RECORD 3 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE; a Controlled, Double-Blind, Randomized Study of BAY 59-7939 in the Prevention of VTE in Subjects Undergoing Elective Total Knee Replacement.

Trial Profile

RECORD 3 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE; a Controlled, Double-Blind, Randomized Study of BAY 59-7939 in the Prevention of VTE in Subjects Undergoing Elective Total Knee Replacement.

Completed
Phase of Trial: Phase III

Latest Information Update: 10 Aug 2017

At a glance

  • Drugs Rivaroxaban (Primary) ; Enoxaparin sodium
  • Indications Deep vein thrombosis; Pulmonary embolism; Thromboembolism
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms RECORD-3
  • Sponsors Bayer
  • Most Recent Events

    • 18 Jan 2016 Retrospective analysis results published in the Annals of Pharmacotherapy
    • 05 Jan 2011 Results from the RECORD trial programme have been included in a complete response filed by Johnson & Johnson with the US FDA, including specific information requested by the FDA, according to a Bayer HealthCare media release.
    • 18 Jul 2009 Results were reported (pooled analysis of RECORD1-4) at the 22nd Congress of the International Society on Thrombosis and Haemostasis.
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