Korean Post-marketing Surveillance Vyndamax® Capsules for the Treatment of Transthyretin Amyloid Cardiomyopathy

Launched by PFIZER · Mar 15, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of Vyndamax® Capsules, a medication used to treat a condition called transthyretin amyloid cardiomyopathy (ATTR-CM), which affects the heart. The study is part of a program to monitor the drug's performance after it has been approved for use, and it will take place over a period of 10 years in Korea. Researchers want to see how well the medication works in everyday practice and to ensure that it is safe for patients.

To be eligible for this trial, participants must be adults diagnosed with either wild type or hereditary ATTR-CM and must have been prescribed Vyndamax® Capsules for their condition. They will need to sign a consent form, which means they understand what the study involves. However, individuals who have certain allergies to the medication or its ingredients, or specific health conditions that make it unsafe for them to take Vyndamax®, will not be included. Participants in the study can expect to provide information about their health and how they feel while taking the medication, contributing to the overall understanding of its use in treating this heart condition.

Gender

ALL

Eligibility criteria

• \*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