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    Clinical Trial Results:
    A Double-Blind Placebo Controlled Study of Atomoxetine Hydrochloride for the Treatment of ADHD in Children and Adolescents With ADHD and Comorbid Dyslexia

    Summary
    EudraCT number
    		 2017-000739-15
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    25 Feb 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Dec 2021
    First version publication date
    22 Dec 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    B4Z-US-LYEB
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00607919
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 11672
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, 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
    25 Feb 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Feb 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study is to evaluate the effect of atomoxetine in treating Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms in children and adolescents with ADHD and comorbid reading disability (dyslexia)
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (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
    18 Mar 2008
    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
    United States: 209
    Worldwide total number of subjects
    209
    EEA total number of subjects
    0
    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)
    0
    Adolescents (12-17 years)
    209
    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
    		 The study comprised a 16-week placebo-controlled, double-blind acute phase and followed by an optional 16-week open-label in which all participants were treated with Atomoxetine.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Atomoxetine/Atomoxetine
    Arm description
    		 Participants were assigned to Atomoxetine treatment in both acute and open-label phase. Atomoxetine was administered at 1.0 to 1.4 milligram/kilogram/day (mg/kg/day) given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atomoxetine
    Investigational medicinal product code
    Other name
    LY139603
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Atomoxetine administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 to 32 weeks.

    Arm title
    		 Placebo/Atomoxetine
    Arm description
    		 Participants were assigned to placebo in acute phase and Atomoxetine in open-label phase. Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo was administered oral, daily, for 16 weeks.

    Number of subjects in period 1
    		Atomoxetine/Atomoxetine Placebo/Atomoxetine
    Started
    120
    89
    Completed
    86
    73
    Not completed
    34
    16
         Parent/Caregiver Decision
    6
    4
         Consent withdrawn by subject
    3
    3
         Adverse event, non-fatal
    9
    2
         Lost to follow-up
    9
    3
         Entry Criteria Not Met
    1
    1
         Lack of efficacy
    1
    2
         Protocol deviation
    5
    1
    Period 2
    Period 2 title
    Open-Label Phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Atomoxetine/Atomoxetine
    Arm description
    		 Participants were assigned to Atomoxetine treatment in both acute and open-label phase. Atomoxetine was administered at 1.0 to 1.4 milligram/kilogram/day (mg/kg/day) given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atomoxetine
    Investigational medicinal product code
    Other name
    LY139603
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 to 32 weeks.

    Arm title
    		 Placebo/Atomoxetine
    Arm description
    		 Participants were assigned to placebo in acute phase and Atomoxetine in open-label phase. Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo was administered oral, daily, for 16 weeks.

    Number of subjects in period 2 [1]
    		Atomoxetine/Atomoxetine Placebo/Atomoxetine
    Started
    84
    71
    Completed
    74
    59
    Not completed
    10
    12
         Parent/Caregiver Decision
    1
    2
         Consent withdrawn by subject
    2
    2
         Adverse event, non-fatal
    1
    5
         Lost to follow-up
    4
    1
         Protocol deviation
    2
    2
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Two participants completed acute phase but did not continue into open-label.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Atomoxetine/Atomoxetine
    Reporting group description
    		 Participants were assigned to Atomoxetine treatment in both acute and open-label phase. Atomoxetine was administered at 1.0 to 1.4 milligram/kilogram/day (mg/kg/day) given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

    Reporting group title
    Placebo/Atomoxetine
    Reporting group description
    		 Participants were assigned to placebo in acute phase and Atomoxetine in open-label phase. Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

    Reporting group values
    		 Atomoxetine/Atomoxetine Placebo/Atomoxetine Total
    Number of subjects
    		 120 89 209
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 12.24 ± 1.72 12.44 ± 1.90 -
    Gender categorical
    Units: Subjects
        Female
    		 46 34 80
        Male
    		 74 55 129
    Race/Ethnicity
    Units: Subjects
        African
    		 13 11 24
        Caucasian
    		 86 66 152
        East Asian
    		 2 1 3
        Hispanic
    		 18 11 29
        West Asian
    		 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    Atomoxetine/Atomoxetine
    Reporting group description
    		 Participants were assigned to Atomoxetine treatment in both acute and open-label phase. Atomoxetine was administered at 1.0 to 1.4 milligram/kilogram/day (mg/kg/day) given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

