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    Clinical Trial Results:
    A Randomized, Controlled, Open-Label Comparison Study of the Efficacy and Safety of Slow Transitioning compared with Fast Transitioning from a Stimulant Medication to Atomoxetine in Pediatric and Adolescent Outpatients with DSM-IV Attention-Deficit/Hyperactivity Disorder (ADHD).

    Summary
    EudraCT number
    		 2008-001767-11
    Trial protocol
    		 GB   ES   PT  
    Global end of trial date
    08 Sep 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Nov 2020
    First version publication date
    15 Nov 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    12305
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    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 877CTLilly,
    Scientific contact
    Available Mon Fri 9 AM 5 PM EST, Eli Lilly and Company, 1 8772854559,
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    08 Sep 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Sep 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD) who are not tolerating or not responding well to stimulant therapy will be included in this study. Two different strategies for transition from Stimulant to Atomoxetine will be used: Slow (10 weeks) and fast (2 weeks). Changes in ADHD symptoms and tolerability of medication will be compared between the two different switching approaches.
    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
    30 Sep 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
    Portugal: 7
    Country: Number of subjects enrolled
    Spain: 57
    Country: Number of subjects enrolled
    United Kingdom: 15
    Country: Number of subjects enrolled
    Australia: 12
    Country: Number of subjects enrolled
    Mexico: 20
    Worldwide total number of subjects
    111
    EEA total number of subjects
    79
    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)
    62
    Adolescents (12-17 years)
    49
    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
    		 Study Period II was a 10-week treatment period. Study Period III was a 4-week period, during which participants continued on atomoxetine treatment at the same dose as given at the end of Study Period II or at a higher dose, up to a maximum of 1.8 mg/kg/day.

    Pre-assignment
    Screening details
    		 NA

    Period 1
    Period 1 title
    Study Period II
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Slow Switching Group
    Arm description
    		 Switch from full stimulants dose to atomoxetine 1.2 milligrams per kilogram per day (mg/kg/day) without stimulants, orally (PO), during (or over) 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atomoxetine
    Investigational medicinal product code
    LY139603
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Atomoxetine 1.2 milligrams per kilogram per day (mg/kg/day), orally (PO), during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.

    Arm title
    		 Fast Switching Group
    Arm description
    		 Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, without stimulants during the first 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atomoxetine
    Investigational medicinal product code
    LY139603
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Atomoxetine 1.2mg/kg/day, PO, within 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.

    Number of subjects in period 1
    		Slow Switching Group Fast Switching Group
    Started
    57
    54
    Completed
    44
    41
    Not completed
    13
    13
         Parent/Caregiver Decision
    3
    -
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    3
    4
         Protocol deviation
    6
    3
         Lack of efficacy
    -
    6
    Period 2
    Period 2 title
    Study Period III
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Slow Switching Group
    Arm description
    		 Switch from full stimulant dose to atomoxetine 1.2 milligrams per kilogram per day (mg/kg/day) without stimulants, orally (PO), during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atomoxetine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Atomoxetine 1.2 milligrams per kilogram per day (mg/kg/day), orally (PO), during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.

    Arm title
    		 Fast Switching Group
    Arm description
    		 Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, without stimulants during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atomoxetine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.

    Number of subjects in period 2
    		Slow Switching Group Fast Switching Group
    Started
    44
    41
    Completed
    41
    38
    Not completed
    3
    3
         Parent/Caregiver Decision
    -
    1
         Physician decision
    -
    1
         Adverse event, non-fatal
    1
    -
         Lack of efficacy
    1
    -
         Protocol deviation
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Slow Switching Group
    Reporting group description
    		 Switch from full stimulants dose to atomoxetine 1.2 milligrams per kilogram per day (mg/kg/day) without stimulants, orally (PO), during (or over) 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.

    Reporting group title
    Fast Switching Group
    Reporting group description
    		 Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, without stimulants during the first 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.

    Reporting group values
    		 Slow Switching Group Fast Switching Group Total
    Number of subjects
    		 57 54 111
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 11.1 ± 2.51 12.0 ± 2.16 -
    Gender categorical
    Units: Subjects
        Female
    		 8 10 18
        Male
    		 49 44 93
    Race/Ethnicity
    Units: Subjects
        Caucasian
    		 46 43 89
        African
    		 1 0 1
        Hispanic
    		 10 11 21
    Attention Deficit Hyperactivity Disorder (ADHD) subtype
    ADHD subtype was classified by Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria.
    Units: Subjects
        Combined
    		 38 36 74
        Hyperactive/Impulsive
    		 1 3 4
        Inattentive
    		 17 15 32
        Not otherwise categorized
    		 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    Slow Switching Group
    Reporting group description
    		 Switch from full stimulants dose to atomoxetine 1.2 milligrams per kilogram per day (mg/kg/day) without stimulants, orally (PO), during (or over) 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.

