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 |
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.
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
sites
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University of Maryland, Baltimore Welcome to the University of Maryland, Baltimore (UMB) founded in 1807...
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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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
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
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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University of Utah Research is a major component in the life of the U benefiting...
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Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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1 Boston Medical Center Place
Boston, Massachusetts 02118
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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Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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9452 Medical Center Drive
La Jolla, California 92037
La Jolla, California 92037
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9452 Medical Center Drive
La Jolla, California 92037
La Jolla, California 92037
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New York, New York 10034
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Newark Beth Israel Medical Center Newark Beth Israel Medical Center, a regional care, teaching hospital...
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Advocate Christ Medical Center Advocate Health Care, named among the nation
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Stanford university Hospital and Clinics Throughout our history, we have pioneered medical advances that save...
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