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

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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
Enrollment 153

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Atomoxetine 0.2 Milligrams Per Kilogram, Per Day (mg/kg/Day) Atomoxetine 0.5 mg/kg/Day Atomoxetine 1.2 mg/kg/Day
Hide Arm/Group Description Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period. Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period. 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.
Period Title: Overall Study
Started 51 51 51
Completed 41 46 46
Not Completed 10 5 5
Reason Not Completed
Adverse Event             2             3             3
Withdrawal by Subject             7             2             2
Protocol Violation             1             0             0
Arm/Group Title Atomoxetine 0.2 mg/kg/Day Atomoxetine 0.5 mg/kg/Day Atomoxetine 1.2 mg/kg/Day Total
Hide Arm/Group Description Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period. Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period. 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 of all reporting groups
Overall Number of Baseline Participants 51 51 51 153
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 51 participants 51 participants 51 participants 153 participants
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)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 51 participants 51 participants 153 participants
Female
4
   7.8%
41
  80.4%
40
  78.4%
85
  55.6%
Male
47
  92.2%
10
  19.6%
11
  21.6%
68
  44.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 51 participants 51 participants 51 participants 153 participants
51 51 51 153
Age-Categorical   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 51 participants 51 participants 51 participants 153 participants
6-12 years 38 44 44 126
13-18 years 13 7 7 27
[1]
Measure Description: Pediatric participant age categories
Race/Ethnicity  
Measure Type: Number
Unit of measure:  Participants
Korean Number Analyzed 51 participants 51 participants 51 participants 153 participants
51 51 51 153
ADHD Rating Scale-IV-Parent:Investigator Rated Hyperactivity Subscale Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 51 participants 51 participants 51 participants 153 participants
17.51  (5.825) 16.61  (5.107) 15.96  (5.553) 16.69  (5.504)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 51 participants 51 participants 51 participants 153 participants
21.57  (3.312) 21.06  (3.630) 20.20  (3.476) 20.94  (3.499)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 51 participants 51 participants 51 participants 153 participants
39.08  (7.896) 37.67  (7.064) 36.16  (7.341) 37.63  (7.489)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 51 participants 51 participants 51 participants 153 participants
5.35  (0.688) 5.31  (0.787) 5.16  (0.703) 5.27  (0.728)
[1]
Measure Description: 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  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 51 participants 51 participants 51 participants 153 participants
35.67  (12.348) 35.54  (10.647) 35.48  (11.536) 35.56  (11.455)
1.Primary Outcome
Title 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
Hide Description 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 (no symptoms) to 54 (highly symptomatic).
Time Frame Baseline, Day 42
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis included all randomized participants (intent-to-treat population)
Arm/Group Title Atomoxetine 0.2 mg/kg/Day Atomoxetine 0.5 mg/kg/Day Atomoxetine 1.2 mg/kg/Day
Hide Arm/Group Description:
Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
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.
Overall Number of Participants Analyzed 51 51 51
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-9.55
(-12.03 to -7.07)
-12.31
(-14.76 to -9.85)
-14.51
(-16.99 to -12.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine 0.2 mg/kg/Day, Atomoxetine 0.5 mg/kg/Day, Atomoxetine 1.2 mg/kg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0240
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title 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
Hide Description Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).
Time Frame Baseline, Days 7, 14, 42
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population; last observation carried forward (LOCF)
Arm/Group Title Atomoxetine 0.2 mg/kg/Day Atomoxetine 0.5 mg/kg/Day Atomoxetine 1.2 mg/kg/Day
Hide Arm/Group Description:
Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
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.
Overall Number of Participants Analyzed 51 51 51
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 7 -0.24  (0.480) -0.53  (0.612) -0.30  (-.036)
Day 14 -0.73  (0.736) -0.90  (0.918) -0.92  (0.786)
Day 42 -1.04  (0.729) -1.30  (1.121) -1.56  (1.090)
LOCF Endpoint -0.98  (0.750) -1.22  (1.119) -1.54  (1.073)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine 0.2 mg/kg/Day, Atomoxetine 0.5 mg/kg/Day, Atomoxetine 1.2 mg/kg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0048
Comments This is the p value for CGI-ADHD-S score change at endpoint
Method Mixed Models Analysis
Comments [Not Specified]
3.Secondary Outcome
Title 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
Hide Description Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment. (1=very much improved, 7=very much worsened)
Time Frame Baseline, Days 7, 14, 42
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population; LOCF
Arm/Group Title Atomoxetine 0.2 mg/kg/Day Atomoxetine 0.5 mg/kg/Day Atomoxetine 1.2 mg/kg/Day
Hide Arm/Group Description:
Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
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.
