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A double-blind, active-controlled, multicenter, international Phase 3 clinical trial comparing Gencaro with Toprol-XL (metoprolol succinate) for the prevention of recurrent AF or all-cause mortality (ACM) in HFrEF patients

Trial Profile

A double-blind, active-controlled, multicenter, international Phase 3 clinical trial comparing Gencaro with Toprol-XL (metoprolol succinate) for the prevention of recurrent AF or all-cause mortality (ACM) in HFrEF patients

Planning
Phase of Trial: Phase III

Latest Information Update: 20 Dec 2018

At a glance

  • Drugs Bucindolol (Primary) ; Metoprolol succinate
  • Indications Atrial fibrillation; Heart failure
  • Focus Registrational; Therapeutic Use
  • Acronyms PRECISION-AF
  • Sponsors ARCA biopharma Inc
  • Most Recent Events

    • 20 Dec 2018 According to an ARCA biopharma media release, the company announced that it has submitted an amendment to its Special Protocol Assessment (SPA) request to the U.S. Food and Drug Administration (FDA). The amendment addresses FDA feedback and guidance on the target population for this trial. The SPA request is part of the Companys ongoing interaction with the FDA focused on the planned Phase 3 clinical development program of Gencaro(bucindolol hydrochloride).
    • 18 Sep 2018 According to an ARCA biopharma media release, the company has submitted a Special Protocol Assessment (SPA) request to the U.S. Food and Drug Administration (FDA). Subject to FDA approval of the SPA, the company anticipates initiating PRECISION-AF in the second half of 2019.
    • 23 Aug 2018 New trial record
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