Overview

This trial is active, not recruiting.

Condition gout
Treatments lesinurad
Phase phase 3
Sponsor Ardea Biosciences, Inc.
Start date March 2013
End date August 2016
Trial size 200 participants
Trial identifier NCT01808144, 2012-004390-54, RDEA594-307

Summary

This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with febuxostat 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
Arm
(Experimental)
Patients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 3, dated 07 October 2015.
lesinurad
Tablets, 400 mg once daily (QD)
(Experimental)
lesinurad
Tablets, 200 mg QD

Primary Outcomes

Measure
Proportion of subjects with an sUA level that is < 5.0 mg/dL
time frame: Up to approximately 2.5 years

Secondary Outcomes

Measure
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 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 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 Febuxostat for Subjects With Gout Completing an Efficacy and Safety Study of Lesinurad and Febuxostat
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 RDEA594-304.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Ardea Biosciences, Inc..