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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

la cascata della coagulazione.  

"Siamo lieti di annunciare il completamento del reclutamento dei pazienti  per lo studio Hokusai-VTE, il più ampio studio clinico di questo tipo ed attendiamo i primi risultati nel corso del 2013", ha dichiarato Glenn Gormley, direttore globale della Divisione Ricerca & Sviluppo e Senior Executive Officer Daiichi Sankyo.

Il programma globale di trial clinici per edoxaban include due studi di fase 3: Hokusai-VTE e ENGAGE AF-TIMI 48 (Efficace aNticoaGulazione con fattore xA di ultima GEnerazione nella Fibrillazione Atriale).

Hokusai-VTE

Hokusai-VTE è il più ampio studio clinico internazionale di fase 3, randomizzato, in doppio cieco e double dummy, a gruppi paralleli, che studia 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.

Lo studio, che coinvolge più di 8.250 pazienti in 400 centri di ricerca in 38 stati nel mondo, deriva il suo nome dall'artista e pittore giapponese Katsushika Hokusai.

ENGAGE AF-TIMI 48

ENGAGE AF-TIMI 48 è uno studio clinico internazionale di fase 3, randomizzato, in doppio cieco e double dummy, a gruppi paralleli, che studia l'efficacia e la sicurezza di edoxaban versus warfarin nella prevenzione degli eventi di ictus ed embolia sistemica (SEE) in pazienti con fibrillazione atriale non valvolare. ENGAGE AF-TIMI 48 è il più grande studio sulla fibrillazione atriale (FA), includendo più di 20.500 pazienti in 46 Paesi e più di 1000 centri di ricerca.

La tromboembolia venosa  

TEV è il termine che descrive la formazione di coaguli ematici all'interno di una vena o il successivo distacco del coagulo in un'arteria polmonare. La trombosi venosa profonda (
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SOURCE Daiichi-Sankyo
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