Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 264
Healthy volunteers: no

Brief summary:
The study is designed to evaluate the efficacy and safety of SHP465 in the treatment of ADHD in children and adolescents (aged 6-17 years). The primary objective of this study is to evaluate the efficacy of SHP465 administered as a daily morning dose compared to placebo in the treatment of children and adolescents (6-17 years of age inclusive) diagnosed with ADHD.

Detailed description:

Arms:
arm 1: Subjects will receive SHP465 (12.5mg and 25mg capsules) or matching placebo. Subjects will take 1 capsule daily throughout the study at approximately 7:00am (+/- 2 hours) arm 2: Subjects will receive SHP465 (12.5mg and 25mg capsules) or matching placebo. Subjects will take 1 capsule daily throughout the study at approximately 7:00am (+/- 2 hours)

Interventions: intervention 1: SHP465 intervention 2: Placebo
Intervention descriptions: intervention 1: 12.5mg and 25mg capsules (one capsule daily) intervention 2: Matching placebo capsule that appear identical in size, weight, shape, color

Protocol document: