Long-Term, Open Label Atomoxetine Study

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Atomoxetine Hydrochloride

Criteria

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