Lesinurad and Febuxostat Combination Extension Study in Gout
Study identifier:RDEA594-307
ClinicalTrials.gov identifier:NCT01808144
EudraCT identifier:2012-004390-54
CTIS identifier:N/A
Study Complete
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
Medical condition
Gout
Phase
Phase 3
Healthy volunteers
No
Study drug
lesinurad
Sex
All
Actual Enrollment
196
Study type
Interventional
Age
18 Years - 85 Years
Date
Study Start Date: 01 Mar 2013
Primary Completion Date: 01 Aug 2016
Study Completion Date: 01 Oct 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 400 mg + febuxostat 80 mg Patients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 3, dated 07 October 2015. | Drug: lesinurad Tablets, 400 mg once daily (QD) |
| Experimental: lesinurad 200 mg + febuxostat 80 mg | Drug: lesinurad Tablets, 200 mg QD |
Contacts
Investigators
Principal Investigator
Nihar Bhakta
Ardea Biosciences, Inc.
