A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Dotinurad Compared With Allopurinol in Adult Participants With Hyperuricemia Associated With Gout
DotinuradPlacebo capsules to match overencapsulated dotinurad tablets and overencapsulated allopurinol tablets contain microcrystalline cellulose in a gelatin capsule.ALLOPURINOLALLOPURINOLALLOPURINOLDotinurad 1mg
Eligibility
Age group
65+ years, 18-64 years
Sex
Female, Male
Primary endpoint
1. Proportion of participants with an sUA level <6.0 mg/dL at Week 24.
Endpoint detail
1. Proportion of participants with an sUA level <6.0 mg/dL at Weeks 16, 20, and 24, inclusive., 2. Mean rate of gout flares requiring treatment from Week 36 through Week 64., 3. Proportion of participants with an sUA level <5.0 mg/dL at Week 24 AND no gout flares requiring treatment from Week 36 through Week 64.
Official registry record
This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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