Clinical Trial: Vyndaqel Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Vyndaqel Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

Brief 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.

Detailed Summary: Both prospective and retrospective is acceptable All the patients whom an investigator prescribes Vyndaqel should be registered
Sponsor: Pfizer

Current Primary Outcome: The incidence of adverse drug reaction in this study [ Time Frame: 3 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Change from baseline on the following scale; NIS, QOL-DN, mBMI [ Time Frame: 3 years ]

Original Secondary Outcome: Same as current

Information By: Pfizer

Dates:
Date Received: May 21, 2014
Date Started: January 10, 2014
Date Completion: April 29, 2022
Last Updated: May 22, 2017
Last Verified: May 2017