The study is being conducted to evaluate the efficacy and safety of HR091506 tablets for treatment of primary 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
90
HR091506 tablets 40mg qd + placebo of febuxostat tablets 40mg qd in Week 1 and 2, HR091506 tablets 80mg qd + placebo of febuxostat tablets 80mg qd in Week 3 and 4
febuxostat tablets 40mg qd + placebo of HR091506 tablets 40mg qd in Week 1 and 2, febuxostat tablets 80mg qd + placebo of HR091506 tablets 80mg qd in Week 3 and 4
The proportion of subjects with serum uric acid level < 360μmol/L on Day 15.
Time frame: on Day 15.
Proportion of subjects with serum uric acid level < 360μmol/L at test of cure (TOC)
Time frame: Test of cure, defined as the day after end of treatment, equivalent to Study Day 15 or 29
The proportion of subjects with serum uric acid level < 300μmol/L on Day 15.
Time frame: on Day 15.
Proportion of subjects with serum uric acid level < 360μmol/L at TOC
Time frame: Test of cure, defined as the day after end of treatment, equivalent to Study Day 15 or 29
The proportion of subjects with serum uric acid level < 360μmol/L on Day 29.
Time frame: on Day 29.
The proportion of subjects with serum uric acid level < 300μmol/L on Day 29.
Time frame: on Day 29.
Change of serum uric acid level from baseline on Day 15
Time frame: from baseline on Day 15
Change of serum uric acid level from baseline on Day 29
Time frame: from baseline on Day 29
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