An Open-Label Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

257 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-02-28

Brief Summary

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A single arm, open-label, phase 3 multicenter study to evaluate the effectiveness and tolerability of atomoxetine (given once daily, target dose 1.2 mg/kg/day), as perceived by patients, parents and physicians, and its impact on quality of sleep in children (aged 6 through 11 years) with Attention-Deficit/Hyperactivity Disorder treated as outpatients in Germany. An 8-week treatment phase is followed by a 16-week extension period.

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Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Atomoxetine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female outpatients who are at least 6 years of age and who will not have reached their 12th birthday
* Diagnosis of ADHD
* Normal intelligence

Exclusion Criteria

* Weigh less than 20 kg or more than 60 kg at study entry
* Other relevant psychiatric diagnoses
* Are at serious suicidal risk as determined by the investigator
* Have a history of severe allergies
* Alcohol or drug abuse within the past 3 months

Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No