ClinicalTrials.gov
ClinicalTrials.gov Menu

Atomoxetine to Treat Korean Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00568685
Recruitment Status : Completed
First Posted : December 6, 2007
Results First Posted : December 14, 2009
Last Update Posted : January 26, 2010
Sponsor:
Information provided by:
Eli Lilly and Company

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Attention Deficit Hyperactivity Disorder
Interventions: Drug: Atomoxetine Hydrochloride
Drug: Atomoxetine hydrochloride

  Participant Flow

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 0.2 Milligrams Per Kilogram, Per Day (mg/kg/Day) Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
Atomoxetine 0.5 mg/kg/Day Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
Atomoxetine 1.2 mg/kg/Day Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.

Participant Flow:   Overall Study
    Atomoxetine 0.2 Milligrams Per Kilogram, Per Day (mg/kg/Day)   Atomoxetine 0.5 mg/kg/Day   Atomoxetine 1.2 mg/kg/Day
STARTED   51   51   51 
COMPLETED   41   46   46 
NOT COMPLETED   10   5   5 
Adverse Event                2                3                3 
Withdrawal by Subject                7                2                2 
Protocol Violation                1                0                0 



  Baseline Characteristics

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 0.2 mg/kg/Day Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
Atomoxetine 0.5 mg/kg/Day Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
Atomoxetine 1.2 mg/kg/Day Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
Total Total of all reporting groups

Baseline Measures
   Atomoxetine 0.2 mg/kg/Day   Atomoxetine 0.5 mg/kg/Day   Atomoxetine 1.2 mg/kg/Day   Total 
Overall Participants Analyzed 
[Units: Participants]
 51   51   51   153 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 8.87 
 (7.63 to 12.09) 
 10.06 
 (8.11 to 11.17) 
 9.29 
 (8.02 to 11.06) 
 9.41 
 (7.87 to 11.22) 
Gender 
[Units: Participants]
       
Female   4   41   40   85 
Male   47   10   11   68 
Region of Enrollment 
[Units: Participants]
       
Korea, Republic of   51   51   51   153 
Age-Categorical [1] 
[Units: Participants]
       
6-12 years   38   44   44   126 
13-18 years   13   7   7   27 
[1] Pediatric participant age categories
Race/Ethnicity 
[Units: Participants]
       
Korean   51   51   51   153 
ADHD Rating Scale-IV-Parent:Investigator Rated Hyperactivity Subscale Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 17.51  (5.825)   16.61  (5.107)   15.96  (5.553)   16.69  (5.504) 
[1] Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv) is an 18-item scale with one item for each of 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) diagnosis for ADHD. Hyperactive/Impulsive Subscale consists of 9 items. Each item is scored on a 4 point scale (0=never or rarely; 1=sometimes; 2=often; 3=very often) for total score range of 0 (no symptoms) to 27 (highly symptomatic).
ADHRS-IV-Parent: Inv. Inattention Subscale Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 21.57  (3.312)   21.06  (3.630)   20.20  (3.476)   20.94  (3.499) 
[1] Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv) is an 18-item scale with one item for each of 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) diagnosis for ADHD. Inattention Subscale consists of 9 items. Each item is scored on a 4 point scale (0=never or rarely; 1=sometimes; 2=often; 3=very often) for total score range of 0 (no symptoms) to 27 (highly symptomatic).
ADHRS-IV-Parent: Inv. Total Scores [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 39.08  (7.896)   37.67  (7.064)   36.16  (7.341)   37.63  (7.489) 
[1] Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv) is an 18-item scale with one item for each of 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) diagnosis for ADHD. Total Score consists of all 18 items. Each item is scored on a 4 point scale (0=never or rarely; 1=sometimes; 2=often; 3=very often) for total score range of 0 (no symptoms) to 54 (highly symptomatic).
Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder Severity Scale (CGI-ADHD-S) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 5.35  (0.688)   5.31  (0.787)   5.16  (0.703)   5.27  (0.728) 
[1] Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder Severity Scale (CGI-ADHD-S) rates severity using a 7-point scale (1=normal, not at all ill; 7=among the most extremely ill subjects). A higher score indicates greater severity of ADHD symptoms.
Weight 
[Units: Kilograms]
Mean (Standard Deviation)
 35.67  (12.348)   35.54  (10.647)   35.48  (11.536)   35.56  (11.455) 


  Outcome Measures

1.  Primary:   Change From Baseline to Day 42 Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score   [ Time Frame: Baseline, Day 42 ]

2.  Secondary:   Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint   [ Time Frame: Baseline, Days 7, 14, 42 ]

3.  Secondary:   Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint   [ Time Frame: Baseline, Days 7, 14, 42 ]

4.  Secondary:   Adverse Events Leading to Discontinuation   [ Time Frame: Baseline to Day 42 ]

5.  Secondary:   Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary   [ Time Frame: Baseline to Day 42 ]

6.  Secondary:   Heart Rate Change From Baseline to Day 42 Endpoint   [ Time Frame: Baseline, Day 42 ]

7.  Secondary:   Temperature Change From Baseline to Day 42 Endpoint   [ Time Frame: Baseline, Day 42 ]

8.  Secondary:   Blood Pressure Change From Baseline to Day 42 Endpoint   [ Time Frame: Baseline, Day 42 ]

9.  Secondary:   Weight Change From Baseline to Day 42 Endpoint   [ Time Frame: Baseline, Day 42 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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: 1-800-545-5979



Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00568685     History of Changes
Other Study ID Numbers: 11710
B4Z-KL-LYEC
First Submitted: December 4, 2007
First Posted: December 6, 2007
Results First Submitted: November 11, 2009
Results First Posted: December 14, 2009
Last Update Posted: January 26, 2010