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

NCT05513976 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2022-08-24

No results posted yet for this study

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

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

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
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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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 NCT05513976 on ClinicalTrials.gov