clinical trial · NCT04801329
Korean Post-marketing Surveillance Vyndamax® Capsules for the Treatment of Transthyretin Amyloid Cardiomyopathy
Pfizer·—·active not recruiting·n = 110
ATTR-CM (Transthyretin Amyloid Cardiomyopathy)Vyndamax (tafamidis 61mg)
brief 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.
started
Jun 29, 2021
primary completion
Dec 31, 2026
completion
Dec 31, 2026
last updated
Mar 30, 2026
official title
KOREAN POST-MARKETING SURVEILLANCE VYNDAMAX (Registered) CAPSULES FOR THE TREATMENT OF TRANSTHYRETIN AMYLOID CARDIOMYOPATHY (ATTR-CM)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol