This study will assess the serum uric acid lowering effects and safety of lesinurad over a long-term timeframe.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
143
Tablets, 400 mg QD
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
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Glendale, Arizona, United States
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Peoria, Arizona, United States
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Tempe, Arizona, United States
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Carmichael, California, United States
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Covina, California, United States
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Huntington Park, California, United States
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Irvine, California, United States
...and 65 more locations