A observational safety study of Tafamidis in patients with Transthyretin amyloidcardiomyopathy (ATTR-CM) in India
Phase 4
- Conditions
- Health Condition 1: I425- Other restrictive cardiomyopathy
- Registration Number
- CTRI/2023/08/056905
- Lead Sponsor
- Pfizer Products India Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The safety of VyndaMx Capsules is the primary objective of the study & will be assessed <br/ ><br>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 Outcome Measures
Name Time Method 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