(Apex) Multicenter, Randomized, Active-Controlled Efficacy And Safety Study Comparing Extended Duration Betrixaban With Standard Of Care Enoxaparin For The Prevention Of Venous Thromboembolism In Acute Medically Ill Patients

Trial Profile

(Apex) Multicenter, Randomized, Active-Controlled Efficacy And Safety Study Comparing Extended Duration Betrixaban With Standard Of Care Enoxaparin For The Prevention Of Venous Thromboembolism In Acute Medically Ill Patients

Completed
Phase of Trial: Phase III

Latest Information Update: 13 Apr 2018

At a glance

  • Drugs Betrixaban (Primary) ; Enoxaparin sodium
  • Indications Deep vein thrombosis; Pulmonary embolism; Venous thromboembolism
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms APEX
  • Sponsors Portola Pharmaceuticals
  • Most Recent Events

    • 13 Apr 2018 Results of APEX trial substudy assessing association between low hemoglobin and symptomatic venous thromboembolism published in the American Journal of Medicine
    • 01 Apr 2018 Results of analyses analysing all patients who received study drug and symptomatic events to minimize the missing data due to unobtained and uninterpretable compressible ultrasound published in the American Heart Journal
    • 23 Mar 2018 According to a Portola Pharmaceuticals media release, Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative opinion for betrixaban for the prevention of venous thromboembolism and company intends to appeal the opinion and seek a re-examination by the CHMP.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top