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A Phase Ill, Randomized, Double-Blind, Placebo Controlled, Parallel-Arm, Multi-Center Study Measuring the Efficacy and Safety of Prc-063 in Adolescent ADHD Patients
This is a parallel, randomized, double-blind, forced-dose titration, multicenter, placebo controlled, phase 3 study to evaluate the safety and efficacy of PRC-063 (methylphenidate hydrochloride controlled-release capsules 25, 45, 70 or 85 mg/day) in the treatment of Attention Deficit/Hyperactivity Disorder (ADHD) in adolescent patients aged <12 to <18 years of age. The study will be conducted at approximately 40 centers across the United States and Canada. After obtaining written assent from the subject and informed consent from the subject's parent or guardian, subjects will be screened to ascertain their suitability for the study according to the inclusion and exclusion criteria. There will be: a one week screening/baseline phase; a two week double-blind forced-dose titration period during which patients will be titrated from a starting dose of 25 mg or 45 mg up to his/her final dose (25, 45, 70 or 85 mg); and a two-week double-blind evaluation phase during which patients will be assessed on either active or placebo PRC-063.
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