NCT04801329Completed
Korean Post-marketing Surveillance Vyndamax® Capsules for the Treatment of Transthyretin Amyloid Cardiomyopathy
KOREAN POST-MARKETING SURVEILLANCE VYNDAMAX (REGISTERED) CAPSULES FOR THE TREATMENT OF TRANSTHYRETIN AMYLOID CARDIOMYOPATHY (ATTR-CM)
Source: ClinicalTrials.gov · Last updated 27 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 110 (actual)
- First submitted
- 1 Mar 2021
- Start date
- 29 Jun 2021
- Primary completion date
- 21 Apr 2026
- Lead sponsor
- Pfizer
- Diseases
- Amyloidosis
- NCT number
- NCT04801329
What you commit to
- Study type: Observational
- Participants enrolled: 110
- From 29 Jun 2021 to the primary completion date, 21 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- \*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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pfizer Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.