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Study of Broader Efficacy of Atomoxetine in the Treatment of ADHD in Children/Adolescents

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Atomoxetine Hydrochloride
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

7 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of ADHD Exclusion Criteria: Patients who weigh less than 20kg at visit 1 Have Bipolar Disorder/seizure disorder/taken anticonvulsants for seizures Judged to be at suicidal risk Taking psychotropic medication on a regular basis Hypertension

Sites / Locations

  • For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Outcomes

Primary Outcome Measures

To test whether atomoxetine given for 10 weeks is superior to standard current therapy as measured by CHIP-CE (Child Health and Illness Profile - Child Edition)

Secondary Outcome Measures

CHIP-CE total mean score after 4 weeks of treatment.
The domains of the CHIP-CE after 4 and 10 weeks of treatment.
The following are measured after both 4 and 10 weeks of treatment:
Family Buden of Illness
Harter Self Perception Profile
ADHD-RS
Clinical Global Impression- Severity
Clinical Global Impression -Improvement
To assess whether changes to the above scales are maintained over long term
Long-term safety of atomoxetine

Full Information

First Posted
September 12, 2005
Last Updated
February 28, 2007
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00191659
Brief Title
Study of Broader Efficacy of Atomoxetine in the Treatment of ADHD in Children/Adolescents
Official Title
A Randomised, Controlled, Open-Label Study of the Broader Efficacy of Atomoxetine Hydrochloride in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children and Adolescents
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company

4. Oversight

5. Study Description

Brief Summary
To test the hypothesis that children/adolescents with ADHD, who are treated with atomoxetine hydrochloride in comparison to standard current therapies have greater improvements in their quality of life.

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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Atomoxetine Hydrochloride
Primary Outcome Measure Information:
Title
To test whether atomoxetine given for 10 weeks is superior to standard current therapy as measured by CHIP-CE (Child Health and Illness Profile - Child Edition)
Secondary Outcome Measure Information:
Title
CHIP-CE total mean score after 4 weeks of treatment.
Title
The domains of the CHIP-CE after 4 and 10 weeks of treatment.
Title
The following are measured after both 4 and 10 weeks of treatment:
Title
Family Buden of Illness
Title
Harter Self Perception Profile
Title
ADHD-RS
Title
Clinical Global Impression- Severity
Title
Clinical Global Impression -Improvement
Title
To assess whether changes to the above scales are maintained over long term
Title
Long-term safety of atomoxetine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of ADHD Exclusion Criteria: Patients who weigh less than 20kg at visit 1 Have Bipolar Disorder/seizure disorder/taken anticonvulsants for seizures Judged to be at suicidal risk Taking psychotropic medication on a regular basis Hypertension
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 Director
Facility Information:
Facility Name
For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
City
Basingstoke
State/Province
Hampshire
ZIP/Postal Code
RG24 9NL
Country
United Kingdom

12. IPD Sharing Statement

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Study of Broader Efficacy of Atomoxetine in the Treatment of ADHD in Children/Adolescents

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