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

NCT07362355 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2026-04-07

No results posted yet for this study

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.

Conditions

  • Primary Gout and Hyperuricemia

Interventions

DRUG

SHR4640 ；Febuxostat

SHR4640 high dose + Febuxostat

DRUG

SHR4640 ; Febuxostat

SHR4640 low dose + Febuxostat

DRUG

SHR4640

SHR4640 high dose

DRUG

SHR4640

SHR4640 low dose

DRUG

Febuxostat

Febuxostat

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-09
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07362355 on ClinicalTrials.gov