Overview

Lesinurad and Allopurinol Combination Extension Study in Gout

Status:
Completed
Trial end date:
2016-11-01
Target enrollment:
0
Participant gender:
All
Summary
This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with allopurinol over a long-term timeframe.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ardea Biosciences, Inc.
Treatments:
Allopurinol
Lesinurad
Criteria
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.