Status:
COMPLETED
Placebo-Controlled Comparison of Two Different Brands of Modified-Release Oral Dosage Forms Regarding Safety and Efficacy in Children With Attention Deficit Hyperactivity Disorder (ADHD) Aged 6 - 14
Lead Sponsor:
Novartis
Conditions:
ADHD
Eligibility:
All Genders
6-14 years
Phase:
PHASE3
Brief Summary
Currently two different brands of modified-release formulations are providing 50% immediate release beads/pellets and 50% extended release beads/pellets, resulting in a rapid onset and dual peak conce...
Detailed Description
Currently two different brands of modified-release formulations are providing 50% immediate release beads/pellets and 50% extended release beads/pellets, resulting in a rapid onset and dual peak conce...
Eligibility Criteria
Inclusion
- Patients who meet all of the following inclusion criteria will be eligible for enrollment in the study:
- Male and female patients aged 6-14.
- Patients having a diagnosis of ADHD of any type according to DSM-IV criteria, as established by history, psychiatric examination and a structured diagnostic interview (Kiddie-Sads-Present and Lifetime Version)
- Patients, whose symptoms are adequately controlled by a stable and well-tolerated dose of a immediate release methylphenidate equivalent of 20mg for one month before screening.
Exclusion
- Patients with comorbid psychiatric conditions with symptoms requiring current pharmacological treatment (e.g. major depression, psychosis).
- Patients who are taking any concomitant medications likely to interfere with the study drug or confound efficacy or safety assessments, e.g.
- Tricyclic antidepressants, buproprion, clonidine, buspirone 2 weeks before randomization.
- Atomoxetine 2 weeks before randomization.
- Fluoxetine or antipsychotics 1 month before randomization.
- Pemoline and amphetamines 1 week before randomization.
- Patients with a known non-response to methylphenidate.
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00254878
Start Date
October 1 2005
End Date
February 1 2006
Last Update
December 21 2007
Active Locations (1)
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1
Novartis Investigational Site
Freiburg im Breisgau, Germany