Safety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke
SAINT (Stroke - Acute Ischemic - NXY Treatment) A Double Blind, Randomized, Placebo Controlled, Parallel Group, Multicenter, Phase IIb/III Study to Assess the Efficacy and Safety of Intravenous NXY-059 in Acute Ischemic Stroke
3 other identifiers
interventional
3,200
29 countries
251
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2003
Typical duration for phase_3
251 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
May 20, 2003
CompletedFirst Posted
Study publicly available on registry
May 21, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedNovember 15, 2010
November 1, 2010
3.3 years
May 20, 2003
November 10, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Global disability on modified Rankin scale at 90 days.
Secondary Outcomes (5)
NIH stroke scale
Barthel Index
Stroke Impact Scale
EQ-5D all at 90 days
Safety outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Males and females
- Acute ischemic stroke with limb weakness
- 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 30 days.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (256)
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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
Related Publications (1)
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.
PMID: 17687131DERIVED
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 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 20, 2003
First Posted
May 21, 2003
Study Start
May 1, 2003
Primary Completion
September 1, 2006
Study Completion
September 1, 2006
Last Updated
November 15, 2010
Record last verified: 2010-11