RECORD 1 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE, Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Total Hip Replacement

Trial Profile

RECORD 1 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE, Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Total Hip Replacement

Completed
Phase of Trial: Phase III

Latest Information Update: 23 Feb 2017

At a glance

  • Drugs Rivaroxaban (Primary) ; Enoxaparin sodium
  • Indications Deep vein thrombosis; Pulmonary embolism; Thromboembolism
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms RECORD-1
  • Sponsors Bayer
  • Most Recent Events

    • 18 Jan 2016 Retrospective analysis results published in the Annals of Pharmacotherapy
    • 06 Nov 2012 Planned number of patients changed from 4000 to 4200 as reported by European Clinical Trials Database.
    • 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.
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