Trials / Completed
CompletedNCT01001338
Allopurinol Combination Study
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 227 (actual)
- Sponsor
- Ardea Biosciences, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RDEA594 | Uricosuric agent for the treatment of gout. |
| DRUG | Placebo | Matching Placebo |
| DRUG | Allopurinol | Allopurinol |
Timeline
- Start date
- 2009-10-01
- Primary completion
- 2011-01-01
- Completion
- 2016-08-01
- First posted
- 2009-10-26
- Last updated
- 2017-01-24
Locations
44 sites across 6 countries: United States, Canada, Poland, Spain, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT01001338. Inclusion in this directory is not an endorsement.