    Reporting group title
    Fast Switching Group
    Reporting group description
    		 Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, without stimulants during the first 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
    Reporting group title
    Slow Switching Group
    Reporting group description
    		 Switch from full stimulant dose to atomoxetine 1.2 milligrams per kilogram per day (mg/kg/day) without stimulants, orally (PO), during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.

    Reporting group title
    Fast Switching Group
    Reporting group description
    		 Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, without stimulants during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.

    Primary: Change From Baseline in Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS-IV) Parent Version: Investigator Administered and Scored - Total Score at Week 10 Endpoint

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    End point title
    		 Change From Baseline in Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS-IV) Parent Version: Investigator Administered and Scored - Total Score at Week 10 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 to 54. Higher score indicates greater severity of disease. Least squares means are adjusted for baseline, site, treatment, visit and treatment by visit interaction. Analysis Population Description (APD): Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.
    End point type
    Primary
    End point timeframe
    Baseline, 10 weeks
    End point values
    		 Slow Switching Group Fast Switching Group
    Number of subjects analysed
    57
    54
    Units: units on a scale
        arithmetic mean (standard deviation)
    -14.3 ± 1.2
    -15.0 ± 1.2
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Slow Switching Group v Fast Switching Group
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.692
    Method
    		 Mixed models analysis
    Parameter type
    		 Least square mean differences at week 10
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4
         upper limit
    		 2.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.7
    Notes
    [1] - Superiority or Other (legacy)

    Primary: Change From Baseline in ADHD-RS-IV Parent Version: Investigator Administered and Scored - Total Score at Week 2 Endpoint

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    End point title
    		 Change From Baseline in ADHD-RS-IV Parent Version: Investigator Administered and Scored - Total Score at Week 2 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 ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Higher score indicates greater severity of disease. Least squares means are adjusted for baseline, site, treatment, visit and treatment by visit interaction. APD:Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.
    End point type
    Primary
    End point timeframe
    Baseline, 2 weeks
    End point values
    		 Slow Switching Group Fast Switching Group
    Number of subjects analysed
    57
    54
    Units: Units on scale
        arithmetic mean (standard error)
    -8.0 ± 1.0
    -8.1 ± 1.0
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Slow Switching Group v Fast Switching Group
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 = 0.927
    Method
    		 Mixed models analysis
    Parameter type
    		 Least square mean differences at week 2
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.9
         upper limit
    		 2.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.4
    Notes
    [2] - Superiority or Other (legacy)

    Secondary: Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale - Patient Total Score at Week 10 Endpoint

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    End point title
    		 Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale - Patient Total Score at Week 10 Endpoint
    End point description
    The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction. APD: Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline, 10 weeks
    End point values
    		 Slow Switching Group Fast Switching Group
    Number of subjects analysed
    57
    54
    Units: Units on scale
        least squares mean (standard error)
    -0.6 ± 0.2
    -0.4 ± 0.2
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Slow Switching Group v Fast Switching Group
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0.456
    Method
    		 Mixed models analysis
    Parameter type
    		 Least square mean differences at week 10
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 0.7
    Variability estimate
    Standard error of the mean
    Notes
    [3] - Superiority or Other (legacy)

    Secondary: Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Parent Total Score at Week 10 Endpoint

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    End point title
    		 Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Parent Total Score at Week 10 Endpoint
    End point description
    The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction. APD: Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline, 10 weeks
    End point values
    		 Slow Switching Group Fast Switching Group
    Number of subjects analysed
    57
    54
    Units: Units on a scale
        least squares mean (standard error)
    -1.0 ± 0.2
    -0.8 ± 0.2
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Slow Switching Group v Fast Switching Group
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    P-value
    		 = 0.517
    Method
    		 Mixed models analysis
    Parameter type
    		 Least square mean differences at week 10
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 0.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3
    Notes
    [4] - Superiority or Other (legacy)

    Secondary: Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Investigator Total Score at Week 10 Endpoint

