Korean Post-marketing Surveillance Vyndamax® Capsules for... | NCT04801329

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

NCT04801329

Sponsor

Pfizer

Status

Active, not recruiting

Last Update Posted

Mar 30, 2026Actual

Enrollment

110Actual

Phase

Not provided

Conditions

ATTR-CM (Transthyretin Amyloid Cardiomyopathy)

Interventions

Vyndamax (tafamidis 61mg)

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Vyndamax PMS	Other Identifier	Alias Study Number

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 29, 2021Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Mar 1, 2021

First Submission Date that Met QC Criteria

Mar 15, 2021

First Posted Date

Mar 17, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2026

Last Update Posted Date

Mar 30, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Label	Type	Description	Intervention Names
Adults diagnosed with transthyretin-mediated amyloidosis (ATTR-CM)			Drug: Vyndamax (tafamidis 61mg)

Name	Type	Description	Arm Group Labels	Other Names
Vyndamax (tafamidis 61mg)	Drug	As prescribed in real world practice	Adults diagnosed with transthyretin-mediated amyloidosis (ATTR-CM)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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)

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Label	URL
To obtain contact information for a study center near you, click here.	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided