This trial is active, not recruiting.

Condition gout
Treatments lesinurad
Phase phase 3
Sponsor Ardea Biosciences, Inc.
Start date February 2013
End date August 2016
Trial size 717 participants
Trial identifier NCT01808131, 2012-004389-16, RDEA594-306


This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with allopurinol over a long-term timeframe.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Tablets, 200 mg QD
Patients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 4, dated 07 October 2015.
Tablets, 400 mg QD

Primary Outcomes

Proportion of subjects with an sUA level that is < 6.0 mg/dL
time frame: up to a total of 5 years

Secondary Outcomes

Resolution of at least 1 target tophi
time frame: Up to Month 12

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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.

Additional Information

Official title A Long-Term Extension Study of Lesinurad in Combination With Allopurinol for Subjects Completing an Efficacy and Safety Study of Lesinurad and Allopurinol
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 RDEA594-301 and RDEA594-302.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Ardea Biosciences, Inc..