NCT03006445已完成3 期
Official Title: Safety and Efficacy Evaluation Study of FYU-981 Long-term Administration for Hyperuricemia With or Without Gout (Phase III Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 330
- 主要终点
- Percent reduction from baseline in serum urate level at the final visit
研究概览
简要总结
The purpose of this study is confirmatory investigation of safety and efficacy of FYU-981 administered orally to hyperuricemic patients with and without gout for 34 or 58 weeks by the method of multicenter, open label and ascending dose regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hyperuricemic or gout patients
- •Serum urate level:
- •>= 7.0mg/dL in patients with history of gout, or >= 8.0mg/dL in patients with hypertension, diabetes or metabolic syndrome, or >= 9.0mg/dL
排除标准
- •Gouty arthritis within two weeks before start of study treatment
- •Secondary hyperuricemia
- •HbA1c: >= 8.4%
- •Uric acid-overproduction type in the classification of hyperuricemia
- •History of, clinically significant cardiac, hematologic and hepatic disease
- •Kidney calculi or clinically significant urinary calculi
- •eGFR: < 30mL/min/1.73m^2
- •Systolic blood pressure: >= 180 mmHg
- •Diastolic blood pressure: >= 110 mmHg
研究组 & 干预措施
FYU-981
Experimental
干预措施: FYU-981 (Drug)
结局指标
主要结局
Percent reduction from baseline in serum urate level at the final visit
时间窗: 34 or 58 weeks
次要结局
未报告次要终点
研究者
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