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

NCT04801329 | Active Not Recruiting

• 2 other identifiers: B3461080Vyndamax PMS
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

ATTR-CM (Transthyretin Amyloid Cardiomyopathy)

Outcome Measures

Primary Outcomes (1)

• The incidence of Adverse Events (AEs)

  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.

  Baseline through 6 months of treatment

Secondary Outcomes (3)

• 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

Study Arms (1)

Adults diagnosed with transthyretin-mediated amyloidosis (ATTR-CM)

Drug: Vyndamax (tafamidis 61mg)

Interventions

Vyndamax (tafamidis 61mg) DRUG

As prescribed in real world practice

Also known as: Tafamadis

Adults diagnosed with transthyretin-mediated amyloidosis (ATTR-CM)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be performed in patients who have received at least 1 dose of Vyndamax Capsules for the following indications as per local product label.(Treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization)

You may qualify if:

• \. Adult patients with the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM)
• \. Patients to whom Vyndamax® Capsules is prescribed for the treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM)
• \. 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.

You may not qualify if:

• Patients meeting any of the following criteria will not be included in the study according to the local product label:
• \. Patient with hypersensitivity or case history to tafamidis or to any of the excipients in the product
• \. This product contains sorbitol (E420). Patients with rare hereditary problems of fructose intolerance should not take this medicine.
• \. Patient who has a contraindication to Vyndamax® Capsules according to the approved local product label

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

Seoul, South Korea

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

tafamidis

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 17, 2021
• Study Start: June 29, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)