Trial ID or NCT#

NCT01994889

Status

NOT RECRUITING

Purpose

This Phase 3 study will investigate the efficacy, safety and tolerability of an oral daily dose of 20 mg or 80 mg tafamidis meglumine capsules compared to placebo in subjects with either transthyretin genetic variants or wild-type transthyretin resulting in amyloid cardiomyopathy.

Official Title

A MULTICENTER, INTERNATIONAL, PHASE 3, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF DAILY ORAL DOSING OF TAFAMIDIS MEGLUMINE (PF-06291826) 20 MG OR 80 MG IN COMPARISON TO PLACEBO IN SUBJECTS DIAGNOSED WITH TRANSTHYRETIN CARDIOMYOPATHY (TTR-CM)

Eligibility Criteria

Ages Eligible for Study: 18 Years to 90 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
View All Criteria

Investigator(s)

Ronald Witteles
Cardiologist, Heart failure cardiologist
Associate Professor of Medicine (Cardiovascular Medicine) at the Stanford University Medical Center
Matthew Wheeler
Cardiologist
Assistant Professor of Medicine (Cardiovascular Medicine) at the Stanford University Medical Center

Contact us to find out if this trial is right for you.

CONTACT

Ed Finn
(650) 724-6167

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View on ClinicalTrials.gov