Clinical Trial: Benzbromarone-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout

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

Official Title: Benzbromarone-Controlled, Double-Blind, Comparative Study of FYU-981 for Hyperuricemia With or Without Gout to Evaluate the Safety and Noninferiority of FYU-981 (Phase III Study)

Brief Summary: FYU-981 or Benzbromarone are administrated to hyperuricemia patients with or without gout for 14 weeks to compare the efficacy and safety of these drugs by the method of multicenter, randomized, double-blind, 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: 14 weeks ]

Percent reduction from baseline in serum urate level at the final visit


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Fuji Yakuhin Co., Ltd.

Dates:
Date Received: March 29, 2017
Date Started: April 1, 2017
Date Completion: January 2020
Last Updated: May 7, 2017
Last Verified: May 2017