This study is to examine the hypothesis that administration of RDEA3170 to Japanese patients with gout or asymptomatic hyperuricemia in doses of 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg once daily, respectively will result in greater reduction of sUA compared to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
204
Research Site
Chofu-shi, Japan
Research Site
Fukuoka, Japan
Research Site
Fukuoka, Japan
Research Site
Percent Changes of Serum Uric Acid Levels From Baseline Levels
The primary objective of the study is to compare percent changes of serum uric acid levels from baseline levels after 16 weeks of dosing between RDEA3170 treatment groups and the placebo treatment group.
Time frame: Baseline and Week 16
Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL
To compare the percentage of subjects whose serum uric acid levels are ≤ 6.0 mg/dL between RDEA3170 treatment groups and the placebo treatment group at each study visit
Time frame: Weeks 1,2,4,6,8,10,12,16,18,20,24
Percent Change in sUA
To compare percent change in sUA at each study visit.
Time frame: Baseline, Weeks 1,2,4,6,8,10,12,16,18,20,24
Absolute Change of Serum Uric Acid Levels From Baseline Levels
To compare the absolute change of serum uric acid levels from baseline levels
Time frame: Baseline, Weeks 1,2,4,6,8,10,12,16,18,20,24
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Fukuoka, Japan
Research Site
Kitakyushu-shi, Japan
Research Site
Matsudo-shi, Japan
Research Site
Noda, Japan
Research Site
Ōta-ku, Japan
Research Site
Saitama-shi, Japan
Research Site
Sendai, Japan
...and 4 more locations