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    End point title
    		 Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Investigator Total Score at Week 10 Endpoint
    End point description
    The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction. APD: Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline, 10 weeks
    End point values
    		 Slow Switching Group Fast Switching Group
    Number of subjects analysed
    57
    54
    Units: Units on a scale
        least squares mean (standard error)
    -1.3 ± 0.2
    -1.2 ± 0.2
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Slow Switching Group v Fast Switching Group
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 = 0.526
    Method
    		 Mixed models analysis
    Parameter type
    		 Least square mean differences at week 10
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 0.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2
    Notes
    [5] - Superiority or Other (legacy)

    Secondary: Change From Baseline in Clinical Global Impression Severity (CGI-S) Rating Scale - Total Score at Week 10 Endpoint

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    End point title
    		 Change From Baseline in Clinical Global Impression Severity (CGI-S) Rating Scale - Total Score at Week 10 Endpoint
    End point description
    The CGI- S is a single-item clinician rating of the severity of the participant's ADHD symptoms in relation to the clinician's total experience of ADHD participants. Severity is rated on a seven-point scale (1 = normal, not ill at all; 7 = among the most extremely ill patients). Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction. APD: Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline, 10 weeks
    End point values
    		 Slow Switching Group Fast Switching Group
    Number of subjects analysed
    57
    54
    Units: Units on a scale
        least squares mean (standard error)
    -1.7 ± 0.26
    -1.7 ± 0.2
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Fast Switching Group v Slow Switching Group
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    P-value
    		 = 0.898
    Method
    		 Mixed models analysis
    Parameter type
    		 Least square mean differences at week 10
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 0.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2
    Notes
    [6] - Superiority or Other (legacy)

    Secondary: Change From Baseline in Child Health and Illness Profile Child Edition-Parent Report Form (CHIP-CE-PRF) - Domain Scores at Week 10 Endpoint

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    End point title
    		 Change From Baseline in Child Health and Illness Profile Child Edition-Parent Report Form (CHIP-CE-PRF) - Domain Scores at Week 10 Endpoint
    End point description
    CHIP-CE-PRF consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format. Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation (SD) of 10. Standard scores are expressed in SD units. T-score=[(Score- Mean for the reference population [Ref Pop])*10/SD for the Ref Pop]+50. Higher scores mean better quality of life. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction. APD: Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline, 10 weeks
    End point values
    		 Slow Switching Group Fast Switching Group
    Number of subjects analysed
    57
    54
    Units: standard deviation units
    arithmetic mean (standard error)
        Satisfaction Domain
    3.4 ± 1.6
    2.2 ± 1.6
        Comfort Domain
    0.7 ± 1.2
    4.1 ± 1.1
        Risk Avoidance Domain
    4.9 ± 1.4
    2.9 ± 1.4
        Resilience Domain
    1.8 ± 1.4
    -1.0 ± 1.4
        Achievement Domain
    3.5 ± 1.7
    -1.2 ± 1.6
    No statistical analyses for this end point

    Secondary: Change From Baseline in Treatment Satisfaction Preference Survey Mean Score at Week 10 Endpoint

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    End point title
    		 Change From Baseline in Treatment Satisfaction Preference Survey Mean Score at Week 10 Endpoint
    End point description
    The Treatment Satisfaction Survey consists of a five-question survey each rated on a 5 point scale (0=very satisfied/very likely, 4=very dissatisfied/not at all likely). The mean score over the items is reported. APD: Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment. Last Observation Carried Forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Baseline, 10 weeks
    End point values
    		 Slow Switching Group Fast Switching Group
    Number of subjects analysed
    53
    53
    Units: units on a scale
        arithmetic mean (standard deviation)
    -0.7 ± 1.16
    -0.5 ± 1.11
    No statistical analyses for this end point

    Secondary: Change From Baseline in Blood Pressure (BP) at Week 6 and Week 14 Endpoint

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    End point title
    		 Change From Baseline in Blood Pressure (BP) at Week 6 and Week 14 Endpoint
    End point description
    APD: Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment, and with both baseline and week 6 or 14 values.
    End point type
    Secondary
    End point timeframe
    Baseline, 6 weeks, 14 weeks
    End point values
    		 Slow Switching Group Fast Switching Group
    Number of subjects analysed
    57
    54
    Units: mmHg
    arithmetic mean (standard deviation)
        Week 6 Change Diastolic BP (n=52, 52)
    1.5 ± 7.21
    1.9 ± 8.31
        Week 6 Change Systolic BP (n=52, 52)
    1.2 ± 7.74
    0.5 ± 9.05
        Week 14 Change Diastolic BP (n=43, 40)
    2.3 ± 7.58
    3.1 ± 7.04
        Week 14 Change Systolic BP (n= 43, 40)
    -0.2 ± 8.62
    2.6 ± 9.00
    No statistical analyses for this end point

