Vyndaqel Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

Transthyretin Familial Amyloid Poluneuropathy Clinical Trial

Official title:

VYNDAQEL DRUG USE INVESTIGATION (REGULATORY POST MARKETING COMMITMENT PLAN)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02146378
• Other study ID #: B3461042
• Status: Completed
• Start date: January 10, 2014
• Est. completion date: March 10, 2023

Study information

• Verified date: March 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to understand safety (e.g., occurrence of adverse drug reactions [ADRs]) and efficacy data on the long-term use of Vyndaqel Capsules (hereinafter referred to as Vyndaqel) in all patients who received this drug under actual use conditions after its marketing.

Description:

Both prospective and retrospective is acceptable All the patients whom an investigator prescribes Vyndaqel should be registered

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: March 10, 2023
• Est. primary completion date: March 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

The subjects of this surveillance are all patients who received Vyndaqel.

Exclusion Criteria:

Patients not receive Vyndaqel.

Related Conditions & MeSH terms

• Amyloidosis
• Transthyretin Familial Amyloid Poluneuropathy

Intervention

Drug:
• Vyndaqel
20mg/day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of adverse drug reaction in this study		3 years
Secondary	Change from baseline on the following scale; NIS, QOL-DN, mBMI		3 years

External Links

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