Treatment With Atomoxetine Hydrochloride in Children and Adolescents With ADHD

Lilly

Status and phase: Completed; Phase 4

Conditions: Attention-Deficit/Hyperactivity Disorder; Comorbid Dyslexia

Treatments: Drug: Atomoxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00191048

B4Z-US-LYCE

7975

Details and patient eligibility

About

The purpose of this study is to assess the efficacy and safety of atomoxetine administered once daily in the treatment of children and adolescents with ADHD and comorbid dyslexia.

Sex: All

Ages: 10 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with ADHD only or ADHD and Dyslexia
• At least 10 years old and no more than 16 years old
• IQ score of 80 or more
• Must be able to swallow capsules

Exclusion criteria

• Have received treatment within last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
• Weigh less than 25 kg or greater than 70 kg
• Pregnant or breast feeding
• Documented history of bipolar I or II disorder, or psychosis
• Documented history of autism, Asperger's syndrome or pervasive developmental disorder

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)