A Phase 3, Open-label, Randomized, Multi-center, Controlled Trial to Evaluate the Pharmacokinetics and Pharmacodynamics of Edoxaban and to Compare the Efficacy and Safety of Edoxaban With Standard of Care Anticoagulant Therapy in Pediatric Subjects From Birth to Less Than 18 Years of Age With Confirmed Venous Thromboembolism (VTE)
Phase of Trial: Phase III
Latest Information Update: 23 Apr 2018
At a glance
- Drugs Edoxaban (Primary) ; Acenocoumarol; Enoxaparin sodium; Fondaparinux sodium; Heparin; Nadroparin calcium; Warfarin
- Indications Pulmonary embolism; Thrombosis; Venous thromboembolism
- Focus Therapeutic Use
- Sponsors Daiichi Sankyo Inc
- 04 Oct 2017 Status changed from not yet recruiting to recruiting.
- 16 Mar 2017 Planned initiation date changed from 1 Jan 2017 to 1 Apr 2017.
- 15 Dec 2016 Planned initiation date changed from 1 Sep 2016 to 1 Jan 2017.