Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy

Transthyretin (TTR) Amyloid Cardiomyopathy Clinical Trial

Official title: A PHASE 3 MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY OF DAILY ORAL DOSING OF TAFAMIDIS MEGLUMINE (PF-06291826-83) 20 MG OR 80 MG [OR TAFAMIDIS (PF-06291826-00) 61 MG] IN SUBJECTS DIAGNOSED WITH TRANSTHYRETIN CARDIOMYOPATHY (ATTR-CM)

Status Completed

Clinical Trial Summary

Open label study to evaluate tafamidis for the treatment of transthyretin cardiomyopathy

Clinical Trial Description

Global Phase 3, open label long term extension safety study designed to obtain additional safety data for tafamidis meglumine 20 mg and 80 mg (or tafamidis 61 mg where available), and to continue to provide enrolled subjects with tafamidis for up to 60 months, or until subject has access to tafamidis for ATTR CM via prescription, whichever occurs first. ;

Related Conditions & MeSH terms

• Cardiomyopathies
• Transthyretin (TTR) Amyloid Cardiomyopathy

• NCT number: NCT02791230
• Study type: Interventional
• Source: Pfizer
• Status: Completed
• Phase: Phase 3
• Start date: June 13, 2016
• Completion date: November 23, 2023