CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 228 enrolled
Drug / intervention
Atomoxetine hydrochloridedrug
Likely dose
Atomoxetine hydrochloride 0.5 mg/kg BID orally, titrated to 1.2 mg/kg BID over 2 weeks, then 1.2–1.8 mg/kg BID orally for up to 4 yearsAI-extracted
Key inclusion· 2
  • ✓Completed the prior placebo-controlled study and met all disease diagnostic and study criteria at Visit 2
  • ✓Patient/guardian willing to participate in the extension study
Key exclusion· 1
  • ✕Anticipated relocation outside the study site's geographic range or planned travel incompatible with required visit intervals

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00191386
NCT00191386Phase 3Completed
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Long-Term Extension, Open-Label Study of Atomoxetine Hydrochloride in Child Outpatients With Attention-Deficit/Hyperactivity Disorder

Eli Lilly and Company·interventional·Posted Sep 19, 2005·Updated Dec 28, 2010

In Brief

A Phase 3 clinical trial evaluating Atomoxetine hydrochloride for Attention Deficit Hyperactivity Disorder. Completed, enrolled 228 participants across 24 sites.

Detailed Summary

The study is long-term extension study to evaluate long-term safety and efficacy of Atomoxetine in Japanese pediatric patients with Attention-Deficit/Hyperactivity Disorder (AD/HD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Hyperactivity Disorder
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartMay 1, 2005
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 20.8 years ago

Interventions

Atomoxetine hydrochloridedrug

0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years