Trials / Completed
CompletedNCT01650246
Open-Label Lesinurad Monotherapy Extension Study in Gout
A Long-Term Open-Label Extension Study for Subjects Completing a Phase 3 Efficacy and Safety Study of Lesinurad Monotherapy in Subjects With Gout
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 143 (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 over a long-term timeframe.
Detailed description
This is a Phase 3, open-label, uncontrolled, extension study to assess the long-term efficacy and safety of lesinurad monotherapy in subjects who completed the double-blind treatment period in Study RDEA594-303.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | lesinurad | Tablets, 400 mg QD |
Timeline
- Start date
- 2012-08-01
- Primary completion
- 2014-04-01
- Completion
- 2014-08-01
- First posted
- 2012-07-26
- Last updated
- 2016-05-26
- Results posted
- 2016-05-26
Locations
75 sites across 7 countries: United States, Australia, Belgium, Canada, Germany, New Zealand, South Africa
Source: ClinicalTrials.gov record NCT01650246. Inclusion in this directory is not an endorsement.