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 San Francisco, 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

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

  • UCSF Ambulatory Care Center accepting new patients
    San Francisco, California, 94143, United States
  • University of California accepting new patients
    San Francisco, California, 94143, United States
  • UCSF Cardiovascular Care and Prevention Center accepting new patients
    San Francisco, California, 94158, United States
  • Stanford Hospital and Clinics Investigational Pharmacy accepting new patients
    Stanford, California, 94305, United States
  • Stanford University Hospital and Clinics accepting new patients
    Stanford, California, 94305, United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles, California, 90048, United States
  • California Heart Center accepting new patients
    Beverly Hills, California, 90211, United States
  • Cedars-Sinai Medical Care Foundation accepting new patients
    Beverly Hills, California, 90211, United States

Details

Status
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
Lead Scientist
Teresa De Marco
Study Type
Interventional
Last Updated
April 13, 2018
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