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NCT Number: NCT04801329

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

ATTR-CM (Transthyretin Amyloid Cardiomyopathy)

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

*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

Treatment and study plan

Vyndamax (tafamidis 61mg)

Drug

As prescribed in real world practice

Other names: Tafamadis

Primary outcomes

  1. The incidence of Adverse Events (AEs)

    Time frame: Baseline through 6 months of treatment

    The primary interest of this study is the incidence of AEs investigated during administration period and within 28 days after discontinuation of Vyndamax® Capsules. Incidence of AEs, 95% confidence interval and the number of AEs will be presented.

    Serious AEs/ADRs, unexpected AEs/ADRs, unexpected serious AEs/ADRs will be summarized separately table.

Secondary outcomes

  1. Change from baseline in the New York Heart Association (NYHA) class at Month 6

    Time frame: Baseline, month 6

  2. Change from baseline in the 6 Minute Walk Distance (6MWD) at Month 6

    Time frame: Baseline, month 6

  3. Global assessment by investigator at Month 6

    Time frame: Baseline, month 6

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

KOREAN POST-MARKETING SURVEILLANCE VYNDAMAX (Registered) CAPSULES FOR THE TREATMENT OF TRANSTHYRETIN AMYLOID CARDIOMYOPATHY (ATTR-CM)

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Mar 17, 2021
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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