drugset / Trial / NCT07362355
The Efficacy and Safety of SHR4640 Tablet Combined With 40 mg Febuxostat Tablets in the Treatment of Primary Gout and Hyperuricemia
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2026-02-09
- Primary completion
- 2027-07
- Completion
- 2027-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Febuxostat | Small molecule | 40 mg | — |
| Comparator | Febuxostat | Small molecule | 60 mg | — |
| Subject | SHR4640 | Small molecule | — | — |