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Once daily oral direct factor Xa inhibitor rivaroxaban (BAY59-7939) in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embolism. The Einstein-Extension Study

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Trial Profile

Once daily oral direct factor Xa inhibitor rivaroxaban (BAY59-7939) in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embolism. The Einstein-Extension Study

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Dec 2021

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At a glance

  • Drugs Rivaroxaban (Primary)
  • Indications Deep vein thrombosis; Pulmonary embolism; Venous thromboembolism
  • Focus Registrational; Therapeutic Use
  • Acronyms EINSTEIN-EXT
  • Sponsors Bayer; Bayer HealthCare; Janssen Research & Development

    • Most Recent Events

    • 22 Dec 2021 According to a Bayer media release, based on data from EINSTEIN DVT, PE and EXTENSION, EINSTEIN-Jr., and UNIVERSE, the U.S. FDA has approved two pediatric indications for Xarelto: the treatment of VTE and reduction in the risk of recurrent VTE in patients from birth to less than 18 years after at least five days of initial parenteral anticoagulant treatment; and thromboprophylaxis in children aged two years and older with congenital heart disease who have undergone the Fontan procedure.
    • 15 Jun 2019 This trial has been completed in Spain, according to European Clinical Trials Database.
    • 30 Nov 2012 Pooled data from EINSTEIN-DVT, EINSTEIN-PE and EINSTEIN-EXT will be presented at the 54th American Society of Hematology (ASH) Annual Meeting and Exposition, according to a Bayer HealthCare media release.

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