jRCT2031220036进行中（未招募）不适用
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of FYU-981 in Hyperuricemic Pediatric Patients with or without Gout (Phase II 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
- 6age old over 至 18age old under（—）
- 性别
- All
入选标准
- •Hyperuricemic pediatric patients with or without gout
- •Serum urate level:
- •>= 7.0 mg/dL in patients with history of gout, or
- •>= 8.0 mg/dL in patients complicated with kidney disease, hypertension, diabetes, metabolic syndrome or ischemic heart disease, or
- •>= 9.0 mg/dL in patients with not applicable the above
排除标准
- •Gouty arthritis within two weeks before start of study treatment
- •Renal overload type of hyperuricemia
- •HbA1c: >= 9.0%
- •Clinically significant cardiac, and hepatic disease
- •Kidney calculi or clinically significant urinary calculi
- •eGFR: < 30 mL/min/1.73 m^2
- •AST: >3xULN (upper limit of normal) or ALT: >3xULN
- •Systolic blood pressure: >= 180 mmHg or diastolic blood pressure: >= 110 mmHg
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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