NCT06139393已完成3 期
Study on Efficacy and Safety of HR091506 Tablets in Treatment of Gout With Hyperuricemia in Adults
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
- 765
- 试验地点
- 1
- 主要终点
- The proportion of subjects with serum uric acid level < 360 μmoL/L at Week 28
研究概览
简要总结
The study is being conducted to evaluate the efficacy, and safety of HR091506 tablets for treatment of gout with hyperuricemia in adults, and to compare the results with febuxostat tablets in the same doses.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years old, male or female;
- •BMI: 18.0-30.0 kg/m2;
- •Meet the 2015 ACR/EULAR gout classification criteria;
- •Fast serum uric acid ≥ 480 μmol/L on 2 different days during the screening perid;
- •Willing to ues contraceptive measures during the study;
- •Able and willing to provide a written informed consent.
排除标准
- •History of acute gout attack within 4 weeks before randomization.
- •Subjects who have undergone major surgery or organ transplantation within 3 months before randomization.
- •Subjects with major cardiovascular disease within 6 months before randomization.
- •History of chronic infection or recurrent infection within 1year before randomization.
- •History of malignant tumor or current history of combined malignant tumor within 5 years before screening.
- •History of secondary hyperuricemia, refractory gout, or xanthine metabolism disorder.
- •Subjects with poorly controlled blood pressure or diabetes mellitus.
- •History of chronic diffuse connective tissue disease and/or massively elevated urate diseases and/or untreated clinically significant thyroid disease.
- •History of diseases that may affect the in vivo process, safety evaluation, or subjects' participation in the research.
- •Abnormal laboratory tests that may affect subjects participating in the research.
- •Combined use of prohibited drugs.
- •Allergic to ingredient or component of the experimental drug.
- •Participated in other clinical trials within 1 month before randomization.
- •Pregnant or nursing women.
- •History of drug abuse, drug use and/or excessive drinking within 1 year before screening.
- •The investigators determined that other conditions were inappropriate for participation in this clinical trial.
研究组 & 干预措施
Treatment group A: HR091506 tablets + placebo of febuxostat tablets
Experimental
干预措施: HR091506 tablets + placebo of febuxostat tablets (Drug)
Treatment group B: febuxostat tablets + placebo of HR091506 tablets
Active Comparator
干预措施: febuxostat tablets + placebo of HR091506 tablets (Drug)
结局指标
主要结局
The proportion of subjects with serum uric acid level < 360 μmoL/L at Week 28
时间窗: Week 28
次要结局
- Proportion of subjects with serum uric acid level < 360 μmol/L at each visit.(at week 4,8,12,16,20and24 after administration)
- Proportion of subjects with serum uric acid level < 300 μmol/L at each visit(at week 4,8,12,16,20,24and28 after administration)
- Change of serum uric acid level from baseline to every visit(at week 4,8,12,16,20,24 and28 after administration)
- Proportion of subjects with ≥1 gout flare during treatment stage(during treatment stage)
研究者
研究点 (1)
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