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A Multicenter, International, Phase 3, Double-blind, Placebo-controlled, Randomized Study To Evaluate The Efficacy, Safety, And Tolerability Of Daily Oral Dosing Of Tafamidis Meglumine (Pf-06291826) 20 Mg Or 80 Mg In Comparison To Placebo In Subjects Diagnosed With Transthyretin Cardiomyopathy (ttr-cm)

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Trial Profile

A Multicenter, International, Phase 3, Double-blind, Placebo-controlled, Randomized Study To Evaluate The Efficacy, Safety, And Tolerability Of Daily Oral Dosing Of Tafamidis Meglumine (Pf-06291826) 20 Mg Or 80 Mg In Comparison To Placebo In Subjects Diagnosed With Transthyretin Cardiomyopathy (ttr-cm)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Oct 2023

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At a glance

  • Drugs Tafamidis meglumine (Primary)
  • Indications Cardiomyopathies; Cardiovascular disorders; Transthyretin-related hereditary amyloidosis
  • Focus Registrational; Therapeutic Use
  • Acronyms ATTR-ACT
  • Sponsors FoldRx Pharmaceuticals; Pfizer

    • Most Recent Events

    • 28 Aug 2023 Results (n=11) assessing the clinical outcome and the corresponding myocardial histological changes of tafamidis treated patients using endomyocardial biopsy (EMB), presented at the ESC Congress 2023 - Annual Congress of the European Society of Cardiology.
    • 06 Mar 2023 Results of post-hoc analysis, using single-beat pressure-volume (PV) techniques to delineate the effects of tafamidis on cardiac function, presented at the 72nd Annual Scientific Session of the American College of Cardiology together with the World Heart Federation
    • 06 Mar 2023 Results of post hoc analysis of estimated glomerular filtration rate (eGFR) from ATTR-ACT, presented at the 72nd Annual Scientific Session of the American College of Cardiology together with the World Heart Federation

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