Multicenter, open-label, active-controlled, randomized study to evaluate the efficacy and safety of an age-and body weight-adjusted rivaroxaban regimen compared to standard of care in children with acute venous thromboembolism
Phase of Trial: Phase III
Latest Information Update: 08 Jul 2019
Price : $35 *
At a glance
- Drugs Rivaroxaban (Primary) ; Dalteparin sodium; Enoxaparin sodium; Fondaparinux sodium; Tinzaparin sodium; Warfarin
- Indications Venous thromboembolism
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms EINSTEIN Junior Phase III
- Sponsors Bayer; Bayer HealthCare; Janssen Research & Development
- 08 Jul 2019 According to a Bayer media release, the company will submit an application to the European Medicines Agency (EMA) for the extension of the Xarelto marketing authorization to make this new treatment option, including the granules for oral suspension, available for children with venous thromboembolism.
- 08 Jul 2019 Results presented in a Bayer media release.
- 08 Jul 2019 Primary endpoint has been met. (Composite number of overt major and clinically relevant non-major bleeding.), according to a Janssen Pharmaceuticals media release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History