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

NCT ID: NCT00075959

Last Updated: 2013-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2006-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Intracerebral Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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NXY-059

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca NXY-059 Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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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

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Countries

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United States

Other Identifiers

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0012

Identifier Type: -

Identifier Source: secondary_id

CHANT

Identifier Type: -

Identifier Source: secondary_id

SA-NXY-0012

Identifier Type: -

Identifier Source: org_study_id

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