    Reporting group title
    Placebo/Atomoxetine
    Reporting group description
    		 Participants were assigned to placebo in acute phase and Atomoxetine in open-label phase. Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine
    Reporting group title
    Atomoxetine/Atomoxetine
    Reporting group description
    		 Participants were assigned to Atomoxetine treatment in both acute and open-label phase. Atomoxetine was administered at 1.0 to 1.4 milligram/kilogram/day (mg/kg/day) given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

    Reporting group title
    Placebo/Atomoxetine
    Reporting group description
    		 Participants were assigned to placebo in acute phase and Atomoxetine in open-label phase. Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

    Subject analysis set title
    ADHD+ Dyslexia (D): Atomoxetine
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine. Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

    Subject analysis set title
    ADHD+ Dyslexia (D): Placebo
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo. Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

    Subject analysis set title
    ADHD Alone: Atomoxetine
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine. Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

    Primary: Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total Score - Parent Version at Week 16 Endpoint

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    End point title
    		 Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total Score - Parent Version at Week 16 Endpoint
    End point description
    Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0-54. Least Square mean of change from baseline in ADHDRS is from a restricted maximum likelihood-based, mixed model repeated measures analysis which includes the effects of treatment, investigative site, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. Analysis Population Description (APD): All randomized participants with a baseline and at least one post-baseline result.
    End point type
    Primary
    End point timeframe
    Baseline, 16 weeks
    End point values
    		 ADHD+ Dyslexia (D): Atomoxetine ADHD+ Dyslexia (D): Placebo
    Number of subjects analysed
    47
    54
    Units: units on a scale
        least squares mean (standard error)
    -20.01 ± 1.45
    -12.27 ± 1.41
    Statistical analysis title
    		 Attention-Deficit/Hyperactivity Disorder
    Comparison groups
    ADHD+ Dyslexia (D): Placebo v ADHD+ Dyslexia (D): Atomoxetine
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 16 Endpoint

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    End point title
    		 Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 16 Endpoint
    End point description
    The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Hyperactivity-impulsivity scores range 0-27, and inattention scores range 0-27. Total scores range from 0-54. Higher scores indicate higher impairment. APD: All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Baseline, 16 weeks
    End point values
    		 ADHD+ Dyslexia (D): Atomoxetine ADHD+ Dyslexia (D): Placebo ADHD Alone: Atomoxetine
    Number of subjects analysed
    62
    58
    27
    Units: units on a scale
    arithmetic mean (standard deviation)
        Hyperactivity-Impulsivity Score
    -8.23 ± 5.90
    -5.18 ± 6.01
    -6.26 ± 5.10
        Inattention Score
    -10.64 ± 7.59
    -7.79 ± 6.52
    -10.33 ± 7.95
        Total Score
    -18.87 ± 11.68
    -12.98 ± 10.75
    -16.59 ± 11.31
    No statistical analyses for this end point

    Secondary: Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 16 Endpoint

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    End point title
    		 Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 16 Endpoint
    End point description
    The ADHDRS-IV-Teacher is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Hyperactivity-impulsivity scores range from 0-27, and inattention scores range from 0-27. Total scores range from 0-54. Higher scores indicate higher impairment. APD: All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Baseline, 16 weeks
    End point values
    		 ADHD+ Dyslexia (D): Atomoxetine ADHD+ Dyslexia (D): Placebo ADHD Alone: Atomoxetine
    Number of subjects analysed
    21
    22
    11
    Units: units on a scale
    arithmetic mean (standard deviation)
        Hyperactivity-Impulsivity Score
    -2.71 ± 3.98
    -1.99 ± 6.54
    -0.82 ± 4.92
        Inattention Score
    -4.48 ± 5.17
    -0.99 ± 5.33
    -2.27 ± 5.24
        Total Score
    -7.19 ± 6.83
    -2.98 ± 10.83
    -3.09 ± 9.21
    No statistical analyses for this end point

    Secondary: Change From Baseline in Woodcock-Johnson III Scores at Week 16 Endpoint

