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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Intravenous FDY 5301 in Patients With an Anterior ST-Elevation Myocardial Infarction

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Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Intravenous FDY 5301 in Patients With an Anterior ST-Elevation Myocardial Infarction

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 04 Sep 2024

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At a glance

  • Drugs FDY 5301 (Primary)
  • Indications Myocardial infarction
  • Focus Registrational; Therapeutic Use
  • Acronyms IOCYTE AMI-3
  • Sponsors Faraday Pharmaceuticals

    • Most Recent Events

    • 11 Jun 2024 According to a Faraday Pharmaceuticals media release, trial is being conducted under a Special Protocol Assessment agreement reached with the FDA.
    • 11 Jun 2024 According to a Faraday Pharmaceuticals media release, after a recent, planned interim analysis of safety and efficacy data from over 1,500 patients followed up for at least 28 days, the trial's independent data monitoring committee recommended completing the trial without modification.
    • 11 Jun 2024 Status changed from recruiting to active, no longer recruiting, according to a Faraday Pharmaceuticals media release.

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