Efficacy, Safety & Pharmacokinetic (PK) Study of HLD200 in Children Aged 4-5 Years With ADHD

Stopped FDA release from this PMR study due to their required class-labeling, with a limitation of use for all ER stimulants in pediatric patients under 6 years of age, based on results from studies with other ER stimulants in this age group.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

• DRUG: HLD200 methylphenidate hydrochloride capsules
• DRUG: Placebo HLD200 capsules

Sponsor

Ironshore Pharmaceuticals and Development, Inc

Collaborators

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