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Study of Atomoxetine in Children With ADHD to Assess Symptomatic and Functional Outcomes

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Lilly

Status and phase

Completed
Phase 4

Conditions

Attention-Deficit/Hyperactivity Disorder

Treatments

Drug: Atomoxetine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00191633
B4Z-CA-S012
9684

Details and patient eligibility

About

The purpose of this study is to assess whether changes in the symptoms of ADHD show a relationship with changes in functioning in children with ADHD treated with atomoxetine over a 3-month period.

Sex

All

Ages

6 to 11 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients must have ADHD, be outpatients, who are at least 6 years of age and not more than 11 years 8 months of age at Visit 1 so that all testing will be completed before the child reaches age 12.
  • Patients must have moderately severe symptoms of ADHD.
  • Patients must be able to swallow study drug capsules.

Exclusion criteria

  • Patients must not have Bipolar disorder, psychosis, autism, Asperger's syndrome, pervasive developmental disorder, or seizure disorder.
  • Patients must not have taken atomoxetine prior to starting the study.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

19

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Data sourced from clinicaltrials.gov

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