Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy — ATTR-ACT  

Transthyretin (TTR) Amyloid Cardiomyopathy Clinical Trial

Official title: 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

Clinical Trial Summary

This Phase 3 study will investigate the efficacy, safety and tolerability of an oral daily dose of 20 mg or 80 mg tafamidis meglumine capsules compared to placebo in subjects with either transthyretin genetic variants or wild-type transthyretin resulting in amyloid cardiomyopathy.

Clinical Trial Description

Phase 3, multicenter, global, three-arm, parallel design, placebo-controlled, double-blind, randomized study to determine efficacy, safety and tolerability of tafamidis on clinical outcomes (all-cause mortality and frequency of cardiovascular-related hospitalizations) in subjects with either transthyretin genetic variants or wild-type transthyretin resulting in amyloid cardiomyopathy. ;

Related Conditions & MeSH terms

• Amyloidosis
• Cardiomyopathies
• Transthyretin (TTR) Amyloid Cardiomyopathy

• NCT number: NCT01994889
• Study type: Interventional
• Source: Pfizer
• Status: Completed
• Phase: Phase 3
• Start date: December 9, 2013
• Completion date: February 7, 2018