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A Phase 3, Open Label, Multicenter, Baseline-Controlled Sequential Dose Titration Study Followed by a Fixed Dose Observation Period to Evaluate Pharmacokinetics, Efficacy and Safety of Mirabegron Prolonged-Release Microgranula Based Suspension in Children from 6 Months to Less Than 3 Years of Age with Neurogenic Detrusor Overactivity

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A Phase 3, Open Label, Multicenter, Baseline-Controlled Sequential Dose Titration Study Followed by a Fixed Dose Observation Period to Evaluate Pharmacokinetics, Efficacy and Safety of Mirabegron Prolonged-Release Microgranula Based Suspension in Children from 6 Months to Less Than 3 Years of Age with Neurogenic Detrusor Overactivity

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 08 Mar 2025

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At a glance

  • Drugs Mirabegron (Primary)
  • Indications Detrusor instability; Neurogenic bladder; Overactive bladder
  • Focus Registrational; Therapeutic Use
  • Sponsors Astellas Pharma Global Development

    • Most Recent Events

    • 13 Jun 2024 Planned primary completion date changed from 30 Jun 2026 to 28 Feb 2025.
    • 03 May 2024 Planned End Date changed from 31 Jul 2026 to 30 Jun 2026.
    • 03 May 2024 Planned primary completion date changed from 31 Jul 2026 to 30 Jun 2026.

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