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
765
HR091506 tablets 20mg qd + placebo of febuxostat tablets 20mg qd from Week 1 to 4, HR091506 tablets 40mg qd + placebo of febuxostat tablets 40mg qd from Week 5 to 28.
febuxostat tablets 20mg qd + placebo of HR091506 tablets 20mg qd from Week 1 to 4, febuxostat tablets 40mg qd + placebo of HR091506 tablets 40mg qd from Week 5 to 28.
Peking University First Hospital
Beijing, Beijing Municipality, China
The proportion of subjects with serum uric acid level < 360 μmoL/L at Week 28
Time frame: Week 28
Proportion of subjects with serum uric acid level < 360 μmol/L at each visit.
Time frame: at week 4,8,12,16,20and24 after administration
Proportion of subjects with serum uric acid level < 300 μmol/L at each visit
Time frame: at week 4,8,12,16,20,24and28 after administration
Change of serum uric acid level from baseline to every visit
Time frame: at week 4,8,12,16,20,24 and28 after administration
Proportion of subjects with ≥1 gout flare during treatment stage
Time frame: during treatment stage
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