Efficacy & Safety of KAPVAY™ Extended-Release in Children & Adolescents With Attention Deficit Hyperactivity Disorder

PHASE4CompletedINTERVENTIONAL
Enrollment

135

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

October 31, 2012

Study Completion Date

October 31, 2012

Conditions
Attention Deficit Hyperactivity Disorder
Interventions
DRUG

clonidine hydrochloride

KAPVAY™ (clonidine hydrochloride) 0.1 mg, 0.2 mg, 0.3 mg, or 0.4 mg from Weeks 11-36

DRUG

Placebo

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

All Listed Sponsors
lead

Concordia Pharmaceuticals Inc., Barbados

INDUSTRY