NCT02791230

Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,733 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Transthyretin (TTR) Amyloid Cardiomyopathy

Interventions

Type	Name	Description
DRUG	Tafamidis	Soft gel capsules administered once a day for 60 months

Timeline

• Start date: 2016-06-13
• Primary completion: 2023-10-26
• Completion: 2023-11-02
• First posted: 2016-06-06
• Last updated: 2025-02-03
• Results posted: 2025-02-03

Locations

80 sites across 17 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Czechia, France, Germany, Hong Kong, Italy, Japan, Netherlands, Spain, Sweden, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study