To compare the proportion of subjects whose serum urate (sUA) levels are \< 6.0 mg/dL following 4 weeks of continuous treatment of RDEA594 in combination with allopurinol to allopurinol alone in subjects with documented inadequate hypouricemic response with standard doses of allopurinol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
227
Uricosuric agent for the treatment of gout.
Matching Placebo
Allopurinol
To compare the percent reduction from baseline in serum urate levels following 4 wks of continuous treatment of RDEA594 in combination with allopurinol to allopurinol alone in subjects with documented inadequate hypouricemic response.
Time frame: 28 days
To evaluate the proportion of subjects whose sUA levels are < 6.0 mg/dL, < 5.0 mg/dL and < 4.0 mg/dL at each study visit by treatment group in all subjects and in subjects who have an sUA ≥6 mg/dL at the baseline visit.
Time frame: 28 days and through extension
To evaluate the absolute and percent reduction from baseline in sUA levels at each visit.
Time frame: 28 days and through extension
To evaluate the percentage change in 24-hour urine urate level (excretion) from baseline to Day 28.
Time frame: 28 days and through extension
To evaluate the incidence of gout flares.
Time frame: 28 days and through extension
To evaluate the safety and tolerability of RDEA594 in combination with allopurinol in subjects with gout.
Time frame: 28 days and through extension
To compare the multiple-dose pharmacokinetics (PK) of allopurinol and oxypurinol in the absence versus presence of RDEA594 co-administration.
Time frame: 28 days
To evaluate the proportion of subjects whose sUA level decreases to or is maintained at <6.0 mg/dL and <5.0 mg/dL in the Double-Blind and Open-Label Extension Period.
Time frame: 3 years
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Phoenix, Arizona, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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Stanford, California, United States
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Boca Raton, Florida, United States
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DeLand, Florida, United States
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Fort Lauderdale, Florida, United States
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Jupiter, Florida, United States
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Meridan, Idaho, United States
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Lexington, Kentucky, United States
...and 34 more locations