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MAGELLAN - Multicenter, rAndomized, Parallel Group Efficacy and Safety for the Prevention of VTE in Hospitalized Medically iLL Patients Comparing rivaroxabAN With Enoxaparin.

Trial Profile

MAGELLAN - Multicenter, rAndomized, Parallel Group Efficacy and Safety for the Prevention of VTE in Hospitalized Medically iLL Patients Comparing rivaroxabAN With Enoxaparin.

Completed
Phase of Trial: Phase III

Latest Information Update: 14 Dec 2018

At a glance

  • Drugs Rivaroxaban (Primary) ; Enoxaparin sodium
  • Indications Deep vein thrombosis; Pulmonary embolism; Venous thromboembolism
  • Focus Pharmacogenomic; Registrational; Therapeutic Use
  • Acronyms MAGELLAN
  • Sponsors Bayer HealthCare
  • Most Recent Events

    • 14 Dec 2018 According to a Janssen Pharmaceuticals media release, the company has submitted a supplemental New Drug Application (sNDA) for XARELTO (rivaroxaban) to the U.S. Food and Drug Administration (FDA) for the prevention of venous thromboembolism (VTE), or blood clots, in medically ill patients. This application is based on combined data from the Phase III MAGELLAN and MARINER trials.
    • 14 Nov 2018 Results reevaluating benefit-risk in subpopulation using the efficacy endpoints of symptomatic venous thromboembolism (VTE) and VTE-related death and the safety endpoints of major and fatal bleeding, presented at the 91st Annual Scientific Sessions of the American Heart Association.
    • 12 May 2018 Results (n=3173 ) of subgroup analysis of patients hospitalized for acute infectious diseases in the MAGELLAN trial, were published in the Journal of Thrombosis and Haemostasis
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