CLONICEL (Clonidine Sustained Release) as Add-on to Stimulant Medication in 6 to 17 Yr-olds With ADHD

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if CLONICEL (clonidine HCl sustained release) is a safe and effective add-on to psychostimulant therapy in children and adolescents with attention deficit hyperactivity disorder (ADHD).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Addrenex Pharmaceuticals, Inc.
• Treatments: Clonidine

Criteria

Inclusion Criteria:

• Age 6-17 years, inclusive

• Diagnosis of ADHD

• Currently on a stable psychostimulant regimen for ADHD

• Lack of adequate response to stable psychostimulant regimen

• Ability to swallow tablets

Exclusion Criteria:

• Clinically significant illnesses or abnormalities upon evaluation

• Conduct Disorder

• Intolerance to clonidine

• History of seizures or syncope