Phase 3
N=1,733
Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy
Transthyretin (TTR) Amyloid Cardiomyopathy
Bottom Line
View on ClinicalTrials.gov: NCT02791230 ↗Enrolled (actual)
1,733
Serious AEs
53.9%
Results posted
Feb 2025
Primary outcome: Primary: Time to All-Cause Mortality: Cohort A — 58.7; 35.8 Months — p=0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tafamidis (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to All-Cause Mortality: Cohort A |
58.7; 35.8 | 0.0001 sig |
| PRIMARY Number of Participants With All-Cause Mortality Events: Cohort B |
345 | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) |
168; 79; 1294 | — |
Summary
Open label study to evaluate tafamidis for the treatment of transthyretin cardiomyopathy
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02791230). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.