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Clinical Trials/NCT00191516
NCT00191516CompletedPhase 3

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

Eli Lilly and Company2 sites in 1 country257 target enrollmentStarted: October 2004Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
257
Locations
2
Primary Endpoint
Global Impression of Perceived Difficulties (GIPD) scale at baseline, Week 8 and Week 24
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
6 Years to 11 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

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

Investigators

Sponsor Class
Industry

Study Sites (2)

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