Vyndaqel Capsules Special Investigation (ATTR-CM)

Transthyretin (TTR) Amyloid Cardiomyopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04108091
• Other study ID #: B3461064
• Status: Recruiting
• Start date: October 3, 2019
• Est. completion date: December 9, 2024

Study information

• Verified date: January 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: December 9, 2024
• Est. primary completion date: December 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years and older

Eligibility

Inclusion Criteria:

• Patients administered Vyndaqel for the treatment of ATTR-CM

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Amyloidosis
• Cardiomyopathies
• Transthyretin (TTR) Amyloid Cardiomyopathy

Intervention

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.
• Treatment for TTR amyloidosis
The usual adult dose is 61 mg of tafamidis orally once daily.

Locations

Country	Name	City	State
Japan	Pfizer	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of adverse drug reaction		30 months
Secondary	Number of survival		30months

External Links

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