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An Open-Label, Multicenter, Multiple-Dose, Safety and Tolerability Study of Adhansia XR Extended-Release Capsules in Children 4 to 12 Years of Age

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Trial Profile

An Open-Label, Multicenter, Multiple-Dose, Safety and Tolerability Study of Adhansia XR Extended-Release Capsules in Children 4 to 12 Years of Age

Status: Discontinued
Phase of Trial: Phase IV

Latest Information Update: 24 Aug 2023

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At a glance

  • Drugs Methylphenidate (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Adverse reactions
  • Sponsors Purdue Pharma L.P.

    • Most Recent Events

    • 31 Jul 2023 Primary endpoints has been amended -Plasma Methylphenidate Concentrations from Multiple Doses of Adhansia XR in Children 4 to <6 years of Age Who Have Been Diagnosed with Attention Deficit/Hyperactivity Disorder (ADHD) has been removed.
    • 26 May 2022 Status changed from active, no longer recruiting to discontinued.
    • 08 Mar 2022 Status changed from recruiting to active, no longer recruiting.

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