Evaluate Safety and Efficacy of ORADUR®-Methylphenidate in Children and Adolescents With ADHD

Exclusion Criteria

• •1. Subjects have received ADHD treatment for over 1 year or those who have received other ADHD treatment within 30 days prior to the study treatment initiation.
• •2. By investigator's evaluation, subjects are very anxious, tense or agitated.
• •3. Subjects known to be allergic to any ORADUR®-methylphenidate ingredients.
• •4. Subjects with an estimated intelligence quotient (IQ) \< 80.
• •5. Subjects are taking a concomitant medication (ex: Monoamine Oxidase Inhibitor (MAOI)) that is likely to interfere with safe administration of methylphenidate within 14 day prior to the study treatment initiation.
• •6. Subjects are joining other clinical studies and receiving any other investigational medical products within 30 days prior to the study treatment initiation.
• •7. Subjects have glaucoma (narrow angle glaucoma), on-going seizure disorder, or other psychotic disorder.
• •8. Subjects have chronic tics, Tourette's syndrome, or a family history of Tourette's syndrome.
• •9. Subjects have clinically significant gastrointestinal problems, including narrowing of the gastrointestinal tract.
• •10. Subjects/caregivers are (in the case of subjects whose parents/caregivers were to fill out the study questionnaires) with drug or alcohol abuse/dependence within the prior 6 months.
• •11. By the investigators' discretion, subjects with serious or unstable medical illness that will interfere with the evaluations of study efficacy and safety.
• •12. In the investigators' opinion, subjects cannot understand or follow the instructions given in the study.
• •13. Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.