Not Yet RecruitingPhase 3

Clinical Trial of HR091506 Tablets in Treatment of Gout With Hyperuricemia in Adults

434 participantsStarted 2024-06

Plain-language summary

The study is being conducted to evaluate the efficacy, and safety of HR091506 tablets for treatment of gout with hyperuricemia in adults, and to compare the results with febuxostat tablets in the same doses.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 18-75 years old, male or female;
✓. Meet the 2015 ACR/EULAR gout classification criteria;
✓. Fast serum uric acid ≥ 480 μmol/L on 2 different days during the screening perid;
✓. Patients with tophi, chronic arthropathy, frequent attacks;
✓. Willing to ues contraceptive measures during the study;
✓. Able and willing to provide a written informed consent.

Exclusion criteria

✕. History of acute gout attack within 4 weeks before randomization.
✕. Subjects who have undergone major surgery or organ transplantation within 3 months before randomization.
✕. Subjects with major cardiovascular disease within 6 months before randomization.
✕. History of chronic infection or recurrent infection within 1year before randomization.
✕. History of malignant tumor or current history of combined malignant tumor within 5 years before screening.
✕. History of secondary hyperuricemia, refractory gout, or xanthine metabolism disorder.
✕. Subjects with poorly controlled blood pressure or diabetes mellitus.
✕. History of chronic diffuse connective tissue disease and/or massively elevated urate diseases and/or untreated clinically significant thyroid disease.

What they're measuring

The proportion of subjects with serum uric acid level < 300 μmoL/L at Week 36

Timeframe: Week 36

Trial details

NCT IDNCT06414837

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06

Contact for this trial

Ninghui Yan

+0518-82342973 ninghui.yan@hengrui.com

View on ClinicalTrials.gov More Gout With Hyperuricemia in Adults trials