drugset / Trial / NCT00447278
A Study Comparing the Effect of Atomoxetine Versus Other Standard Care Therapy on the Long Term Functioning in Attention-Deficit/Hyperactivity Disorder (ADHD) Children and Adolescents
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to demonstrate that atomoxetine is superior to other early standard therapy (any treatment that investigator considers is appropriate to initiate for the treatment of Attention-Deficit/Hyperactivity Disorder \[ADHD\]) on the long term functioning in approximately 400 children and adolescents with ADHD. Patients will be pharmacological naïve prior to entry into the study.
Timeline
- Start
- 2007-03
- Primary completion
- 2009-03
- Completion
- 2009-07
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Atomoxetine vs OEST; p <0.001; Least Squares Mean Difference -4.36 (95% CI -6.47 to -2.25) NCT00447278 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atomoxetine | Other / unclassified | 1.2 mg/kg | — |
| Subject | Atomoxetine | Other / unclassified | 1.8 mg/kg | — |