drugset / Trial / NCT05513976

Clinical Study of SHR4640 Tablets Combined With Febuxostat Tablets in the Treatment of Primary Gout and Hyperuricemia

NCT05513976

Phase 2 Unknown 129 enrolled Jiangsu HengRui Medicine Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

SHR4640 tablets is a highly selective and potent URAT1 inhibitors,study number is SHR4640-203. The primary purpose of the study is to evaluate the efficacy and safety of the combination of SHR4640 and febuxostat compared with placebo and febuxostat in primary gout and hyperuricemia subjects with inadequate control on febuxostat for 12 weeks.

Timeline

Start
2022-09-15
Primary completion
2023-05-30
Completion
2023-09-20

Drugs

EvaluationDrugModalityDoseRoute
Subject SHR4640 Small molecule 5 mg
Subject SHR4640 Small molecule 10 mg
Background Febuxostat Small molecule 40 mg
Background Febuxostat Small molecule 60 mg
Background Febuxostat Small molecule 80 mg

Indications