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    End point title
    		 Change From Baseline in Woodcock-Johnson III Scores at Week 16 Endpoint
    End point description
    The Woodcock Johnson Tests of Achievement has a Standard Battery (Tests 1-12) of a broad set of scores and an Extended Battery (Tests 13-22) on specific academic strengths and weaknesses. Tests associated with reading skills (1, 2, 7, 9, 13, 17, 20) were administered. Scores for each individual test can range from 0 to over 200 where anything 69 and below is very low and anything 131 and above is very superior. Higher scores indicate better reading skills. APD: All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Baseline, 16 weeks
    End point values
    		 ADHD+ Dyslexia (D): Atomoxetine ADHD+ Dyslexia (D): Placebo ADHD Alone: Atomoxetine
    Number of subjects analysed
    51
    55
    22
    Units: units on a scale
    arithmetic mean (standard deviation)
        Basic Reading Skills (Tests 1, 13)
    1.75 ± 6.04
    0.87 ± 6.75
    -0.41 ± 7.99
        Letter-Word Identification (Test 1)
    1.18 ± 7.20
    -0.07 ± 6.63
    -0.32 ± 8.04
        Passage Comprehension (Test 9)
    -0.92 ± 11.43
    -1.02 ± 8.94
    -4.50 ± 9.04
        Reading Comprehension (Test 9, 17)
    -0.08 ± 9.68
    -1.09 ± 8.81
    -5.00 ± 7.45
        Reading Fluency (Test 2)
    -0.24 ± 7.91
    -0.11 ± 9.19
    1.36 ± 8.77
        Reading Vocabulary (Test 17)
    0.51 ± 8.92
    -0.16 ± 9.45
    -3.95 ± 8.60
        Spelling (Test 7)
    -0.22 ± 7.32
    -4.16 ± 12.13
    -0.41 ± 5.68
        Spelling of Sounds (Test 20)
    5.67 ± 16.07
    3.31 ± 13.49
    8.45 ± 19.78
        Word Attack (Test 13)
    2.27 ± 6.75
    1.13 ± 9.75
    -0.36 ± 7.88
    No statistical analyses for this end point

    Secondary: Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 16 Endpoint

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    End point title
    		 Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 16 Endpoint
    End point description
    The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better.
    End point type
    Secondary
    End point timeframe
    Baseline, 16 weeks
    End point values
    		 ADHD+ Dyslexia (D): Atomoxetine ADHD+ Dyslexia (D): Placebo ADHD Alone: Atomoxetine
    Number of subjects analysed
    51
    55
    22
    Units: units on a scale
    arithmetic mean (standard deviation)
        Blending Words
    0.96 ± 1.90
    0.95 ± 1.97
    1.86 ± 1.86
        Elision
    0.88 ± 2.18
    -0.24 ± 2.34
    0.27 ± 1.91
        Memory for Digits
    0.47 ± 2.16
    0.13 ± 1.76
    -0.50 ± 1.90
        Non-word Repetition
    0.57 ± 1.79
    0.51 ± 2.00
    0.82 ± 2.52
        Phonological Awareness
    5.20 ± 9.49
    2.00 ± 9.34
    6.82 ± 11.50
        Phonological Memory
    2.22 ± 10.61
    0.96 ± 10.16
    1.36 ± 11.33
        Rapid Digit Naming
    0.26 ± 2.06
    0.16 ± 1.75
    0.23 ± 1.23
        Rapid Letter Naming
    0.31 ± 1.76
    0.24 ± 1.64
    0.14 ± 1.52
        Rapid Naming
    1.06 ± 11.00
    0.35 ± 9.75
    -0.59 ± 10.83
    No statistical analyses for this end point

    Secondary: Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 16 Endpoint

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    End point title
    		 Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 16 Endpoint
    End point description
    The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. APD: All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Baseline, 16 weeks
    End point values
    		 ADHD+ Dyslexia (D): Atomoxetine ADHD+ Dyslexia (D): Placebo ADHD Alone: Atomoxetine
    Number of subjects analysed
    51
    55
    21
    Units: units on a scale
    arithmetic mean (standard deviation)
        Accuracy Score
    0.71 ± 2.22
    0.40 ± 2.02
    0.95 ± 2.16
        Comprehension Score
    0.37 ± 2.35
    0.65 ± 2.50
    -0.33 ± 1.93
        Fluency Score
    0.78 ± 2.81
    0.33 ± 2.82
    1.14 ± 2.94
        Oral Reading Quotient
    -1.43 ± 23.34
    2.87 ± 20.43
    2.43 ± 10.93
        Rate Score
    0.20 ± 1.65
    0.05 ± 1.54
    0.38 ± 2.27
    No statistical analyses for this end point

    Secondary: Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 16 Endpoint

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    End point title
    		 Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 16 Endpoint
    End point description
    The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. Scores range from 45-146. Higher scores indicate higher reading proficiency. APD: All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Baseline, 16 weeks
    End point values
    		 ADHD+ Dyslexia (D): Atomoxetine ADHD+ Dyslexia (D): Placebo ADHD Alone: Atomoxetine
    Number of subjects analysed
    61
    57
    26
    Units: units on a scale
    arithmetic mean (standard deviation)
        Phonemic Decoding Efficiency
    1.92 ± 6.01
    1.21 ± 5.19
    1.77 ± 6.78
        Sight Word Efficiency
    1.38 ± 5.78
    1.19 ± 4.80
    0.69 ± 8.84
        Total Word Reading Efficiency Standard Score
    -0.57 ± 21.98
    2.81 ± 11.90
    -5.88 ± 25.98
    No statistical analyses for this end point

