CLONICEL (Clonidine Sustained Release) as Add-on to Stimulant Medication in 6 to 17 Year-Olds With Attention Deficit Hyperactivity Disorder (ADHD)
Information source: Addrenex Pharmaceuticals, Inc.
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: ADHD
Intervention: CLONICEL (clonidine HCl sustained release) (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Addrenex Pharmaceuticals, Inc. Official(s) and/or principal investigator(s):
Moise Khayrallah, PhD, Study Director, Affiliation: Addrenex Pharmaceuticals
Overall contact:
Kelly J Abernathy, Phone: 919-941-0800, Ext: 203, Email: kabernathy@addrenex.com
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).
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: ADHDRS-IV Total ScoreTreatment Emergent Adverse Events, Laboratory Tests, Vital Signs, and ECGs
Eligibility
Minimum age: 6 Years.
Maximum age: 17 Years.
Gender(s): Both.
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
Locations and Contacts
Kelly J Abernathy, Phone: 919-941-0800, Ext: 203, Email: kabernathy@addrenex.com
Little Rock, Arkansas 72205, United States; Recruiting
San Diego, California 92103, United States; Recruiting
Irvine, California 92612, United States; Recruiting
El Centro, California 92243, United States; Recruiting
Miami, Florida 33161, United States; Recruiting
Bradenton, Florida 34208, United States; Recruiting
Lauderhill, Florida 33319, United States; Recruiting
Baltimore, Maryland 21208, United States; Recruiting
St. Louis, Missouri 63005, United States; Recruiting
Clementon, New Jersey 08021, United States; Recruiting
Durham, North Carolina 27705, United States; Recruiting
Chapel Hill, North Carolina 27514, United States; Recruiting
Cleveland, Ohio 44106, United States; Recruiting
Oklahoma City, Oklahoma 73116, United States; Recruiting
Houston, Texas 77007, United States; Recruiting
Lake Jackson, Texas 77566, United States; Recruiting
Additional Information
Addrenex Pharmaceuticals
Starting date: February 2008
Ending date: November 2008
Last updated: August 11, 2008
|
