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)

Trial Profile

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)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 23 Oct 2017

At a glance

  • Drugs Edoxaban (Primary) ; Enoxaparin sodium; Fondaparinux sodium; Warfarin
  • Indications Pulmonary embolism; Thrombosis; Venous thromboembolism
  • Focus Therapeutic Use
  • Sponsors Daiichi Sankyo Inc
  • Most Recent Events

    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top