At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 45 enrolled

Drug / intervention

Atomoxetinedrug

Likely dose

Atomoxetine 40 mgfrom 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/NCT00636818

NCT00636818Phase 2Completed

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An Open Study of Atomoxetine (LY139603) in Adult Subjects With Attention-deficit/Hyperactivity Disorder

Eli Lilly and Company·interventional·Posted Mar 14, 2008·Updated Nov 4, 2010

In Brief

A Phase 2 clinical trial evaluating Atomoxetine for Attention Deficit Hyperactivity Disorder. Completed, enrolled 45 participants across 11 sites in 3 countries.

Detailed Summary

The primary objective of this clinical study is to assess overall safety and tolerability as measured by discontinuation rate due to adverse events in doses up to 120 mg/day in relation to global clinical studies in adult subjects who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV™) criteria for Attention-Deficit/Hyperactivity Disorder (ADHD).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAttention Deficit Hyperactivity Disorder

CountriesChina, South Korea, Taiwan

Collaborators--

Timeline

Phase 2CompletedFinished

20082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartMar 2008

First PostedMar 2008

Primary CompletionSep 2008

Study CompletionOct 2008

TodayJul 2026

First PostedMar 14, 2008

Enrollment StartMar 1, 2008

Primary CompletionSep 1, 2008

Study CompletionOct 1, 2008

TodayJul 2, 2026

Enrollment to primary: 6 monthsPosted 18.3 years ago

Interventions

Atomoxetinedrug

Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.