Clinical Trial: Study of FYU-981 in Hyperuricemia With or Without Gout

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Official Title: Safety and Efficacy Evaluation Study of FYU-981 Long-term Administration for Hyperuricemia With or Without Gout (Phase III Study)

Brief Summary: The purpose of this study is confirmatory investigation of safety and efficacy of FYU-981 administered orally to hyperuricemic patients with and without gout for 34 or 58 weeks by the method of multicenter, open label and ascending dose regimen.

Detailed Summary:
Sponsor: Fuji Yakuhin Co., Ltd.

Current Primary Outcome: Percent reduction from baseline in serum urate level at the final visit [ Time Frame: 34 or 58 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Fuji Yakuhin Co., Ltd.

Dates:
Date Received: December 28, 2016
Date Started: December 2016
Date Completion: January 2020
Last Updated: April 30, 2017
Last Verified: December 2016