Phase II, Open-label, Dose-titration, Safety Study Designed to Determine the Evening Dose of a Novel Delayed and Extended Release Formulation of Dextroamphetamine Sulfate (HLD100) to Produce Optimal Clinical Effects in Children With ADHD

Trial Profile

Phase II, Open-label, Dose-titration, Safety Study Designed to Determine the Evening Dose of a Novel Delayed and Extended Release Formulation of Dextroamphetamine Sulfate (HLD100) to Produce Optimal Clinical Effects in Children With ADHD

Completed
Phase of Trial: Phase II

Latest Information Update: 22 Sep 2017

At a glance

  • Drugs Amfetamine
  • Indications Attention-deficit hyperactivity disorder
  • Focus Adverse reactions
  • Sponsors Ironshore Pharmaceutical and Development
  • Most Recent Events

    • 19 Sep 2017 Status changed from active, no longer recruiting to completed.
    • 12 Apr 2017 According to an Ironshore Pharmaceutical and Development Media Release, results from this trial were reviewed at an End of Phase 2 meeting with the FDA and based on the feedback company is pursuing for two pivotal Phase 3 studies (see profile 276138 and 269841).
    • 12 Apr 2017 According to an Ironshore Pharmaceutical and Development Media Release, results from this trial has been presented to the U.S. Food and Drug Administration.
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