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    Clinical Trial Results:
    A Randomized Double-Blind, Placebo-Controlled Clinical Trial of Efficacy and Safety of Atomoxetine up to 12 weeks in Newly Diagnosed Children and Adolescents Outpatients with Attention-Deficit/Hyperactivity Disorder (ADHD)

    Summary
    EudraCT number
    		 2004-004088-31
    Trial protocol
    		 ES  
    Global end of trial date
    06 Feb 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jul 2016
    First version publication date
    02 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    B4Z-XM-LYDM
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00191945
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 8836, Trial Alias: B4Z-XM-LYDM
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 877-CTLilly,
    Scientific contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 877-285-4559,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    06 Feb 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Feb 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    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 period will last 12 weeks and the treatment open phase will last up to 1 year, and atomoxetine treatment will be administered. A gatekeeper strategy will be employed for sequentially testing the secondary objectives.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 May 2005
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 151
    Worldwide total number of subjects
    151
    EEA total number of subjects
    151
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    113
    Adolescents (12-17 years)
    38
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 158 patients enrolled during the Screening Period (Visits 1 and 2), but 7 did not receive study drug and are not included in the 151 patients randomized in the Double-Blind Period.

    Period 1
    Period 1 title
    Double-Blind Acute Treatment
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Atomoxetine
    Arm description
    		 Double-Blind Acute Period: 0.5 milligram/kilogram (mg/kg) /day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atomoxetine Hydrochloride
    Investigational medicinal product code
    Other name
    LY139603, Strattera
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks

    Arm title
    		 Placebo
    Arm description
    		 Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week

    Investigational medicinal product name
    Atomoxetine Hydrochloride
    Investigational medicinal product code
    Other name
    LY139603, Strattera
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week

    Number of subjects in period 1
    		Atomoxetine Placebo
    Started
    100
    51
    Completed
    94
    48
    Not completed
    6
    3
         Physician decision
    -
    2
         Non Protocol Compliance
    3
    -
         Lost to follow-up
    -
    1
         Parent's Decision
    3
    -
    Period 2
    Period 2 title
    Open-Label Treatment Extension
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Atomoxetine
    Arm description
    		 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atomoxetine Hydrochloride
    Investigational medicinal product code
    Other name
    LY139603, Strattera
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year

    Arm title
    		 Placebo
    Arm description
    		 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atomoxetine Hydrochloride
    Investigational medicinal product code
    Other name
    LY139603, Strattera
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year

    Number of subjects in period 2
    		Atomoxetine Placebo
    Started
    94
    48
    Completed
    94
    48

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Atomoxetine
    Reporting group description
    		 Double-Blind Acute Period: 0.5 milligram/kilogram (mg/kg) /day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week

    Reporting group values
    		 Atomoxetine Placebo Total
    Number of subjects
    		 100 51 151
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 10.3 ± 2.48 10.3 ± 2.43 -
    Gender categorical
    Units: Subjects
        Female
    		 21 10 31
        Male
    		 79 41 120
    Region of Enrollment
    Units: Subjects
        Spain
    		 100 51 151
    Attention-Deficit/Hyperactivity Disorder Subtype
    Units: Subjects
        Inattentive
    		 30 19 49
        Hyperactive
    		 5 1 6
        Combined (Hyperactive-Inattentive)
    		 64 30 94
        Not Assessed
    		 1 1 2
    Race/Ethnicity
    Units: Subjects
        Caucasian
    		 98 47 145
        African
    		 0 1 1
        Hispanic
    		 2 3 5
    Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered
    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. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 39.1 ± 9 39.5 ± 9 -
    Systolic Blood Pressure
    Units: millimeters of mercury (mmHg)
        arithmetic mean (standard deviation)
    		 101.2 ± 10.01 100.5 ± 10.01 -
    Body Weight
    Units: kilograms
        arithmetic mean (standard deviation)
    		 37.9 ± 11.86 37.4 ± 12.18 -
    Diastolic Blood Pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 57.9 ± 7.15 58 ± 7.68 -

    End points

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    End points reporting groups
    Reporting group title
    Atomoxetine
    Reporting group description
    		 Double-Blind Acute Period: 0.5 milligram/kilogram (mg/kg) /day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week
    Reporting group title
    Atomoxetine
    Reporting group description
    		 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year

    Reporting group title
    Placebo
    Reporting group description
    		 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year

    Subject analysis set title
    Outcome Measure 1 Atomoxetine
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.

