Lesinurad and Allopurinol Combination Extension Study in Gout
Status: | Completed |
---|---|
Conditions: | Gout |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - 85 |
Updated: | 10/14/2017 |
Start Date: | February 2013 |
End Date: | November 2016 |
A Long-Term Extension Study of Lesinurad in Combination With Allopurinol for Subjects Completing an Efficacy and Safety Study of Lesinurad and Allopurinol
This study will assess the serum uric acid lowering effects and safety of lesinurad in
combination with allopurinol over a long-term timeframe.
combination with allopurinol over a long-term timeframe.
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.
combination with allopurinol in subjects who completed the double-blind treatment period in
Studies RDEA594-301 and RDEA594-302.
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.
We found this trial at
130
sites
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