Phase 3 study of edoxaban for recurrent venous thromboembolic (VTE)

Daiichi Sankyo announced it has initiated a Phase 3 trial for edoxaban for the reduction of recurrent venous thromboembolic (VTE) complications in patients with deep vein thrombosis (DVT) and/or pulmonary embolism (PE). This trial, called HOKUSAI (pronounced hoe·koo·sigh) VTE, is a randomized, double-blind, double-dummy, parallel-group study randomizing patients to two different treatment groups.  The primary efficacy endpoint of the trial is the recurrence of symptomatic VTE (i.e., the composite of DVT, non-fatal PE and fatal PE). The primary safety assessment is the incidence of major and clinically relevant non-major bleeding.  This study will include approximately 7,500 patients in more than 450 clinical sites in approximately 40 countries worldwide.

Edoxaban, the free base of DU-176b, is an oral anticoagulant that directly inhibits Factor Xa, an important factor in the coagulation process.  It is currently being developed as a potential new treatment for the prevention of both arterial and venous thromboembolism.

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