Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy
Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy
ClinicalTrials.gov ID: NCT02791230
Sponsor: Pfizer
Information provided by: Pfizer (Responsible Party)
Last Update Posted: 2022-12-22
Brief Summary:
Open label study to evaluate tafamidis for the treatment of transthyretin cardiomyopathy
Detailed Description:
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.
Official Title:
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)
Intervention / Treatment:
- Drug: Tafamidis
| Category | Value |
|---|---|
| Study Start (Actual) | 2016-06-13 |
| Primary Completion (Estimated) |
2027-02-16
|
| Study Completion (Estimated) | 2027-02-16 |
| Enrollment (Actual) | 1735 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
B3461045 |