NCT02190786已完成2 期
Phase II Exploratory Clinical Study of KUX-1151
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 主要终点
- Change from baseline in serum uric acid level
研究概览
简要总结
The purpose of this study is to investigate the efficacy, safety and pharmacokinetics of multiple oral administration of KUX-1151 in patients with hyperuricemia including gout.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese HU patients (Outpatient)
- •Patients who meet the following criteria concerning serum uric acid levels at the screening [1) Gout: > 7.0 mg/dL, 2) HU with complications: ≥ 8.0 mg/dL, 3) HU without complications: ≥ 9.0 mg/dL]
排除标准
- •Patients who have any symptom of gouty arthritis within 2 weeks of investigational product administration
研究组 & 干预措施
KUX-1151, Low dose
Experimental
干预措施: KUX-1151 (Drug)
KUX-1151, Middle dose
Experimental
干预措施: KUX-1151 (Drug)
KUX-1151, High dose
Experimental
干预措施: KUX-1151 (Drug)
结局指标
主要结局
Change from baseline in serum uric acid level
时间窗: 14 weeks
Percent change from baseline in serum uric acid level
时间窗: 14 weeks
Proportion of subjects achieving serum uric acid level ≤ 6 mg/dL
时间窗: 14 weeks
次要结局
未报告次要终点
研究者
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