CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 269 enrolled
Drug / intervention
atomoxetinedrug
Likely dose
atomoxetine 0.5 milligramsfrom 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.

Search/NCT00320528
NCT00320528Phase 3Completed

An Open-Label Study of the Efficacy of Atomoxetine Hydrochloride on Quality of Life of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder With or Without Comorbid Conditions

Eli Lilly and Company·interventional·Posted May 3, 2006·Updated Jan 6, 2010

In Brief

A Phase 3 clinical trial evaluating atomoxetine for Attention Deficit Disorder With Hyperactivity. Completed, enrolled 269 participants across 20 sites.

Detailed Summary

This study aims to assess the effectiveness of atomoxetine on psychosocial functioning and emotional well being of children and adolescents with ADHD and to evaluate whether and in what measure the presence of comorbid conditions (internalizing and externalizing disorders) influences atomoxetine's ability to improve the quality of life of ADHD subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 3, 2006
Enrollment StartApr 1, 2006
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 20.2 years ago

Interventions

atomoxetinedrug

0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks