NCT04052932已完成3 期
A Phase3, Multicentre, Randomized, Double-Blind, Allopurinol and Placebo-Controlled Study to Evaluate the Efficacy and Safety of SHR4640 Monotherapy in Subjects With Gout
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
- 594
- 试验地点
- 1
- 主要终点
- Proportion of subjects with a serum uric level≤360μmol/l.
研究概览
简要总结
This study will assess the serum uric acid lowering effects and safety of SHR4640 compared to placebo and Allopurinol in patients with gout
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
- •Subject who met 1977 or 2015 ACR (American College of Rheumatology) classification of Gout and has a serum acid ≥ 480 μmol/L at screening;
- •18 kg/m2 ≤Body mass index (BMI)≤ 35 kg/m2
排除标准
- •Subject who is pregnant or breastfeeding;
- •Alanine aminotransferase or Aspartate aminotransferase or total bilirubin>1.5 upper normal limit;
- •Subject with a positive test for HLA-B*5801;
- •Estimated glomerular filtration rate (MDRD formula) <60ml/min;
- •Subject with known hypersensitivity or allergy to SHR4640 and allopurinal, or any component of SHR4640;
- •Subject with kidney stones or suspicion of kidney stones;
- •Subject who has acute gout flares within 2 weeks before randomization;
- •Subject with a history of malignancy within the previous 5 years;
- •Subject with a history of active peptic ulcer within a year;
- •Subject with a history of xanthine urine.
研究组 & 干预措施
Allopurinol
Active Comparator
Allopurinol 300mg (milligram) once a day, Orally, for 36 week
干预措施: Allopurinol 300 MG (Drug)
Placebo
Placebo Comparator
Placebo once a day, orally, for 12 weeks, followed by SHR4640 treatment to 36 weeks
干预措施: Placebo oral tablet (Drug)
SHR4640 dose1
Experimental
SHR4640 dose1 once a day, orally, for 36 weeks
干预措施: SHR4640 dose1 (Drug)
SHR4640 dose2
Experimental
SHR4640 dose2 once a day, orally, for 36 weeks
干预措施: SHR4640 dose2 (Drug)
结局指标
主要结局
Proportion of subjects with a serum uric level≤360μmol/l.
时间窗: Week 12
Proportion of subjects with a serum uric level≤360μmol/l.
次要结局
- Proportion of subjects with a serum uric level≤360μmol/l(Up to 36 weeks)
- Percentage change from baseline in serum uric level(Up to 36 weeks)
- Actual change from baseline in serum uric level(Up to 36 weeks)
研究者
研究点 (1)
Loading locations...
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