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)...
Date First Received: March 19, 2008
Last Updated: August 11, 2008
Verified by: Addrenex Pharmaceuticals, Inc., August 2008
Clinical Trial Phase: Phase 3 | Start Date: February 2008
Overall Status: Recruiting
Estimated Enrollment: 200
Brief Summary
Official Title: “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”
Condition Keyword(s):
Intervention(s):
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).
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Study Primary Completion Date: November 2008
Intervention(s) in this Clinical Trial
- Drug: CLONICEL (clonidine HCl sustained release)
- Flexible Dose (0.1 - 0.4 mg)
- Drug: Placebo
- Matching placebo tablets
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Placebo Comparator: 2
Outcome Measures for this Clinical Trial
Primary Measures
- ADHDRS-IV Total Score
- Time Frame: Week 5
Safety Issue?: No
- Time Frame: Week 5
- Treatment Emergent Adverse Events, Laboratory Tests, Vital Signs, and ECGs
- Time Frame: Throughout Treatment and Follow-up Period
Safety Issue?: Yes
- Time Frame: Throughout Treatment and Follow-up Period
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 6 Years
Maximum Age for this Clinical Trial: 17 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Addrenex Pharmaceuticals, Inc.
Overall Clinical Trial Officials and Contacts
Moise Khayrallah, PhD Study Director Addrenex Pharmaceuticals
Overall Contact: Kelly J Abernathy 919-941-0800 kabernathy@addrenex.com
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00641329
Study ID Number: CLON-302
ClinicalTrials.gov Identifier: NCT00641329
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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