    Secondary: Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 16 Endpoint

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    End point title
    		 Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 16 Endpoint
    End point description
    WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). APD: All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Baseline, 16 weeks
    End point values
    		 ADHD+ Dyslexia (D): Atomoxetine ADHD+ Dyslexia (D): Placebo ADHD Alone: Atomoxetine
    Number of subjects analysed
    54
    56
    23
    Units: units on a scale
    arithmetic mean (standard deviation)
        Phonological Loop Component Score (n=51, 54, 21)
    3.57 ± 10.79
    1.63 ± 9.00
    2.24 ± 9.78
        Central Executive Component Score (n=41, 44,12)
    7.34 ± 10.65
    -0.89 ± 13.65
    2.17 ± 11.77
        Visuo-Spatial Sketchpad Score (n=47, 43, 21)
    4.15 ± 11.96
    -0.47 ± 12.85
    3.67 ± 10.77
        Digit Recall (n=54, 56, 23)
    0.17 ± 3.42
    0.55 ± 3.01
    0.22 ± 4.45
        Word List Matching (n=54, 56, 23)
    -0.20 ± 7.08
    0.05 ± 8.65
    2.04 ± 9.24
        Word List Recall (n=54, 56, 23)
    1.00 ± 3.29
    0.02 ± 3.15
    0.35 ± 2.98
        Non-Word List Recall (n=53, 56, 23)
    0.89 ± 2.74
    0.71 ± 2.20
    0.43 ± 3.53
        Block Recall (n=54, 56, 23)
    -0.37 ± 4.20
    -0.80 ± 4.18
    0.70 ± 4.24
        Mazes Memory (n=54, 56, 23)
    1.94 ± 5.90
    1.18 ± 5.94
    0.78 ± 7.33
        Listening Recall (n=54, 56, 23)
    1.52 ± 3.32
    1.00 ± 3.77
    0.04 ± 5.90
        Counting Recall (n=54, 56, 23)
    0.50 ± 4.63
    0.45 ± 5.07
    0.48 ± 5.41
        Backward Digit Recall (n=54, 56, 23)
    1.30 ± 3.87
    0.16 ± 3.62
    1.26 ± 4.20
    No statistical analyses for this end point

    Secondary: Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 16 Endpoint

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    End point title
    		 Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 16 Endpoint
    End point description
    LPS-C is a short (24 item, 0-3 points per item) parent-rated scale that is designed to assess changes in adaptive functioning related to treatment for ADHD. This scale measures improvements in social, emotional, cognitive, educational, and affiliative (family, friends) functioning, which indirectly reflect improvements in executive functioning. Happy/social subscores range from 0-18, and self-control subscores range from 0-54. Total scores range from 0-72. Higher scores are better for LPS. APD: All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Baseline, 16 weeks
    End point values
    		 ADHD+ Dyslexia (D): Atomoxetine ADHD+ Dyslexia (D): Placebo ADHD Alone: Atomoxetine
    Number of subjects analysed
    58
    57
    26
    Units: units on a scale
    arithmetic mean (standard deviation)
        LPS Happy/Social Score
    0.57 ± 4.19
    0.53 ± 4.80
    1.38 ± 3.73
        LPS Self Control Score
    6.06 ± 8.54
    4.29 ± 10.60
    7.49 ± 8.46
        LPS Total Score
    6.51 ± 11.61
    4.82 ± 14.20
    9.05 ± 10.63
    No statistical analyses for this end point

    Secondary: Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 16 Endpoint

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    End point title
    		 Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 16 Endpoint
    End point description
    The K-SCT rating scale contains 3 components: Youth, Parent, and Teacher ratings. It queries 17 candidate SCT symptoms, such as daydreams, lost in a fog, sluggish/drowsy. Scores range from 0-51. Lower scores indicate less sluggish. APD: All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Baseline, 16 weeks
    End point values
    		 ADHD+ Dyslexia (D): Atomoxetine ADHD+ Dyslexia (D): Placebo ADHD Alone: Atomoxetine
    Number of subjects analysed
    56
    57
    23
    Units: units on a scale
    arithmetic mean (standard deviation)
        Total Score-Parent Variation (n= 56, 57, 23)
    -7.82 ± 10.98
    -4.64 ± 9.67
    -8.24 ± 9.90
        Total Score-Teacher Variation (n= 22, 22, 11)
    -8.82 ± 11.77
    -1.64 ± 6.53
    -3.47 ± 8.83
        Total Score-Youth Variation (n= 56, 57, 23)
    -4.71 ± 9.27
    -4.21 ± 6.85
    -6.17 ± 7.71
    No statistical analyses for this end point

