NCT05513976

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

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR4640 Tablets Combined With Febuxostat Tablets in the Treatment of Primary Gout and Hyperuricemia Subjects With Inadequate Control on Febuxostat

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 129 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Gout and Hyperuricemia

Interventions

Type	Name	Description
DRUG	SHR4640 tablet	SHR4640 tablet 5mg
DRUG	SHR4640 tablet	SHR4640 tablet 10mg
DRUG	febuxostat tablet	febuxostat tablet 40mg or 60mg or 80mg based on prior medication
DRUG	SHR4640 placebo tablet	SHR4640 placebo tablet 5 or 10mg

Timeline

• Start date: 2022-09-15
• Primary completion: 2023-05-30
• Completion: 2023-09-20
• First posted: 2022-08-24
• Last updated: 2022-08-24