A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of Edoxaban (DU-176b) Versus Warfarin In Subjects With Atrial Fibrillation - Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation (ENGAGE - AF TIMI - 48)
A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of Edoxaban (DU-176b) Versus Warfarin In Subjects With Atrial Fibrillation - Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation (ENGAGE - AF TIMI - 48)
This study is to demonstrate the safety and efficacy profile, in two different dose regimens of Edoxaban (DU-176b), (an investigational new drug being tested for the prevention of stroke/systemic embolic events (SEE)), in individuals with atrial fibrillation. Patients will be randomized to one of three treatment groups: High Dose Regimen, Low Dose Regimen, & Warfarin. The expected duration of the study is 24 months.
Inclusion Criteria:
Exclusion Criteria:
Transient atrial fibrillation secondary to other reversible disorders
Subjects with moderate or severe mitral stenosis, unresected atrial myxoma, or a mechanical heart valve
Subjects with any contraindication for anticoagulant agents;
Subjects with conditions associated with high risk of bleeding or have known or suspected hereditary or acquired bleeding disorders
Females of childbearing potential including the following:
Paraguay, Argentina
Provincia de Chaco, Argentina
Provincia de Rio Negro, Argentina
Provincia de Salta, Argentina
Sante Fe, Argentina
Mousron, Belgium
Saint Georges de Beauce, Quebec, Canada
Hainan Province, China
Liaoning Province, China
Shaanxi Province, China
Krapinski Toplice, Croatia
Brno-Lesna, Czechia
Havlickux Brod, Czechia
Ostrava-Trebovice, Czechia
Puusepa, Tartu, Estonia
Kiel-Kronshagen, Germany
Northeinm, Germany
Offenbach-beiber, Germany
Woerishofen, Germany
Rio-Patras, Greece
Ciudad, Guatemala
Clinica, Guatemala
Edificio Multimedica, Guatemala
Nivel, Guatemala
Oficina, Guatemala
Keeskemet, Hungary
Hyderabad, Andhra Pradesh, India
Angamaly, Kerala, India
Anddhra Pradesh, India
Andhra Pradesh, India
Karnataka, India
Kerala, India
Madhya Pradesh, India
Maharashtra, India
Punjab, India
Rajasthan, India
Cantania, Italy
Venezia Mestre, Italy
Lida-shi, Nagano, Japan
Ueda-shi, Nagano, Japan
Minato-ku, Tokyo, Japan
Chiaki, Japan
Ehime, Japan
Gunma, Japan
Hokkai-do, Japan
Hokkaido, Japan
Isesaki-shi, Japan
Nagaoka-shi, Japan
Wildervlank, Netherlands
Komenskiego, Poland
Sucharskiego, Poland
Warzawa, Poland
Buccuresti, Romania
Dambovita, Romania
Judetul Maramures, Romania
Judetul Mures, Romania
Judetul Suceava, Romania
Judetul Vrancea, Romania
Zmaj Jovina, Serbia
Parktown West, South Africa
Gangwon-do, South Korea
De La Castellana, Spain
Taoyuan County, Taiwan
Chang Mai, Thailand
Ivano-Frankivsh, Ukraine
Devon, United Kingdom
East Sussex, United Kingdom
Essex, United Kingdom
Surrey, United Kingdom
Warwickshire, United Kingdom