Vyndaqel Capsules Special Investigation (ATTR-CM)

Active, not recruiting

• Conditions: Transthyretin (TTR) Amyloid Cardiomyopathy
• Interventions: Drug: Treatment for TTR amyloidosis

• Registration Number: NCT04108091
• Lead Sponsor: Pfizer

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.

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.

Study Timeline

• Study First Submitted: 2019-09-26
• Study First Submitted QC: 2019-09-26
• Study First Posted: 2019-09-27
• Study Start: 2019-10-03
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-10
• Primary Completion: 2025-02-19
• Study Completion: 2025-02-19

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1214

Inclusion Criteria

• Patients administered Vyndaqel for the treatment of ATTR-CM

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Exclusion Criteria

• N/A

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment for TTR amyloidosis	Treatment for TTR amyloidosis	Transthyretin amyloid cardiomyopathy (wild-type or variants) patients administered Vyndaqel and Vynmac.

Primary Outcome Measures

Name	Time	Method
The incidence of adverse drug reaction	30 months

Secondary Outcome Measures

Name	Time	Method
Number of survival	30months

Trial Locations

Locations (1)

Pfizer; 🇯🇵 Tokyo, Japan