A phase 3 clinical trial to compare and evaluate efficacy and safety of epaminurad with febuxostat in gout patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
612
Epaminurad 6 mg tablet
Epaminurad 9 mg tablet
Febuxostat 40 mg tablet
Inha University Hospital
Incheon, South Korea
Proportion of subjects with sUA (serum uric acid) <6 mg/dL at the last 3 time points during the main study period
Time frame: Week 24
Proportion of subjects with sUA <6 mg/dL post-dose at each visit
Time frame: up to Week 24
Proportion of subjects with sUA <5 mg/dL at the last 3 time points
Time frame: Week 16, 20, 24
Proportion of subjects with sUA <5 mg/dL post-dose at each visit
Time frame: up to Week 24
Change from baseline in sUA (mg/dL) at each visit
Time frame: up to Week 24
Percent change from baseline in sUA at each visit
Time frame: up to Week 24
Incidence of gout flare post-dose up to Week 24
Time frame: up to Week 24
Proportion of subjects who had rescue therapy for gout flare post-dose up to Week 24
Time frame: up to Week 24
Adverse events
Safety endpoint
Time frame: up to Week 52
Number of subjects with clinical significant results of Laboratory tests
Safety endpoint
Time frame: up to Week 52
Number of subjects with clinical significant results of Vital signs
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Febuxostat 80 mg tablet
Placebo tablet
Placebo tablet
Placebo tablet
Placebo tablet
Safety endpoint
Time frame: up to Week 52
Number of subjects with clinical significant results of Electrocardiogram
Safety endpoint
Time frame: up to Week 52