Clinical Trial: Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 3 Multicenter, Randomized, Double-blind, Extension Study To Evaluate The Safety Of Daily Oral Dosing Of Tafamidis Meglumine (Pf-06291826) 20 Mg Or 80 Mg In Subjects Diagnosed With Transthyreti

Brief Summary: Phase 3 extension study to evaluate the safety of oral daily dosing of 20 mg or 80 mg tafamidis meglumine in subjects with either transthyretin genetic variants or wild-type transthyretin resulting in amyloid cardiomyopathy

Detailed Summary: Global, Phase 3, double-blind, randomized, long-term extension study to evaluate the safety of oral daily dosing of 20 mg or 80 mg tafamidis meglumine in subjects with transthyretin cardiomyopathy (TTR-CM), who have completed 30 months of study treatment on Pfizer protocol B3461028, for up to 60 months or until local access to tafamidis for TTR-CM via prescription, whichever occurs first
Sponsor: Pfizer

Current Primary Outcome: All-cause mortality and incidence of treatment emergent adverse events [ Time Frame: Baseline to Month 60 ]

Safety endpoints for analysis of the treatment groups


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Pfizer

Dates:
Date Received: June 1, 2016
Date Started: June 13, 2016
Date Completion: December 31, 2021
Last Updated: May 23, 2017
Last Verified: May 2017