    Secondary: Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 16 Endpoint

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    End point title
    		 Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 16 Endpoint
    End point description
    The MSCS is an overall assessment of self concept or an individual measure of any of the six scaled dimensions of self concept: Social, Competence, Affect, Academic, Family, and Physical. Standard scores range from 45-145. Higher scores are better (indicate higher self concept). APD: All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Baseline, 16 weeks
    End point values
    		 ADHD+ Dyslexia (D): Atomoxetine ADHD+ Dyslexia (D): Placebo ADHD Alone: Atomoxetine
    Number of subjects analysed
    58
    57
    25
    Units: units on a scale
    arithmetic mean (standard deviation)
        Academic Standard Section Score
    5.91 ± 9.01
    4.23 ± 12.77
    5.52 ± 6.78
        Affect Standard Section Score
    3.62 ± 10.32
    2.35 ± 10.81
    3.56 ± 10.58
        Competence Standard Section Score
    6.64 ± 12.99
    4.95 ± 12.05
    5.20 ± 9.06
        Family Standard Section Score
    0.39 ± 12.52
    -3.12 ± 11.66
    -1.00 ± 12.26
        Physical Standard Section Score
    4.09 ± 10.34
    1.32 ± 12.06
    3.04 ± 5.99
        Social Standard Section Score
    4.36 ± 11.73
    2.72 ± 11.14
    3.88 ± 10.39
        Standard Total Score
    4.72 ± 9.47
    1.98 ± 10.19
    3.44 ± 7.70
    No statistical analyses for this end point

    Secondary: Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 32 Endpoint

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    End point title
    		 Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 32 Endpoint
    End point description
    The ADHDRS-IV-parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3 =severe (very often). Hyperactivity-impulsivity scores range from 0-27, and inattention scores range from 0-27. Total scores range from 0-54. Higher scores indicate higher impairment. APD: All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Baseline, 32 weeks
    End point values
    		 ADHD+ Dyslexia (D): Atomoxetine ADHD Alone: Atomoxetine
    Number of subjects analysed
    45
    21
    Units: units on a scale
    arithmetic mean (standard deviation)
        Hyperactivity-Impulsivity Score
    -9.8 ± 6.17
    -8.29 ± 4.61
        Inattention Score
    -13.84 ± 6.56
    -14.33 ± 7.16
        Total Score
    -23.64 ± 10.43
    -22.62 ± 9.07
    No statistical analyses for this end point

    Secondary: Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 32 Endpoint

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    End point title
    		 Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 32 Endpoint
    End point description
    The ADHDRS-IV-Teacher is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3 =severe (very often). Hyperactivity-impulsivity scores range from 0-27, and inattention scores range from 0-27. Total scores range from 0-54. Higher scores indicate higher impairment. APD: All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Baseline, 32 weeks
    End point values
    		 ADHD+ Dyslexia (D): Atomoxetine ADHD Alone: Atomoxetine
    Number of subjects analysed
    23
    9
    Units: units on a scale
    arithmetic mean (standard deviation)
        Hyperactivity-Impulsivity Score
    -1.87 ± 4.80
    -2.89 ± 4.48
        Inattention Score
    -4.28 ± 6.08
    -4.19 ± 4.11
        Total Score
    -6.15 ± 8.51
    -7.08 ± 7.34
    No statistical analyses for this end point

    Secondary: Change From Baseline in Woodcock-Johnson III Scores at Week 32 Endpoint

