SHR4640 tablets is a highly selective and potent URAT1 inhibitors. The study is being conducted to evaluate the efficacy, and safety of SHR4640 tablet combined with 40 mg/d febuxostat tablet in reducing uric acid in subjects with primary gout and hyperuricemia The primary purpose of the study is to evaluate the efficacy and safety of the combination of SHR4640 and 40 mg/d febuxostat compared with 60 mg/d febuxostat in primary gout and hyperuricemia subjects with inadequate control on 40 mg/d febuxostat for 12 weeks.
Voluntarily signed the informed consent, understood the procedures and methods of the study, and was willing to complete the study strictly in accordance with the clinical trial protocol;
The screening age should be 18-75 years old (including both ends), male or female;
Receive febuxostat at a stable dose of 40 mg/day for ≥6 weeks before randomization; have a fasting serum uric acid level ≥390 µmol/L at the first measurement, and a repeat fasting serum uric acid level ≥360 µmol/L after taking febuxostat 40 mg/day stably for ≥2 weeks during screening and run-in period,;
Meet the gout classification criteria formulated by the American College of Rheumatology (ACR) in 1977 or the joint gout classification criteria formulated by the American College of Rheumatology and the European League Against Rheumatism (ACR/EULAR) in 2015;
Pregnant or lactating women;
Females of childbearing potential or males (except those whose partners are infertile) who refuse to use or use medically unapproved highly effective contraceptive measures within 6 months (for females) or 3 months (for males) from screening to the last dose of study medication;
Average daily alcohol intake exceeding 14 g for females (e.g., 145 mL of wine, 497 mL of beer, or 43 mL of low-alcohol liquor) or exceeding 28 g for males (e.g., 290 mL of wine, 994 mL of beer, or 86 mL of low-alcohol liquor) within 1 month before screening;
Drug abusers;
Parallel
SHR4640 ；Febuxostat
DrugSHR4640 high dose + Febuxostat
SHR4640 ; Febuxostat
DrugSHR4640 low dose + Febuxostat
SHR4640
DrugSHR4640 high dose
SHR4640
DrugSHR4640 low dose
Febuxostat
DrugFebuxostat
The proportion of subjects with serum uric acid levels of ≤360 μmol/L at week 12
Proportion of subjects with serum uric acid levels ≤300 μmol/L at week 12;
Proportion of subjects with serum uric acid levels ≤360 μmol/L at the last two test at week 12;
Proportion of subjects with serum uric acid levels ≤360 μmol/L at week 24;
Proportion of subjects with serum uric acid levels ≤300 μmol/L at week 24;
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