Long-Term Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder (AD/HD)

Lilly

Status and phase: Completed; Phase 3

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Drug: Atomoxetine hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00191386

9315

B4Z-JE-LYDA (Other Identifier)

Details and patient eligibility

About

The study is long-term extension study to evaluate long-term safety and efficacy of Atomoxetine in Japanese pediatric patients with Attention-Deficit/Hyperactivity Disorder (AD/HD).

Enrollment: 228 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who met all of the disease diagnostic and study criteria at Visit 2 of previous placebo-controlled study, completed the study
• Patients wish to enter into this study

Exclusion criteria

• Patients whose families anticipate a move outside the geographic range of the investigative site, or who plan extended travel inconsistent with the recommended visit interval

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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228 participants in 1 patient group

Atomoxetine

Experimental group

Description:

0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years

Treatment:

Drug: Atomoxetine hydrochloride