Status:
COMPLETED
Lesinurad and Febuxostat 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 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 RDEA594-3...
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 Study RDEA594-304 and was actively receiving and tolerating study medication (lesinurad or placebo) and febuxostat 80 mg 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 control during the study and for at least 14 days after the last dose of study medication.
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 :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2016
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT01808144
Start Date
March 1 2013
End Date
October 6 2016
Last Update
January 30 2018
Active Locations (72)
Enter a location and click search to find clinical trials sorted by distance.
1
Birmingham, Alabama, United States, 35211
2
Tempe, Arizona, United States, 85282
3
Glendale, California, United States, 91204
4
Huntington Beach, California, United States, 92646