Gout
Conditions
Keywords
Gout
Brief 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.
Interventions
DRUGLesinurad
Tablets, 200 mg QD
Sponsors
Ardea Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study related activity. * Subject completed the double-blind treatment period in either Study RDEA594-301 or RDEA594-302 and was actively receiving and tolerating study medication (lesinurad or placebo) and allopurinol at the Month 12 visit. * Subject is male or female; female subjects of childbearing potential must agree to use an effective non-hormonal method of birth
Exclusion criteria
* Subject has any medical or psychological condition, which in the opinion of the Investigator and/or the Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with an sUA level that is < 6.0 mg/dL | up to a total of 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Resolution of at least 1 target tophi | Up to Month 12 |
Countries
Australia, Belgium, Canada, Germany, New Zealand, Poland, South Africa, Spain, Switzerland, Ukraine, United States
Outcome results
None listed