痛風の有無にかかわらず高尿酸血症におけるFYU-981の研究

基本情報

NCT ID: NCT02344862
ステータス: 完了
試験のフェーズ: 第2相
試験タイプ: 介入
目標被験者数: 80
治験依頼者名: Fuji Yakuhin Co., Ltd.

概要

The purpose of this study is exploratory investigation of safety and efficacy (dose response and optimal dose according to the percent reduction from baseline in serum urate level at the final visit) of FYU-981 administered orally to hyperuricemic patients with and without gout for 8 weeks (dose-escalating initial period: 4 weeks followed by maintenance period: 4 weeks) by the method of randomized (dynamic allocation), placebo-controlled, double-blind, parallel group comparison.

対象疾患

Hyperuricemia

介入

FYU-981 High dose, (Oral daily dosing for 8 weeks)(DRUG)

FYU-981 Middle dose, (Oral daily dosing for 8 weeks)(DRUG)

FYU-981 Low dose, (Oral daily dosing for 8 weeks)(DRUG)

Placebo, (Oral daily dosing for 8 weeks)(DRUG)

依頼者（Sponsor）

株式会社富士薬品 (INDUSTRY)