This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with febuxostat over a long-term timeframe.
This is a Phase 3 extension study to assess the long-term efficacy and safety of lesinurad in combination with febuxostat in subjects who completed the double-blind treatment period in Study RDEA594-304.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
196
Tablets, 400 mg once daily (QD)
Tablets, 200 mg QD
Tabletsm 80 mg QD
Percentage of Participants With an sUA Level That is < 5.0 mg/dL
Percentage of participants in Study 307 With sUA \< 5.0 mg/dL from the Core Studies 304 and Extension Study 307 - Observed Cases
Time frame: Up to approximately 2.5 years (at Extension Month 12)
Percentage of Participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus
Percentage of participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus During the Core and Extension Studies at Extension Month 12 (Observed Cases)
Time frame: Up to approximatley 2.5 years (at Extension Month 12)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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Birmingham, Alabama, United States
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Tempe, Arizona, United States
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Glendale, California, United States
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Huntington Beach, California, United States
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Irvine, California, United States
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San Diego, California, United States
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Denver, Colorado, United States
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Englewood, Colorado, United States
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Boynton Beach, Florida, United States
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Naples, Florida, United States
...and 62 more locations