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

NCT ID: NCT00061022

Last Updated: 2010-11-15

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

PHASE3

Total Enrollment

3200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2006-09-30

Brief Summary

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This study will determine if NXY-059 will improve recovery from an acute stroke. The study is designed to look at both overall recovery and recovery of motor function, for example muscle strengthen and coordination.

Detailed Description

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Conditions

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Cerebral Stroke Stroke, Acute Cerebrovascular Stroke Ischemic Attack, Transient

Keywords

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Stroke cerebral vascular accident CVA Ischemia Hemorrhage TIA Transient Ischemic Attack Brain Attack Cataplexy

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
* Acute ischemic stroke with limb weakness
* 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 30 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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Phoenix, Arizona, United States

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Fort Smith, Arkansas, United States

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Arcadia, California, United States

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Concord, California, United States

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Englewood, California, United States

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La Jolla, California, United States

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La Mesa, California, United States

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Los Angeles, California, United States

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Oceanside, California, United States

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Palo Alto, California, United States

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Poway, 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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Englewood, Colorado, United States

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Danbury, Connecticut, United States

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Fairfield, Connecticut, United States

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Delray Beach, Florida, United States

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Fort Lauderdale, Florida, United States

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Lakeland, Florida, United States

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Lane Panama City, Florida, United States

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Melbourne, Florida, United States

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Naples, Florida, United States

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Ocala, Florida, United States

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Orlando, Florida, United States

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Port Charlotte, Florida, United States

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Sarasota, Florida, United States

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Tampa, Florida, United States

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Weston, Florida, United States

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Decatur, Georgia, United States

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Lithonia, Georgia, United States

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Chicago, Illinois, United States

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Des Plaines, Illinois, United States

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Elk Grove Village, Illinois, United States

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Maywood, Illinois, United States

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Oak Park, Illinois, United States

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Fort Wayne, Indiana, United States

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Cedar Rapids, Iowa, 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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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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Pontiac, Michigan, United States

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Golden Valley, Minnesota, United States

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Kansas City, Missouri, United States

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Springfield, Missouri, United States

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Great Falls, Montana, United States

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Lincoln, Nebraska, United States

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Reno, Nevada, United States

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Edison, New Jersey, United States

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Long Branch, New Jersey, United States

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Lumberton, New Jersey, United States

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Morristown, New Jersey, United States

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Neptune City, New Jersey, United States

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Red Bank, 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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Toms River, New Jersey, United States

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Trenton, New Jersey, United States

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Buffalo, New York, United States

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Flushing, New York, United States

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New Hyde, New York, United States

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Rochester, New York, United States

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Schenectady, New York, United States

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Asheville, North Carolina, United States

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Chapel Hill, North Carolina, United States

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Charlotte, North Carolina, United States

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Durham, North Carolina, United States

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Greensboro, North Carolina, United States

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Salisbury, North Carolina, United States

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Winston-Salem, North Carolina, 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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Portland, Oregon, United States

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Tualatin, Oregon, United States

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Abington, Pennsylvania, United States

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Doylestown, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Beaufort, South Carolina, 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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Seattle, Washington, United States

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Tacoma, Washington, United States

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Charleston, West Virginia, United States

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Madison, Wisconsin, United States

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Marshfield, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Boulogne Sur Mer, , Argentina

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Buenos Aires, , Argentina

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Capital Federal, , Argentina

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Ciudad de Buenos Aires, , Argentina