    Subject analysis set title
    Outcome Measure 1 Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.

    Subject analysis set title
    Outcome Measure 2 Atomoxetine
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.

    Subject analysis set title
    Outcome Measure 2 Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.

    Subject analysis set title
    Outcome Measure 3 Atomoxetine
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.

    Subject analysis set title
    Outcome Measure 3 Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.

    Subject analysis set title
    Outcome Measure 4 Atomoxetine
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.

    Subject analysis set title
    Outcome Measure 4 Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.

    Subject analysis set title
    Outcome Measure 5 Atomoxetine
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.

    Subject analysis set title
    Outcome Measure 5 Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.

    Subject analysis set title
    Outcome Measure 6 Atomoxetine
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.

    Subject analysis set title
    Outcome Measure 6 Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.

    Subject analysis set title
    Outcome Measure 7 Atomoxetine
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to Treat analysis. Last observation carried forward.

    Subject analysis set title
    Outcome Measure 8 Atomoxetine
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to Treat analysis. Last observation carried forward.

    Subject analysis set title
    Outcome Measure 8 Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to Treat analysis. Last observation carried forward.

    Subject analysis set title
    Outcome Measure 9 Atomoxetine
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to Treat analysis. Last observation carried forward.

    Subject analysis set title
    Outcome Measure 9 Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to Treat analysis. Last observation carried forward.

    Subject analysis set title
    Outcome Measure 10 Atomoxetine
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to Treat analysis. All randomized participants who took at least one dose of study drug.

    Subject analysis set title
    Outcome Measure 10 Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to Treat analysis. All randomized participants who took at least one dose of study drug.

    Subject analysis set title
    Outcome Measure 11 Atomoxetine
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to Treat analysis. Last observation carried forward.

    Subject analysis set title
    Outcome Measure 12 Atomoxetine
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomized participants.

    Subject analysis set title
    Outcome Measure 12 Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomized participants.

    Subject analysis set title
    Outcome Measure 13 Atomoxetine
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomized participants.

    Subject analysis set title
    Outcome Measure 13 Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomized participants.

    Subject analysis set title
    Outcome Measure 14 Atomoxetine
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomized participants.

    Subject analysis set title
    Outcome Measure 14 Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomized participants.

    Subject analysis set title
    Outcome Measure 15 Atomoxetine
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomized participants.

    Subject analysis set title
    Outcome Measure 15 Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomized participants.

    Primary: Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 12 Week Endpoint

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    End point title
    		 Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 12 Week Endpoint
    End point 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 to 54.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    		 Outcome Measure 1 Atomoxetine Outcome Measure 1 Placebo
    Number of subjects analysed
    99
    50
    Units: units on a scale
        arithmetic mean (standard deviation)
    26.3 ± 12.7
    34.8 ± 12.3
    Statistical analysis title
    		 Statistical Analysis 1 for Outcome Measure 1
    Statistical analysis description
    Other relevant estimation information: Least Squares Mean difference at week 12 (Atomoxetine minus Placebo)
    Comparison groups
    Outcome Measure 1 Atomoxetine v Outcome Measure 1 Placebo
    Number of subjects included in analysis
    149
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -7.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11
         upper limit
    		 -4.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.6
    Notes
    [1] - Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline. Least Squares Mean difference at week 12 (Atomoxetine minus Placebo)

    Secondary: Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 9 Weeks

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    End point title
    		 Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 9 Weeks
    End point 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 to 54.
    End point type
    Secondary
    End point timeframe
    Week 9
    End point values
    		 Outcome Measure 2 Atomoxetine Outcome Measure 2 Placebo
    Number of subjects analysed
    99
    50
    Units: units on a scale
        arithmetic mean (standard deviation)
    27.3 ± 12.3
    34.4 ± 12
    Statistical analysis title
    		 Statistical Analysis 1 for Outcome Measure 2
    Statistical analysis description
    A gatekeeper strategy was employed for sequentially testing the secondary hypotheses using a REML-based Mixed-Model Repeated Measures (MMRM) technique as defined for the primary efficacy analyses. If primary hypothesis is significant at 0.05 (2-sided), first secondary hypothesis will be tested at Visit 6 from MMRM. If comparison is significant, subsequent secondary hypotheses will be tested in sequence until first null hypothesis fails to be rejected.
    Comparison groups
    Outcome Measure 2 Atomoxetine v Outcome Measure 2 Placebo
    Number of subjects included in analysis
    149
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority [2]
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -6.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.5
         upper limit
    		 -3.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.5
    Notes
    [2] - Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline.

