At a glance
ClinicalIndex Comparison Record- ✓Age 6 to <18 years at enrollment in first atomoxetine study
- ✓Confirmed ADHD meeting study diagnostic criteria
- ✓Willing to undergo blood draws and required study tests
- ✕Allergic to more than one type of medicine or multiple severe drug reactions
- ✕Concurrent use of medicines with potential interactions with atomoxetine
- ✕Planned relocation beyond reasonable distance from study site within 5 years
- ✕Alcohol or drug abuse within past 3 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Long-Term, Open Label Safety Study of Atomoxetine Hydrochloride in Patients, 6 Years and Older With Attention-Deficit/Hyperactivity Disorder
In Brief
A Phase 3 clinical trial evaluating atomoxetine for Attention Deficit Hyperactivity Disorder. Completed, enrolled 1,553 participants across 100 sites in 14 countries.
Detailed 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.
Study Details
Timeline
Interventions
0.5-1.8 mg/kg/day, by mouth (PO), for up to 5 years