Combination Treatment Study in Subjects With Tophaceous Gout With Lesinurad and Febuxostat (CRYSTAL)
Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Double-Blind, Multicenter, Placebo- Controlled, Combination Study to Evaluate the Efficacy and Safety of Lesinurad and Febuxostat Compared to Febuxostat Alone at Lowering Serum Uric Acid and Resolving Tophi in Subjects With Tophaceous Gout
Enrollment: 330
Study Start Date: January 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms:
- Experimental: lesinurad 400 mg + febuxostat 80 mg
- Experimental: lesinurad 200 mg + febuxostat 80 mg
- Placebo Comparator: placebo + febuxostat 80 mg
Related Journal: Lesinurad: A Review in Hyperuricaemia of Gout.
Category | Value |
---|---|
Date last updated at source | 2016-04-10 |
Study type(s) | Interventional |
Expected enrolment | 330 |
Study start date | 2012-01-01 |
Estimated primary completion date | 2014-06-01 |