To compare the proportion of subjects whose serum urate (sUA) level is \< 6.0 mg/dL after 28 days of dosing by treatment group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
123
Unnamed facility
Los Angeles, California, United States
Unnamed facility
DeLand, Florida, United States
To compare the proportion of subjects whose serum urate (sUA) level is < 6.0 mg/dL after 28 days of dosing by treatment group.
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 weekly study visit during the Double-Blind Period.
Time frame: 28 Days
To evaluate the absolute and percent reduction from baseline in sUA levels at each weekly study 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 subjects with gout.
Time frame: 28 Days and through extension
To evaluate the proportion of subjects whose sUA level decreases to or is maintained at <6.0 mg/dL in the Open-Label Extension Period.
Time frame: 18 Months
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Unnamed facility
Winston-Salem, North Carolina, United States
Unnamed facility
Jackson, Tennessee, United States
Unnamed facility
Pleven, Bulgaria
Unnamed facility
Plovdiv, Bulgaria
Unnamed facility
Plovidv, Bulgaria
Unnamed facility
Sofia, Bulgaria
Unnamed facility
Sofia, Bulgaria
Unnamed facility
Varna, Bulgaria
...and 19 more locations