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Daiichi Sankyo ha completato l'arruolamento dei pazienti per lo studio Hokusai-VTE su Edoxaban, il più ampio trial clinico di fase 3 per il trattamento delle tromboembolie venose ricorrenti
Date:10/30/2012

TOKYO e ROMA, October 30, 2012 /PRNewswire/ --

Edoxaban è un nuovo anticoagulante orale in monosomministrazione giornaliera, inibitore del fattore Xa

Daiichi Sankyo ha annunciato oggi il completamento dell'arruolamento dei pazienti nello studio Hokusai-VTE, il più ampio trial clinico di fase 3, che sta sperimentando edoxaban in monosomministrazione giornaliera per il trattamento e la prevenzione delle tromboembolie venose ricorrenti (TEV) in pazienti con trombosi venosa profonda (TVP) e/o embolia polmonare (EP) sintomatiche.  

Hokusai-VTE coinvolge più di 8.250 pazienti in 400 centri di ricerca in 38 nazioni nel mondo.

Lo studio è stato disegnato per rispecchiare la pratica clinica, prevedendo un trattamento iniziale standard con eparina e una durata flessibile del trattamento di tre, sei o dodici mesi. La monosomministrazione giornaliera di 60mg di edoxaban viene comparata con la terapia di controllo a base di warfarin (target INR 2-3). Il disegno dello studio consentirà ai ricercatori di valutare la risposta clinica di pazienti con un ampia gamma di rischi, inclusi i pazienti affetti da TVP e EP moderate o severe.

"Lo studio Hokusai-VTE, grazie alla sua struttura rigorosa ed alla vasta popolazione di pazienti presi in esame, segna una tappa fondamentale nello sviluppo di una nuova classe di anticoagulanti orali, inibitori del fattore Xa", ha dichiarato Harry Büller, direttore del Dipartimento di Medicina Vascolare dell'Academic Medical Center, Paesi Bassi e del board scientifico di Hokusai-VTE. "Ciò che rende lo studio Hokusai-VTE unico nel suo genere è l'obiettivo di rispecchiare la pratica clinica quotidiana attraverso una durata flessibile del trattamento".  

Edoxaban è un nuovo anticoagulante orale in monosomministrazione giornaliera, che inibisce in modo specifico, reversibile e diretto il fattore Xa, importante fattore del
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SOURCE Daiichi-Sankyo
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