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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)

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: 08 Jul 2019

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At a glance

  • Drugs Tafamidis meglumine (Primary)
  • Indications Cardiomyopathies; Cardiovascular disorders
  • Focus Registrational; Therapeutic Use
  • Acronyms ATTR-ACT
  • Sponsors FoldRx Pharmaceuticals; Pfizer
  • Most Recent Events

    • 06 May 2019 According to a Food and Drug Administration media release, based on the data of this trial, the U.S. Food and Drug Administration approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for the treatment of the heart disease (cardiomyopathy) caused by transthyretin-mediated amyloidosis (ATTR-CM) in adults.
    • 06 Apr 2019 Results assessing the efficacy of Tafamidis in Patients with Hereditary or Wild-Type Transthyretin Amyloid Cardiomyopathy, presented at the 39th Annual Meeting and Scientific Sessions of the International Society for Heart and Lung Transplantation
    • 18 Mar 2019 Results of a responder analysis, presented at the 68th Annual Scientific Session of the American College of Cardiology
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