Conditions: Gout
Keywords: Gout
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 196
Healthy volunteers: no

Brief summary:
This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with febuxostat over a long-term timeframe.

Detailed description:
This is a Phase 3 extension study to assess the long-term efficacy and safety of lesinurad in combination with febuxostat in subjects who completed the double-blind treatment period in Study RDEA594-304.

Arms:
arm 1: Patients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 3, dated 07 October 2015. arm 2: None

Interventions: intervention 1: lesinurad intervention 2: lesinurad intervention 3: febuxostat
Intervention descriptions: intervention 1: Tablets, 400 mg once daily (QD) intervention 2: Tablets, 200 mg QD intervention 3: Tabletsm 80 mg QD

Protocol document: