Study of Broader Efficacy of Atomoxetine in the Treatment of ADHD in Children/Adolescents

Lilly

Status and phase: Completed; Phase 3

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Drug: Atomoxetine Hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00191659

6962

B4Z-BP-LYBS

Details and patient eligibility

About

To test the hypothesis that children/adolescents with ADHD, who are treated with atomoxetine hydrochloride in comparison to standard current therapies have greater improvements in their quality of life.

Sex: All

Ages: 7 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of ADHD

Exclusion criteria

• Patients who weigh less than 20kg at visit 1
• Have Bipolar Disorder/seizure disorder/taken anticonvulsants for seizures
• Judged to be at suicidal risk
• Taking psychotropic medication on a regular basis
• Hypertension

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)