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

Last updated: January 29, 2025
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

N/A

Condition

Amyloidosis

Circulation Disorders

Treatment

Vyndamax (tafamidis 61mg)

Clinical Study ID

NCT04801329
B3461080
Vyndamax PMS
  • Ages > 19
  • All Genders

Study 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

*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)
  1. Patients to whom Vyndamax® Capsules is prescribed for the treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM)
  1. 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
  1. This product contains sorbitol (E420). Patients with rare hereditary problems of fructose intolerance should not take this medicine.
  1. Patient who has a contraindication to Vyndamax® Capsules according to the approved local product label

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Vyndamax (tafamidis 61mg)
Phase:
Study Start date:
June 29, 2021
Estimated Completion Date:
March 30, 2030

Connect with a study center

  • Pfizer

    Seoul,
    Korea, Republic of

    Active - Recruiting

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