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Eligibility
for people ages 18–90
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

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

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

  • 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

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
May 1, 2017
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