A "Real-World", Randomized, Open-Label, Study on the Efficacy, Safety, and Tolerability of Tecarfarin (ATI-5923) a Novel Vitamin K Antagonist, Versus Warfarin in Subjects Requiring Chronic Anticoagulation

Trial Profile

A "Real-World", Randomized, Open-Label, Study on the Efficacy, Safety, and Tolerability of Tecarfarin (ATI-5923) a Novel Vitamin K Antagonist, Versus Warfarin in Subjects Requiring Chronic Anticoagulation

Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 14 Feb 2017

At a glance

  • Drugs Tecarfarin (Primary) ; Warfarin
  • Indications Thromboembolism; Thrombosis
  • Focus Registrational; Therapeutic Use
  • Acronyms TACT
  • Sponsors Armetheon
  • Most Recent Events

    • 14 Feb 2017 According to Armetheon media release, company has received advice from the European Medicines Agency (EMA) Scientific Advice Working Group (SAWG) to conduct a single 1000 patient pivotal study prior to filing the Market Authorization Application (MAA) for tecarfarin.
    • 09 Feb 2017 According to an Armetheon media release, the company has reached an agreement with the U.S. Food and Drug Administration (FDA) for a single 1000 patient final pivotal trial for tecarfarin and can amend the existing Special Protocol Assessment (SPA) for the 1000 patient TACT study.
    • 09 Feb 2017 Planned number of patients changed from 3000 to 1000, according to an Armetheon media release.
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