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    End point title
    		 Change From Baseline in Woodcock-Johnson III Scores at Week 32 Endpoint
    End point description
    The Woodcock Johnson Tests of Achievement has a Standard Battery (Tests 1-12) of a broad set of scores and an Extended Battery (Tests 13-22) on specific academic strengths and weaknesses. Tests associated with reading skills (1, 2, 7, 9, 13, 17, 20) were administered. Scores for each individual test can range from 0 to over 200 where anything 69 and below is very low and anything 131 and above is very superior. Higher scores indicate better reading skills. APD: All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Baseline, 32 weeks
    End point values
    		 ADHD+ Dyslexia (D): Atomoxetine ADHD Alone: Atomoxetine
    Number of subjects analysed
    45
    21
    Units: units on a scale
    arithmetic mean (standard deviation)
        Basic Reading Skills (Tests 1, 13)
    2.73 ± 6.51
    -0.24 ± 5.37
        Letter-Word Identification (Test 1)
    1.69 ± 7.19
    0.24 ± 5.73
        Passage Comprehension (Test 9)
    2.31 ± 9.18
    1.24 ± 5.63
        Reading Comprehension (Tests 9, 17)
    2.89 ± 9.07
    0.86 ± 7.04
        Reading Fluency (Test 2)
    2.69 ± 9.04
    3.24 ± 8.64
        Reading Vocabulary (Test 17)
    2.60 ± 8.55
    -0.14 ± 10.57
        Spelling (Test 7)
    0.60 ± 7.74
    0.38 ± 5.96
        Spelling of Sounds (Test 20)
    2.98 ± 10.77
    5.90 ± 14.17
        Word Attack (Test 13)
    3.27 ± 7.09
    -0.90 ± 6.59
    No statistical analyses for this end point

    Secondary: Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 32 Endpoint

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    End point title
    		 Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 32 Endpoint
    End point description
    he CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better. APD included all randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Baseline, 32 weeks
    End point values
    		 ADHD+ Dyslexia (D): Atomoxetine ADHD Alone: Atomoxetine
    Number of subjects analysed
    45
    21
    Units: units on a scale
    arithmetic mean (standard deviation)
        Blending Words
    1.31 ± 2.01
    1.90 ± 2.98
        Elision
    1.07 ± 2.00
    0.71 ± 3.05
        Memory for Digits
    0.87 ± 2.17
    -0.05 ± 2.13
        Non-word Repetition
    0.93 ± 2.27
    0.43 ± 3.03
        Phonological Awareness
    7.33 ± 9.50
    5.33 ± 15.99
        Phonological Memory
    4.93 ± 10.57
    -0.67 ± 12.44
        Rapid Digit Naming
    0.43 ± 1.91
    0.62 ± 2.31
        Rapid Letter Naming
    0.43 ± 2.06
    0.90 ± 2.34
        Rapid Naming
    1.30 ± 11.27
    1.76 ± 12.35
    No statistical analyses for this end point

    Secondary: Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 32 Endpoint

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    End point title
    		 Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 32 Endpoint
    End point description
    The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. APD: All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Baseline, 32 weeks
    End point values
    		 ADHD+ Dyslexia (D): Atomoxetine ADHD Alone: Atomoxetine
    Number of subjects analysed
    45
    20
    Units: units on a scale
    arithmetic mean (standard deviation)
        Accuracy Score
    0.82 ± 1.30
    0.95 ± 1.82
        Comprehension Score
    0.04 ± 1.73
    -0.30 ± 1.59
        Fluency Score
    0.76 ± 1.40
    1.10 ± 2.63
        Oral Reading Quotient
    2.64 ± 15.05
    -1.30 ± 21.22
        Rate Score
    0.58 ± 1.74
    0.15 ± 1.98
    No statistical analyses for this end point

    Secondary: Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 32 Endpoint

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    End point title
    		 Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 32 Endpoint
    End point description
    The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. Scores range from 45-146. Higher scores indicate higher reading proficiency. APD: All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Baseline, 32 weeks
    End point values
    		 ADHD+ Dyslexia (D): Atomoxetine ADHD Alone: Atomoxetine
    Number of subjects analysed
    45
    21
    Units: units on a scale
    arithmetic mean (standard deviation)
        Phonemic Decoding Efficiency
    2.64 ± 6.54
    5.33 ± 6.98
        Sight Word Efficiency
    1.93 ± 6.51
    4.62 ± 8.74
        Total Word Reading Efficiency Standard Score
    2.56 ± 17.35
    1.52 ± 20.64
    No statistical analyses for this end point

    Secondary: Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 32 Endpoint

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    End point title
    		 Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 32 Endpoint
    End point description
    WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). APD: All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Baseline, 32 weeks
    End point values
    		 ADHD+ Dyslexia (D): Atomoxetine ADHD Alone: Atomoxetine
    Number of subjects analysed
    45
    21
    Units: units on a scale
    arithmetic mean (standard deviation)
        Phonological Loop Component Score (n=43, 20)
    3.67 ± 11.27
    1.70 ± 9.66
        Central Executive Component Score (n=38, 14)
    6.53 ± 11.34
    1.64 ± 11.30
        Visuo-Spatial Sketchpad Component Score (n=40, 20)
    3.85 ± 12.89
    2.65 ± 9.96
        Digit Recall (n=45, 21)
    -0.04 ± 2.92
    0.52 ± 4.08
        Word List Matching (n=45, 21)
    2.38 ± 7.96
    1.95 ± 8.22
        Word List Recall (n=45, 21)
    1.49 ± 3.00
    0.33 ± 2.50
        Non-Word List Recall (n=44, 21)
    0.55 ± 2.90
    -0.67 ± 4.39
        Block Recall (n=45, 21)
    0.71 ± 3.88
    1.05 ± 4.24
        Mazes Memory (n=45, 21)
    2.33 ± 7.04
    3.48 ± 7.77
        Listening Recall (n=45, 21)
    2.18 ± 4.01
    -1.05 ± 6.42
        Counting Recall (n=45, 21)
    1.53 ± 4.65
    1.24 ± 6.54
        Backward Digit Recall (n=45, 21)
    1.07 ± 3.24
    2.29 ± 5.20
    No statistical analyses for this end point

    Secondary: Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 32 Endpoint

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    End point title
    		 Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 32 Endpoint
    End point description
    LPS-C is a short (24 item, 0-3 points per item) parent-rated scale that is designed to assess changes in adaptive functioning related to treatment for ADHD. This scale measures improvements in social, emotional, cognitive, educational, and affiliative (family, friends) functioning, which indirectly reflect improvements in executive functioning. Happy/social subscores range from 0-18, and self-control subscores range from 0-54. Total scores range from 0-72. Higher scores are better for LPS. APD: All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Baseline, 32 weeks
    End point values
    		 ADHD+ Dyslexia (D): Atomoxetine ADHD Alone: Atomoxetine
    Number of subjects analysed
    45
    21
    Units: units on a scale
    arithmetic mean (standard deviation)
        LPS Happy/Social Score (n=45, 21)
    1.57 ± 4.37
    2.14 ± 4.30
        LPS Self Control Score (n=45, 20)
    9.10 ± 10.73
    10.44 ± 10.42
        LPS Total Score (n=45, 20)
    10.67 ± 14.27
    12.64 ± 13.95
    No statistical analyses for this end point

    Secondary: Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 32 Endpoint

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    End point title
    		 Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 32 Endpoint
    End point description
    The K-SCT rating scale contains 3 components: Youth, Parent, and Teacher ratings. It queries 17 candidate SCT symptoms, such as daydreams, lost in a fog, sluggish/drowsy. Scores range from 0-51. Lower scores indicate less sluggish. APD: All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).Total Score-Parent Variation (n=45, 21)
    End point type
    Secondary
    End point timeframe
    Baseline, 32 weeks
    End point values
    		 ADHD+ Dyslexia (D): Atomoxetine ADHD Alone: Atomoxetine
    Number of subjects analysed
    45
    21
    Units: units on a scale
    arithmetic mean (standard deviation)
        Total Score-Parent Variation (n=45, 21)
    -10.40 ± 11.94
    -10.83 ± 10.84
        Total Score-Teacher Variation (n=23, 9)
    -7.00 ± 12.82
    -7.89 ± 5.18
        Total Score-Youth Variation (n=45, 21)
    -4.36 ± 7.57
    -5.43 ± 8.44
    No statistical analyses for this end point

    Secondary: Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 32 Endpoint

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    End point title
    		 Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 32 Endpoint
    End point description
    The MSCS is an overall assessment of self concept or an individual measure of any of the six scaled dimensions of self concept: Social, Competence, Affect, Academic, Family, and Physical. Standard scores range from 45-145. Higher scores are better (indicate higher self concept). APD: All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Baseline, 32 weeks
    End point values
    		 ADHD+ Dyslexia (D): Atomoxetine ADHD Alone: Atomoxetine
    Number of subjects analysed
    45
    21
    Units: units on a scale
    arithmetic mean (standard deviation)
        Academic Standard Section Score
    6.02 ± 9.72
    5.43 ± 6.98
        Affect Standard Section Score
    4.29 ± 11.14
    3.14 ± 10.45
        Competence Standard Section Score
    6.76 ± 11.77
    5.19 ± 7.94
        Family Standard Section Score
    0.16 ± 14.40
    0.33 ± 9.79
        Physical Standard Section Score
    6.09 ± 12.00
    2.43 ± 7.20
        Social Standard Section Score
    4.84 ± 11.84
    2.38 ± 11.75
        Standard Total Score
    5.61 ± 10.82
    3.48 ± 7.21
    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
    All randomized participants.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    Placebo/Atomoxetine
    Reporting group description
    		 Participants were assigned to placebo in acute phase and Atomoxetine in open-label phase. Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine.

