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Brief Title: Cancer Venous Thromboembolism (VTE)
Official Title: A Phase 3b, Prospective, Randomized, Open-label, Blind Evaluator (PROBE) Study Evaluating the Efficacy and Safety of (LMW) Heparin/Edoxaban Versus Dalteparin in Venous Thromboembolism Associated With Cancer
Study ID: NCT02073682
Brief Summary: The primary objective is to demonstrate the non-inferiority of edoxaban (preceded by a short course of LMWH) compared with dalteparin for the prevention of the combined outcome of recurrent venous thromboembolism (VTE) or major bleeding in subjects with VTE associated with cancer during a 12-month study period. If non-inferiority is established, LMWH/edoxaban will be compared with dalteparin for superiority.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, Brandon, Florida, United States
, Jonesboro, Georgia, United States
, Detroit, Michigan, United States
, Norfolk, Virginia, United States
, Leuven, Vlaams-Brabant, Belgium
, Saint-Etienne cedex 2, , France
, Debrecen, Hajdu-Bihar Megye, Hungary
, Varese, , Italy
, Amsterdam, , Netherlands
Name: Global Clinical Leader
Affiliation: Daiichi Sankyo
Role: STUDY_DIRECTOR