Conditions: Attention-deficit/Hyperactivity Disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 528
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the long-term maintenance of efficacy of Extended-Release Guanfacine HCl in children and adolescents (6-17 years) with attention-deficit/hyperactivity disorder (ADHD) who respond to an initial open-label, short term treatment with SPD503.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Extended-release Guanfacine Hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: The test product will be provided as 1, 2, 3, and 4mg tablets. Subjects will be administered a once-daily dose between 1-7mg/day depending on age and weight. intervention 2: Matching placebo will be provided as 1, 2, 3, and 4mg tablets. Subjects will be administered a once-daily dose of placebo between 1-7mg/day depending on age and weight.

Protocol document: