Comparative Investigation of Low Molecular Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus (LMW) Heparin/Warfarin in the Treatment of Symptomatic Deep-Vein Blood Clots and/or Lung Blood Clots. (The Edoxaban Hokusai-VTE Study).
NCT ID: NCT00986154
Last Updated: 2019-03-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
8292 participants
INTERVENTIONAL
2009-10-31
2013-04-30
Brief Summary
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A Randomized, Open-Label, Parallel-Group, Multi-Center Study for the Evaluation of Efficacy and Safety of Edoxaban Monotherapy Versus Low Molecular Weight (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis
NCT01662908
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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heparin/edoxaban tosylate
edoxaban tosylate(DU-176b)
edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment
low molecular weight heparin/unfractionated heparin
LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.
Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment
heparin/warfarin
low molecular weight heparin/unfractionated heparin
LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.
Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment
warfarin
tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment
Interventions
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edoxaban tosylate(DU-176b)
edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment
low molecular weight heparin/unfractionated heparin
LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.
Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment
warfarin
tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment
Eligibility Criteria
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Inclusion Criteria
* Acute symptomatic proximal DVT and/or symptomatic PE confirmed at the site by appropriate diagnostic imaging;
* Able to provide written informed consent
Exclusion Criteria
* More than 48 hours pre-treatment with anticoagulant therapy prior to randomization;
* Calculated Creatinine clearance (CrCL) \< 30 mL/min;
* significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis) or alanine transaminase (ALT) \>\\= 2 times the upper limit of normal (ULN), or total bilirubin (TBL) x 1.5 times the ULN;
* patients with active cancer for whom long term treatment with (LMW) heparin is anticipated;
* active bleeding or high risk for bleeding contraindicating treatment with (LMW) heparin or warfarin;
* chronic treatment with non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs);
* treatment with aspirin in a dosage of more than 100 mg/per day or dual antiplatelet therapy;
* concurrent treatment with potent P-gp inhibitors;
* subjects with any condition that, as judged by the investigator, would place the subject at increased risk of harm if he/she participated in the study
18 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Responsible Party
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Locations
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Investigational Site 7103
Mobile, Alabama, United States
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Montgomery, Alabama, United States
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Phoenix, Arizona, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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Los Alamitos, California, United States
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Monterey, California, United States
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Palm Springs, California, United States
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San Diego, California, United States
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Vista, California, United States
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Aurora, Colorado, United States
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Boulder, Colorado, United States
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Denver, Colorado, United States
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Lakewood, Colorado, United States
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Littleton, Colorado, United States
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Thornton, Colorado, United States
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Thornton, Colorado, United States
Brandon, Florida, United States
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Clearwater, Florida, United States
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Fort Myers, Florida, United States
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Gainesville, Florida, United States
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Ocoee, Florida, United States
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Orlando, Florida, United States
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Sarasota, Florida, United States
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St. Petersburg, Florida, United States
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Winter Park, Florida, United States
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Albany, Georgia, United States
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Columbus, Georgia, United States
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Jonesboro, Georgia, United States
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Savannah, Georgia, United States
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Park Ridge, Illinois, United States
Carmel, Indiana, United States
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Paducah, Kentucky, United States
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Covington, Louisiana, United States
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Baltimore, Maryland, United States
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Westminster, Maryland, United States
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Westminster, Maryland, United States
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Kansas City, Missouri, United States
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Butte, Montana, United States
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Las Vegas, Nevada, United States
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Rochester, New York, United States
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Durham, North Carolina, United States
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Statesville, North Carolina, United States
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Maumee, Ohio, United States
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Toledo, Ohio, United States
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Bend, Oregon, United States
Portland, Oregon, United States
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Camp Hill, Pennsylvania, United States
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Ephrata, Pennsylvania, United States
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Kingston, Pennsylvania, United States
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Lancaster, Pennsylvania, United States
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Sellersville, Pennsylvania, United States
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Uniontown, Pennsylvania, United States
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Easley, South Carolina, United States
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Spartanburg, South Carolina, United States
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New Braunfels, Texas, United States
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Sugar Land, Texas, United States
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Tyler, Texas, United States
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Waco, Texas, United States
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Salt Lake City, Utah, United States
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Fredericksburg, Virginia, United States
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Newport News, Virginia, United States
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Norfolk, Virginia, United States
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Randallstown, Virginia, United States
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Virginia Beach, Virginia, United States
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Seattle, Washington, United States
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Tacoma, Washington, United States
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Perth, , Australia
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Saint Leonards NSW, , Australia
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South Brisbane, , Australia
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Westmead NSW, , Australia
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Windsor, , Australia
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Feldkirch, , Austria
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Graz, , Austria
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Innsbruck, , Austria
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Linz, , Austria
Sr. M. Restitutagasse, , Austria
Vienna, , Austria
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Grodno, , Belarus
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Homyel, , Belarus
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Minsk, , Belarus
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Minsk, , Belarus
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Mogilev, , Belarus
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Aalst, , Belgium
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Lier, , Belgium
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Belo Horizonte, , Brazil
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Campinas, , Brazil
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Curitiba, , Brazil
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Curitiba, , Brazil
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Porto Alegre, , Brazil
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Edmonton, Alberta, Canada
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Newmarket, Ontario, Canada
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Ottawa, Ontario, Canada
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Richmond Hill, Ontario, Canada
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Halifax, , Canada
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Montreal, , Canada
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Santiago, , Chile
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Guangzhou, , China
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Hangzhou, , China
Hebei Province, , China
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Jiangsu, , China
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Kunming, , China
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Nanjing, , China
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Nanning, , China
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Qingdao, , China
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Shanghai, , China
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Shanghai, , China
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Shanghai, , China
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Shenyang, , China
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Sichuan Province, , China
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Taiyuan, , China
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Tianjin, , China
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Xi'an, , China
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Yinchuan, , China
Chodov, , Czechia
Jihlava, , Czechia
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Liberec, , Czechia
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Olomouc, , Czechia
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Ostrava, , Czechia
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Pilsen, , Czechia
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Pilsen, , Czechia
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Prague, , Czechia
Ústí nad Labem, , Czechia
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Aarhus, , Denmark
Arhus N., , Denmark
Copenhagen, , Denmark
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Herlev, , Denmark
Ringvej, , Denmark
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Svendborg, , Denmark
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Tallinn, , Estonia
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Tallinn, , Estonia
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Tartu, , Estonia
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Agen, , France
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Amiens, , France
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Angers, , France
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Annecy, , France
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Arras, , France
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Besançon, , France
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Bordeaux, , France
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Brest, , France
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Cannes, , France
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Colombes, , France
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Dijon, , France
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Grenoble, , France
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Grenoble, , France
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Hetztessy, , France
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Le Mans, , France
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Lille, , France
Lormont, , France
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Lyon, , France
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Montpellier, , France
Nantes, , France
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Nice, , France
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Pessac, , France
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Pierre-Bénite, , France
Roskilde, , France
Saint Aubin Surscie, , France
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Saint-Etienne, , France
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Toulon, , France
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Berlin, , Germany
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Bielefeld, , Germany
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Bruchsal, , Germany
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Darmstadt, , Germany
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Dortmund, , Germany
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Dresden, , Germany
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Dresden, , Germany
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Hamburg, , Germany
Magdeburg, , Germany
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Mainz, , Germany
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München, , Germany