    Secondary: Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 6 Weeks

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    End point title
    		 Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 6 Weeks
    End point 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 to 54.
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    		 Outcome Measure 3 Atomoxetine Outcome Measure 3 Placebo
    Number of subjects analysed
    99
    50
    Units: units on a scale
        arithmetic mean (standard deviation)
    28.7 ± 12.9
    34.4 ± 12
    Statistical analysis title
    		 Statistical Analysis 1 for Outcome Measure 3
    Statistical analysis description
    A gatekeeper strategy was employed for sequentially testing the secondary hypotheses using a REML-based Mixed-Model Repeated Measures (MMRM) technique as defined for the primary efficacy analyses. If primary hypothesis is significant at 0.05 (2-sided), first secondary hypothesis will be tested at Visit 6 from MMRM. If comparison is significant, subsequent secondary hypotheses will be tested in sequence until first null hypothesis fails to be rejected.
    Comparison groups
    Outcome Measure 3 Atomoxetine v Outcome Measure 3 Placebo
    Number of subjects included in analysis
    149
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.0009
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -5.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.2
         upper limit
    		 -2.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.5
    Notes
    [3] - Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline.

    Secondary: Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 4 Weeks

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    End point title
    		 Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 4 Weeks
    End point 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 to 54.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Outcome Measure 4 Atomoxetine Outcome Measure 4 Placebo
    Number of subjects analysed
    99
    50
    Units: units on a scale
        arithmetic mean (standard deviation)
    31.2 ± 12
    35.5 ± 12
    Statistical analysis title
    		 Statistical Analysis for Ouctome Measure 4
    Statistical analysis description
    A gatekeeper strategy was employed for sequentially testing the secondary hypotheses using a REML-based Mixed-Model Repeated Measures (MMRM) technique as defined for the primary efficacy analyses. If primary hypothesis is significant at 0.05 (2-sided), first secondary hypothesis will be tested at Visit 6 from MMRM. If comparison is significant, subsequent secondary hypotheses will be tested in sequence until first null hypothesis fails to be rejected.
    Comparison groups
    Outcome Measure 4 Atomoxetine v Outcome Measure 4 Placebo
    Number of subjects included in analysis
    149
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 = 0.0033
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -3.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.4
         upper limit
    		 -1.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.3
    Notes
    [4] - Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline.

    Secondary: Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score Change From Week 6 to Week 12

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    End point title
    		 Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score Change From Week 6 to Week 12
    End point 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 to 54.
    End point type
    Secondary
    End point timeframe
    week 6 and week 12
    End point values
    		 Outcome Measure 5 Atomoxetine Outcome Measure 5 Placebo
    Number of subjects analysed
    99
    50
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 6
    28.7 ± 12.9
    34.4 ± 12
        Week 12
    26.3 ± 12.7
    34.8 ± 12.3
    Statistical analysis title
    		 Statistical Analysis 1 for Outcome Measure 5
    Statistical analysis description
    A gatekeeper strategy was employed for sequentially testing the secondary hypotheses using a REML-based Mixed-Model Repeated Measures (MMRM) technique as defined for the primary efficacy analyses. If primary hypothesis is significant at 0.05 (2-sided), first secondary hypothesis will be tested at Visit 6 from MMRM. If comparison is significant, subsequent secondary hypotheses will be tested in sequence until first null hypothesis fails to be rejected.
    Comparison groups
    Outcome Measure 5 Atomoxetine v Outcome Measure 5 Placebo
    Number of subjects included in analysis
    149
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 = 0.013 [6]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.9
         upper limit
    		 -0.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.1
    Notes
    [5] - Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline.
    [6] - P-value is for the difference between groups in the change from 12 weeks minus 6 weeks.

