NCT01510158

Combining Lesinurad With Allopurinol in Inadequate Responders

A Phase 3 Randomized, Double-Blind, Multicenter, Placebo-Controlled, Combination Study to Evaluate the Efficacy and Safety of Lesinurad and Allopurinol Compared to Allopurinol Alone in Subjects With Gout Who Have Had an Inadequate Hypouricemic Response to Standard of Care Allopurinol.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 607 (actual)
• Sponsor: Ardea Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study that compare the serum uric acid lowering effects, clinical benefits, and safety of lesinurad in combination with allopurinol to allopurinol alone in subjects with gout who have had an inadequate response to allopurinol.

Detailed description

Allopurinol is the standard of care for the treatment of gout. Nevertheless, most patients treated with allopurinol do not achieve the recommended serum urate (sUA) target of \< 6.0 mg/dL and need additional therapy to achieve the target. Probenecid and benzbromarone are uric acid transporter 1 (URAT1) inhibitors, generally recommended as second-line agents for patients who are either resistant to or intolerant of allopurinol. However, benzbromarone is not available in the US and probenecid is rarely used. Consequently, there is a clear unmet medical need for a new safe and effective therapy for gout, such as lesinurad, a potent URAT1 inhibitor, that can be used in combination with allopurinol in patients not responding adequately to allopurinol monotherapy so that very high rates of response can be achieved by nearly all gout patients, rather than a minority.The subjects selected for this study will have moderate to severe gout with an inadequate response to allopurinol

Conditions

• Gout

Interventions

Type	Name	Description
DRUG	Lesinurad	Tablets, 200 mg once daily (qd)
DRUG	Lesinurad	Tablets, 400 mg qd
DRUG	Placebo	Tablets, Placebo qd
DRUG	Allopurinol	Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment)
DRUG	Allopurinol	Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment)
DRUG	Allopurinol	Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment)

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-07-01
• Completion: 2014-08-01
• First posted: 2012-01-13
• Last updated: 2016-08-18
• Results posted: 2016-08-18

Locations

165 sites across 1 country: United States