Vyndaqel Capsules Special Investigation (ATTR-CM)

Pfizer

Status: Active, not recruiting

Conditions: Transthyretin (TTR) Amyloid Cardiomyopathy

Treatments: Drug: Treatment for TTR amyloidosis

Study type: Observational

Funder types: Industry

Identifiers

NCT04108091

B3461064

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,214 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients administered Vyndaqel for the treatment of ATTR-CM

Exclusion criteria

• N/A

Trial design

1,214 participants in 1 patient group

Treatment for TTR amyloidosis

Description:

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

Treatment:

Drug: Treatment for TTR amyloidosis

Drug: Treatment for TTR amyloidosis