Overall Number of Participants Analyzed 51 51 51
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 7 3.57  (0.645) 3.22  (0.642) 3.54  (0.813)
Day 14 3.25  (0.729) 3.20  (0.957) 2.98  (0.721)
Day 42 3.24  (0.970) 3.09  (0.952) 2.77  (0.973)
LOCF Endpoint 3.29  (0.957) 3.16  (0.946) 2.80  (0.969)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine 0.2 mg/kg/Day, Atomoxetine 0.5 mg/kg/Day, Atomoxetine 1.2 mg/kg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0153
Comments This is the p value for CGI-ADHD-I score change at endpoint
Method Mixed Models Analysis
Comments [Not Specified]
4.Secondary Outcome
Title Adverse Events Leading to Discontinuation
Hide Description Adverse Events (Preferred Term) leading to discontinuation by decreasing frequency
Time Frame Baseline to Day 42
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated population
Arm/Group Title 0-0.35 mg/kg/Day 0.36-0.85 mg/kg/Day > 0.85 mg/kg/Day
Hide Arm/Group Description:
Patients received atomoxetine 0-0.35 mg/kg/day
Patients received atomoxetine 0.36-0.85 mg/kg/day
Patients received atomoxetine >0.85 mg/kg/day
Overall Number of Participants Analyzed 51 54 48
Measure Type: Number
Unit of Measure: events
Anorexia 0 1 0
Appendicitis 0 1 0
Dizziness 0 1 0
Dysphemia 0 0 1
Irritability 1 0 0
Sedation 0 0 1
Decreased appetite 0 1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0-0.35 mg/kg/Day, 0.36-0.85 mg/kg/Day, > 0.85 mg/kg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .4500
Comments P-value relates to the sum of adverse events leading to discontinuation.
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary
Hide Description Columbia Suicide-Severity Rating Scale (C-SSRS) captures occurrence, severity & frequency of suicide-related thoughts & behaviors, via questions designed to solicit information to determine if a suicide-related thought or behavior occurred. The C-SSRS is not scored; recorded incidents are counted. C-SSRS was only required if an adverse event was reported that the investigator suspected to represent a suicidal thought or behavior. If the C-SSR was completed at a visit, the Self-Harm Supplement was also required. If a self-harm event was reported, the Self-Harm Follow-Up form was also required.
Time Frame Baseline to Day 42
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As treated population
Arm/Group Title 0-0.35 mg/kg/Day 0.36-0.85 mg/kg/Day >0.85 mg/kg/Day
Hide Arm/Group Description:
Patients received atomoxetine 0-0.35 mg/kg/day
Patients received atomoxetine 0.36-0.85 mg/kg/day
Patients received atomoxetine >0.85 mg/kg/day
Overall Number of Participants Analyzed 51 54 48
Measure Type: Number
Unit of Measure: participants
0 0 0
6.Secondary Outcome
Title Heart Rate Change From Baseline to Day 42 Endpoint
Hide Description [Not Specified]
Time Frame Baseline, Day 42
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Atomoxetine 0.2 mg/kg/Day Atomoxetine 0.5 mg/kg/Day Atomoxetine 1.2 mg/kg/Day
Hide Arm/Group Description:
Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
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.
Overall Number of Participants Analyzed 51 51 51
Mean (Standard Deviation)
Unit of Measure: beats per minute (bpm)
Baseline 87.86  (12.324) 85.78  (10.769) 90.10  (12.852)
Day 42 90.43  (10.278) 90.35  (11.028) 93.89  (13.287)
Change at endpoint 2.59  (13.041) 5.24  (13.621) 4.98  (14.649)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine 0.2 mg/kg/Day, Atomoxetine 0.5 mg/kg/Day, Atomoxetine 1.2 mg/kg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8005
Comments This is the p value for heart rate change at endpoint
Method ANOVA
Comments [Not Specified]
7.Secondary Outcome
Title Temperature Change From Baseline to Day 42 Endpoint
Hide Description [Not Specified]
Time Frame Baseline, Day 42
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Atomoxetine 0.2 mg/kg/Day Atomoxetine 0.5 mg/kg/Day Atomoxetine 1.2 mg/kg/Day
Hide Arm/Group Description:
Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
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.
Overall Number of Participants Analyzed 51 51 51
Mean (Standard Deviation)
Unit of Measure: degrees Celsius
Baseline 36.63  (0.260) 36.56  (0.397) 36.50  (0.400)
Day 42 36.58  (0.331) 36.55  (0.332) 36.59  (0.270)
Change at endpoint -0.05  (0.343) -0.02  (0.339) 0.07  (0.327)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine 0.2 mg/kg/Day, Atomoxetine 0.5 mg/kg/Day, Atomoxetine 1.2 mg/kg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4128
Comments This is the p value for temperature change at endpoint
Method ANOVA
Comments [Not Specified]
8.Secondary Outcome
Title Blood Pressure Change From Baseline to Day 42 Endpoint
Hide Description [Not Specified]
Time Frame Baseline, Day 42
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Atomoxetine 0.2 mg/kg/Day Atomoxetine 0.5 mg/kg/Day Atomoxetine 1.2 mg/kg/Day
Hide Arm/Group Description:
Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
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.
