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A Randomized, Open-label, Two-arm Parallel Group, No Treatment Group-controlled, Multicenter Phase III Study to Evaluate the Safety and Efficacy of Saizen 0.067 mg/kg/Day Subcutaneous Injection in Children With Idiopathic Short Stature

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A Randomized, Open-label, Two-arm Parallel Group, No Treatment Group-controlled, Multicenter Phase III Study to Evaluate the Safety and Efficacy of Saizen 0.067 mg/kg/Day Subcutaneous Injection in Children With Idiopathic Short Stature

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Sep 2021

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At a glance

  • Drugs Somatropin (Primary)
  • Indications Short stature
  • Focus Registrational; Therapeutic Use
  • Sponsors Merck KGaA

    • Most Recent Events

    • 04 Apr 2017 Primary endpoint (Change From Baseline in Height Velocity at Month 6 Using Last Observation Carried Forward (LOCF) Method) has been met, according to results presented at The 99th Annual Meeting of the Endocrine Society.
    • 04 Apr 2017 Results presented at The 99th Annual Meeting of the Endocrine Society.
    • 20 Jul 2015 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record.

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