Clinical Trial

The Efficacy and Safety of SHR4640 Tablet Combined With 40 mg Febuxostat Tablets in the Treatment of Primary Gout and Hyperuricemia

Recruiting Phase 2
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Summary
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.
Protocol Amendment History 1 change
critical Recruitment opened 2026-04-08
Trial Details
NCT Number NCT07362355
Lead Sponsor Jiangsu HengRui Medicine Co., Ltd.
Conditions Primary Gout and Hyperuricemia
Enrollment 340 participants
Start Date 2026-02-09
Primary Completion 2027-07 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2026-04-07