Overview

Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE)

Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
This is an event driven Phase 3, prospective, randomized, open-label, blinded endpoint evaluation (PROBE) parallel group study in subjects with confirmed VTE. This study is designed to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of edoxaban and to compare the efficacy and safety of edoxaban against standard of care in pediatric subjects with confirmed VTE.
Phase:
Phase 3
Details
Lead Sponsor:
Daiichi Sankyo Inc.
Daiichi Sankyo, Inc.
Treatments:
Edoxaban
Enoxaparin
Fondaparinux
Heparin
Warfarin