search
Back to results

An Open-Label Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Atomoxetine
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • 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.

Outcomes

Primary Outcome Measures

Global Impression of Perceived Difficulties (GIPD) scale at baseline, Week 8 and Week 24

Secondary Outcome Measures

Pediatric Adverse Events Rating Scale (PAERS) during 8 and 24 weeks of treatment.
O'Brien Sleep Questionnaire during 8 and 24 weeks of treatment

Full Information

First Posted
September 12, 2005
Last Updated
January 24, 2007
Sponsor
Eli Lilly and Company
search

1. Study Identification

Unique Protocol Identification Number
NCT00191516
Brief Title
An Open-Label Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
257 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Atomoxetine
Primary Outcome Measure Information:
Title
Global Impression of Perceived Difficulties (GIPD) scale at baseline, Week 8 and Week 24
Secondary Outcome Measure Information:
Title
Pediatric Adverse Events Rating Scale (PAERS) during 8 and 24 weeks of treatment.
Title
O'Brien Sleep Questionnaire during 8 and 24 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Chair
Facility Information:
Facility Name
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.
City
Koln
ZIP/Postal Code
D-50931
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
21432592
Citation
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.
Results Reference
derived

Learn more about this trial

An Open-Label Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder

We'll reach out to this number within 24 hrs