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Clinical Trials/NCT00191295
NCT00191295
Completed
Phase 2

A Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Comparison of Fixed-Dose Ranges of Atomoxetine Hydrochloride in Child Outpatients With Attention-Deficit/Hyperactivity Disorder

Eli Lilly and Company1 site in 1 country240 target enrollmentFebruary 2005
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ConditionsAttention Deficit Hyperactivity Disorder
DrugsAtomoxetinePlacebo

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Attention Deficit Hyperactivity Disorder
Sponsor
Eli Lilly and Company
Enrollment
240
Locations
1
Primary Endpoint
Change of total score on ADHD RS-IV-JParent Version: Investigation-Administered and Scored
Status
Completed
Last Updated
18 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

Atomoxetine versus placebo in Children with Attention-Deficit/Hyperactivity Disorder (ADHD)

Registry
clinicaltrials.gov
Start Date
February 2005
End Date
September 2006
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Patients are diagnosed with ADHD
  • •Patients must be able to swallow capsules
  • •Patients must be of normal intelligence

Exclusion Criteria

  • •Patients who weigh less than 15 kg or more than 75 kg
  • •Patients with organic brain disease (for example, dementia or traumatic brain injury residual)

Outcomes

Primary Outcomes

Change of total score on ADHD RS-IV-JParent Version: Investigation-Administered and Scored

Secondary Outcomes

  • Relationship between atomoxetine doses and both efficacy and safety variables
  • Plasma concentration of atomoxetine and its metabolites
  • Changes on ADHD RS-IV-J-School Version score

Study Sites (1)

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