    Secondary: Clinical Global Impressions- Attention-Deficit/Hyperactivity Disorder-Severity Changes From Baseline to Visit 7 (12 Weeks)

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    End point title
    		 Clinical Global Impressions- Attention-Deficit/Hyperactivity Disorder-Severity Changes From Baseline to Visit 7 (12 Weeks)
    End point 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).
    End point type
    Secondary
    End point timeframe
    Baseline and 12 weeks
    End point values
    		 Outcome Measure 6 Atomoxetine Outcome Measure 6 Placebo
    Number of subjects analysed
    99
    50
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline
    5.06 ± 0.93
    5.04 ± 0.83
        Week 12
    3.89 ± 1.15
    4.5 ± 0.91
    No statistical analyses for this end point

    Secondary: Clinical Global Impressions- Attention-Deficit/Hyperactivity Disorder-Severity Change From Baseline to Endpoint (Visit 18) of the Open-Label Extension (107 Weeks)

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    End point title
    		 Clinical Global Impressions- Attention-Deficit/Hyperactivity Disorder-Severity Change From Baseline to Endpoint (Visit 18) of the Open-Label Extension (107 Weeks)
    End point 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).
    End point type
    Secondary
    End point timeframe
    Baseline and Open-Label Endpoint (107 weeks)
    End point values
    		 Outcome Measure 7 Atomoxetine
    Number of subjects analysed
    140
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline
    5.1 ± 0.92
        Week 107
    3.2 ± 1.28
    No statistical analyses for this end point

    Secondary: Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Total Score Changes From Baseline to Endpoint (Week 12)

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    End point title
    		 Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Total Score Changes From Baseline to Endpoint (Week 12)
    End point description
    The CPRS-R:S has 27 items to be completed by the parent to assess behavioral problems related to ADHD. Individual item scores range from 0 (not at all true/never/seldom: lowest impairment) to 3 (very much true/very often/very frequent: highest impairment). The total score is calculated as the sum of all items. Total scores range from 0 to 81.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Outcome Measure 8 Atomoxetine Outcome Measure 8 Placebo
    Number of subjects analysed
    99
    50
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline
    54.6 ± 12.6
    54.7 ± 13.6
        Week 12
    37.8 ± 18.7
    48.5 ± 17.4
    Statistical analysis title
    		 Statistical Analysis 1 for Outcome Measure 8
    Comparison groups
    Outcome Measure 8 Placebo v Outcome Measure 8 Atomoxetine
    Number of subjects included in analysis
    149
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -10.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.1
         upper limit
    		 -6.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.3
    Notes
    [7] - mixed model repeated measures analyis: treatment, visit, patient, and CPRS-R: S Total score at baseline as covariate, with treatment*visit interaction. P-value is for the difference between groups in the change from 12 weeks minus baseline.

    Secondary: Child Health and Illness Profile (CHIP) Change From Baseline to Endpoint (12 Weeks)

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    End point title
    		 Child Health and Illness Profile (CHIP) Change From Baseline to Endpoint (12 Weeks)
    End point description
    Parent-rated assessment of a child’s health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, ‘how good is your child at making friends?’ 1=never, 5=always). Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Standard scores are expressed in standard deviation units. T-score=[(Score-4.2382)*10/0.32835]+50. Higher scores mean improvement.
    End point type
    Secondary
    End point timeframe
    Baseline to 12 weeks
    End point values
    		 Outcome Measure 9 Atomoxetine Outcome Measure 9 Placebo
    Number of subjects analysed
    99
    50
    Units: standard deviation units
    arithmetic mean (standard deviation)
        Parent: Satisfaction Baseline
    38 ± 14.9
    39 ± 14.7
        Parent: Comfort Baseline
    42.8 ± 12.5
    44.4 ± 11.7
        Parent: Resilience Baseline
    42.1 ± 11.2
    41.8 ± 11.6
        Parent: Risk Avoidance Baseline
    31.7 ± 15.8
    34.1 ± 15.9
        Parent: Achievement Baseline
    33.2 ± 9.5
    33.1 ± 10.8
        Parent: Satisfaction 12 Weeks
    40.4 ± 12.5
    40 ± 13.8
        Parent: Comfort 12 Weeks
    44.6 ± 11.4
    44.1 ± 11.5
        Parent: Resilience 12 Weeks
    45.3 ± 11
    42.2 ± 10.8
        Parent: Risk Avoidance 12 Weeks
    40.5 ± 14.8
    35.9 ± 13.9
        Parent: Achievement 12 Weeks
    38 ± 10
    34.4 ± 10.3
        Child/Adolescent: Satisfaction Baseline
    49.2 ± 9.2
    50 ± 12.6
        Child/Adolescent: Comfort Baseline
    49.9 ± 9.6
    50.6 ± 7.9
        Child/Adolescent: Resilience Baseline
    52 ± 10.8
    52 ± 11.6
        Child/Adolescent: Risk Avoidance Baseline
    47.6 ± 10.4
    49.1 ± 11.3
        Child/Adolescent: Achievement Baseline
    42.1 ± 10.3
    44.6 ± 10.8
        Child/Adolescent: Satisfaction 12 Weeks
    50.6 ± 9.2
    52.3 ± 11.1
        Child/Adolescent: Comfort 12 Weeks
    52.7 ± 8.2
    51.9 ± 7.7
        Child/Adolescent: Resilience 12 Weeks
    52.4 ± 9.5
    52.2 ± 9.4
        Child/Adolescent: Risk Avoidance 12 Weeks
    51.9 ± 8.7
    49.7 ± 11.7
        Child/Adolescent: Achievement 12 Weeks
    45.5 ± 10.2
    45.7 ± 11.5
    Statistical analysis title
    		 Statistical Analysis 2 for Outcome Measure 9
    Statistical analysis description
    ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.
    Comparison groups
    Outcome Measure 9 Atomoxetine v Outcome Measure 9 Placebo
    Number of subjects included in analysis
    149
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.243 [8]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    1.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.35
         upper limit
    		 5.29
    Notes
    [8] - P-value for Parent: Comfort difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.
    Statistical analysis title
    		 Statistical Analysis 1 for Outcome Measure 9
    Statistical analysis description
    ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.
    Comparison groups
    Outcome Measure 9 Atomoxetine v Outcome Measure 9 Placebo
    Number of subjects included in analysis
    149
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.81 [9]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.39
         upper limit
    		 4.33
    Notes
    [9] - P-value for Parent: Satisfaction difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.
    Statistical analysis title
    		 Statistical Analysis 3 for Outcome Measure 9
    Statistical analysis description
    ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.
    Comparison groups
    Outcome Measure 9 Atomoxetine v Outcome Measure 9 Placebo
    Number of subjects included in analysis
    149
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.419 [10]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    1.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.26
         upper limit
    		 5.39
    Notes
    [10] - P-value for Parent: Resilience difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.
    Statistical analysis title
    		 Statistical Analysis 4 for Outcome Measure 9
    Comparison groups
    Outcome Measure 9 Atomoxetine v Outcome Measure 9 Placebo
    Number of subjects included in analysis
    149
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [11]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    8.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.27
         upper limit
    		 12.55
    Notes
    [11] - P-value for Parent:Risk Avoidance difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.
    Statistical analysis title
    		 Statistical Analysis 5 for Outcome Measure 9
    Statistical analysis description
    ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.
    Comparison groups
    Outcome Measure 9 Atomoxetine v Outcome Measure 9 Placebo
    Number of subjects included in analysis
    149
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.042 [12]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    3.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.13
         upper limit
    		 6.65
    Notes
    [12] - P-value for Parent:Achievement difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.
    Statistical analysis title
    		 Statistical Analysis 6 for Outcome Measure 9
    Statistical analysis description
    ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.
    Comparison groups
    Outcome Measure 9 Atomoxetine v Outcome Measure 9 Placebo
    Number of subjects included in analysis
    149
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.323 [13]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -1.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.06
         upper limit
    		 1.35
    Notes
    [13] - P-value for Child/Adolescent:Satisfaction difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.
    Statistical analysis title
    		 Statistical Analysis 7 for Outcome Measure 9
    Statistical analysis description
    ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.
    Comparison groups
    Outcome Measure 9 Atomoxetine v Outcome Measure 9 Placebo
    Number of subjects included in analysis
    149
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.452 [14]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.49
         upper limit
    		 3.34
    Notes
    [14] - P-value for Child/Adolescent:Comfort difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.
    Statistical analysis title
    		 Statistical Analysis 8 for Outcome Measure 9
    Statistical analysis description
    ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.
    Comparison groups
    Outcome Measure 9 Atomoxetine v Outcome Measure 9 Placebo
    Number of subjects included in analysis
    149
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.91 [15]
    Method
    		 ANCOVA
    Parameter type
    		 Median difference (net)
    Point estimate
    0.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.59
         upper limit
    		 2.9
    Notes
    [15] - P-value for Child/Adolescent:Resilience difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.
    Statistical analysis title
    		 Statistical Analysis 9 for Outcome Measure 9
    Statistical analysis description
    ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.
    Comparison groups
    Outcome Measure 9 Atomoxetine v Outcome Measure 9 Placebo
    Number of subjects included in analysis
    149
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006 [16]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    3.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.04
         upper limit
    		 6.08
    Notes
    [16] - P-value for Child/Adolescent:Risk Avoidance difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.
    Statistical analysis title
    		 Statistical Analysis 10 for Outcome Measure 9
    Statistical analysis description
    ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.
    Comparison groups
    Outcome Measure 9 Atomoxetine v Outcome Measure 9 Placebo
    Number of subjects included in analysis
    149
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.541 [17]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.21
         upper limit
    		 4.19
    Notes
    [17] - P-value for Child/Adolescent:Achievement difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.

