Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention Deficit Hyperactivity Disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 135
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the long-term efficacy and safety of KAPVAY™ (clonidine hydrochloride) extended-release in children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD)

Detailed description:

Arms:
arm 1: Subjects in the KAPVAY™ arm receive their optimal dose of KAPVAY™ for the 26-week randomized-withdrawal period (Period 3) arm 2: Subjects in placebo arm tapered off optimal dose of KAPVAY™ (ie, Period 2 Maintenance Dose) at weekly intervals in decrements of 0.1 mg/day until reaching dose of 0 mg/day; subjects then receive only placebo for the rest of the study

Interventions: intervention 1: clonidine hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: KAPVAY™ (clonidine hydrochloride) 0.1 mg, 0.2 mg, 0.3 mg, or 0.4 mg from Weeks 11-36 intervention 2: KAPVAY™ (clonidine hydrochloride) 0.1 mg, 0.2 mg, or 0.3 mg at Week 11; KAPVAY™ 0.1 mg, KAPVAY™ 0.2 mg, or placebo at Week 12; KAPVAY™ 0.1 mg or placebo at Week 13; placebo from Weeks 14-36

Protocol document: