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

StatusCompleted
PhaseNot specified
SponsorPfizer
Started2021-06-29
View on ClinicalTrials.gov ↗
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.

Amendment history 3 changes detected by DataLookout

2026-08-28
notable
Trial completed
2026-08-28
minor
Primary completion moved earlier: 2026-12-31 → 2026-04-21
2026-08-28
minor
Completion moved earlier: 2026-12-31 → 2026-04-21
Trial Details
NCT Number NCT04801329
Lead Sponsor Pfizer
Conditions ATTR-CM (Transthyretin Amyloid Cardiomyopathy)
Enrollment 110 participants
Start Date 2021-06-29
Primary Completion 2026-04-21 (estimated)
Study Completion 2026-04-21 (estimated)
Updated on ClinicalTrials.gov 2026-08-27