    Secondary: Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (K-SADS-PL)

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    End point title
    		 Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (K-SADS-PL)
    End point description
    The 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.
    End point type
    Secondary
    End point timeframe
    Baseline
    End point values
    		 Outcome Measure 10 Atomoxetine Outcome Measure 10 Placebo
    Number of subjects analysed
    99
    50
    Units: participants
    number (not applicable)
        Participants with any Comorbidity
    46
    22
        Participants with Oppositional Defiant Disorder
    28
    10
        Participants with Tic Disorder
    16
    9
        Participants with Affective Disorders
    3
    2
        Participants with Anxiety Disorders
    13
    6
        Participants with Conduct Disorder
    0
    0
    No statistical analyses for this end point

    Secondary: Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) at 107 Weeks (Open-Label Extension)

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    End point title
    		 Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) at 107 Weeks (Open-Label Extension)
    End point 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 to 54.
    End point type
    Secondary
    End point timeframe
    Week 107
    End point values
    		 Outcome Measure 11 Atomoxetine
    Number of subjects analysed
    140
    Units: units on a scale
        arithmetic mean (standard deviation)
    21.4 ± 12.8
    No statistical analyses for this end point

    Secondary: Vital Signs - Systolic Blood Pressure

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    End point title
    		 Vital Signs - Systolic Blood Pressure
    End point description
    No text entered
    End point type
    Secondary
    End point timeframe
    Baseline and 12 weeks
    End point values
    		 Outcome Measure 12 Atomoxetine Outcome Measure 12 Placebo
    Number of subjects analysed
    100
    51
    Units: mmHg
    arithmetic mean (standard deviation)
        Baseline
    98.7 ± 13
    102.2 ± 11.4
        12 Weeks
    102.9 ± 10.2
    101.2 ± 11.7
    No statistical analyses for this end point

    Secondary: Vital Signs - Diastolic Blood Pressure

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    End point title
    		 Vital Signs - Diastolic Blood Pressure
    End point description
    No text entered
    End point type
    Secondary
    End point timeframe
    Baseline and 12 weeks
    End point values
    		 Outcome Measure 13 Atomoxetine Outcome Measure 13 Placebo
    Number of subjects analysed
    100
    51
    Units: mmHg
    arithmetic mean (standard deviation)
        Baseline
    56.4 ± 9
    58.2 ± 7.2
        12 Weeks
    59.3 ± 7.1
    57.5 ± 8.6
    No statistical analyses for this end point

    Secondary: Vital Signs - Pulse

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    End point title
    		 Vital Signs - Pulse
    End point description
    No text entered
    End point type
    Secondary
    End point timeframe
    Baseline and 12 weeks
    End point values
    		 Outcome Measure 14 Atomoxetine Outcome Measure 14 Placebo
    Number of subjects analysed
    100
    51
    Units: beats per minute
    arithmetic mean (standard deviation)
        Baseline
    75.8 ± 9.8
    77 ± 9.3
        12 Weeks
    84.5 ± 12.5
    79 ± 9.7
    No statistical analyses for this end point

