This study is in progress, not accepting new patients

Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy

a study on Transthyretin (TTR) Amyloid Cardiomyopathy

Summary

for people ages 18-90 (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

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

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 Transthyretin Cardiomyopathy (ttr-cm)

Details

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

Keywords

Transthyretin (TTR) Amyloid Cardiomyopathy amyloidosis amyloid transthyretin TTR Cardiomyopathies Tafamidis meglumine Tafamidis meglumine - 20 mg Tafamidis meglumine - 40 mg Tafamidis meglumine - 80 mg

Eligibility

You can join if…

Open to people ages 18-90

-Completion of 30 months of study treatment on Pfizer Protocol B3461028

You CAN'T join if...

-Liver and/or heart transplant, or implanted cardiac mechanical assist device

Locations

  • UCSD Sulpizio Cardiovascular Center
    La Jolla California 92037 United States
  • University of California, San Diego Clinical and Translational Research Institute -
    La Jolla California 92037 United States
  • University of California, San Diego Medical Center - Hillcrest
    San Diego California 92103 United States
  • Altman Clinical Translational Research Institute
    La Jolla California 92037 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT02791230
Phase
Phase 3
Study Type
Interventional
Last Updated
July 2, 2018