UnknownPhase 2

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

129 participantsStarted 2022-09-15

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Voluntarily signed the informed consent, understood the procedures and methods of the study, and was willing to complete the study strictly in accordance with the clinical trial protocol;
✓. The screening age should be 18-65 years old (including both ends), male or female; 3. Receiving febuxostat dose ≥40mg/ day, not more than 80mg/ day, stable dose for ≥6 weeks, fasting serum uric acid ≥390µmol/L at screening; 4. Meet the 1977 or 2015 American College of Rheumatology (ACR) criteria for classification of gout; 5、18kg/m2≤ Body weight Mass index (BMI) ≤35kg/m2.

Exclusion criteria

✕. General Situation:
✕. The following conditions occurred in the laboratory examination within 3 weeks before randomization:
✕. Any of the following medical history or comorbidities:
✕. Use any of the following drugs or participate in clinical trials:

What they're measuring

Proportion of subjects with serum uric acid ≤360μmol/L

Timeframe: After 12 weeks of treatment

Trial details

NCT IDNCT05513976

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-05-30

Contact for this trial

Wangwang Zhi

+86 18036618683 Wangwang.zhi@hengrui.com.cn

View on ClinicalTrials.gov More Primary Gout and Hyperuricemia trials