Safety and Efficacy Study of SHP465 in Children and Adolescents Aged 6-17 Years With Attention-Deficit Hyperactivity Disorder (ADHD)

Inclusion Criteria:

1. Subject must be 6-17 years of age, inclusive, at the time of consent.
2. Subject's parent or legally authorized representative (LAR) must provide signature ofinformed consent, and there must be documentation of assent (if applicable) by thesubject indicating that the subject is aware of the investigational nature of thestudy and the required procedures and restrictions in accordance with the ICH GCPGuideline E6 (1996) and applicable regulations before completing any study-relatedprocedures.
3. Subject and parent/LAR are willing and able to comply with all of the testing andrequirements defined in the protocol, including oversight of morning dosing.Specifically, the parent/LAR must be available at approximately 7:00AM (±2 hours) todispense the dose of investigational product for the study duration.
4. Subject, who is a female and of child-bearing potential, must not have a positiveserum beta human chorionic gonadotropin pregnancy test at the Screening Visit (Visit

1. and must have a negative urine pregnancy test at the Baseline Visit (Visit 2) andagree to comply with any applicable contraceptive requirements of the protocol.

5. Subject must have a satisfactory medical assessment with no clinically significant orrelevant abnormalities.
6. Subject meets DSM-IV-TR criteria for a primary diagnosis of ADHD based on a detailedpsychiatric evaluation.
7. Subject has an ADHD-RS-IV Total Score >28 at the Baseline Visit (Visit 2).
8. Subject is functioning at an age-appropriate level intellectually, as determined bythe study Investigator.
9. Subject is currently not on ADHD therapy, or is not completely satisfied with anyaspect of their current ADHD therapy.
10. Subject is able to swallow a capsule whole.

Exclusion Criteria:

1. Subject has a current, controlled (with medications prohibited in this study) oruncontrolled, comorbid psychiatric diagnosis with significant symptoms such as anysignificant comorbid Axis II disorder or significant Axis I disorder (such aspost-traumatic stress disorder, psychosis, bipolar illness, pervasive developmentaldisorder, severe obsessive compulsive disorder, depressive or anxiety disorder) orother symptomatic manifestations that, in the opinion of the examining clinician, willcontraindicate treatment with SHP465 or confound efficacy or safety assessments.Comorbid psychiatric diagnoses will be established with the Screening Visit (Visit 1)interview of the K-SADS-PL and additional modules if warranted by the results of theinitial interview. Subjects may continue participation in a behavioral modificationprogram during the study as long as they have been participating in the program for atleast 1 month at the time of the Baseline Visit (Visit 2).
2. Subject meets DSM-IV-TR diagnosis of conduct disorder. Oppositional defiant disorderis not exclusionary.
3. Subject is considered a suicide risk in the opinion of the Investigator, haspreviously made a suicide attempt, or is currently demonstrating active suicidalideation. Subjects with intermittent passive suicidal ideation are not necessarilyexcluded based on the assessment of the Investigator.
4. Subject is underweight based on Centers for Disease Control and Prevention body massindex (BMI)-for-age sex-specific values at the Screening Visit (Visit 1). Underweightis defined as a BMI <3rd percentile
5. Subject is significantly overweight based on Centers for Disease Control andPrevention BMI-for-age sex specific values at the Screening Visit (Visit 1).Significantly overweight is defined as a BMI >97th percentile for this study
6. Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis oran infectious process requiring antibiotics), disability, or other condition thatmight confound the results of safety assessments conducted in the study or that mightincrease risk to the subject. Similarly, the subject will be excluded if he or she hasany additional condition(s) that, in the Investigator's opinion, would prohibit thesubject from completing the study or would not be in the best interest of the subject.The additional conditions would include any significant illness or unstable medicalcondition that could lead to difficulty complying with the protocol. Mild, stableasthma is not exclusionary.
7. Subject has a history of seizure (other than infantile febrile seizures), a chronic orcurrent tic disorder, or a current diagnosis of Tourette's Disorder. Subject has ahistory of tics that are judged by the Investigator to be exclusionary.
8. Subject's blood pressure measurements exceed the 90th percentile for age, sex, andheight (based on the Blood Pressure Levels by Age and Height Percentile [for boys andgirls]) at the Screening Visit (Visit 1) and the Baseline Visit (Visit 2)
9. Subject has a known history of hypertension
10. Subject has a known history of symptomatic cardiovascular disease, advancedarteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythmabnormalities, coronary artery disease, or other serious cardiac problems that mayplace him/her at increased vulnerability to the sympathomimetic effects of a stimulantmedication.
11. Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
12. Subject has any clinically significant ECG or clinically significant laboratoryabnormality at the Screening Visit (Visit 1).
13. Subject has current abnormal thyroid function, defined as abnormal thyroid stimulatinghormone and thyroxine at the Screening Visit (Visit 1). Treatment with a stable doseof thyroid medication for at least 3 months is permitted.
14. Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine orto any excipients in the investigational product.
15. Subject has failed to respond, based on Investigator judgment, to an adequatecourse(s) (dose and duration) of amphetamine therapy
16. Subject has a history of suspected substance abuse or dependence disorder (excludingnicotine) in accordance with DSM-IV-TR criteria. Subjects with a lifetime history ofamphetamine, cocaine, or other stimulant abuse and/or dependence will be excluded.
17. Subject has a positive urine drug result at the Screening Visit (Visit 1) (with theexception of subject's current stimulant therapy, if any) or the Baseline Visit (Visit 2), if repeated unless the Investigator can verify that the positive result at theScreening Visit (Visit 1) is attributed to medication that has been prescribed to thesubject and will be discontinued prior to the Baseline Visit (Visit 2). A positiveresult at the Screening Visit (Visit 1) attributed to a prescribed medication requiresa re-test and a negative result at the Baseline Visit (Visit 2) to confirm subjecteligibility.
18. Subject has taken another investigational product or has taken part in a clinicalstudy within 30 days prior to the Screening Visit (Visit 1).
19. Subject has previously completed, discontinued, or was withdrawn from this study.
20. Subject is taking any medication that is excluded or has not been appropriately washedout according to the protocol requirements.
21. Subject is required to take or anticipates the need to take medications that havecentral nervous system effects or affect performance, such as sedating antihistaminesand decongestant sympathomimetics, or are monoamine oxidase inhibitors. Stable use ofbronchodilator inhalers is not exclusionary.
22. Subject is female and is pregnant or lactating