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| Sponsor: | Ardea Biosciences, Inc. |
|---|---|
| Information provided by (Responsible Party): | Ardea Biosciences, Inc. |
| ClinicalTrials.gov Identifier: | NCT01001338 |
Purpose
To compare the proportion of subjects whose serum urate (sUA) levels are < 6.0 mg/dL following 4 weeks of continuous treatment of RDEA594 in combination with allopurinol to allopurinol alone in subjects with documented inadequate hypouricemic response with standard doses of allopurinol.
| Condition | Intervention | Phase |
|---|---|---|
|
Gout |
Drug: RDEA594 Drug: Placebo Drug: Allopurinol |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Randomized, Double-Blind, Multicenter, Placebo-Controlled, Combination Study to Evaluate the Safety, Efficacy and Potential Pharmacokinetic Interaction of RDEA594 and Allopurinol in Gout Patients With an Inadequate Hypouricemic Response With Standard Doses of Allopurinol |
| Estimated Enrollment: | 216 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | March 2013 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: RDEA594 200 mg qd
RDEA594 200 mg qd plus allopurinol qd
|
Drug: RDEA594
Uricosuric agent for the treatment of gout.
Drug: Allopurinol
Allopurinol
|
|
Experimental: RDEA594 200 mg, 400 mg qd
RDEA594 200 mg then 400 mg qd plus allopurinol qd
|
Drug: RDEA594
Uricosuric agent for the treatment of gout.
Drug: Allopurinol
Allopurinol
|
|
Placebo Comparator: Matching Placebo
RDEA594 matching placebo qd plus allopurinol qd.
|
Drug: Placebo
Matching Placebo
|
|
Experimental: RDEA594 600 mg qd
RDEA594 200 mg then 400 mg then 600 mg plus allopurinol qd
|
Drug: RDEA594
Uricosuric agent for the treatment of gout.
Drug: Allopurinol
Allopurinol
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 51 Study Locations| Study Director: | Vijay Hingorani, MD, PhD, MBA | Ardea Biosciences, Inc. |
More Information
| Responsible Party: | Ardea Biosciences, Inc. |
| ClinicalTrials.gov Identifier: | NCT01001338 History of Changes |
| Other Study ID Numbers: | RDEA594-203 |
| Study First Received: | October 22, 2009 |
| Last Updated: | December 21, 2011 |
| Health Authority: | Canada: Health Canada; Georgia: Ministry of Health; Poland: Ministry of Health; Spain: Spanish Agency of Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Ukraine: Ministry of Health; United States: Food and Drug Administration |
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Gout Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Metabolic Diseases Allopurinol Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Gout Suppressants Antirheumatic Agents Therapeutic Uses Free Radical Scavengers Antioxidants Antimetabolites Protective Agents Physiological Effects of Drugs |