NCT04956432已完成3 期
A Multicentre, Randomized, Double-blind, Allopurinol Controlled Study to Evaluate the Efficacy and Safety of SHR4640 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
- 779
- 试验地点
- 1
- 主要终点
- Proportion of subjects with a serum uric acid level≤360 μmol/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 Allopurinol in subjects 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
- Double (Participant, Investigator)
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; 2、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 allopurinol, 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
Treatment group A
Experimental
SHR4640+Allopurinol Placebo；once a day, orally, for 52 weeks
干预措施: SHR4640 (Drug)
Treatment group B
Active Comparator
Allopurinol+ SHR4640 Placebo；once a day, orally, for 52 weeks.
干预措施: Allopurinol (Drug)
结局指标
主要结局
Proportion of subjects with a serum uric acid level≤360 μmol/L
时间窗: Start of Treatment to end of study (approximately 16 weeks)
次要结局
- Percentage change in serum uric acid from baseline at each visit during 16 weeks of treatment(Start of Treatment to end of study (approximately 16 weeks))
- change value of serum uric acid from baseline at each visit within 52 weeks of treatment(Start of Treatment to end of study (approximately 52 weeks))
- proportion of subjects with serum uric acid ≤ 360 μmol/L at each visit within 52 weeks of treatment(Start of Treatment to end of study (approximately 52 weeks))
- serum uric acid value at each visit within 52 weeks of treatment(Start of Treatment to end of study (approximately 52 weeks))
- Absolute changes in serum uric acid from baseline at each visit during 16 weeks of treatment(Start of Treatment to end of study (approximately 16 weeks))
- The proportion of subjects with A serum uric acid level≤ 360 μmol/L at each visit within 16 weeks of treatment(Start of Treatment to end of study (approximately 16 weeks))
- Percentage change of serum uric acid from baseline at each visit within 52 weeks of treatment(Start of Treatment to end of study (approximately 52 weeks))
研究者
研究点 (1)
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