The objective of the study is to assess efficacy and safety of SHR4640 in subjects with hyperuricemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
198
Placebo once daily for 5 weeks
1mg SHR4640 once daily for a week, 2.5mg, 5mg or 10mg SHR4640 once daily for 4 weeks
25mg benzbromarone once daily for a week, 50mg benzbromarone once daily for 4 weeks
Jiangsu Hengrui Medicine Co., Ltd.
Shanghai, Shanghai Municipality, China
Proportion of subjects with a serum uric level≤360μmol/l.
Time frame: Week 5
Actual change from baseline in serum uric level.
Time frame: Week 5
Percentage change from baseline in serum uric level .
Time frame: Week 5
Rate of gout flares requiring treatment.
Time frame: Up to week 5
Incidence of gout flares requiring treatment.
Time frame: Up to week 5
Proportion of subjects with a serum uric level≤360μmol/l
Time frame: At week1, 2, 3 and 4
Proportion of subjects with a serum uric level consistent ≤360μmol/l
Time frame: At week 3, 4 and 5
Actual change from baseline in serum uric level
Time frame: At week 1, 2, 3 and 4
Percentage change from baseline in serum uric level
Time frame: At week 1, 2, 3 and 4
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