Allopurinol Combination Study

Phase 2 Completed 227 enrolled Ardea Biosciences, Inc.

RandomizedFactorialTriple-blindTreatment

Summary

To compare the proportion of subjects whose serum urate (sUA) levels are \< 6.0 mg/dL following 4 weeks of continuous treatment of RDEA594 in combination with allopurinol to allopurinol alone in subjects with documented inadequate hypouricemic response with standard doses of allopurinol.

Timeline

Start: 2009-10
Primary completion: 2011-01
Completion: 2016-08

Outcome

Met primary endpoint

paper produced significant mean percent reductions from baseline sUA of 16%, 22% and 30%, respectively, versus a mean 3% increase with placebo (p<0.0001 PMID 26742777 ↗

Publications

Perez-Ruiz F, Sundy JS, Miner JN, Cravets M, Storgard C; RDEA594-203 Study Group. Lesinurad in combination with allopurinol: results of a phase 2, randomised, double-blind study in patients with gout with an inadequate response to allopurinol. Ann Rheum Dis. 2016 Jun;75(6):1074-80. doi: 10.1136/annrheumdis-2015-207919. Epub 2016 Jan 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lesinurad	Small molecule	200 mg	Oral
Subject	Lesinurad	Small molecule	400 mg	Oral
Subject	Lesinurad	Small molecule	600 mg	Oral
Background	Allopurinol	Small molecule	—	—