Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy



Status:Completed
Conditions:Cardiology, Hematology
Therapuetic Areas:Cardiology / Vascular Diseases, Hematology
Healthy:No
Age Range:18 - 90
Updated:4/5/2019
Start Date:December 9, 2013
End Date:February 7, 2018

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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 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.

Phase 3, multicenter, global, three-arm, parallel design, placebo-controlled, double-blind,
randomized study to determine efficacy, safety and tolerability of tafamidis on clinical
outcomes (all-cause mortality and frequency of cardiovascular-related hospitalizations) in
subjects with either transthyretin genetic variants or wild-type transthyretin resulting in
amyloid cardiomyopathy.

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

Exclusion Criteria:

- 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.
We found this trial at
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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9500 Euclid Avenue
Cleveland, Ohio 44106
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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1211 Medical Center Dr
Nashville, Tennessee 37232
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Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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1150 East Medical Center Drive
Ann Arbor, Michigan 48109
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655 West Baltimore Street
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1800 Orleans Street
Baltimore, Maryland 21287
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
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Chicago, Illinois 60611
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Deerfield Beach, Florida 33442
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
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9452 Medical Center Drive
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La Jolla, California 92093
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49 Herestraat
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8700 Beverly Boulevard
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1514 Jefferson Hwy.
New Orleans, Louisiana 70121
504-842-3000
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201 Lyons Ave
Newark, New Jersey 07112
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3303 Southwest Bond Avenue
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Seattle, Washington 98101
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Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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300 Pasteur Dr
Stanford, California 94305
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