Overall Number of Participants Analyzed 51 51 51
Mean (Standard Deviation)
Unit of Measure: mmHg
Systolic Baseline 105.98  (12.888) 102.49  (11.279) 106.12  (13.749)
Systolic Day 42 107.82  (14.440) 104.98  (10.988) 108.48  (11.067)
Systolic Change at Endpoint 0.98  (16.535) 2.35  (12.122) 1.72  (13.391)
Diastolic Baseline 66.53  (10.567) 65.39  (11.742) 66.78  (11.524)
Diastolic Day 42 67.45  (10.199) 68.78  (11.677) 70.02  (8.734)
Diastolic Change at Endpoint 0.16  (13.201) 3.65  (12.058) 2.17  (13.200)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine 0.2 mg/kg/Day, Atomoxetine 0.5 mg/kg/Day, Atomoxetine 1.2 mg/kg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9761
Comments This is the p value for systolic change at endpoint
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine 0.2 mg/kg/Day, Atomoxetine 0.5 mg/kg/Day, Atomoxetine 1.2 mg/kg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6419
Comments This is the p value for diastolic change at endpoint
Method ANOVA
Comments [Not Specified]
9.Secondary Outcome
Title Weight Change From Baseline to Day 42 Endpoint
Hide Description [Not Specified]
Time Frame Baseline, Day 42
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Atomoxetine 0.2 mg/kg/Day Atomoxetine 0.5 mg/kg/Day Atomoxetine 1.2 mg/kg/Day
Hide Arm/Group Description:
Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
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.
Overall Number of Participants Analyzed 51 51 51
Mean (Standard Deviation)
Unit of Measure: kilograms (kg)
Baseline 35.67  (12.348) 35.54  (10.647) 35.48  (11.536)
Day 42 36.10  (12.524) 35.72  (11.305) 36.39  (11.708)
Change at Endpoint 0.37  (1.500) -0.08  (1.155) -0.15  (1.093)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine 0.2 mg/kg/Day, Atomoxetine 0.5 mg/kg/Day, Atomoxetine 1.2 mg/kg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2213
Comments This is the p value for weight change at endpoint
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description The participant flow module encompasses the 'intention-to-treat' population. All safety data is reported with 'as-treated' population.
 
Arm/Group Title Atomoxetine 0.00-0.35 mg/kg/Day Atomoxetine 0.36-0.85 mg/kg/Day Atomoxetine >0.85 mg/kg/Day
Hide Arm/Group Description Patients who received the actual dose range listed. Patients who received the actual dose range listed. Patients who received the actual dose range listed.
All-Cause Mortality
Atomoxetine 0.00-0.35 mg/kg/Day Atomoxetine 0.36-0.85 mg/kg/Day Atomoxetine >0.85 mg/kg/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Atomoxetine 0.00-0.35 mg/kg/Day Atomoxetine 0.36-0.85 mg/kg/Day Atomoxetine >0.85 mg/kg/Day
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/51 (0.00%)      1/54 (1.85%)      1/48 (2.08%)    
Infections and infestations       
Appendicitis  1  0/51 (0.00%)  0 1/54 (1.85%)  1 0/48 (0.00%)  0
Injury, poisoning and procedural complications       
Road traffic accident  1  0/51 (0.00%)  0 0/54 (0.00%)  0 1/48 (2.08%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Atomoxetine 0.00-0.35 mg/kg/Day Atomoxetine 0.36-0.85 mg/kg/Day Atomoxetine >0.85 mg/kg/Day
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/51 (29.41%)      22/54 (40.74%)      27/48 (56.25%)    
Gastrointestinal disorders       
Abdominal pain upper  1  0/51 (0.00%)  0 5/54 (9.26%)  5 4/48 (8.33%)  5
Nausea  1  2/51 (3.92%)  2 3/54 (5.56%)  3 2/48 (4.17%)  2
General disorders       
Irritability  1  2/51 (3.92%)  2 2/54 (3.70%)  2 4/48 (8.33%)  5
Infections and infestations       
Nasopharyngitis  1  3/51 (5.88%)  3 4/54 (7.41%)  4 2/48 (4.17%)  2
Metabolism and nutrition disorders       
Anorexia  1  2/51 (3.92%)  2 2/54 (3.70%)  2 6/48 (12.50%)  6
Decreased appetite  1  1/51 (1.96%)  1 4/54 (7.41%)  4 6/48 (12.50%)  8
Nervous system disorders       
Dizziness  1  1/51 (1.96%)  1 3/54 (5.56%)  3 0/48 (0.00%)  0
Somnolence  1  0/51 (0.00%)  0 1/54 (1.85%)  1 4/48 (8.33%)  4
Psychiatric disorders       
Sleep disorder  1  4/51 (7.84%)  4 0/54 (0.00%)  0 1/48 (2.08%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
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.
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