Study Stopped
AZ decision to discontinue fostamatinib development in RA; rights to fostamatinib returned to Rigel Pharmaceuticals.
Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA)
OSKIRA-X
(OSKIRA-X): A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis
2 other identifiers
interventional
1,917
30 countries
305
Brief Summary
The purpose of this study is to evaluate the long term safety and tolerability of fostamatinib in patients with rheumatoid arthritis (RA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 rheumatoid-arthritis
Started Jan 2011
Typical duration for phase_3 rheumatoid-arthritis
305 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
First Submitted
Initial submission to the registry
November 10, 2010
CompletedFirst Posted
Study publicly available on registry
November 17, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedResults Posted
Study results publicly available
April 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedApril 4, 2014
February 1, 2014
4 years
November 10, 2010
December 18, 2013
February 25, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Patients Who Had at Least 1 Adverse Event in Any Category
AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event
Entry in extension to end of study (variable duration; maximum 109 weeks)
Secondary Outcomes (3)
Mean DAS28-CRP Score
Weeks 0, 12, 24, 36 and 52
Mean mTSS Score
Weeks 0 and 52
Mean HAQ-DI Score
Weeks 0, 12, 24, 36 and 52
Study Arms (3)
A
EXPERIMENTALOral treatment
B
EXPERIMENTALOral treatment
C
EXPERIMENTALOral treatment
Interventions
Eligibility Criteria
You may qualify if:
- Patients who have successfully completed a qualifying study (D4300C00001, D4300C00002, D4300C00003 or D4300C00004) with fostamatinib
- Patients who have participated in a qualifying study and who have been classified as non-responders due to pre-defined lack of efficacy at Week 12 (D4300C00001, D4300C00002, D4300C00003).
You may not qualify if:
- Premature withdrawal from the qualifying study (D4300C00001, D4300C00002, D4300C00003 and D4300C00004)
- Females who are pregnant or breast feeding
- Poorly controlled hypertension
- Significant liver function test abnormalities or physical symptoms of hepatotoxicity
- Significant infection
- Gastrointestinal intolerance
- Cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (308)
Research Site
Anniston, Alabama, United States
Research Site
Birmingham, Alabama, United States
Research Site
Huntsville, Alabama, United States
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Tuscaloosa, Alabama, United States
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Glendale, Arizona, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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Hot Springs, Arkansas, United States
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Anaheim, California, United States
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Fountain Valley, California, United States
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Huntington Beach, California, United States
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La Jolla, California, United States
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Long Beach, California, United States
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Palo Alto, California, United States
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Roseville, California, United States
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Santa Maria, California, United States
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Santa Monica, California, United States
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Torrance, California, United States
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Upland, California, United States
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Colorado Springs, Colorado, United States
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Bridgeport, Connecticut, United States
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Danbury, Connecticut, United States
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Trumbull, Connecticut, United States
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Lewes, Delaware, United States
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Boca Raton, Florida, United States
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Brandon, Florida, United States
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Daytona Beach, Florida, United States
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Fort Lauderdale, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Ocala, Florida, United States
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Orlando, Florida, United States
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Palm Harbor, Florida, United States
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Pinellas Park, Florida, United States
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Tampa, Florida, United States
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Tavares, Florida, United States
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Venice, Florida, United States
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Zephyrhills, Florida, United States
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Atlanta, Georgia, United States
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Canton, Georgia, United States
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Decatur, Georgia, United States
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Lawrenceville, Georgia, United States
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Macon, Georgia, United States
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Marietta, Georgia, United States
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Idaho Falls, Idaho, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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South Bend, Indiana, United States
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Cedar Rapids, Iowa, United States
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Bowling Green, Kentucky, United States
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Elizabethtown, Kentucky, United States
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Cumberland, Maryland, United States
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Frederick, Maryland, United States
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Hagerstown, Maryland, United States
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Oxon Hill, Maryland, United States
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Boston, Massachusetts, United States
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Fall River, Massachusetts, United States
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Worcester, Massachusetts, United States
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Kalamazoo, Michigan, United States
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Lansing, Michigan, United States
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Saint Clair Shores, Michigan, United States
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Eagan, Minnesota, United States
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Flowood, Mississippi, United States
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Florissant, Missouri, United States
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Richmond Heights, Missouri, United States
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St Louis, Missouri, United States
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Kalispell, Montana, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Freehold, New Jersey, United States
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Albuquerque, New Mexico, United States
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Las Cruces, New Mexico, United States
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Albany, New York, United States
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Brooklyn, New York, United States
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Cooperstown, New York, United States
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Olean, New York, United States
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Roslyn, New York, United States
