Trials / Completed
CompletedNCT01808131
Lesinurad and Allopurinol Combination Extension Study in Gout
A Long-Term Extension Study of Lesinurad in Combination With Allopurinol for Subjects Completing an Efficacy and Safety Study of Lesinurad and Allopurinol
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 717 (actual)
- Sponsor
- Ardea Biosciences, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with allopurinol over a long-term timeframe.
Detailed description
This is a Phase 3 extension study to assess the long-term efficacy and safety of lesinurad in combination with allopurinol in subjects who completed the double-blind treatment period in Studies RDEA594-301 and RDEA594-302.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lesinurad | Tablets, 200 mg QD |
| DRUG | Lesinurad | Tablets, 400 mg QD |
Timeline
- Start date
- 2013-02-01
- Primary completion
- 2016-08-01
- Completion
- 2016-11-01
- First posted
- 2013-03-11
- Last updated
- 2017-01-24
Locations
207 sites across 11 countries: United States, Australia, Belgium, Canada, Germany, New Zealand, Poland, South Africa, Spain, Switzerland, Ukraine
Source: ClinicalTrials.gov record NCT01808131. Inclusion in this directory is not an endorsement.