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
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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COMPLETED
PHASE3
3200 participants
INTERVENTIONAL
2003-05-31
2006-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Interventions
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NXY-059
Eligibility Criteria
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Inclusion Criteria
* Acute ischemic stroke with limb weakness
* Onset of symptoms within 6 hours
* Full functional independence prior to the present stroke
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
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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Edmonton, , Canada
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Greenfield Park, , Canada
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Halifax, , Canada
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Kitchener, , Canada
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Lethbridge, , Canada
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Lévis, , Canada
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Mississauga, , Canada
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Montreal, , Canada
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Ottawa, , Canada
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Penticton, , Canada
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Québec, , Canada
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Saint John, , Canada
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Saskatoon, , Canada
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Thunder Bay, , Canada
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Toronto, , Canada
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Trois-Rivières, , 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
Countries
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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.
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