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
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
- Secondary Outcome Measures
Name Time Method