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A Phase II, Two-Stage, Open-Label, Single-Treatment, Adaptive Trial Design Examining the Pharmacokinetic and Pharmacodynamic Effects of up to Three Separate HLD100 Modified Release Formulations of Dextroamphetamine Sulfate in Adolescent (Stage 1) and Pediatric (Stage 2) Patients With Attention-Deficit Hyperactivity Disorder.

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Trial Profile

A Phase II, Two-Stage, Open-Label, Single-Treatment, Adaptive Trial Design Examining the Pharmacokinetic and Pharmacodynamic Effects of up to Three Separate HLD100 Modified Release Formulations of Dextroamphetamine Sulfate in Adolescent (Stage 1) and Pediatric (Stage 2) Patients With Attention-Deficit Hyperactivity Disorder.

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 12 Nov 2014

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At a glance

  • Drugs Dexamfetamine (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Pharmacokinetics
  • Sponsors Ironshore Pharmaceutical and Development
  • Most Recent Events

    • 01 Sep 2013 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
    • 15 Aug 2013 Dosing of adolescent patients in the phase I/II study has begun and dosing in the paediatric study is expected to begin this week, according to Highland Therapeutics.
    • 01 Jul 2013 Status changed from not yet recruiting to recruiting as reported by ClinicalTrials.gov record.
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