Health Condition 1: I425- Other restrictive cardiomyopathy
Conditions
Interventions
Intervention1: Tafamidis: Tafamidis 61 mg capsules (VyndaMx) once daily for 6 months
Control Intervention1: Nil: Nil
Sponsors
Pfizer Products India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients aged 18 years and more with diagnosis of cardiomyopathy of wild type or hereditary transthyretin mediated amyloidosis and Patients to whom VyndaMx Capsules is prescribed for the treatment of ATTR-CM.
Exclusion criteria
Exclusion criteria: Patient with hypersensitivity to VyndaMx® Capsule or to any of the excipients in the product Patients with rare hereditary problems of fructose intolerance. Patient who has a contraindication to VyndaMx® Capsules according to the approved local product label.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety of VyndaMx Capsules is the primary objective of the study & will be assessed based on AEs which would occur within 6 months from first dosing.Timepoint: AEs which would assessed at end of 6 months from first dosing. | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality_all cause hospitalization_CV related mortality_CV related hospitalization will be collected & evaluated if available.Timepoint: Event at end of 6 months from first dosing | — |
Countries
India
Contacts
Public ContactDr Hitesh Muley
Pfizer Products India Private Limited
Outcome results
None listed