Status:
COMPLETED
Efficacy and Safety of Atomoxetine in Children With Recent Diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD)
Lead Sponsor:
Eli Lilly and Company
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
6-15 years
Phase:
PHASE3
Brief Summary
Double blinded clinical trial placebo controlled in 153 children (planned enrollment) with recent diagnosis of ADHD. Patients will be randomized to atomoxetine or placebo arm (2:1). The double blinded...
Eligibility Criteria
Inclusion
- Child or adolescent patients must be at least 6 years of age, but must not yet have reached their 16th birthday prior to Visit 1, when informed consent is obtained.
- Patients must meet the Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition Text Revision (DSM-IV-TR) diagnostic criteria for ADHD. For the purposes of this study the diagnosis of ADHD will be confirmed during Visit 1 by administering the K-SADS-PL. Patients must also have an ADHDRS-IV-Parent:Inv score at least 1.5 standard deviations above the age norm for their diagnostic subtype at both Visit 1 and Visit 2. In addition, they must have a CGI-ADHD-S score 4 at both Visit 1 and Visit 2.
- Patients must have a newly diagnosed case of ADHD. Newly diagnosed case of ADHD means that a specialist (including pediatrician, child psychiatrist, or child neurologist) or child psychologist has diagnosed ADHD (according DSM-IV-TR or International Statistical Classification of Diseases and Related Health Problems \[World Health Organisation; 10th Revision\] \[ICD 10\] criteria) within 3 months prior to Visit 1.
Exclusion
- Patients with history of ADHD diagnosis longer than 3 months prior to Visit 1. Diagnosis of ADHD means that a specialist (including pediatrician, child psychiatrist, or child neurologist) or child psychologist has diagnosed ADHD (according DSM-IV-TR or ICD 10 criteria) and has registered it in medical records or verbally informed parents about this diagnosis.
- Patients who weigh less than 20 kg at study entry (Visit 1). If a patient's weight changes after Visit 1 to a value outside of the stated range, the patient will still be eligible, and the weight should be rounded to the nearest value within the above range for dosing purposes.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT00191945
Start Date
May 1 2005
End Date
February 1 2008
Last Update
February 2 2010
Active Locations (11)
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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.
Badajoz, Spain, 06080
2
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.
Barcelona, Spain, 08035
3
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.
Donostia / San Sebastian, Spain, 20009
4
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.
Espluges de Llobregat, Spain, 08950