Conditions: Attention-Deficit/Hyperactivity Disorder
Keywords: ADHD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 340
Healthy volunteers: no

Brief summary:
The primary purpose is to assess the efficacy of once daily dosing with optimized SPD503 (1, 2, 3 and 4mg/day), dosed either in the morning or evening, compared to placebo, in children with ADHD as measured by change from baseline score at endpoint on the ADHD-RS-IV.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: extended-release guanfacine hydrochloride (SPD503) intervention 2: placebo intervention 3: extended-release guanfacine hydrochloride
Intervention descriptions: intervention 1: dosed in AM intervention 2: dosed in the AM or PM intervention 3: Dosed in the PM

Protocol document: