A Phase 3, Multicenter, Open-label Treatment-optimized, Double-blind, Randomized, Placebo-controlled, Forced-withdrawal, Parallel Group Study to Evaluate the Safety and Efficacy of Evening Dosed HLD200, a Novel Delayed and Extended Release Formulation (DELEXIS) of Methylphenidate Hydrochloride, in Children Aged 6-12 With Attention Deficit Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting

Trial Profile

A Phase 3, Multicenter, Open-label Treatment-optimized, Double-blind, Randomized, Placebo-controlled, Forced-withdrawal, Parallel Group Study to Evaluate the Safety and Efficacy of Evening Dosed HLD200, a Novel Delayed and Extended Release Formulation (DELEXIS) of Methylphenidate Hydrochloride, in Children Aged 6-12 With Attention Deficit Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting

Completed
Phase of Trial: Phase III

Latest Information Update: 23 Sep 2017

At a glance

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

    • 15 Dec 2016 According to Ironshore Pharmaceutical media release, U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for HLD200 in the treatment of patients with Attention-Deficit/Hyperactivity Disorder and expected action date by the FDA under the Prescription Drug User Fee Act (PDUFA) is July 30, 2017.
    • 28 Oct 2016 According to Ironshore Pharmaceuticals Media Release, company today announced the presentation of data at the American Academy of Child and Adolescent Psychiatry (AACAP) annual conference in New York, NY
    • 28 Oct 2016 Results published in the Ironshore Pharmaceuticals Media Release.
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