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Córdoba, , Argentina

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Mar del Plata, , Argentina

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Bedford Park, , Australia

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Box Hill, , Australia

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Camperdown, , Australia

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Gosford, , Australia

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Heidelberg, , Australia

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New Lambton, , Australia

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Parkville, , Australia

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Klosterneuburg, , Austria

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Linz, , Austria

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Salzburg, , Austria

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Sankt Pölten, , Austria

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Vienna, , Austria

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Antwerp, , Belgium

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Bruges, , Belgium

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Leuven, , Belgium

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Belo Horizonte, , Brazil

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Curitiba, , Brazil

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Goiânia, , Brazil

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Porto Alegre, , Brazil

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Rio de Janeiro, , Brazil

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São Paulo, , Brazil

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Pleven, , Bulgaria

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Plovdiv, , Bulgaria

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Rousse, , Bulgaria

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Sofia, , Bulgaria

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Varna, , Bulgaria

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Barrie, , Canada

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Calgary, , Canada

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Vancouver, , Canada

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Victoriaville, , Canada

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Windsor, , Canada

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Santiago, , Chile

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Beijing, , China

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Guangzhou, , China

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Shanghai, , China

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Hradec Králové, , Czechia

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Olomouc, , Czechia

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Ostrava, , Czechia

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Pardubice, , Czechia

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Pelhřimov, , Czechia

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Prague, , Czechia

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Belfort, , France

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Besançon, , France

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Bordeaux, , France

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Bourg-en-Bresse, , France

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Créteil, , France

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Le Chesnay, , France

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Lille, , France

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Marseille, , France

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Montbéliard, , France

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Montpellier, , France

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Paris, , France

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Perpignan, , France

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Toulouse, , France

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Freiburg im Breisgau, , Germany

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Hamburg, , Germany

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Heidelberg, , Germany

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Leipzig, , Germany

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Minden, , Germany

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Wiesbaden, , Germany

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Athens, , Greece

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Heraklion, , Greece

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Ioannina, , Greece

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Thessaloniki, , Greece

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Chai Wan, , Hong Kong

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Hong Kong, , Hong Kong

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Budapest, , Hungary

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Debrecen, , Hungary

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Győr, , Hungary

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Kistarcsa, , Hungary

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Ashkelon, , Israel

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Beersheba, , Israel

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Hadera, , Israel

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Haifa, , Israel

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Holon, , Israel

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Jerusalem, , Israel

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Nahariya, , Israel

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Petah Tikva, , Israel

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Tel Aviv, , Israel

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Tel Litwinsky, , Israel

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Zrifin, , Israel

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Aguascalientes, , Mexico

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Chihuahua City, , Mexico

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Guadalajara, , Mexico

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Monterrey, Nuevo León, , Mexico

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San Luis Potosí City, , Mexico

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Zapopan, Jalisco, , Mexico

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Grafton, , New Zealand

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Manila, , Philippines

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Pasay, , Philippines

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Quezon City, , Philippines

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Częstochowa, , Poland

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Gdansk, , Poland

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Katowice, , Poland

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Kielce, , Poland

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Krakow, , Poland

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Lodz, , Poland

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Lublin, , Poland

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Opole, , Poland

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Siedlce, , Poland

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Szczecin, , Poland

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Warsaw, , Poland

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Zabrze, , Poland

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Amadora, , Portugal

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Coimbra, , Portugal

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Lisbon, , Portugal

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Porto, , Portugal

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Setúbal, , Portugal

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Moscow, , Russia

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Saint Petersburg, , Russia

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Lovoca, , Slovakia

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Martin, , Slovakia

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Nitra, , Slovakia

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Ziliha, , Slovakia

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Cape Town, , South Africa

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George, , South Africa

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Morningside, , South Africa

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Somerset West, , South Africa

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Anyang, , South Korea

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Seoul, , South Korea

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Barcelona, , Spain

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Girona, , Spain

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Madrid, , Spain

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Santiago(A Coruña), , Spain

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Aarau, , Switzerland

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Basel, , Switzerland

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Bern, , Switzerland

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Lausanne, , Switzerland

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Sankt Gallen, , Switzerland

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Zurich, , Switzerland

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Taichung, , Taiwan

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Taipei, , Taiwan

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Taoyuan Hsien, , Taiwan

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Edinburgh, , United Kingdom

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Glasgow, , United Kingdom

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Newcastle upon Tyne, , United Kingdom

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Countries

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United States Argentina Australia Austria Belgium Brazil Bulgaria Canada Chile China Czechia France Germany Greece Hong Kong Hungary Israel Mexico New Zealand Philippines Poland Portugal Russia Slovakia South Africa South Korea Spain Switzerland Taiwan United Kingdom

References

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Shuaib A, Lees KR, Lyden P, Grotta J, Davalos A, Davis SM, Diener HC, Ashwood T, Wasiewski WW, Emeribe U; SAINT II Trial Investigators. NXY-059 for the treatment of acute ischemic stroke. N Engl J Med. 2007 Aug 9;357(6):562-71. doi: 10.1056/NEJMoa070240.

Reference Type DERIVED
PMID: 17687131 (View on PubMed)

Other Identifiers

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007

Identifier Type: -

Identifier Source: secondary_id

SAINT 2

Identifier Type: -

Identifier Source: secondary_id

SA-NXY-0007

Identifier Type: -

Identifier Source: org_study_id