At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 121 enrolled
Drug / intervention
Atomoxetine Hydrochloride +1 moredrug
Likely dose
Atomoxetine 1.2 mg/kg/day by mouthAI-extracted
Key inclusion· 1
- ✓Clinical diagnosis of ADHD and/or Reading Disorder
Key exclusion· 3
- ✕History of Bipolar I or II Disorder, psychosis, or Pervasive Development Disorder
- ✕Conduct Disorder
- ✕Current Vocal Tic Disorder, Obsessive Compulsive Disorder, Major Depressive Disorder, Post Traumatic Stress Disorder, or Anxiety Disorder
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Crossover Comparison of Atomoxetine and Placebo in Child Outpatients With Attention-Deficit/Hyperactivity Disorder, Reading Disorder, or Comorbid Attention-Deficit/Hyperactivity Disorder and Reading Disorder.
In Brief
A Phase 4 clinical trial evaluating Atomoxetine Hydrochloride and placebo for Attention Deficit Hyperactivity Disorder and Reading Disorder. Completed, enrolled 121 participants across 5 sites in 2 countries.
Detailed Summary
To test the hypothesis that a 4 week treatment with atomoxetine is more effective than placebo in patients with combined type Attention Deficit/Hyperactivity Disorder (ADHD), patients with only Reading Disorder, and patients with combined type ADHD and Reading Disorder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Netherlands
Collaborators--
Timeline
Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2005
First PostedSep 2005
Primary CompletionDec 2007
TodayJul 2026
First PostedSep 19, 2005
Enrollment StartApr 1, 2005
Primary CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 20.8 years ago
Interventions
Atomoxetine Hydrochloridedrug
Atomoxetine, 1.2 mg/kg/day, by mouth (PO)
placebodrug
Placebo, every day (QD), by mouth (PO)