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

Addrenex Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: ADHD

Treatments: Drug: Placebo; Drug: CLONICEL (clonidine HCl sustained release)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00641329

CLON-302

Details and patient eligibility

About

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).

Enrollment: 198 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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198 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: CLONICEL (clonidine HCl sustained release)

2

Placebo Comparator group

Treatment:

Drug: Placebo