At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 151 enrolled
Drug / intervention
Atomoxetine Hydrochloride +1 moredrug
Likely dose
Not stated in record
Key inclusion· 6
- ✓Age 6 to <16 years old at Visit 1
- ✓Diagnosis confirmed by DSM-IV-TR criteria using K-SADS-PL at Visit 1
- ✓ADHDRS-IV-Parent:Inv score at least 1.5 standard deviations above age norm at both Visit 1 and Visit 2
- ✓CGI-ADHD-S score ≥4 at both Visit 1 and Visit 2
Key exclusion· 1
- ✕Prior ADHD diagnosis more than 3 months before Visit 1
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Double-Blind, Placebo-Controlled Clinical Trial of Efficacy and Safety of Atomoxetine up to 12 Weeks in Newly Diagnosed Children and Adolescents Outpatients With Attention-Deficit/Hyperactivity Disorder
In Brief
A Phase 3 clinical trial evaluating Atomoxetine Hydrochloride and placebo for Attention Deficit Hyperactivity Disorder. Completed, enrolled 151 participants across 11 sites.
Detailed Summary
Double blinded clinical trial placebo controlled in 153 children (planned enrollment) with recent diagnosis of ADHD. Patients will be randomized to atomoxetine or placebo arm (2:1). The double blinded period will last 12 weeks and the treatment open phase will last up to 1 year, and atomoxetine treatment will be administered. A gatekeeper strategy will be employed for sequentially testing the secondary objectives.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Hyperactivity Disorder
CountriesSpain
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2005
First PostedSep 2005
Primary CompletionFeb 2008
TodayJul 2026
First PostedSep 19, 2005
Enrollment StartMay 1, 2005
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 20.8 years ago
Interventions
Atomoxetine Hydrochloridedrug
placebodrug