NCT03372200已完成3 期
Febuxostat-Controlled, Double-Blind, Comparative Study of FYU-981 for Hyperuricemia With or Without Gout to Evaluate the Safety and Noninferiority of FYU-981 (Phase III Study)
Mochida Pharmaceutical Company, Ltd.1 个研究点 分布在 1 个国家目标入组 203 人开始时间: 2018年1月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- Percent reduction from baseline in serum urate level at the final visit
研究概览
简要总结
FYU-981 or Febuxostat are administrated to hyperuricemia patients (underexcretion and mixed types) with or without gout for 14 weeks to compare the efficacy and safety of these drugs by the method of multicenter, randomized, double-blind, ascending dose regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Serum urate level:
- •>= 7.0mg/dL in patients with gouty nodule or with history of gout, or >= 8.0mg/dL in patients with hypertension, diabetes or metabolic syndrome, or >= 9.0mg/dL
- •Disease type in the classification of hyperuricemia: Uric acid-underexcretion type or mixed type
- •Outpatients
排除标准
- •Gouty arthritis within 14 days before randomized allocation
- •Secondary hyperuricemia
- •HbA1c: >= 8.4%
- •Clinically significant cardiac, hepatic, renal, hematologic or endocrine disease
- •Kidney calculi or clinically significant urinary calculi
- •AST: >= 100 IU/L or ALT: >= 100 IU/L
- •eGFR: < 30 mL/min/1.73m^2
- •Systolic blood pressure: >= 180 mmHg or diastolic blood pressure: >= 110 mmHg
研究组 & 干预措施
FYU-981
Experimental
干预措施: FYU-981 (Drug)
Febuxostat
Active Comparator
干预措施: Febuxostat (Drug)
结局指标
主要结局
Percent reduction from baseline in serum urate level at the final visit
时间窗: 14 weeks
Percent reduction from baseline in serum urate level at the final visit
次要结局
未报告次要终点
研究者
研究点 (1)
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