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Nordhausen, , Germany
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Paderborn, , Germany
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Tübingen, , Germany
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Witten, , Germany
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Baja, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Kecskemét, , Hungary
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Kistarcsa, , Hungary
Maglodi, , Hungary
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Miskolc, , Hungary
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Pécs, , Hungary
Rakoczi, , Hungary
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Szentes, , Hungary
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Szombathely, , Hungary
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Zalaegerszeg, , Hungary
Zrinyi, , Hungary
Ahmedabad, , India
Andhra Pradesh, , India
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Bangalore, , India
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Bangalore, , India
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Bangalore, , India
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Bangalore, , India
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Bangalore, , India
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Bangalore, , India
Gujarat, , India
Gurgaon, , India
Haryāna, , India
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Holon, , India
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Hyderabad, , India
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Hyderabad, , India
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Hyderabad, , India
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Hyderabad, , India
Karnataka, , India
Kerala, , India
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Lucknow, , India
Madhya Pradesh, , India
Maharashtra, , India
Investigational Site 4409
Mumbai, , India
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Mumbai, , India
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New Delhi, , India
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New Delhi, , India
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New Delhi, , India
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Pune, , India
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Pune, , India
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Pune, , India
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Pune, , India
Punjab, , India
Rajasthan, , India
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Secunderbad, , India
Tamil Nadu, , India
Uttar Pradesh, , India
Vadodara, , India
Visakhapatnam, , India
Afula, , Israel
Ashkelon, , Israel
Hadera, , Israel
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Haifa, , Israel
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Haifa, , Israel
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Holon, , Israel
Investigational Site 5501
Jerusalem, , Israel
Investigational Site 5505
Kfar Saba, , Israel
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Nahariya, , Israel
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Petah Tikva, , Israel
Investigational Site 5512
Poria – Neve Oved, , Israel
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Tel Aviv, , Israel
Investigational Site 5509
Tel Litwinsky, , Israel
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Bergamo, , Italy
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Chieti, , Italy
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Emilia, , Italy
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Milan, , Italy
Padua, , Italy
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Palermo, , Italy
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Parma, , Italy
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Pavia, , Italy
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Rozzano, , Italy
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Udine, , Italy
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Varese, , Italy
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Venezia, , Italy
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Aichi, , Japan
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Aomori, , Japan
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Chiba, , Japan
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Fukuoka, , Japan
Fukuoka, , Japan
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Fukushima, , Japan
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Hiroshima, , Japan
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Hokkaido, , Japan
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Hokkaido, , Japan
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Hyōgo, , Japan
Hyōgo, , Japan
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Ishikawa, , Japan
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Kagoshima, , Japan
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Kanagawa, , Japan
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Kumamoto, , Japan
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Kumamoto, , Japan
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Kumamoto, , Japan
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Mie, , Japan
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Nagano, , Japan
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Nagasaki, , Japan
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Niigata, , Japan
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Okayama, , Japan
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Okinawa, , Japan
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Osaka, , Japan
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Sapporo, , Japan
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Shizuoka, , Japan
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Tokyo, , Japan
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Tottori, , Japan
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Zapopan, Jalisco, Mexico
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Monterrey, Nuevo León, Mexico
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Col. Lomas Altas C.P, , Mexico
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Guadalajara, , Mexico
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Guadalajara, , Mexico
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Hermosillo, , Mexico
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Monterrey, Nuevo Leon, , Mexico
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San Luis Potosí City, , Mexico
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Yucatán, , Mexico
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Alkmaar, , Netherlands
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Almere Stad, , Netherlands
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Amersfoort, , Netherlands
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Amsterdam, , Netherlands
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Assen, , Netherlands
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Groningen, , Netherlands
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Heerlen, , Netherlands
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Hoofddorp, , Netherlands
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Nijmegen, , Netherlands
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Rotterdam, , Netherlands
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Auckland, , New Zealand
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Auckland, , New Zealand
