Clinical Trial: A Study of RDEA806 in Hyperuricemic Subjects With Symptomatic Gout
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Randomized, Double-Blind, Multicenter,Placebo-Controlled, Dose Ranging, Efficacy and Safety Study of RDEA806 in Hyperuricemic Subjects With Symptomatic Gout
Brief Summary: The purpose of this study is to determine whether RDEA806 is effective in the treatment of hyperuricemia in gout patients.
Detailed Summary:
Sponsor: Ardea Biosciences, Inc.
Current Primary Outcome: To compare the proportion of subjects whose serum uric acid (sUA) level is <6.0 mg/dL following 4 weeks of continuous treatment with RDEA806. [ Time Frame: 4 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 visit. [ Time Frame: 4 weeks ]
- To evaluate the absolute and percent reduction from baseline in sUA levels [ Time Frame: 4 weeks ]
- To evaluate percent change in 24-hour urine uric acid level [ Time Frame: 4 weeks ]
Original Secondary Outcome: Same as current
Information By: Ardea Biosciences, Inc.
Dates:
Date Received: August 25, 2008
Date Started: July 2008
Date Completion:
Last Updated: January 7, 2014
Last Verified: January 2014
