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ACTIVE NOT RECRUITING
NCT04801329

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

Sponsor: Pfizer

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

OBSERVATIONAL

Enrollment

110

Start Date

2021-06-29

Completion Date

2026-12-31

Last Updated

2026-03-30

Healthy Volunteers

No

Interventions

DRUG

Vyndamax (tafamidis 61mg)

As prescribed in real world practice

Locations (1)

Pfizer

Seoul, South Korea