Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy

Completed · Phase 3 · Has a placebo group

Conditions studied: Transthyretin (TTR) Amyloid Cardiomyopathy

In brief

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.

Key facts

Study ID

NCT01994889

Run by

Pfizer

People needed

441

Starts

2013-12-09

Expected to finish

2018-02-07

Last updated by the study team

2019-04-24

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• UAB Hospital Department of Pharmacy IDS — Birmingham, Alabama, United States
• University Hospital, University of Alabama at Birmingham — Birmingham, Alabama, United States
• Mayo Clinic Arizona - Mayo Clinic Speciality Building — Phoenix, Arizona, United States
• Mayo Clinic Hospital — Phoenix, Arizona, United States
• Mayo Clinic Arizona - Mayo Clinic Building — Scottsdale, Arizona, United States
• UCSD Clinical and Translational Research Institute, Investigational Drug Service — La Jolla, California, United States
• Altman Clinical Translational Research institute — La Jolla, California, United States
• Altman Clinical Translational Research Institute — La Jolla, California, United States
• UCSD Sulpizio Cardiovascular Center — La Jolla, California, United States
• Cedars-Sinai Medical Center, Investigational Drug Pharmacy Services — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Cedars-Sinai Medical Care Foundation — Los Angeles, California, United States
• UCSF Cardiovascular Care and Prevention Center — San Francisco, California, United States
• Stanford University Hospital and Clinics — Stanford, California, United States
• UM Sylvester at Deerfield Beach — Deerfield Beach, Florida, United States
• University of Miami Hospital & Clinics — Miami, Florida, United States
• Northwestern Medical Group — Chicago, Illinois, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Advocate Christ Medical Centre — Oak Lawn, Illinois, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• University of Maryland, School of Medicine — Baltimore, Maryland, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• The Johns Hopkins Hospital IDS Pharmacy — Baltimore, Maryland, United States
• Boston Medical Center - Cardiovascular Center, Outpatient Clinic — Boston, Massachusetts, United States
• The Kirklin Clinic — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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