Clinical Study of HR091506 Tablets in Treatment of Gout With Hyperuricemia in Adults (NCT06139393) | Clinical Trial Compass
CompletedPhase 3
Clinical Study of HR091506 Tablets in Treatment of Gout With Hyperuricemia in Adults
China765 participantsStarted 2023-12-14
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;
✓. BMI: 18.0-30.0 kg/m2;
✓. Meet the 2015 ACR/EULAR gout classification criteria;
✓. Fast serum uric acid ≥ 480 μmol/L on 2 different days during the screening perid;
✓. 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.
✕
What they're measuring
1
The proportion of subjects with serum uric acid level < 360 μmoL/L at Week 28