Status:
COMPLETED
Safety and Efficacy of Methylphenidate in Children With Attention-deficit Hyperactivity Disorder (ADHD)
Lead Sponsor:
Novartis
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
Brief Summary
This study evaluated the safety and clinical effect of treatment with methylphenidate under different breakfast conditions (minimal breakfast versus standard continental breakfast) in children with At...
Eligibility Criteria
Inclusion
- Children aged 6-12
- Diagnosis of Attention-Deficit Hyperactivity Disorder (ADHD)
- Current medication with either 20 mg or 40 mg immediate release methylphenidate
Exclusion
- Concomitant psychiatric disorders requiring pharmacological treatment
- Concomitant severe somatic disorders
- Eating disorders
- Addiction disorders
- Very high or low body weight according to age
- Known hypersensitivity to methylphenidate
- Contraindications for methylphenidate
- Other protocol-defined inclusion/exclusion criteria applied to the study.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00428792
Start Date
April 1 2007
End Date
December 1 2007
Last Update
May 6 2011
Active Locations (1)
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1
Novartis Investigative Site
Freiburg im Breisgau, Germany