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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

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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

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 20 Jul 2021

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At a glance

  • Drugs Dexamfetamine (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Adverse reactions
  • Sponsors Ironshore Pharmaceutical and Development

Most Recent Events

  • 20 Jun 2051 Study design is changed from single group assignment to sequential assignment.
  • 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).

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