Trials / Active Not Recruiting
Active Not RecruitingNCT04801329
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)
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 110 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vyndamax (tafamidis 61mg) | As prescribed in real world practice |
Timeline
- Start date
- 2021-06-29
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
- First posted
- 2021-03-17
- Last updated
- 2026-03-30
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT04801329. Inclusion in this directory is not an endorsement.