A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Evening-dosed HLD200, a Novel Delayed and Extended Release Formulation (DELEXIS) of Methylphenidate Hydrochloride, on Post-waking, Early Morning Function in Children Aged 6 to 12 With Attention Deficit Hyperactivity Disorder (ADHD)

Trial Profile

A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Evening-dosed HLD200, a Novel Delayed and Extended Release Formulation (DELEXIS) of Methylphenidate Hydrochloride, on Post-waking, Early Morning Function in Children Aged 6 to 12 With Attention Deficit Hyperactivity Disorder (ADHD)

Completed
Phase of Trial: Phase III

Latest Information Update: 25 Oct 2017

At a glance

  • Drugs Methylphenidate (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Registrational; Therapeutic Use
  • Acronyms AHEAD Study
  • Sponsors Ironshore Pharmaceutical and Development
  • Most Recent Events

    • 25 Oct 2017 Post hoc analysis from this trial presented in a Cayman Chemical Media Release.
    • 23 May 2017 Results published in an Ironshore Pharmaceutical and Development media release.
    • 23 May 2017 Data will be presented at the American Psychiatric Association Annual Meeting 2017, according to an Ironshore Pharmaceutical and Development media release.
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