Lesinurad and Allopurinol Combination Extension Study in Gout
Study identifier:RDEA594-306
ClinicalTrials.gov identifier:NCT01808131
EudraCT identifier:2012-004389-16
CTIS identifier:N/A
Study Complete
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
Medical condition
Gout
Phase
Phase 3
Healthy volunteers
No
Study drug
Lesinurad
Sex
All
Actual Enrollment
717
Study type
Interventional
Age
18 Years - 85 Years
Date
Study Start Date: 01 Feb 2013
Primary Completion Date: 01 Aug 2016
Study Completion Date: 01 Nov 2016
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Jan 2017 by Ardea Biosciences, Inc.
Sponsors
Ardea Biosciences, Inc.
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| 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 |
Contacts
Investigators
Principal Investigator
Nihar Bhakta
Ardea Biosciences, Inc.
