Safety and Tolerability Study of SHP465 in Children Aged 4 to 12 Years Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD)

Exclusion Criteria

• •Participant is required or anticipated to take medications that have central nervous system effects or affect performance. Stable use of bronchodilator inhalers is not exclusionary.
• •Participant has a concurrent chronic or acute illness, disability, or other condition that might confound the results of safety assessments conducted in the study or that might increase risk to the participant. - Participant has a documented allergy, hypersensitivity, or intolerance to amphetamine or to any excipients in the investigational product.
• •Participant has failed to fully respond, based on investigator judgment, to an adequate course of amphetamine therapy.
• •Participant has a known family history of sudden cardiac death or ventricular arrhythmia.
• •Participant has a blood pressure measurement \>=95th percentile for age, sex, and height at screening (Visit 1) and/or baseline (Visit 2).
• •Participant has a height less than or equal to (\<=) 5th percentile for age and sex at screening (Visit 1) or baseline (Visit 2).
• •Participant has a weight \<=5th percentile for age and sex at screening (Visit 1) or baseline (Visit 2).
• •Participant has a known history of symptomatic cardiovascular disease, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac conditions placing them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
• •Participant has a history of seizures (other than infantile febrile seizures).
• •Participant is taking any medication that is excluded per the protocol.
• •Participant had any clinically significant ECG or clinical laboratory abnormalities at the screening (Visit 1) or baseline visit (Visit 2).
• •Participant has current abnormal thyroid function, defined as abnormal thyroid-stimulating hormone and thyroxine at the screening or baseline visit. Treatment with a stable dose of thyroid medication for at least 3 months is permitted.
• •Participant is currently considered a suicide risk in the opinion of the investigator, has previously made a suicide attempt, or has a prior history of or currently demonstrating suicidal ideation.