Lesinurad and Allopurinol Combination Extension Study in Gout
- Registration Number
- NCT01808131
- Lead Sponsor
- Ardea Biosciences, Inc.
- Brief Summary
This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with allopurinol 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 allopurinol in subjects who completed the double-blind treatment period in Studies RDEA594-301 and RDEA594-302.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 717
Inclusion Criteria
- Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study related activity.
- Subject completed the double-blind treatment period in either Study RDEA594-301 or RDEA594-302 and was actively receiving and tolerating study medication (lesinurad or placebo) and allopurinol at the Month 12 visit.
- Subject is male or female; female subjects of childbearing potential must agree to use an effective non-hormonal method of birth
Exclusion Criteria
- Subject has any medical or psychological condition, which in the opinion of the Investigator and/or the Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description lesinurad 200 mg + allopurinol Lesinurad - lesinurad 400 mg + allopurinol Lesinurad Patients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 4, dated 07 October 2015.
- Primary Outcome Measures
Name Time Method Proportion of subjects with an sUA level that is < 6.0 mg/dL up to a total of 5 years
- Secondary Outcome Measures
Name Time Method Resolution of at least 1 target tophi Up to Month 12