At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Randomized, Double-Blind, Multicenter, Placebo-Controlled, Combination Study to Evaluate the Efficacy and Safety of Lesinurad and Allopurinol Compared to Allopurinol Alone in Subjects With Gout Who Have Had an Inadequate Hypouricemic Response to Standard of Care Allopurinol.
In Brief
A Phase 3 clinical trial evaluating Lesinurad, Placebo, and 1 other intervention for Gout. Completed, enrolled 607 participants across 165 sites.
Detailed Summary
This study that compare the serum uric acid lowering effects, clinical benefits, and safety of lesinurad in combination with allopurinol to allopurinol alone in subjects with gout who have had an inadequate response to allopurinol.
Study Details
Timeline
Interventions
Tablets, 200 mg once daily (qd)
Tablets, 400 mg qd
Tablets, Placebo qd
Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment)
Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment)
Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment)