NCT01808131CompletedPhase 3
A Long-Term Extension Study of Lesinurad in Combination With Allopurinol for Subjects Completing an Efficacy and Safety Study of Lesinurad and Allopurinol
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Ardea Biosciences, Inc.
- Enrollment
- 717
- Primary Endpoint
- Proportion of subjects with an sUA level that is < 6.0 mg/dL
Study Overview
Brief Summary
This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with allopurinol over a long-term timeframe.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study related activity.
- •Subject completed the double-blind treatment period in either Study RDEA594-301 or RDEA594-302 and was actively receiving and tolerating study medication (lesinurad or placebo) and allopurinol at the Month 12 visit.
- •Subject is male or female; female subjects of childbearing potential must agree to use an effective non-hormonal method of birth
Exclusion Criteria
- •Subject has any medical or psychological condition, which in the opinion of the Investigator and/or the Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.
Arms & Interventions
lesinurad 200 mg + allopurinol
Experimental
Intervention: Lesinurad (Drug)
lesinurad 400 mg + allopurinol
Experimental
Patients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 4, dated 07 October 2015.
Intervention: Lesinurad (Drug)
Outcomes
Primary Outcomes
Proportion of subjects with an sUA level that is < 6.0 mg/dL
Time Frame: up to a total of 5 years
Secondary Outcomes
- Resolution of at least 1 target tophi(Up to Month 12)
Investigators
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