drugset / Trial / NCT00191516
An Open-Label Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder
Non-randomizedSingle-groupOpen-labelTreatment
Summary
A single arm, open-label, phase 3 multicenter study to evaluate the effectiveness and tolerability of atomoxetine (given once daily, target dose 1.2 mg/kg/day), as perceived by patients, parents and physicians, and its impact on quality of sleep in children (aged 6 through 11 years) with Attention-Deficit/Hyperactivity Disorder treated as outpatients in Germany. An 8-week treatment phase is followed by a 16-week extension period.
Timeline
- Start
- 2004-10
- Primary completion
- —
- Completion
- 2006-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atomoxetine | Other / unclassified | 1.2 mg/kg | — |