Open-Label Lesinurad Monotherapy Extension Study in Gout
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This study will assess the serum uric acid lowering effects and safety of lesinurad over a long-term timeframe.
Condition or disease
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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Ages Eligible for Study:
18 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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