    Reporting group title
    Atomoxetine/Atomoxetine
    Reporting group description
    		 Participants were assigned to Atomoxetine treatment in both acute and open-label phase. Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with atomoxetine.

    Serious adverse events
    		 Placebo/Atomoxetine Atomoxetine/Atomoxetine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 120 (0.83%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    wound infection staphylococcal
    alternative dictionary used: MedDRA 13.1
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo/Atomoxetine Atomoxetine/Atomoxetine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    71 / 89 (79.78%)
    108 / 120 (90.00%)
    Investigations
    weight decreased
    alternative dictionary used: MedDRA 13.1
         subjects affected / exposed
    1 / 89 (1.12%)
    6 / 120 (5.00%)
         occurrences all number
    1
    6
    Nervous system disorders
    dizziness
    alternative dictionary used: MedDRA 13.1
         subjects affected / exposed
    5 / 89 (5.62%)
    15 / 120 (12.50%)
         occurrences all number
    5
    16
    headache
    alternative dictionary used: MedDRA 13.1
         subjects affected / exposed
    16 / 89 (17.98%)
    27 / 120 (22.50%)
         occurrences all number
    21
    36
    somnolence
    alternative dictionary used: MedDRA 13.1
         subjects affected / exposed
    0 / 89 (0.00%)
    10 / 120 (8.33%)
         occurrences all number
    0
    12
    General disorders and administration site conditions
    fatigue
    alternative dictionary used: MedDRA 13.1
         subjects affected / exposed
    9 / 89 (10.11%)
    31 / 120 (25.83%)
         occurrences all number
    11
    34
    irritability
    alternative dictionary used: MedDRA 13.1
         subjects affected / exposed
    8 / 89 (8.99%)
    14 / 120 (11.67%)
         occurrences all number
    11
    15
    pyrexia
    alternative dictionary used: MedDRA 13.1
         subjects affected / exposed
    6 / 89 (6.74%)
    2 / 120 (1.67%)
         occurrences all number
    6
    3
    therapeutic response unexpected
    alternative dictionary used: MedDRA 13.1
         subjects affected / exposed
    2 / 89 (2.25%)
    6 / 120 (5.00%)
         occurrences all number
    2
    12
    Gastrointestinal disorders
    abdominal discomfort
    alternative dictionary used: MedDRA 13.1
         subjects affected / exposed
    2 / 89 (2.25%)
    7 / 120 (5.83%)
         occurrences all number
    2
    8
    abdominal pain upper
    alternative dictionary used: MedDRA 13.1
         subjects affected / exposed
    6 / 89 (6.74%)
    23 / 120 (19.17%)
         occurrences all number
    8
    31
    diarrhoea
    alternative dictionary used: MedDRA 13.1
         subjects affected / exposed
    3 / 89 (3.37%)
    7 / 120 (5.83%)
         occurrences all number
    3
    7
    nausea
    alternative dictionary used: MedDRA 13.1
         subjects affected / exposed
    5 / 89 (5.62%)
    34 / 120 (28.33%)
         occurrences all number
    6
    42
    vomiting
    alternative dictionary used: MedDRA 13.1
         subjects affected / exposed
    8 / 89 (8.99%)
    16 / 120 (13.33%)
         occurrences all number
    9
    24
    Respiratory, thoracic and mediastinal disorders
    cough
    alternative dictionary used: MedDRA 13.1
         subjects affected / exposed
    8 / 89 (8.99%)
    6 / 120 (5.00%)
         occurrences all number
    8
    6
    oropharyngeal pain
    alternative dictionary used: MedDRA 13.1
         subjects affected / exposed
    6 / 89 (6.74%)
    6 / 120 (5.00%)
         occurrences all number
    6
    6
    Skin and subcutaneous tissue disorders
    rash
    alternative dictionary used: MedDRA 13.1
         subjects affected / exposed
    6 / 89 (6.74%)
    6 / 120 (5.00%)
         occurrences all number
    6
    6
    Psychiatric disorders
    aggression
    alternative dictionary used: MedDRA 13.1
         subjects affected / exposed
    0 / 89 (0.00%)
    6 / 120 (5.00%)
         occurrences all number
    0
    6
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 13.1
         subjects affected / exposed
    4 / 89 (4.49%)
    22 / 120 (18.33%)
         occurrences all number
    5
    22

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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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    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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