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Open-Label Trial of Atomoxetine to Evaluate Academic Outcome in Children Ages 8-11 Years With Attention Deficit/Hyperactivity Disorder

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Lilly

Status and phase

Completed
Phase 3

Conditions

Attention Deficit Hyperactivity Disorder

Treatments

Drug: atomoxetine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00191880
7649
B4Z-CA-LYCS

Details and patient eligibility

About

Open-label trial of Atomoxetine to Evaluate Academic Outcome in Children Ages 8-11 years with Attention- Deficit/Hyperactivity Disorder

Sex

All

Ages

8 to 11 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

-Patients must have ADHD, be psychotropic medication naive and be outpatients who are at least 8 years of age and not more than 10 years of age at Visit 1 (that is, not yet reached their 11 birthday) so that all year testing will be completed before the child reaches age 12.

Exclusion criteria

-Patients with current or past history of Bipolar I or II disorder, psychosis, autism, Asperger's syndrome, pervasive developmental disorder, conduct disorder, seizure disorder or serious suicidal risk are excluded

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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