Trials / Completed
CompletedNCT01808144
Lesinurad and Febuxostat Combination Extension Study in Gout
A Long-Term Extension Study of Lesinurad in Combination With Febuxostat for Subjects With Gout Completing an Efficacy and Safety Study of Lesinurad and Febuxostat
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 196 (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 febuxostat 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 febuxostat in subjects who completed the double-blind treatment period in Study RDEA594-304.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | lesinurad | Tablets, 400 mg once daily (QD) |
| DRUG | lesinurad | Tablets, 200 mg QD |
| DRUG | febuxostat | Tabletsm 80 mg QD |
Timeline
- Start date
- 2013-03-01
- Primary completion
- 2016-08-09
- Completion
- 2016-10-06
- First posted
- 2013-03-11
- Last updated
- 2018-01-30
- Results posted
- 2018-01-30
Locations
72 sites across 6 countries: United States, Australia, Canada, New Zealand, Poland, Switzerland
Source: ClinicalTrials.gov record NCT01808144. Inclusion in this directory is not an endorsement.