Study identifier:RDEA594-306
ClinicalTrials.gov identifier:NCT01808131
EudraCT identifier:2012-004389-16
CTIS identifier:N/A
A Long-Term Extension Study of Lesinurad in Combination with Allopurinol for Subjects Completing an Efficacy and Safety Study of Lesinurad and Allopurinol
Gout
Phase 3
No
Lesinurad
All
717
Interventional
18 Years - 85 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Jan 2017 by Ardea Biosciences, Inc.
Ardea Biosciences, Inc.
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This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with allopurinol over a long-term timeframe.
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.
Location
Location
Birmingham, AL, United States, 35294
Location
Birmingham, AL, United States, 35213
Location
Birmingham, AL, United States, 35235
Location
Gulf Shores, AL, United States, 36542
Location
Pinson, AL, United States, 35126
Location
Glendale, AZ, United States, 85308
Location
Mesa, AZ, United States, 85203
Location
Peoria, AZ, United States, 85381
Arms | Assigned Interventions |
---|---|
Experimental: lesinurad 200 mg + allopurinol | Drug: Lesinurad Tablets, 200 mg QD |
Experimental: lesinurad 400 mg + allopurinol Patients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 4, dated 07 October 2015. | Drug: Lesinurad Tablets, 400 mg QD |
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