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01
Overview
Phase 3, randomised, double-blind trial of ruzinurad in gout (4 arms), sponsored by Hengrui. Primary endpoint: Proportion of subjects with a serum uric level ≤360 μmol/L at 12 weeks. Started Jul 2019; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Placebo / Ruzinurad
Placebo QD for 12 weeks, then Ruzinurad QD
Ruzinurad Dose 1
Ruzinurad dose 1 QD for 36 weeks
Ruzinurad Dose 2
Ruzinurad dose 2 QD for 36 weeks
Allopurinol
Allopurinol 300mg QD for 36 weeks
03
Who it enrols
Adult patients with Gout meeting ACR classification and sUA >= 480 μmol/L, without severe renal impairment, liver dysfunction, uncontrolled diabetes, or risk factors for allopurinol hypersensitivity.
04
Endpoints
Primary
Proportion of subjects with a serum uric level ≤360 μmol/L
Secondary
Proportion of subjects with a serum uric level ≤360 μmol/L
Percentage change from baseline in serum uric level
Actual change from baseline in serum uric level
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