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A Study for Patients With Attention-Deficit/Hyperactivity Disorder Treated With Atomoxetine

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00471354
First received: May 7, 2007
Last updated: January 4, 2010
Last verified: January 2010
Results First Received: November 19, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Attention Deficit Hyperactivity Disorder
Intervention: Drug: Atomoxetine

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Atomoxetine 0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.

Participant Flow:   Overall Study
    Atomoxetine  
STARTED     228  
COMPLETED     176  
NOT COMPLETED     52  
Protocol Entry Criteria Not Met                 1  
Adverse Event                 13  
Protocol Violation                 12  
Withdrawal by Subject                 1  
Physician Decision                 4  
Sponsor Decision                 1  
Lost to Follow-up                 3  
Lack of Efficacy                 5  
Patient/Caregiver Decision                 12  



  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 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.

Baseline Measures
    Atomoxetine  
Number of Participants  
[units: participants]
  228  
Age  
[units: years]
Mean ± Standard Deviation
  9.6  ± 0.96  
Gender  
[units: participants]
 
Female     34  
Male     194  
Region of Enrollment  
[units: participants]
 
Taiwan     76  
China     82  
Korea, Republic of     70  
Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Subtypes  
[units: participants]
 
Hyperactive     5  
Combined     141  
Inattentive     82  
Race/Ethnicity  
[units: participants]
 
East Asian     228  
Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) Total Score [1]
[units: units on a scale]
Mean ± Standard Deviation
  35.3  ± 7.09  
Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) [2]
[units: units on a scale]
Mean ± Standard Deviation
  5.0  ± 0.80  
Conners' Parent Rating Scale-Revised:Short Form - ADHD Index Subscale [3]
[units: units on a scale]
Mean ± Standard Deviation
  24.5  ± 5.90  
Height  
[units: centimeters (cm)]
Mean ± Standard Deviation
  136.4  ± 8.25  
School Grade Average (SGA) Language Score [4]
[units: units on a scale]
Mean ± Standard Deviation
  73.8  ± 18.35  
School Grade Average (SGA) Math Score [5]
[units: units on a scale]
Mean ± Standard Deviation
  72.7  ± 19.89  
School Grade Average (SGA) Total Score [6]
[units: units on a scale]
Mean ± Standard Deviation
  73.9  ± 15.82  
School Grade Score (SGA) Science Score [7]
[units: units on a scale]
Mean ± Standard Deviation
  75.0  ± 17.04  
Weight  
[units: kilograms (kg)]
Mean ± Standard Deviation
  33.3  ± 8.0  
[1] Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored - Total Score measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.
[2] Measures severity of the patient's overall severity of ADHD symptoms on a scale of 1-7 (1=normal, not at all ill; 7=among the most extremely ill patients).
[3] A 27-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the parent to assess problem behaviors related to ADHD. ADHD Index score ranges from 0 to 36. Higher scores reflect more severe problem behaviors related to ADHD.
[4] Language school grade on a scale of 0-100, with higher scores indicating better grades/apptitude in language.
[5] Math school grade on a scale of 0-100, with higher scores indicating better grades/apptitude in math.
[6] School grades in the classes of Language, Math, and Science were obtained. A score between 0 and 100 was provided for each of the three classes, and the average taken to get a SGA Total Score between 0 and 100, with higher scores indicating better grades/apptitude.
[7] Science school grade on a scale of 0-100, with higher scores indicating better grades/apptitude in science.



  Outcome Measures
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1.  Primary:   Correlation Between Change From Baseline and 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent:Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score and School Grade Average (SGA)   [ Time Frame: Baseline, 24 weeks ]

2.  Secondary:   Correlation Between Change From Baseline to 24 Week Endpoint in ADHDRS-IV-Parent:Inv Total Score and School Grade Averages in Separate Language, Math and Science Classes   [ Time Frame: Baseline, 24 weeks ]

3.  Secondary:   Change From Baseline to 24 Week Endpoint in Academic Performance by School Grade Average (SGA) Total, and Separate Language, Math, and Science Scores   [ Time Frame: Baseline, 24 weeks ]

4.  Secondary:   Change From Baseline to 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored - Total Score   [ Time Frame: Baseline, 24 weeks ]

5.  Secondary:   Change From Baseline to 24 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder - Severity Scale (CGI-ADHD-S)   [ Time Frame: Baseline, 24 weeks ]

6.  Secondary:   CGI-ADHD-Improvement Scale (CGI-ADHD-I) at 24 Week Endpoint   [ Time Frame: 24 weeks ]

7.  Secondary:   Change From Baseline to 24 Week Endpoint in Revised Conners' Parent Rating Scale: Short Form (CPRS-R:S) Attention-Deficit/Hyperactivity Disorder Index Score   [ Time Frame: Baseline, 24 weeks ]


  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


No publications provided


Responsible Party: Chief Medical Officer, ELi Lilly
ClinicalTrials.gov Identifier: NCT00471354     History of Changes
Other Study ID Numbers: 11098, B4Z-CR-S018
Study First Received: May 7, 2007
Results First Received: November 19, 2009
Last Updated: January 4, 2010
Health Authority: China: Ethics Committee
Korea: Food and Drug Administration
Taiwan: Institutional Review Board