Phase III Study Comparing Betrixiban with Enoxaparin in VTE
Research type
Research Study
Full title
MULTICENTER, RANDOMIZED, ACTIVE-CONTROLLED EFFICACY AND SAFETY STUDY COMPARING EXTENDED DURATION BETRIXABAN WITH STANDARD OF CARE ENOXAPARIN® FOR THE PREVENTION OF VENOUS THROMBOEMBOLISM IN ACUTE MEDICALLY ILL PATIENTS
IRAS ID
104294
Contact name
James Uprichard
Contact email
Sponsor organisation
Portola Pharmaceuticals, Inc
Eudract number
2012-000255-13
Clinicaltrials.gov Identifier
Research summary
This is a phase III randomised, active-controlled efficacy and safety study funded by Portola Pharmaceuticals Inc. The purpose of this study is to find out if a new investigational drug called betrixaban is safe and effective compared to enoxaparin (approved standard of care treatment) to prevent venous thromboembolism (VTE) in hospitalised patients. It is expected that approximately 6850 subjects will be eligible to enter this study. Approximately 100 participants will be recruited in the UK. The duration of participation is expected to be about 77 days. The study will involve a screening period, a 35 day treatment period and a follow up visit. Participants will be randomised (1:1) to one of 2 treatment groups: - Betrixaban and enoxaparin placebo - Betrixaban placebo and enoxaparin Each participant will receive Betrixaban orally for 35 days ( days) and Enoxaparin by injection for 10 days ( 4 days). There will be a follow up visit 30 days ( days) after the Day 35 visit. This study involves procedures including:- Physical examination, vital signs, ECG, blood tests, urine tests ultrasound imaging and possibly a CT scan and chest x-ray.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
12/EE/0371
Date of REC Opinion
4 Sep 2012
REC opinion
Favourable Opinion