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A Phase 1 Open-label Study of the Safety, Tolerability, and Pharmacokinetics of d- and l-Amphetamine After Multiple Daily Doses of SHP465 6.25 mg Administered in Children Aged 4 to 5 Years With Attention-Deficit/Hyperactivity Disorder

Trial Profile

A Phase 1 Open-label Study of the Safety, Tolerability, and Pharmacokinetics of d- and l-Amphetamine After Multiple Daily Doses of SHP465 6.25 mg Administered in Children Aged 4 to 5 Years With Attention-Deficit/Hyperactivity Disorder

Completed
Phase of Trial: Phase I

Latest Information Update: 09 Jan 2019

At a glance

  • Drugs Mixed amfetamine salts (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Shire
  • Most Recent Events

    • 02 Jan 2019 Status changed from recruiting to completed.
    • 08 Mar 2018 Status changed from not yet recruiting to recruiting.
    • 05 Jan 2018 Planned initiation date changed from 31 Jan 2018 to 20 Jan 2018.
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