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A Randomized, Parallel, Double-Blind Efficacy and Safety Study of Biphentin Methylphenidate HCl Extended Release Capsules Compared to Placebo in Children and Adolescents 6 to 18 Years With Attention Deficit Hyperactivity Disorder (ADHD)

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Trial Profile

A Randomized, Parallel, Double-Blind Efficacy and Safety Study of Biphentin Methylphenidate HCl Extended Release Capsules Compared to Placebo in Children and Adolescents 6 to 18 Years With Attention Deficit Hyperactivity Disorder (ADHD)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Feb 2023

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At a glance

  • Drugs Methylphenidate (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors Rhodes Pharmaceuticals

    • Most Recent Events

    • 22 May 2015 Aptensio XR [methyphenidate extended release] was approved by the U.S. FDA based on the data from this and another phase III trial [see CT profile 700192830].
    • 01 Feb 2012 Actual end date (Nov 2011) added as reported by ClinicalTrials.gov.
    • 01 Feb 2012 Status changed from recruiting to completed as reported by ClinicalTrials.gov.

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