Status:
COMPLETED
Lesinurad and Allopurinol Combination Extension Study in Gout
Lead Sponsor:
Ardea Biosciences, Inc.
Conditions:
Gout
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
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 RDEA59...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
717 Patients enrolled
Trial Details
Trial ID
NCT01808131
Start Date
February 1 2013
End Date
November 1 2016
Last Update
January 24 2017
Active Locations (207)
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1
Birmingham, Alabama, United States, 35213
2
Birmingham, Alabama, United States, 35235
3
Birmingham, Alabama, United States, 35294
4
Gulf Shores, Alabama, United States, 36542