Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy



Status:Recruiting
Conditions:Cardiology, Hematology
Therapuetic Areas:Cardiology / Vascular Diseases, Hematology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:June 13, 2016
End Date:December 16, 2024
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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A PHASE 3 MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY OF DAILY ORAL DOSING OF TAFAMIDIS MEGLUMINE (PF-06291826-83) 20 MG OR 80 MG [OR TAFAMIDIS (PF-06291826-00) 61 MG] IN SUBJECTS DIAGNOSED WITH TRANSTHYRETIN CARDIOMYOPATHY (ATTR-CM)

Open label study to evaluate tafamidis for the treatment of transthyretin cardiomyopathy

Global Phase 3, open label long term extension safety study designed to obtain additional
safety data for tafamidis meglumine 20 mg and 80 mg (or tafamidis 61 mg where available), and
to continue to provide enrolled subjects with tafamidis for up to 60 months, or until subject
has access to tafamidis for ATTR CM via prescription, whichever occurs first.

Inclusion Criteria:

Cohort A: Completion of 30 months of study treatment on Pfizer Protocol B3461028

Cohort B: Patients in specific countries diagnosed with ATTR-CM who did not previously
participate in Pfizer Study B3461028

Exclusion Criteria:

-Liver and/or heart transplant, or implanted cardiac mechanical assist device
We found this trial at
46
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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621 West Lombard Street
Baltimore, Maryland 21201
(410) 706-7101
University of Maryland, Baltimore Welcome to the University of Maryland, Baltimore (UMB) founded in 1807...
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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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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Los Angeles, CA
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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Ann Arbor, Michigan 48109
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1150 East Medical Center Drive
Ann Arbor, Michigan 48109
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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1800 Orleans Street
Baltimore, Maryland 21287
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Baltimore, Maryland 21201
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8536 Wilshire Boulevard
Beverly Hills, California 90211
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Beverly Hills, California 90211
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Birmingham, Alabama 35233
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Birmingham, Alabama 35249
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Birmingham, Alabama 35294
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Boston, Massachusetts 02118
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1 Boston Medical Center Place
Boston, Massachusetts 02118
617.638.8000
Boston University Medical Center Boston Medical Center is an extraordinary community of health care providers...
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Chicago, Illinois 60611
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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303 East Superior Street
Chicago, Illinois 60611
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Deerfield Beach, Florida 33442
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9452 Medical Center Drive
La Jolla, California 92037
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La Jolla, California 92093
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Leuven, 3001
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462 1st Avenue
New York, New York 10010
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201 Lyons Ave
Newark, New Jersey 07112
(973) 926-7000
Newark Beth Israel Medical Center Newark Beth Israel Medical Center, a regional care, teaching hospital...
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4440 West 95th Street
Oak Lawn, Illinois 60453
708.684.8000
Advocate Christ Medical Center Advocate Health Care, named among the nation
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Philadelphia, Pennsylvania
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3303 Southwest Bond Avenue
Portland, Oregon 97239
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Portland, Oregon 97239
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Rochester, Minnesota 55902
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Rochester, Minnesota 55905
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Salt Lake City, Utah 84132
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San Francisco, California 94143
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San Francisco, California 94143
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San Francisco, California 94143
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Stanford university Hospital and Clinics Throughout our history, we have pioneered medical advances that save...
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