Randomized, Double-Blind, Multicenter, Placebo-Controlled, Combination Study to Evaluate the Safety, Efficacy and Potential Pharmacokinetic Interaction of RDEA594 and Allopurinol in Gout Patients With an Inadequate Hypouricemic Response With Standard Doses of Allopurinol.

Trial Profile

Randomized, Double-Blind, Multicenter, Placebo-Controlled, Combination Study to Evaluate the Safety, Efficacy and Potential Pharmacokinetic Interaction of RDEA594 and Allopurinol in Gout Patients With an Inadequate Hypouricemic Response With Standard Doses of Allopurinol.

Completed
Phase of Trial: Phase II

Latest Information Update: 02 Feb 2017

At a glance

  • Drugs Lesinurad (Primary) ; Allopurinol
  • Indications Gout
  • Focus Therapeutic Use
  • Sponsors Ardea Biosciences
  • Most Recent Events

    • 07 Sep 2016 Status changed from active, no longer recruiting to completed.
    • 15 Apr 2016 Patients on lesinurad 400 mg and lesinurad 600 mg had their dose changed to lesinurad 200 mg; Patients on allopurinol qd alone were discontinued after protocol amendment 16 dated 07 October 2015.
    • 15 Apr 2016 Planned End Date changed from 1 Apr 2015 to 1 Jul 2016.
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