This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with allopurinol over a long-term timeframe.
Full Title of Study: “A Long-Term Extension Study of Lesinurad in Combination With Allopurinol for Subjects Completing an Efficacy and Safety Study of Lesinurad and Allopurinol”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: August 2016
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.
- Drug: Lesinurad
- Tablets, 200 mg QD
- Drug: Lesinurad
- Tablets, 400 mg QD
Arms, Groups and Cohorts
- Experimental: lesinurad 200 mg + allopurinol
- Experimental: lesinurad 400 mg + allopurinol
- Patients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 4, dated 07 October 2015.
Clinical Trial Outcome Measures
- Proportion of subjects with an sUA level that is < 6.0 mg/dL
- Time Frame: up to a total of 5 years
- Resolution of at least 1 target tophi
- Time Frame: Up to Month 12
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 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
- 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.
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)
- Nihar Bhakta, MD, Study Director, Ardea Biosciences, Inc.
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