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
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