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A Multicenter, Multiple-dose, Two-arm, Active-controlled, Double-blind, Double-dummy Study to Compare the Therapeutic Efficacy and Safety of Oral Doses of Cinacalcet HCl With Intravenous Doses of AMG 416 in Hemodialysis Subjects With Secondary Hyperparathyroidism

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Trial Profile

A Multicenter, Multiple-dose, Two-arm, Active-controlled, Double-blind, Double-dummy Study to Compare the Therapeutic Efficacy and Safety of Oral Doses of Cinacalcet HCl With Intravenous Doses of AMG 416 in Hemodialysis Subjects With Secondary Hyperparathyroidism

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Feb 2023

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At a glance

  • Drugs Etelcalcetide (Primary) ; Cinacalcet
  • Indications Secondary hyperparathyroidism
  • Focus Registrational; Therapeutic Use
  • Sponsors Amgen

    • Most Recent Events

    • 15 Feb 2017 According to an Ono Pharmaceuticals media release, in the US, Amgen received an approval for a New Drug Application (NDA) of Parsabiv for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis from the Food and Drug Administration (FDA) on February 7, 2017.
    • 10 Jan 2017 Results published in the JAMA: the Journal of the American Medical Association.
    • 10 Jan 2017 According to an Amgen media release, results from the study have been published in the Journal of the American Medical Association (JAMA).

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