Confirmatory Study of FYU-981 for Hyperuricemia With or Without Gout (Phase II (IIb) Study)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 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
The purpose of this study is confirmatory investigation of safety and efficacy (dose response and optimal dose according to the percent reduction from baseline in serum urate level at the final visit) of FYU-981 administered orally to hyperuricemic patients with and without gout for 12 weeks (dose-escalating initial period: 4 weeks followed by maintenance period: 8 weeks) by the method of randomized (dynamic allocation), placebo-controlled, double-blind, parallel group comparison.
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
- •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 Low dose
Drug: FYU-981 Low dose, (Oral daily dosing for 8 week-maintenance period) Subjects randomized to the FYU-981 Low dose arm receive active drug, FYU-981 Low dose.
干预措施: FYU-981 (Drug)
FYU-981 High dose
Drug: FYU-981 High dose, (Oral daily dosing for 8 week-maintenance period) Subjects randomized to the FYU-981 High dose arm receive active drug, FYU-981 High dose.
干预措施: FYU-981 (Drug)
FYU-981 High middle dose
Drug: FYU-981 High middle dose, (Oral daily dosing for 8 week-maintenance period) Subjects randomized to the FYU-981 High middle dose arm receive active drug, FYU-981 High middle dose.
干预措施: FYU-981 (Drug)
FYU-981 Middle dose
FYU-981 Middle dose, (Oral daily dosing for 8 week-maintenance period) Subjects randomized to the FYU-981 Middle dose arm receive active drug, FYU-981 Middle dose.
干预措施: FYU-981 (Drug)
Placebo
Drug: Placebo, (Oral daily dosing for 12 weeks) Subjects randomized to the placebo arm receive placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent reduction from baseline in serum urate level at the final visit
时间窗: 12 weeks
次要结局
未报告次要终点