jRCT2041220061进行中（未招募）不适用
A Study to Evaluate the Safety and Efficacy of FYU-981 in Hyperuricemic Pediatric Patients with or without Gout (Phase III Study) (Extension Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- No limit 至 No limit（—）
- 性别
- All
入选标准
- •Hyperuricemic pediatric patients with or without gout, who completed the observation for 30 weeks of Study FYU-981-018 (jRCT2031220036).
排除标准
- •Kidney calculi or clinically significant urinary calculi
- •Patients deemed inappropriate by the investigator to conduct this study
结局指标
主要结局
-
Percentage of subjects with serum urate <=6.0 mg/dL at the end of administration
次要结局
未报告次要终点
研究者
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未知
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