Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy

Completed · Phase 3

Conditions studied: Transthyretin (TTR) Amyloid Cardiomyopathy

In brief

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

Key facts

Study ID

NCT02791230

Run by

Pfizer

People needed

1733

Starts

2016-06-13

Expected to finish

2023-11-02

Last updated by the study team

2025-02-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Liver and/or heart transplant, or implanted cardiac mechanical assist device

Where it is running

• Cardiovascular Clinical Trials Unit (CCTU) — Birmingham, Alabama, United States
• University Hospital, University of Alabama at Birmingham — Birmingham, Alabama, United States
• California Heart Center — Beverly Hills, California, United States
• Cedars-Sinai Medical Care Foundation — Beverly Hills, California, United States
• Altman Clinical Translational Research Institute — La Jolla, California, United States
• University of California, San Diego — La Jolla, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of California, San Diego Medical Center - Hillcrest — San Diego, California, United States
• Center Adv Lab Medicine — San Diego, California, United States
• UCSF Ambulatory Care Center — San Francisco, California, United States
• University of California — San Francisco, California, United States
• UCSF Cardiovascular Care and Prevention Center — San Francisco, California, United States
• Stanford University Hospital and Clinics — Stanford, California, United States
• Sylvester at Deerfield Beach — Deerfield Beach, Florida, United States
• University of Miami Hospital & Clinics/Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• Northwestern Medical Group — Chicago, Illinois, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Advocate Christ Medical Center — Oak Lawn, Illinois, United States
• University of Maryland, Baltimore — Baltimore, Maryland, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Boston Medical Center Investigational Pharmacy — Boston, Massachusetts, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Boston University Medical Center — Boston, Massachusetts, United States
• Michigan Medicine,University of Michigan — Ann Arbor, Michigan, United States
• The Kirklin Clinic of UAB Hospital — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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