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Smithtown, New York, United States
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Syracuse, New York, United States
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Asheville, 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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Research Triangle Park, North Carolina, United States
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Dayton, Ohio, United States
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Mayfield Village, Ohio, United States
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Perrysburg, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Lake Oswego, Oregon, United States
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Duncansville, Pennsylvania, United States
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Erie, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Waxford, Pennsylvania, United States
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West Reading, Pennsylvania, United States
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Charleston, South Carolina, United States
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Greenville, South Carolina, United States
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Orangeburg, South Carolina, United States
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Rapid City, South Dakota, United States
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Hixson, Tennessee, United States
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Jackson, Tennessee, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Amarillo, Texas, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Katy, Texas, United States
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Lubbock, Texas, United States
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Mesquite, Texas, United States
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Nassau Bay, Texas, United States
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San Antonio, Texas, United States
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Chesapeake, Virginia, United States
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Tacoma, Washington, United States
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Buenos Aires, Buenos Aires F.D., Argentina
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Ciudad Autonoma Bs As, CBA, Argentina
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Córdoba, CRD, Argentina
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San Juan, San Juan Province, Argentina
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Rosario, Santa Fe Province, Argentina
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San Miguel de Tucumán, TUC, Argentina
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Caba Buenos Aires, Argentina
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Ciudad Autonoma Bs As, Argentina
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Ciudad de Buenos Aires, Argentina
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Quilmes, Argentina
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Camperdown, New South Wales, Australia
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Southport, Queensland, Australia
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Cairns, Australia
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Ghent, Belgium, Belgium
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Liège, Belgium, Belgium
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Brussels, Belgium
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Gilly, Belgium
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Yvoir, Belgium
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Goiânia, Goiás, Brazil
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Curitiba, Paraná, Brazil
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Recife, Pernambuco, Brazil
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São Paulo, São Paulo, Brazil
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Rio de Janeiro, Brazil
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Pleven, Bulgaria
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Plovdiv, Bulgaria
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Sevlievo, Bulgaria
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Sofia, Bulgaria
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Edmonton, Alberta, Canada
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Victoria, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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St. John's, Newfoundland and Labrador, Canada
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Bowmanville, Ontario, Canada
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Etobicoke, Ontario, Canada
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Hamilton, Ontario, Canada
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Mississauga, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Pointe-Claire, Quebec, Canada
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Québec, Quebec, Canada
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Rimouski, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Osorno, Los Lagos Region, Chile
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Santiago, Chile
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Barranquilla, Atlántico, Colombia
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Bogota, Cundinamarca, Colombia
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Bucaramanga, Santander Department, Colombia
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Brno, Czechia
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Bruntál, Czechia
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Česká Lípa, Czechia
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České Budějovice, Czechia
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Hlučín, Czechia
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Hostivice, Czechia
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Kladno, Czechia
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Liberec, Czechia
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Ostrava, Czechia
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Ostrava - Trebovice, Czechia
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Prague, Czechia
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Sokolov, Czechia
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Terezín, Czechia
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Zlín, Czechia
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Pärnu, Estonia
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Tallinn, Estonia
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Tartu, Estonia
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Orléans, France
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Aachen, North Rhine-Westphalia, Germany
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Halle, Saxony, Germany
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Cologne, Germany
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Erlangen, Germany
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Frankfurt, Germany
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Hamburg, Germany
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Heidelberg, Germany
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Herne, Germany
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Leipzig, Germany
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München, Germany
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Balatonfüred, Hungary
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Békéscsaba, Hungary
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Budapest, Hungary
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Debrecen, Hungary
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Makó, Hungary
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Sopron, Hungary
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Szentes, Hungary
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Zalaegerszeg-pozva, Hungary
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Hyderabad, Andhra Pradesh, India
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Secunderabad, Andhra Pradesh, India
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Ahmedabad, Gujarat, India
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Gandhinagar, Gujarat, India
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Vadodara, Gujarat, India
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Bangalore, Karnataka, India
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Mangalore, Karnataka, India
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Udupi, Karnataka, India
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Mumbai, Maharashtra, India
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Pune, Maharashtra, India
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Nagpur, Maharshtra, India
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Coimbatore, Tamil Nadu, India
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Madurai, Tamil Nadu, India
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Lucknow, Uttar Pradesh, India
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Ashkelon, Israel
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Haifa, Israel
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Kfar Saba, Israel
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Ramat Gan, Israel
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Rehovot, Israel
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Iesi, AN, Italy
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Udine, UD, Italy
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Varese, VA, Italy
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Liepāja, Latvia
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Riga, Latvia
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Valmiera, Latvia
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Kaunas, Lithuania
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Klaipėda, Lithuania
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Šiauliai, Lithuania
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Chihuahua City, Chihuahua, Mexico
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Saltillo, Coahuila, Mexico
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Mexicali, Estado de Baja California, Mexico
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Guadalajara, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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San Luis Potosi, Mexico, Mexico
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Monterrey, Nuevo León, Mexico
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Obrergon, Sonora, Mexico
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Arequipa, Arequipa, Peru
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Lima, Lima Province, Peru
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Pueblo Libre, Lima region, Peru
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San Borja, Lima region, Peru
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San Isidro, Lima region, Peru
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Bytom, Poland
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Chełm Śląski, Poland
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Grodzisk Mazowiecki, Poland
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Kalisz, Poland
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Katowice, Poland
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Krakow, Poland
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Lodz, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Żyrardów, Poland
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Aveiro, Portugal
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Coimbra, Portugal
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Lisbon, Portugal
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Porto, Portugal
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Ploieşti, Prahova, Romania
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Brăila, Romania
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Moscow, Russia
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Nizhny Novgorod, Russia
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Petrozavodsk, Russia
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Ryazan, Russia
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Saint Petersburg, Russia
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Voronezh, Russia
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Yaroslavl, Russia
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Belgrade, Serbia
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Kragujevac, Serbia
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Niška Banja, Serbia
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Novi Sad, Serbia
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Bratislava, Slovakia, Slovakia
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Žilina, Slovakia, Slovakia
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Poprad, Slovakia
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Rimavská Sobota, Slovakia
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Ružomberok, Slovakia
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Trnava, Slovakia
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Panorama, Cape Town, South Africa
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Port Elizabeth, E Cape, South Africa
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Kempron Park, Gauteng, South Africa
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Pretoria, Gauteng, South Africa
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Durban, KwaZulu-Natal, South Africa
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Cape Town, Western Cape, South Africa
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Stellenbosch, South Africa
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Mérida, Extremadura, Spain
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Barcelona, Spain
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Donetsk, Ukraine
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Ivano-Frankivsk, Ukraine
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Kharkiv, Ukraine
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Kyiv, Ukraine
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Luhansk, Ukraine
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Lutsk, Ukraine
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Lviv, Ukraine
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Odesa, Ukraine
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Simferopol, Ukraine
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Vinnytsia, Ukraine
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Zaporizhzhya, Ukraine
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Zaporyzhzhya, Ukraine
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Bracknell, Berkshire, United Kingdom
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Warrington, Cheshire, United Kingdom
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London, Greater London, United Kingdom
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Maidstone, Kent, United Kingdom
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Eastbourne, Sussex, United Kingdom
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Solihull, West Midlands, United Kingdom
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Basingstoke, United Kingdom
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Cambridge, United Kingdom
Research Site
Christchurch, United Kingdom
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Ipswich, United Kingdom
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Metropolitan Borough of Wirral, United Kingdom
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Nottingham, United Kingdom
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Stoke-on-Trent, United Kingdom
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Westcliff-on-the Sea, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dave Goldstraw
- Organization
- AstraZeneca Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Chris O'Brien, MD PhD
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2010
First Posted
November 17, 2010
Study Start
January 1, 2011
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
April 4, 2014
Results First Posted
April 4, 2014
Record last verified: 2014-02