    Secondary: Vital Signs - Weight

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    End point title
    		 Vital Signs - Weight
    End point description
    No text entered
    End point type
    Secondary
    End point timeframe
    Baseline and 12 weeks
    End point values
    		 Outcome Measure 15 Atomoxetine Outcome Measure 15 Placebo
    Number of subjects analysed
    100
    51
    Units: kilograms
    arithmetic mean (standard deviation)
        Baseline
    38 ± 12
    37.5 ± 12.3
        12 Weeks
    37 ± 11.5
    38.9 ± 12.8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire Study
    Adverse event reporting additional description
    B4Z-XM-LYDM
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    Atomoxetine
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Atomoxetine Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 100 (2.00%)
    2 / 51 (3.92%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    overdose
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    dizziness
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    headache
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    nausea
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vomiting
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    asthma
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    appendicitis
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Atomoxetine Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    89 / 100 (89.00%)
    44 / 51 (86.27%)
    Cardiac disorders
    tachycardia
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    5 / 100 (5.00%)
    3 / 51 (5.88%)
         occurrences all number
    5
    3
    Nervous system disorders
    dizziness
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    12 / 100 (12.00%)
    7 / 51 (13.73%)
         occurrences all number
    14
    7
    headache
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    44 / 100 (44.00%)
    19 / 51 (37.25%)
         occurrences all number
    60
    25
    somnolence
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    28 / 100 (28.00%)
    10 / 51 (19.61%)
         occurrences all number
    33
    10
    General disorders and administration site conditions
    fatigue
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    13 / 100 (13.00%)
    9 / 51 (17.65%)
         occurrences all number
    17
    10
    irritability
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    16 / 100 (16.00%)
    7 / 51 (13.73%)
         occurrences all number
    20
    8
    pyrexia
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    14 / 100 (14.00%)
    6 / 51 (11.76%)
         occurrences all number
    16
    7
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    23 / 100 (23.00%)
    12 / 51 (23.53%)
         occurrences all number
    32
    17
    abdominal pain upper
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    7 / 100 (7.00%)
    3 / 51 (5.88%)
         occurrences all number
    8
    3
    constipation
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    7 / 100 (7.00%)
    0 / 51 (0.00%)
         occurrences all number
    7
    0
    diarrhoea
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    9 / 100 (9.00%)
    7 / 51 (13.73%)
         occurrences all number
    12
    7
    nausea
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    8 / 100 (8.00%)
    6 / 51 (11.76%)
         occurrences all number
    10
    7
    vomiting
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    25 / 100 (25.00%)
    13 / 51 (25.49%)
         occurrences all number
    42
    21
    Respiratory, thoracic and mediastinal disorders
    cough
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    8 / 100 (8.00%)
    3 / 51 (5.88%)
         occurrences all number
    9
    4
    pharyngolaryngeal pain
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    7 / 100 (7.00%)
    5 / 51 (9.80%)
         occurrences all number
    7
    7
    Skin and subcutaneous tissue disorders
    rash
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    2 / 100 (2.00%)
    3 / 51 (5.88%)
         occurrences all number
    3
    3
    Psychiatric disorders
    initial insomnia
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    5 / 100 (5.00%)
    4 / 51 (7.84%)
         occurrences all number
    6
    4
    tic
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    6 / 100 (6.00%)
    2 / 51 (3.92%)
         occurrences all number
    8
    4
    Infections and infestations
    ear infection
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    2 / 100 (2.00%)
    7 / 51 (13.73%)
         occurrences all number
    2
    10
    gastroenteritis
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    8 / 100 (8.00%)
    2 / 51 (3.92%)
         occurrences all number
    13
    3
    influenza
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    6 / 100 (6.00%)
    2 / 51 (3.92%)
         occurrences all number
    6
    2
    nasopharyngitis
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    33 / 100 (33.00%)
    12 / 51 (23.53%)
         occurrences all number
    54
    18
    tonsillitis
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    13 / 100 (13.00%)
    4 / 51 (7.84%)
         occurrences all number
    14
    10
    Metabolism and nutrition disorders
    anorexia
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    6 / 100 (6.00%)
    3 / 51 (5.88%)
         occurrences all number
    6
    3
    decreased appetite
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    36 / 100 (36.00%)
    18 / 51 (35.29%)
         occurrences all number
    39
    21

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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