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
- 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.