Open-Label Lesinurad Monotherapy Extension Study in Gout
Status: | Completed |
---|---|
Conditions: | Gout |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | Any |
Updated: | 2/4/2013 |
Start Date: | August 2012 |
End Date: | September 2014 |
Contact: | M Suster |
Phone: | 866-784-8116 |
A Long-Term Open-Label Extension Study for Subjects Completing a Phase 3 Efficacy and Safety Study of Lesinurad Monotherapy in Subjects With Gout
This study will assess the serum uric acid lowering effects and safety of lesinurad over a
long-term timeframe.
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.
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 Study RDEA594-303 and was
actively receiving and tolerating study medication (lesinurad or placebo) at Month 6
visit.
- Subject is willing to adhere to the visit/protocol schedules.
- Subject is male or female; female subjects of childbearing potential must agree to
use an effective non-hormonal method of birth control during the study and for at
least 14 days after the last dose of study medication.
Exclusion Criteria:
- Subject has any other 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.
We found this trial at
13
sites
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