At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 112 enrolled
Drug / intervention
Atomoxetinedrug
Likely dose
Atomoxetine 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.
A Randomized, Controlled, Open-Label Comparison Study of the Efficacy and Safety of Slow Transitioning Compared With Fast Transitioning From a Stimulant Medication to Atomoxetine in Pediatric and Adolescent Outpatients With DSM-IV Attention-Deficit/Hyperactivity Disorder (ADHD)
In Brief
A Phase 4 clinical trial evaluating Atomoxetine for Attention Deficit Hyperactivity Disorder. Completed, enrolled 112 participants across 6 sites in 3 countries.
Detailed Summary
Children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD) who are not tolerating or not responding well to stimulant therapy will be included in this study. Two different strategies for transition from Stimulant to Atomoxetine will be used: Slow (10 weeks) and fast (2 weeks). Changes in ADHD symptoms and tolerability of medication will be compared between the two different switching approaches.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Hyperactivity Disorder
CountriesAustralia, Mexico, United Kingdom
Collaborators--
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2008
First PostedSep 2008
Primary CompletionAug 2010
Study CompletionSep 2010
TodayJul 2026
First PostedSep 26, 2008
Enrollment StartSep 1, 2008
Primary CompletionAug 1, 2010
Study CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 17.8 years ago
Interventions
Atomoxetinedrug
1.2 mg/kg/day up to 1.8 mg/kg/day, orally (PO)