Vyndaqel Capsules Special Investigation (ATTR-CM)

NCT04108091 | Completed

• 2 other identifiers: B3461064NCT04108091
• Study Type: observational
• Target: 1,214
• Locations: 1 country
• Sites: 1

Brief Summary

Secondary Data Collection : To confirm the safety and effectiveness profiles under the actual medical practice of Vyndaqel in Japan. This study is conducted in accordance with the protocol even when Vynmac is used, and information the use of Vynmac during the observation period is also collected.

Conditions

Transthyretin (TTR) Amyloid Cardiomyopathy

Keywords

transthyretin amyloid cardiomyopathy;; TTR Cardiomyopathy;; Transthyretin (TTR) Amyloid Cardiomyopathy;; Vyndaqel;; Tafamidis meglumine;; ATTR-CM;; Vynmac;

Outcome Measures

Primary Outcomes (1)

• The incidence of adverse drug reaction

  30 months

Secondary Outcomes (1)

• Number of survival

  30months

Study Arms (1)

Treatment for TTR amyloidosis

Transthyretin amyloid cardiomyopathy (wild-type or variants) patients administered Vyndaqel and Vynmac.

Drug: Treatment for TTR amyloidosis

Interventions

Treatment for TTR amyloidosis DRUG

The usual adult dose is 80 mg of Tafamidis Meglumine orally once daily. The dose may be reduced if not tolerated.

Also known as: Vyndaqel

Treatment for TTR amyloidosis

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who are administered with this drug for the treatment of ATTR-CM

You may qualify if:

• Patients administered Vyndaqel for the treatment of ATTR-CM

You may not qualify if:

• N/A

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

Tokyo, Japan

Location

Related Links

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

MeSH Terms

Conditions

Amyloid Neuropathies, Familial

Interventions

Therapeutics; tafamidis

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: September 27, 2019
• Study Start: October 3, 2019
• Primary Completion: March 27, 2025
• Study Completion: March 27, 2025
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)