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

Phase III Evaluation of the Safety and Efficacy of CLONICEL (Clonidine HCl Sustained Release) as Add-on to Psychostimulant Medication vs. Psychostimulant Medication Alone in Children and Adolescents With ADHD

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00641329

Enrollment

198

Registered

2008-03-24

Start date

2008-02-29

Completion date

2009-02-28

Last updated

2010-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD

Keywords

ADHD, ADD, Attention Deficit Hyperactivity Disorder, Attention Deficit, Clonidine, CLONICEL, Addrenex

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).

Interventions

DRUGCLONICEL (clonidine HCl sustained release)

Flexible Dose (0.1 - 0.4 mg)

DRUGPlacebo

Matching placebo tablets

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Years to 17 Years

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026