Study identifier:RDEA594-202
ClinicalTrials.gov identifier:NCT00955981
EudraCT identifier:N/A
CTIS identifier:N/A
Randomized, Double-Blind, Multicenter, Placebo-Controlled, Safety and Efficacy Study of RDEA594 Versus Placebo in the Treatment of Hyperuricemia in Patients with Gout
Hyperuricemia
Phase 2
No
RDEA594, Placebo
All
123
Interventional
18 Years - 75 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Jan 2017 by Ardea Biosciences, Inc.
Ardea Biosciences, Inc.
-
To compare the proportion of subjects whose serum urate (sUA) level is < 6.0 mg/dL after 28 days of dosing by treatment group.
Location
Location
Toronto, ON, Canada, M9W 4L6
Location
Mirabel, Quebec, Canada, J7J 2K8
Location
Coquitlam, BC, Canada, V3K 3P4
Location
Thornhill, Ontario, Canada, L4J6W6
Location
Kelowna, British Columbia, Canada, V1Y8E7
Location
Lodz, Poland, 90-153
Location
Lublin, Poland, 20-607
Location
Wroclaw, Poland, 53-025
Arms | Assigned Interventions |
---|---|
Experimental: RDEA594 200 mg qd for 28 days | Drug: RDEA594 Uricosuric agent for the treatment of gout |
Experimental: RDEA594 200 mg, 400 mg RDEA594 200 mg qd for 7 days followed by 400 mg qd for 21 days | Drug: RDEA594 Uricosuric agent for the treatment of gout |
Experimental: RDEA594 200 mg, 400 mg and 600 mg RDEA594 200 mg qd for 7 days followed by 400 mg qd for 7 days followed by 600 mg qd for 14 days | Drug: RDEA594 Uricosuric agent for the treatment of gout |
Placebo Comparator: Matching placebo RDEA594 matching placebo qd for 28 days | Drug: Placebo Matching placebo |
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