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

Sponsor
Pfizer (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04801329
Collaborator
(none)
100
Enrollment
1
Location
105
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Vyndamax (tafamidis 61mg)

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
KOREAN POST-MARKETING SURVEILLANCE VYNDAMAX (Registered) CAPSULES FOR THE TREATMENT OF TRANSTHYRETIN AMYLOID CARDIOMYOPATHY (ATTR-CM)
Actual Study Start Date :
Jun 29, 2021
Anticipated Primary Completion Date :
Mar 30, 2030
Anticipated Study Completion Date :
Mar 30, 2030

Arms and Interventions

Arm Intervention/Treatment
Adults diagnosed with transthyretin-mediated amyloidosis (ATTR-CM)

Drug: Vyndamax (tafamidis 61mg)
As prescribed in real world practice
Other Names:
  • Tafamadis

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. Change from baseline in the New York Heart Association (NYHA) class at Month 6 [Baseline, month 6]

    2. Change from baseline in the 6 Minute Walk Distance (6MWD) at Month 6 [Baseline, month 6]

    3. Global assessment by investigator at Month 6 [Baseline, month 6]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    *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)
      1. Patients to whom Vyndamax® Capsules is prescribed for the treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM)
      1. 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
      1. This product contains sorbitol (E420). Patients with rare hereditary problems of fructose intolerance should not take this medicine.
      1. Patient who has a contraindication to Vyndamax® Capsules according to the approved local product label

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Seoul Korea, Republic of

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT04801329
    Other Study ID Numbers:
    • B3461080
    • Vyndamax PMS
    First Posted:
    Mar 17, 2021
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Cardiomyopathies
    Amyloidosis

    Study Results

    No Results Posted as of Aug 18, 2022