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Christchurch, , New Zealand
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Wellington, , New Zealand
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Fredrikstad, , Norway
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Oslo, , Norway
Pasig, , Philippines
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Quezon City, , Philippines
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Quezon City, , Philippines
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Quezon City, , Philippines
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Bialystok, , Poland
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Krakow, , Poland
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Olsztyn, , Poland
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Tarnów, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
Barnaul, , Russia
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Chelyabinsk, , Russia
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Irkutsk, , Russia
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Kemerovo, , Russia
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Krasnoyarsk, , Russia
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Krasnoyarsk, , Russia
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Moscow, , Russia
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Novosibirsk, , Russia
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Omsk, , Russia
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Ryazan, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
Saratov, , Russia
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Sochi, , Russia
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Tyumen, , Russia
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Ufa, , Russia
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Yaroslavl, , Russia
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Yaroslavl, , Russia
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Outram Road, , Singapore
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Singapore, , Singapore
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Cape Town, , South Africa
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Lyttleton, , South Africa
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Pretoria, , South Africa
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Pretoria, , South Africa
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Somerset West, , South Africa
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Worcester, , South Africa
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Busan, , South Korea
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Daegu, , South Korea
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Gyeonggi-do, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Barcelona, , Spain
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Cabra, , Spain
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Hällingsjö, , Sweden
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Kristianstad, , Sweden
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Stockholm, , Sweden
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Stockholm, , Sweden
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Sundsvall, , Sweden
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Aarau, , Switzerland
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Basel, , Switzerland
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Bellinzona, , Switzerland
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Chur, , Switzerland
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Lausanne, , Switzerland
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Lucerne, , Switzerland
Hualien City, , Taiwan
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Bangkok, , Thailand
Investigational Site 5202
Bangkok, , Thailand
Investigational Site 5203
Nakhorn Nayok, , Thailand
Investigational Site 5702
Ankara, , Turkey (Türkiye)
Investigational Site 5703
Ankara, , Turkey (Türkiye)
Investigational Site 5702
Istanbul, , Turkey (Türkiye)
Investigational Site 5706
Istanbul, , Turkey (Türkiye)
Chernihiv, , Ukraine
Investigational Site 4008
Dnipropetrovsk, , Ukraine
Investigational Site 4010
Donetsk, , Ukraine
Investigational Site 4000
Ivano-Frankivsk, , Ukraine
Investigational Site 4002
Kharkiv, , Ukraine
Investigational Site 4001
Kiev, , Ukraine
Investigational Site 4007
Ternopil, , Ukraine
Investigational Site 4009
Uzhhorod, , Ukraine
Investigational Site 4003
Vinnitsya, , Ukraine
Investigational Site 4006
Zaporizhzhia, , Ukraine
Investigational Site 7005
Coventry, , United Kingdom
Investigational Site 7006
Hull, , United Kingdom
Investigational Site 7000
London, , United Kingdom
Investigational Site 7003
London, , United Kingdom
Investigational Site 7004
London, , United Kingdom
Investigational Site 7001
Newcastle, , United Kingdom
Investigational Site 7007
Plymouth, , United Kingdom
Countries
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References
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Vanassche T, Verhamme P, Wells PS, Segers A, Ageno W, Brekelmans MPA, Chen CZ, Cohen AT, Grosso MA, Medina AP, Mercuri MF, Winters SM, Zhang G, Weitz JI, Raskob GE, Buller HR. Impact of age, comorbidity, and polypharmacy on the efficacy and safety of edoxaban for the treatment of venous thromboembolism: An analysis of the randomized, double-blind Hokusai-VTE trial. Thromb Res. 2018 Feb;162:7-14. doi: 10.1016/j.thromres.2017.12.005. Epub 2017 Dec 13.
Vandell AG, Walker J, Brown KS, Zhang G, Lin M, Grosso MA, Mercuri MF. Genetics and clinical response to warfarin and edoxaban in patients with venous thromboembolism. Heart. 2017 Nov;103(22):1800-1805. doi: 10.1136/heartjnl-2016-310901. Epub 2017 Jul 8.
Brekelmans MP, Ageno W, Beenen LF, Brenner B, Buller HR, Chen CZ, Cohen AT, Grosso MA, Meyer G, Raskob G, Segers A, Vanassche T, Verhamme P, Wells PS, Zhang G, Weitz JI. Recurrent venous thromboembolism in patients with pulmonary embolism and right ventricular dysfunction: a post-hoc analysis of the Hokusai-VTE study. Lancet Haematol. 2016 Sep;3(9):e437-45. doi: 10.1016/S2352-3026(16)30080-1.
Raskob GE, van Es N, Segers A, Angchaisuksiri P, Oh D, Boda Z, Lyons RM, Meijer K, Gudz I, Weitz JI, Zhang G, Lanz H, Mercuri MF, Buller HR; Hokusai-VTE investigators. Edoxaban for venous thromboembolism in patients with cancer: results from a non-inferiority subgroup analysis of the Hokusai-VTE randomised, double-blind, double-dummy trial. Lancet Haematol. 2016 Aug;3(8):e379-87. doi: 10.1016/S2352-3026(16)30057-6. Epub 2016 Jul 1.
Nakamura M, Wang YQ, Wang C, Oh D, Yin WH, Kimura T, Miyazaki K, Abe K, Mercuri M, Lee LH, Segers A, Buller H. Efficacy and safety of edoxaban for treatment of venous thromboembolism: a subanalysis of East Asian patients in the Hokusai-VTE trial. J Thromb Haemost. 2015 Sep;13(9):1606-14. doi: 10.1111/jth.13055. Epub 2015 Aug 27.
Hokusai-VTE Investigators; Buller HR, Decousus H, Grosso MA, Mercuri M, Middeldorp S, Prins MH, Raskob GE, Schellong SM, Schwocho L, Segers A, Shi M, Verhamme P, Wells P. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013 Oct 10;369(15):1406-15. doi: 10.1056/NEJMoa1306638. Epub 2013 Aug 31.
Camm AJ, Bounameaux H. Edoxaban: a new oral direct factor xa inhibitor. Drugs. 2011 Aug 20;71(12):1503-26. doi: 10.2165/11595540-000000000-00000.
Other Identifiers
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The Edoxaban Hokusai VTE Study
Identifier Type: -
Identifier Source: secondary_id
DU176b-D-U305
Identifier Type: -
Identifier Source: org_study_id
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