NCT04108091

Vyndaqel Capsules Special Investigation (ATTR-CM)

Vyndaqel Capsules Special Investigation - Investigation on Patients With Transthyretin Amyloid Cardiomyopathy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,214 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 0 Years
• Healthy volunteers: Not accepted

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.

Detailed description

To comprehend information on the long-term safety (e.g., onset status of adverse reactions), etc. of patients who are treated with Vyndaqel for the treatment of transthyretin amyloid cardiomyopathy. When Vynmac is used, conduct the study to grasp information on safety (e.g., onset status of adverse reactions),etc. during the observation period.

Conditions

• Transthyretin (TTR) Amyloid Cardiomyopathy

Interventions

Type	Name	Description
DRUG	Treatment for TTR amyloidosis	The usual adult dose is 80 mg of Tafamidis Meglumine orally once daily. The dose may be reduced if not tolerated.
DRUG	Treatment for TTR amyloidosis	The usual adult dose is 61 mg of tafamidis orally once daily.

Timeline

• Start date: 2019-10-03
• Primary completion: 2025-03-27
• Completion: 2025-03-27
• First posted: 2019-09-27
• Last updated: 2025-05-08

Locations

1 site across 1 country: Japan