At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 610 enrolled
Drug / intervention
Lesinurad +3 moredrug
Likely dose
Lesinurad 200 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, 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 610 participants across 175 sites in 11 countries.
Detailed Summary
This study will 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
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGout
CountriesAustralia, Belgium, Canada, Germany, New Zealand, Poland, South Africa, Spain, Switzerland, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2011
First PostedDec 2011
Primary CompletionMay 2014
Study CompletionJul 2014
TodayJul 2026
First PostedDec 16, 2011
Enrollment StartDec 1, 2011
Primary CompletionMay 1, 2014
Study CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 14.5 years ago
Interventions
Lesinuraddrug
Tablets, 200 mg QD
Lesinuraddrug
Tablets, 400 mg QD
Placebodrug
Tablets, Placebo QD
Allopurinoldrug
Tablets