Study of Esomeprazole 20 mg or 40 mg vs Placebo Effectiveness on the Occurrence of Peptic Ulcers in Subjects on Low Dose Acetylsalicylic Acid (LDA)
NCT ID: NCT00441727
Last Updated: 2012-07-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2426 participants
INTERVENTIONAL
2007-02-28
2008-08-31
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
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Esomeprazole 40 mg
Esomeprazole 40 mg
Esomeprazole 40 mg
Esomeprazole 40 mg once daily
Esomeprazole 20 mg
Esomeprazole 20 mg
Esomeprazole 20 mg
Esomeprazole 20 mg once daily
Placebo
Placebo
Placebo
Placebo once daily
Interventions
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Esomeprazole 40 mg
Esomeprazole 40 mg once daily
Esomeprazole 20 mg
Esomeprazole 20 mg once daily
Placebo
Placebo once daily
Eligibility Criteria
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Inclusion Criteria
* Aged ≥65 years.
* Aged ≥18 years and with a documented history of uncomplicated peptic ulcer(s).
* Aged ≥60 years and naïve to low-dose ASA (ie, treatment started within 1 month prior to randomization).
* Aged ≥60 years and with stable coronary artery disease.
* Aged ≥60 years and with complaints of upper gastrointestinal (GI) symptoms that, as judged by the investigator, requires an Esophagogastroduodenoscopy (EGD) and with the finding of ≥5 gastric and/or duodenal erosions at the baseline endoscopy.
Exclusion Criteria
* Reflux esophagitis Los Angeles (LA) classification grade C or D at baseline
* History of peptic ulcer complications such as clinically significant bleeding and/or perforation.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Tore Lind, MD, PhD
Role: STUDY_DIRECTOR
AstraZeneca
James Scheiman, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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Birmingham, Alabama, United States
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Tucson, Arizona, United States
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Anaheim, California, United States
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Lancaster, California, United States
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Los Angeles, California, United States
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Orange, California, United States
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San Carlos, California, United States
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San Diego, California, United States
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Torrington, Connecticut, United States
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Boynton Beach, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Jupiter, Florida, United States
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Miami, Florida, United States
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New Smyrna Beach, Florida, United States
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Pembroke Pines, Florida, United States
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Plantation, Florida, United States
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South Miami, Florida, United States
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Tampa, Florida, United States
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Zephyrhills, Florida, United States
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Fulton, Illinois, United States
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Wichita, Kansas, United States
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Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
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Hollywood, Maryland, United States
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Prince Frederick, Maryland, United States
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Brockton, Massachusetts, United States
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Jackson, Mississippi, United States
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Las Vegas, Nevada, United States
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Egg Harbor, New Jersey, United States
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Albuquerque, New Mexico, United States
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Great Neck, New York, United States
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Fayetteville, North Carolina, United States
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Greensboro, North Carolina, United States
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Jacksonville, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Centerville, Ohio, United States
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Cincinnati, Ohio, United States
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Dayton, Ohio, United States
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Guthrie, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Harrisburg, Pennsylvania, United States
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Cranston, Rhode Island, United States
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Johnston, Rhode Island, United States
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Anderson, South Carolina, United States
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Simpsonville, South Carolina, United States
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Knoxville, Tennessee, United States
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Houston, Texas, United States
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Ogden, Utah, United States
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Burke, Virginia, United States
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Chesapeake, Virginia, United States
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Christiansburg, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Milwaukee, Wisconsin, United States
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Capital Federal, Buenos Aires, Argentina
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Loma Hermosa, Buenos Aires, Argentina
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Lomas de Zamora, Buenos Aires, Argentina
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Buenos Aires, Buenos Aires- Argentina, Argentina
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Rosario, Santa Fe Province, Argentina
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Mendoza, , Argentina
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Rosario, , Argentina
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Caboolture, Queensland, Australia
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Carina Heights, Queensland, Australia
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Adelaide, South Australia, Australia
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Ballarat, Victoria, Australia
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Box Hill, Victoria, Australia
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Geelong, Victoria, Australia
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NSW, , Australia
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Chirpan, , Bulgaria
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Pleven, , Bulgaria
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Rousse, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Bay Roberts, Newfoundland and Labrador, Canada
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Carbonear, Newfoundland and Labrador, Canada
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Mount Pearl, Newfoundland and Labrador, Canada
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St. John's, Newfoundland and Labrador, Canada
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Brampton, Ontario, Canada
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Cambridge, Ontario, Canada
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Hamilton, Ontario, Canada
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Niagara Falls, Ontario, Canada
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North York, Ontario, Canada
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Tillsonburg, Ontario, Canada
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Toronto, Ontario, Canada
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Pointe-Claire, Quebec, Canada
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Laval, , Canada
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Longueuil, , Canada
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Québec, , Canada
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Beroun, , Czechia
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Brno, , Czechia
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Liberec, , Czechia
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Litoměřice, , Czechia
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Ostrava - Trebovice, , Czechia
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Podbořany, , Czechia
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Poobram, , Czechia
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Prague, , Czechia
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Praha 4 - Sporilov, , Czechia
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Tábor, , Czechia
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Jakobstad, , Finland
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Joensuu, , Finland
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Mikkeli, , Finland
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Tampere, , Finland
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Turku, , Finland
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Vantaa, , Finland
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Bochum, , Germany
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Dresden, , Germany
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Ludwigshafen, , Germany
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Lüdenscheid, , Germany
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Magdeburg, , Germany
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München, , Germany
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Oelde, , Germany
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Potsdam, , Germany
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Rodgau-dudenhofen, , Germany
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Siegen, , Germany
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Wangen, , Germany
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Wolmirstedt, , Germany
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Jakarta, , Indonesia
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Semarang, , Indonesia
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Surabaya, , Indonesia
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Yogyakarta, , Indonesia
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México, D.f., Mexico
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Guadalajara, Jalisco, Mexico
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Zapopan, Jalisco, Mexico
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D.F, , Mexico
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Mexico City, , Mexico
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Asker, , Norway
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Bergen, , Norway
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Elverum, , Norway
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Gjøvik, , Norway
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Hamar, , Norway
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Levanger, , Norway
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Lysaker, , Norway
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Oslo, , Norway
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Osteros, , Norway
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Paradis, , Norway
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Stavanger, , Norway
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Tromsø, , Norway
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Ølesund, , Norway
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Manila, , Philippines
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Quezon City, , Philippines
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Bydgoszcz, , Poland
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Chojnice, , Poland
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Chrzanów, , Poland
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Czechowice-Dziedzice, , Poland
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Częstochowa, , Poland
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Elblog, , Poland
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Gdansk, , Poland
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Gdynia, , Poland
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Iława, , Poland
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Kościerzyna, , Poland
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Krakow, , Poland
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Sopot, , Poland
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Tczew, , Poland
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Warsaw, , Poland
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Angra Do Herosmo, , Portugal
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Braga, , Portugal
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Castelo Branco, , Portugal
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Coimbra, , Portugal
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Covilha, , Portugal
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Lisbon, , Portugal
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Setúbal, , Portugal
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Vila Real, , Portugal
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Brasov, Brașov County, Romania
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Iași, Iaşi, Romania
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Bucharest, , Romania
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Satu Mare, , Romania
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Tg. Mures, , Romania
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Moscow, , Russia
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Saint Petersburg, , Russia
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Banska Bysterica, , Slovakia
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Bánovce nad Bebravou, , Slovakia
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Brastislava, , Slovakia
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Liptovský Mikuláš, , Slovakia
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Martin, , Slovakia
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Nitra, , Slovakia
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Nové Mesto nad Váhom, , Slovakia
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Piešťany, , Slovakia
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Považská Bystrica, , Slovakia
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Trnava, , Slovakia
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Cape Town, , South Africa
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Durban, , South Africa
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Johannesburg, , South Africa
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Seongnam-si, Kyeonggi-do, South Korea
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Seoul, , South Korea
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Bangkok, , Thailand
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Chiang Mai, , Thailand
Countries
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References
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Scheiman JM, Herlitz J, Veldhuyzen van Zanten SJ, Lanas A, Agewall S, Naucler EC, Svedberg LE, Nagy P. Esomeprazole for prevention and resolution of upper gastrointestinal symptoms in patients treated with low-dose acetylsalicylic acid for cardiovascular protection: the OBERON trial. J Cardiovasc Pharmacol. 2013 Mar;61(3):250-7. doi: 10.1097/FJC.0b013e31827cb626.
Scheiman JM, Devereaux PJ, Herlitz J, Katelaris PH, Lanas A, Veldhuyzen van Zanten S, Naucler E, Svedberg LE. Prevention of peptic ulcers with esomeprazole in patients at risk of ulcer development treated with low-dose acetylsalicylic acid: a randomised, controlled trial (OBERON). Heart. 2011 May;97(10):797-802. doi: 10.1136/hrt.2010.217547. Epub 2011 Mar 17.
Other Identifiers
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EudraCT No. 2006-005073-22
Identifier Type: -
Identifier Source: secondary_id
D961FC00003
Identifier Type: -
Identifier Source: org_study_id