizona, United States
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Fort Smith, Arkansas, United States
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Carmichael, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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San Jose, California, United States
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Santa Rosa, California, United States
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Walnut Creek, California, United States
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Danbury, Connecticut, United States
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Melbourne, Florida, United States
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Ocala, Florida, United States
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Pompano Beach, Florida, United States
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Port Charlotte, Florida, United States
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Punta Gorda, Florida, United States
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Tampa, Florida, United States
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Weston, Florida, United States
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Atlanta, Georgia, United States
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Decatur, Georgia, United States
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Duluth, Georgia, United States
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Lawrenceville, Georgia, United States
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Honolulu, Hawaii, United States
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Arlington Heights, Illinois, United States
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Maywood, Illinois, United States
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Fort Wayne, Indiana, United States
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Des Moines, Iowa, United States
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Louisville, Kentucky, United States
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Marrero, Louisiana, United States
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Shreveport, Louisiana, United States
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South Weymouth, Massachusetts, United States
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Worcester, Massachusetts, United States
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Ann Arbor, Michigan, United States
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East Lansing, Michigan, United States
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Robbinsdale, Minnesota, United States
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Kansas City, Missouri, United States
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Omaha, Nebraska, United States
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Reno, Nevada, United States
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Edison, New Jersey, United States
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Holmdel, New Jersey, United States
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Morristown, New Jersey, United States
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Ridgewood, New Jersey, United States
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Summit, New Jersey, United States
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Manhasset, New York, United States
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Schenectady, New York, United States
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Durham, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Akron, Ohio, United States
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Cleveland, Ohio, United States
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Toledo, Ohio, United States
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Youngstown, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Abington, Pennsylvania, United States
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Danville, Pennsylvania, United States
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Hershey, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Bristol, Tennessee, United States
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Memphis, Tennessee, United States
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Houston, Texas, United States
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Lubbock, Texas, United States
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Virginia Beach, Virginia, United States
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Olympia, Washington, United States
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Madison, Wisconsin, United States
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Marshfield, Wisconsin, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca NXY-059 Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 12, 2004
First Posted
January 14, 2004
Study Start
August 1, 2004
Primary Completion
January 1, 2006
Study Completion
January 1, 2006
Last Updated
January 4, 2013
Record last verified: 2013-01