At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 94 enrolled
Drug / intervention
Atomoxetine and OROS Methylphenidatedrug
Likely dose
Atomoxetine and OROS Methylphenidate 1.2 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy and Safety/Tolerability of OROS MPH (Concerta) Plus Atomoxetine (ATMX) in Children and Adolescents (Age 6-17) With Attention Deficit Hyperactivity Disorder (ADHD)
In Brief
A Phase 4 clinical trial evaluating Atomoxetine and OROS Methylphenidate for ADHD and Attention Deficit Hyperactivity Disorder. Completed, enrolled 94 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the safety, effectiveness, and tolerability of atomoxetine and OROS methylphenidate, taken together, in the treatment of ADHD in children and adolescents ages 6-17.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsADHD, Attention Deficit Hyperactivity Disorder
CountriesUnited States
CollaboratorsOrtho-McNeil Janssen Scientific Affairs, LLC
Timeline
Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2004
Primary CompletionDec 2007
First PostedJan 2008
TodayJul 2026
First PostedJan 4, 2008
Enrollment StartJan 1, 2004
Primary CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 18.5 years ago
Interventions
Atomoxetine and OROS Methylphenidatedrug
Subjects must have at least attempted to tolerate a dose of 1.2 mg/kg of atomoxetine. If tolerated, they must remain on this dose for at least two weeks. OROS methylphenidate will be target dosed and titrated to a maximum dose of 54 mg.