Status:
ACTIVE_NOT_RECRUITING
Korean Post-marketing Surveillance Vyndamax® Capsules for the Treatment of Transthyretin Amyloid Cardiomyopathy
Lead Sponsor:
Pfizer
Conditions:
ATTR-CM (Transthyretin Amyloid Cardiomyopathy)
Eligibility:
All Genders
19+ years
Brief Summary
This non-interventioal study will be performed by design of post-marketing surveillance (PMS) as an additional pharmacovigilance activity of the Risk Management Plan (RMP) for Vyndamax® Capsules, whic...
Eligibility Criteria
Inclusion
- \*Inclusion Criteria:
- Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- 1\. Adult patients with the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM)
- 2\. Patients to whom Vyndamax® Capsules is prescribed for the treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM)
- 3\. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
- Exclusion criteria
- Patients meeting any of the following criteria will not be included in the study according to the local product label:
- 1\. Patient with hypersensitivity or case history to tafamidis or to any of the excipients in the product
- 2\. This product contains sorbitol (E420). Patients with rare hereditary problems of fructose intolerance should not take this medicine.
- 3\. Patient who has a contraindication to Vyndamax® Capsules according to the approved local product label
Exclusion
Key Trial Info
Start Date :
June 29 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04801329
Start Date
June 29 2021
End Date
December 31 2026
Last Update
August 5 2025
Active Locations (1)
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1
Pfizer
Seoul, South Korea