This study will assess the serum uric acid lowering effects and safety of lesinurad over a long-term timeframe.
Full Title of Study: “A Long-Term Open-Label Extension Study for Subjects Completing a Phase 3 Efficacy and Safety Study of Lesinurad Monotherapy in Subjects With Gout”
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: April 2014
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.
- Drug: lesinurad
- Tablets, 400 mg QD
Arms, Groups and Cohorts
- Experimental: lesinurad 400 mg
Clinical Trial Outcome Measures
- Proportion of Subjects With a Serum Urate (sUA) Level That is < 6.0 mg/dL
- Time Frame: Month 1
- Incidence of Treatment-emergent Adverse Events (TEAEs)
- Time Frame: Up to approximately 2 years
Participating in This Clinical Trial
- 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 Study RDEA594-303 and was actively receiving and tolerating study medication (lesinurad or placebo) at Month 6 visit.
- Subject is willing to adhere to the visit/protocol schedules.
- Subject is male or female; female subjects of childbearing potential must agree to use an effective non-hormonal method of birth control during the study and for at least 14 days after the last dose of study medication.
- Subject has any other 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.
- Subject has a past medical history of urolithiasis, nephrolithiasis, or kidney stone diathesis.
- Subject developed kidney stones during Study RDEA594-303
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 85 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Ardea Biosciences, Inc.
- Provider of Information About this Clinical Study
- Overall Official(s)
- Chris Storgard, MD, Study Director, Ardea Biosciences, Inc.
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