Long-Term, Open Label Atomoxetine Study

Lilly

Status and phase: Completed; Phase 3

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Drug: atomoxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00190684

4331

B4Z-MC-LYAI (Other Identifier)

Details and patient eligibility

About

To learn about the safety and any side effects of atomoxetine when given to children and adolescents for about 5 years (long-term) and to learn whether atomoxetine can help children and adolescents with attention-deficit/hyperactivity disorder (ADHD) who take the drug for about 5 years (long-term).

Study participants can be atomoxetine naive, atomoxetine experienced whose therapy has been interrupted or, atomoxetine experienced on a known stable dose.

Enrollment: 1,553 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be at least 6 years old but less than 18 years old when enrolled in first atomoxetine study
• Must meet the study criteria for ADHD
• Must be willing to have blood drawn and to complete other test required for this study

Exclusion criteria

• allergic to more than 1 kind of medicine or have had multiple bad reactions to any drug
• taking certain medicines that could interact with atomoxetine
• plan to move too far away from a doctor participating in this study in the next 5 years
• current or past history of any of the following: alcohol or drug abuse within the past 3 months, bipolar I or II disorder, high blood pressure, organic brain disease or seizures, psychosis, other disorders or conditions diagnosed by a doctor that might make you unsuitable to participate in this study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,553 participants in 1 patient group

Atomoxetine

Experimental group

Description:

Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted with be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.

Treatment:

Drug: atomoxetine