An Open-Label Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Study on Effectiveness and Tolerability of Atomoxetine as Perceived by Patients, Parents, and Physicians in Children With Attention-Deficit/Hyperactivity Disorder in Germany|
- Global Impression of Perceived Difficulties (GIPD) scale at baseline, Week 8 and Week 24
- Pediatric Adverse Events Rating Scale (PAERS) during 8 and 24 weeks of treatment.
- O'Brien Sleep Questionnaire during 8 and 24 weeks of treatment
|Study Start Date:||October 2004|
|Estimated Study Completion Date:||February 2006|
|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.|
|Koln, Germany, D-50931|
|Study Chair:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)||Eli Lilly and Company|