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Sponsored by: |
Ardea Biosciences, Inc. |
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Information provided by: | Ardea Biosciences, Inc. |
ClinicalTrials.gov Identifier: | NCT00955981 |
To compare the proportion of subjects whose serum urate (sUA) level is < 6.0 mg/dL after 28 days of dosing by treatment group.
Condition | Intervention | Phase |
---|---|---|
Hyperuricemia |
Drug: RDEA594 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Double-Blind, Multicenter, Placebo-Controlled, Safety and Efficacy Study of RDEA594 Versus Placebo in the Treatment of Hyperuricemia in Patients With Gout |
Estimated Enrollment: | 140 |
Study Start Date: | July 2009 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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RDEA594 200 mg qd for 28 days: Experimental |
Drug: RDEA594
Uricosuric agent for the treatment of gout
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RDEA594 200 mg, 400 mg: Experimental
RDEA594 200 mg qd for 7 days followed by 400 mg qd for 21 days
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Drug: RDEA594
Uricosuric agent for the treatment of gout
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RDEA594 200 mg, 400 mg and 600 mg: Experimental
RDEA594 200 mg qd for 7 days followed by 400 mg qd for 7 days followed by 600 mg qd for 14 days
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Drug: RDEA594
Uricosuric agent for the treatment of gout
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Matching placebo: Placebo Comparator
RDEA594 matching placebo qd for 28 days
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Drug: Placebo
Matching placebo
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jody Welp | 858.652.6641 | jwelp@ardeabio.com |
Canada, British Columbia | |
Recruiting | |
Coquitlam, British Columbia, Canada, V3K 3P4 | |
Recruiting | |
Kelowna, British Columbia, Canada, V1Y8E7 | |
Canada, Manitoba | |
Recruiting | |
Winnipeg, Manitoba, Canada, R3A1M3 | |
Canada, Ontario | |
Recruiting | |
Toronto, Ontario, Canada, M9W 4L6 | |
Recruiting | |
Thornhill, Ontario, Canada, L4J6W6 | |
Canada, Quebec | |
Recruiting | |
Mirabel, Quebec, Canada, J7J 2K8 | |
Georgia | |
Recruiting | |
Tbilisi, Georgia, 0186 | |
Recruiting | |
Tbilisi, Georgia, 0102 |
Responsible Party: | Ardea Biosciences, Inc. ( Kimberly J. Manhard ) |
Study ID Numbers: | RDEA594-202 |
Study First Received: | August 7, 2009 |
Last Updated: | August 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00955981 History of Changes |
Health Authority: | Canada: Health Canada; Georgia: Ministry of Health |
Hyperuricemia Gout |
Pathologic Processes Hyperuricemia |