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A Phase 2/3, Prospective, Open-label Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of Remimazolam for Intravenous Sedation in Paediatric Patients Undergoing Diagnostic and/or Therapeutic Procedures

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Trial Profile

A Phase 2/3, Prospective, Open-label Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of Remimazolam for Intravenous Sedation in Paediatric Patients Undergoing Diagnostic and/or Therapeutic Procedures

Status: Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 12 Sep 2023

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At a glance

  • Drugs Remimazolam (Primary)
  • Indications Sedation
  • Focus Registrational; Therapeutic Use
  • Sponsors Acacia Pharma; PAION

    • Most Recent Events

    • 30 Jan 2023 This trial has been suspended in Denmark, according to European Clinical Trials Database.
    • 12 Dec 2022 Planned End Date changed from 1 Dec 2022 to 1 Dec 2024.
    • 12 Dec 2022 Planned primary completion date changed from 1 Dec 2022 to 1 Dec 2024.

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