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Daiichi Sankyo Initiates Largest Single, Double-Blind, Randomized, Phase III Trial for Treatment and Prevention of Recurrent Venous Thromboembolism
Date:2/3/2010

VT, non-fatal PE and fatal PE). The primary safety assessment of the trial is the incidence of major and clinically relevant non-major bleeding.

"HOKUSAI VTE is the largest, single Phase III study ever undertaken in the area of VTE, and is our second large-scale edoxaban trial," said Glenn Gormley, president of Daiichi Sankyo Pharma Development. "Daiichi Sankyo is proud to be advancing the research of Factor Xa inhibitors with edoxaban, which may help prevent deadly clots in various patient populations."  

HOKUSAI VTE Study Design

HOKUSAI VTE is a Phase III multi-center study that will include approximately 7,500 patients in more than 450 clinical sites in approximately 40 countries worldwide. This is an event-driven, randomized, double-blind, double-dummy, parallel-group, multi-center, multi-national study, which will randomize patients to two different treatment groups. Both groups will receive open label enoxaparin or unfractionated heparin for at least five days and up to 12 days, followed by double-blind warfarin or edoxaban 60 mg once-daily. Patients will be treated for up to 12 months in accordance to the standard of care and international guidelines.

The HOKUSAI VTE study is named after the famous Japanese artist and painter Katsushika Hokusai (1760-1849) of the former Edo period; Edo is the city currently known as Tokyo, the location of the Daiichi Sankyo global headquarters.  

About Venous Thromboembolism

Venous thromboembolism (VTE) is the term for the generation of a blood clot and the obstruction of a vein or a pulmonary artery by a blood clot. Deep vein thrombosis (DVT) and pulmonary embolism (PE) are types of VTE. DVT is a blood clot anywhere in the deep veins of the legs or pelvis. PE is caused by a clot that travels to the lungs, lodging in the pulmonary arteries.

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SOURCE Daiichi Sankyo
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