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A double-blind, randomized study looking at the efficacy, safety and tolerability of tafamidis meglumine (PF-06291826) 20 mg or 80 mg compared to placebo when taken daily by oral administration mouth ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2012-002465-35

A double-blind, randomized study looking at the efficacy, safety and tolerability of tafamidis meglumine (PF-06291826) 20 mg or 80 mg compared to placebo when taken daily by oral administration mouth in subjects diagnosed with transthyretin cardiomyopathy (TTR-CM)

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Extrait

The primary objective of this study is to assess the efficacy of an oral dose of 20 mg or 80 mg tafamidis meglumine soft-gel capsules based on all-cause mortality and on frequency of cardiovascular-related hospitalizations as well as to assess safety and tolerability in comparison to placebo. Tafamidis or placebo will be administered once daily, in addition to standard of care, for 30 months in subjects diagnosed with variant or wild-type TTR cardiomyopathy (TTR-CM).

Critère d'inclusion

  • Transthyretin amyloid cardiomyopathy (TTR-CM)

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