Open-Label Lesinurad Monotherapy Extension Study in Gout
This study will assess the serum uric acid lowering effects and safety of lesinurad over a long-term timeframe.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Long-Term Open-Label Extension Study for Subjects Completing a Phase 3 Efficacy and Safety Study of Lesinurad Monotherapy in Subjects With Gout|
- Proportion of subjects with an sUA level that is < 6.0 mg/dL [ Time Frame: Up to approximately 2 years ] [ Designated as safety issue: No ]
- Incidence of TEAEs [ Time Frame: Up to approximately 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
This is a Phase 3, open-label, uncontrolled, extension study to assess the long-term efficacy and safety of lesinurad monotherapy in subjects who completed the double-blind treatment period in Study RDEA594-303.
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|Study Director:||Scott Baumgartner, MD||Ardea Biosciences, Inc.|