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

Phase 3CompletedNCT00191516

Eli Lilly and Company257 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

257

Conditions

Attention Deficit Hyperactivity Disorder

Interventions

AtomoxetineDRUG

Eligibility

Sex: ALLMin age: 6 YearsMax age: 11 Years

Medical Language ↔ Plain English

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

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Cologne, Germany

Outcomes

Primary Outcomes

Global Impression of Perceived Difficulties (GIPD) scale at baseline, Week 8 and Week 24

Secondary Outcomes

Pediatric Adverse Events Rating Scale (PAERS) during 8 and 24 weeks of treatment.

O'Brien Sleep Questionnaire during 8 and 24 weeks of treatment

Data from ClinicalTrials.gov

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