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Long-Term Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder (AD/HD)

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191386
First received: September 12, 2005
Last updated: December 14, 2010
Last verified: December 2010
Results First Received: August 24, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Attention Deficit Hyperactivity Disorder
Intervention: Drug: Atomoxetine hydrochloride

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This ongoing study is being conducted as a follow-up investigation of ADHD pediatric patients who completed Study LYBC (NCT00191295).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Atomoxetine 0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years

Participant Flow:   Overall Study
    Atomoxetine
STARTED   228 
6 Months   183 
12 Months   149 
2 Years   105 
3 Years   65 
COMPLETED   68 
NOT COMPLETED   160 
Adverse Event                16 
Lost to Follow-up                1 
Entry Criteria Exclusion                3 
Protocol Violation                18 
Withdrawal by Subject                96 
Physician Decision                11 
Lack of Efficacy                15 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Atomoxetine 0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years

Baseline Measures
   Atomoxetine 
Overall Participants Analyzed 
[Units: Participants]
 228 
Age 
[Units: Years]
Mean (Standard Deviation)
 10.69  (2.48) 
Gender 
[Units: Participants]
 
Female   33 
Male   195 
Race/Ethnicity, Customized 
[Units: Participants]
 
East Asian   228 
Region of Enrollment 
[Units: Participants]
 
Japan   228 
ADHD Rating Scale-IV-Translated in Japanese Parent Version: Investigator Administered/Scored [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 22.23  (10.42) 
[1] Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.
Clinical Global Impressions-Attention Deficit Hyperactivity Disorder-Severity (CGI-ADHD-S) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 4.00  (1.04) 
[1] Measures total improvement (or worsening) of a participant's ADHD symptoms from the beginning of treatment. (1=very much improved, 7=very much worsened).
Mean Age at Onset of Attention Deficit Hyperactivity Disorder (ADHD) 
[Units: Years]
Mean (Standard Deviation)
 3.93  (1.57) 
Age at Onset of ADHD 
[Units: Participants]
 
0 Years   1 
1 Years   17 
2 Years   25 
3 Years   49 
4 Years   45 
5 Years   47 
6 Years   40 
7 Years   4 
Duration of ADHD 
[Units: Years]
Mean (Standard Deviation)
 6.25  (2.85) 
Duration of ADHD 
[Units: Participants]
 
1 Years   6 
2 Years   8 
3 Years   30 
4 Years   24 
5 Years   32 
6 Years   26 
7 Years   31 
8 Years   21 
9 Years   22 
10 Years   11 
11 Years   4 
12 Years   7 
13 Years   3 
14 Years   3 
Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-PL [1] 
[Units: Participants with Disorder Presently]
 
Oppositional Defiant Disorder   32 
Conduct Disorder   2 
Specific Phobia   3 
Generalized Anxiety Disorder   1 
Obsessive Compulsive Disorder   1 
[1] The Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (K-SADS-PL) is a semi-structured interview schedule for assessing psychiatric disorders in children and adolescents. It is used to assess the status of 32 DSM-IV child and adolescent psychiatric diagnosis.


  Outcome Measures
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1.  Primary:   Number of Participants With Adverse Events for Long Term Safety and Tolerability   [ Time Frame: Baseline through 4 years ]

2.  Secondary:   Change From Baseline at Various Timepoints in Attention Deficit Hyperactivity Disorder Rating Scale-IV-Translated in Japanese Parent Version: Investigator Administered and Scored (ADHDRS-IV-J:I) Total Score   [ Time Frame: Baseline, 6 Months, 12 Months, 2 Years, 3 Years, 4 Years ]

3.  Secondary:   Change From Baseline at Various Timepoints in the Clinical Global Impressions-Attention Deficit Hyperactivity Disorder-Severity (CGI-ADHD-S)   [ Time Frame: Baseline, 6 Months, 12 Months, 2 Years, 3 Years, 4 Years ]

4.  Secondary:   Cytochrome P450 2D6 (CYP2D6) Phenotype Status   [ Time Frame: Over 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979



Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00191386     History of Changes
Other Study ID Numbers: 9315
B4Z-JE-LYDA ( Other Identifier: Eli Lilly and Company )
Study First Received: September 12, 2005
Results First Received: August 24, 2010
Last Updated: December 14, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare