Open-Label Lesinurad Monotherapy Extension Study in Gout

Overview

This study will assess the serum uric acid lowering effects and safety of lesinurad over a long-term timeframe.

Full Title of Study: “A Long-Term Open-Label Extension Study for Subjects Completing a Phase 3 Efficacy and Safety Study of Lesinurad Monotherapy in Subjects With Gout”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2014

Detailed Description

This is a Phase 3, open-label, uncontrolled, extension study to assess the long-term efficacy and safety of lesinurad monotherapy in subjects who completed the double-blind treatment period in Study RDEA594-303.

Interventions

  • Drug: lesinurad
    • Tablets, 400 mg QD

Arms, Groups and Cohorts

  • Experimental: lesinurad 400 mg

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of Subjects With a Serum Urate (sUA) Level That is < 6.0 mg/dL
    • Time Frame: Month 1
  • Incidence of Treatment-emergent Adverse Events (TEAEs)
    • Time Frame: Up to approximately 2 years

Participating in This Clinical Trial

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 Study RDEA594-303 and was actively receiving and tolerating study medication (lesinurad or placebo) at Month 6 visit.
  • Subject is willing to adhere to the visit/protocol schedules.
  • Subject is male or female; female subjects of childbearing potential must agree to use an effective non-hormonal method of birth control during the study and for at least 14 days after the last dose of study medication.

Exclusion Criteria

  • Subject has any other 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.
  • Subject has a past medical history of urolithiasis, nephrolithiasis, or kidney stone diathesis.
  • Subject developed kidney stones during Study RDEA594-303

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ardea Biosciences, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Chris Storgard, MD, Study Director, Ardea Biosciences, Inc.

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