Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy

Trial ID or NCT#

NCT01994889

Status

not recruiting iconNOT 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
Inclusion Criteria:
  1. * Medical history of Heart Failure (HF) with at least 1 prior hospitalization for HF or clinical evidence of HF (without hospitalization) manifested by signs or symptoms of volume overload or elevated intracardiac pressures (e.g., elevated jugular venous pressure, shortness of breath or signs of pulmonary congestion on x-ray or auscultation, peripheral edema) that required/requires treatment with a diuretic for improvement,* Evidence of cardiac involvement by echocardiography with an end-diastolic interventricular septal wall thickness \> 12 mm,* Presence of amyloid deposits in biopsy tissue and presence of a variant TTR genotype and/or TTR precursor protein identification by immunohistochemistry, scintigraphy or mass spectrometry
Exclusion Criteria:
  1. * A New York Heart Association (NYHA) classification of IV.* Presence of primary (light chain) amyloidosis.* Prior liver or heart transplantation or implanted cardiac mechanical assist device.
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Investigator(s)

Ronald Witteles
Ronald Witteles
Cardiologist, Heart failure cardiologist
Professor of Medicine (Cardiovascular Medicine)

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

Contact

Ed Finn
650-724-6167

View on ClinicalTrials.gov