ATTR-CM (Transthyretin Amyloid Cardiomyopathy)
Conditions
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.
Interventions
DRUGVyndamax (tafamidis 61mg)
As prescribed in real world practice
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\*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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of Adverse Events (AEs) | Baseline through 6 months of treatment | The primary interest of this study is the incidence of AEs investigated during administration period and within 28 days after discontinuation of Vyndamax® Capsules. Incidence of AEs, 95% confidence interval and the number of AEs will be presented. Serious AEs/ADRs, unexpected AEs/ADRs, unexpected serious AEs/ADRs will be summarized separately table. |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in the New York Heart Association (NYHA) class at Month 6 | Baseline, month 6 |
| Change from baseline in the 6 Minute Walk Distance (6MWD) at Month 6 | Baseline, month 6 |
| Global assessment by investigator at Month 6 | Baseline, month 6 |
Countries
South Korea
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed