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)

This study will investigate the efficacy, safety, and tolerability of an oral dose of 20 mg or 80 mg tafamidis meglumine soft gel capsules in comparison to placebo and given once daily, in addition to standard of care, for 30 months in subjects diagnosed with transthyretin cardiomyopathy (familial and wild-type). The study is designed to assess the potential for benefit from treatment with tafamidis relative to placebo based on all-cause mortality and frequency of cardiovascular-related hospitalizations.

Stanford is now accepting new patients for this trial. Please contact Ed Finn at 650-724-6167 for more information.

Investigator(s):

Intervention(s):

  • drug : Tafamidis
  • drug : Placebo
  • drug : Tafamidis

Phase: Phase 3

Eligibility

Ages Eligible For Study:

18 Years - 90 Years

Inclusion Criteria

- 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

External Links

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Contact information

Primary Contact:

Ed Finn 650-724-6167

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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