RECORD 4 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.
Phase of Trial: Phase III
Latest Information Update: 18 Jan 2016
At a glance
- Drugs Rivaroxaban (Primary) ; Enoxaparin sodium
- Indications Deep vein thrombosis; Pulmonary embolism; Thromboembolism
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms RECORD-4
- Sponsors Bayer
- 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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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History