An Open-Label Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder
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
2 other identifiers
interventional
257
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2004
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedJanuary 26, 2007
January 1, 2007
September 12, 2005
January 24, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
Global Impression of Perceived Difficulties (GIPD) scale at baseline, Week 8 and Week 24
Secondary Outcomes (2)
Pediatric Adverse Events Rating Scale (PAERS) during 8 and 24 weeks of treatment.
O'Brien Sleep Questionnaire during 8 and 24 weeks of treatment
Interventions
Eligibility Criteria
You may qualify if:
- Male or female outpatients who are at least 6 years of age and who will not have reached their 12th birthday
- Diagnosis of ADHD
- Normal intelligence
You may not qualify if:
- Weigh less than 20 kg or more than 60 kg at study entry
- Other relevant psychiatric diagnoses
- Are at serious suicidal risk as determined by the investigator
- Have a history of severe allergies
- Alcohol or drug abuse within the past 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
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.
Cologne, D-50931, Germany
Related Publications (1)
Wehmeier PM, Schacht A, Dittmann RW, Banaschewski T. Minor differences in ADHD-related difficulties between boys and girls treated with atomoxetine for attention-deficit/hyperactivity disorder. Atten Defic Hyperact Disord. 2010 Jun;2(2):73-85. doi: 10.1007/s12402-010-0022-2. Epub 2010 Mar 30.
PMID: 21432592DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 19, 2005
Study Start
October 1, 2004
Study Completion
February 1, 2006
Last Updated
January 26, 2007
Record last verified: 2007-01