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OpenTrials
Completed

NCT Number: NCT00191516

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

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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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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, D-50931, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atomoxetine

Drug

Primary outcomes

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

Secondary outcomes

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

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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

An Open-Label Study on Effectiveness and Tolerability of Atomoxetine as Perceived by Patients, Parents, and Physicians in Children With Attention-Deficit/Hyperactivity Disorder in Germany

Important dates

Study start
2004
Study completion
2006
First posted
Sep 19, 2005
Registry last updated
Jan 26, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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