Status:
COMPLETED
CLONICEL (Clonidine Sustained Release) as Add-on to Stimulant Medication in 6 to 17 Yr-olds With ADHD
Lead Sponsor:
Addrenex Pharmaceuticals, Inc.
Conditions:
ADHD
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
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 hyp...
Eligibility Criteria
Inclusion
- 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
- Clinically significant illnesses or abnormalities upon evaluation
- Conduct Disorder
- Intolerance to clonidine
- History of seizures or syncope
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT00641329
Start Date
February 1 2008
End Date
February 1 2009
Last Update
April 9 2010
Active Locations (23)
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1
Little Rock, Arkansas, United States, 72205
2
El Centro, California, United States, 92243
3
Irvine, California, United States, 92612
4
San Diego, California, United States, 92103