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Completed NCT04801329

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

Conditions: ATTR-CM (Transthyretin Amyloid Cardiomyopathy)

Sex: All
Ages: 19 Years – N/A
Healthy volunteers: No
Enrollment: 110
Sponsor: Pfizer

Location: Pfizer Seoul

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, which is required by the Ministry of Food and Drug Safety (MFDS) according to the local regulation. This post-marketing surveillance will investigate the safety and effectiveness of Vyndamax® Capsules as the treatment of transthyretin amyloid cardiomyopathy during 10 years under the setting of routine practice in Korea.

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04801329). StuddyBuddy aggregates publicly available trial information.