Monitoring the use of Vyndamax® Capsules for treating heart disease caused by amyloidosis
KOREAN POST-MARKETING SURVEILLANCE VYNDAMAX (Registered) CAPSULES FOR THE TREATMENT OF TRANSTHYRETIN AMYLOID CARDIOMYOPATHY (ATTR-CM)
This study is looking at how well Vyndamax® Capsules work and how safe they are for adults with heart disease caused by amyloidosis over the next 10 years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT04801329 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on post-marketing surveillance of Vyndamax® Capsules, a treatment for transthyretin amyloid cardiomyopathy (ATTR-CM). Conducted in Korea, it aims to assess the safety and effectiveness of the medication over a 10-year period in routine clinical practice. The study will gather data from adult patients diagnosed with either wild type or hereditary ATTR-CM who are prescribed Vyndamax® Capsules. This initiative is part of a pharmacovigilance activity mandated by local regulations to ensure ongoing monitoring of the drug's performance in the real-world setting.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients diagnosed with wild type or hereditary transthyretin-mediated amyloidosis who are prescribed Vyndamax® Capsules.
Not a fit: Patients with hypersensitivity to tafamidis or those with hereditary fructose intolerance may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of Vyndamax® Capsules for patients with ATTR-CM.
How similar studies have performed: Other studies have shown success with similar post-marketing surveillance approaches, indicating the potential for valuable findings in this area.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Pfizer — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.