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Open-label Extension to Study ZS-004 [Phase 3 Multicenter, Multi-phase, Multi-dose, Prospective, Randomized, Double-blind, Placebo-controlled Maintenance Study of Safety Efficacy of ZS (Sodium Zirconium Cycolsilicate) in Hyperkalemia.]

Trial Profile

Open-label Extension to Study ZS-004 [Phase 3 Multicenter, Multi-phase, Multi-dose, Prospective, Randomized, Double-blind, Placebo-controlled Maintenance Study of Safety Efficacy of ZS (Sodium Zirconium Cycolsilicate) in Hyperkalemia.]

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Aug 2018

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At a glance

  • Drugs Zirconium silicate (Primary)
  • Indications Hyperkalaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors ZS Pharma
  • Most Recent Events

    • 18 May 2018 According to an AstraZaneca media release, based on the data of these studies (238578, 240595,240601, 242292 and 242482), the US Food and Drug Administration (FDA) has approved LOKELMATM (sodium zirconium cyclosilicate), formerly ZS-9, for the treatment of hyperkalemia in adults.
    • 09 Dec 2015 Status changed from active, no longer recruiting to completed, as reported by ClinicalTrials.gov.
    • 02 Nov 2014 Planned End Date changed from 1 Nov 2014 to 1 Nov 2015 as reported by ClinicalTrials.gov record.
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