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

Phase 3

Completed

• Conditions: ADHD
• Interventions: Drug: CLONICEL (clonidine HCl sustained release); Drug: Placebo

• Registration Number: NCT00641329
• Lead Sponsor: Addrenex Pharmaceuticals, Inc.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-03-19
• Study First Submitted QC: 2008-03-19
• Study First Posted: 2008-03-24
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2009-03
• Last Update Submitted: 2010-04-08
• Last Update Posted: 2010-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	CLONICEL (clonidine HCl sustained release)	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
ADHDRS-IV Total Score	Week 5
Treatment Emergent Adverse Events, Laboratory Tests, Vital Signs, and ECGs	Throughout Treatment and Follow-up Period