At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 214 enrolled
Drug / intervention
lesinurad +1 moredrug
Likely dose
lesinurad 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Randomized, Double-Blind, Multicenter, Placebo- Controlled Study to Assess the Efficacy and Safety of Lesinurad Monotherapy Compared to Placebo in Subjects With Gout and an Intolerance or Contraindication to a Xanthine Oxidase Inhibitor
In Brief
A Phase 3 clinical trial evaluating lesinurad and Placebo for Gout. Completed, enrolled 214 participants across 106 sites in 7 countries.
Detailed Summary
This study will assess the serum uric acid lowering effects and safety of lesinurad compared to placebo in patients who are intolerant or have a contraindication to allopurinol or febuxostat.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGout
CountriesAustralia, Belgium, Canada, Germany, New Zealand, South Africa, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2012
First PostedJan 2012
Primary CompletionOct 2013
Study CompletionNov 2013
TodayJul 2026
First PostedJan 12, 2012
Enrollment StartJan 1, 2012
Primary CompletionOct 1, 2013
Study CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.5 years ago
Interventions
lesinuraddrug
Tablets, 400 mg QD
Placebodrug
Tablets, Placebo QD