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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
434
HR091506 tablets 20mg/ 40mg/ 60mg/80mg qd + placebo of febuxostat tablets 20mg/ 40mg/ 60mg/80mg qd, from Week 1 to 36.
febuxostat tablets 20mg/ 40mg/ 60mg/80mg qd + placebo of HR091506 tablets 20mg/ 40mg/ 60mg/80mg qd . from Week 1 to 36.
The proportion of subjects with serum uric acid level < 300 μmoL/L at Week 36
Time frame: Week 36
Proportion of subjects with serum uric acid level < 360 μmol/L at week 4,8,12,16,20,24,28,32,36 after administration
Time frame: at week 4,8,12,16,20,24,28,32,36 after administration
Proportion of subjects with serum uric acid level < 300 μmol/L at week 4,8,12,16,20,24,28,32,36 after administration
Time frame: at week 4,8,12,16,20,24,28,32,36 after administration
Change of serum uric acid level from baseline week 4,8,12,16,20,24,28,32,36 after administration
Time frame: week 4,8,12,16,20,24,28,32,36 after administration
Proportion of subjects with ≥1 gout flare during the 36 weeks treatment stage
Time frame: during the 36 weeks treatment stage
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