    Secondary: Change From Baseline in Pulse Rate at Week 6 and Week 14 Endpoint

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    End point title
    		 Change From Baseline in Pulse Rate at Week 6 and Week 14 Endpoint
    End point description
    APD: Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment, and with both baseline and week 6 or 14 values.
    End point type
    Secondary
    End point timeframe
    Baseline, 6 weeks, 14 weeks
    End point values
    		 Slow Switching Group Fast Switching Group
    Number of subjects analysed
    57
    54
    Units: beats per minute
    arithmetic mean (standard deviation)
        Week 6 Change (n=52, 52)
    6.8 ± 11.12
    4.2 ± 8.83
        Week 14 Change (n=43, 40)
    3.4 ± 12.69
    5.9 ± 10.17
    No statistical analyses for this end point

    Secondary: Change From Baseline in Body Weight at Week 6 and Week 14 Endpoint

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    End point title
    		 Change From Baseline in Body Weight at Week 6 and Week 14 Endpoint
    End point description
    APD: Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment, and with both baseline and week 6 or 14 values.
    End point type
    Secondary
    End point timeframe
    Baseline, 6 weeks, 14 weeks
    End point values
    		 Slow Switching Group Fast Switching Group
    Number of subjects analysed
    57
    54
    Units: kilogram(s)
    arithmetic mean (standard deviation)
        Week 6 Change (n=52, 52)
    -0.4 ± 1.12
    0.6 ± 1.25
        Week 14 Change (n=43, 40)
    0.6 ± 1.64
    1.1 ± 2.15
    No statistical analyses for this end point

    Secondary: Number of Participants With Suicidal Behaviors and Ideations

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    End point title
    		 Number of Participants With Suicidal Behaviors and Ideations
    End point description
    Columbia Suicide Rating Scale (C-SSRS): scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors and ideations are provided. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. APD: Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline through 14 weeks
    End point values
    		 Slow Switching Group Fast Switching Group
    Number of subjects analysed
    57
    54
    Units: Subjects
        number (not applicable)
    1
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire Study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    Slow Switching Group
    Reporting group description
    		 Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.

    Reporting group title
    Fast Switching Group
    Reporting group description
    		 Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.

    Serious adverse events
    		 Slow Switching Group Fast Switching Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 57 (1.75%)
    1 / 54 (1.85%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Nervous system disorders
    VIth nerve paralysis
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicide Attempt
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 54 (1.85%)
         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: 5%
    Non-serious adverse events
    		 Slow Switching Group Fast Switching Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    35 / 57 (61.40%)
    30 / 54 (55.56%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    11 / 57 (19.30%)
    12 / 54 (22.22%)
         occurrences all number
    16
    19
    Somnolence
         subjects affected / exposed
    4 / 57 (7.02%)
    9 / 54 (16.67%)
         occurrences all number
    4
    9
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 57 (5.26%)
    4 / 54 (7.41%)
         occurrences all number
    3
    4
    Irritability
         subjects affected / exposed
    4 / 57 (7.02%)
    3 / 54 (5.56%)
         occurrences all number
    5
    3
    Pyrexia
         subjects affected / exposed
    4 / 57 (7.02%)
    2 / 54 (3.70%)
         occurrences all number
    4
    3
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    3 / 57 (5.26%)
    6 / 54 (11.11%)
         occurrences all number
    3
    13
    Abdominal Pain Upper
         subjects affected / exposed
    8 / 57 (14.04%)
    5 / 54 (9.26%)
         occurrences all number
    11
    5
    Nausea
         subjects affected / exposed
    4 / 57 (7.02%)
    0 / 54 (0.00%)
         occurrences all number
    4
    0
    Vomiting
         subjects affected / exposed
    1 / 57 (1.75%)
    5 / 54 (9.26%)
         occurrences all number
    1
    6
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 57 (5.26%)
    1 / 54 (1.85%)
         occurrences all number
    4
    2
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 57 (1.75%)
    3 / 54 (5.56%)
         occurrences all number
    1
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    7 / 57 (12.28%)
    3 / 54 (5.56%)
         occurrences all number
    8
    3
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 57 (5.26%)
    0 / 54 (0.00%)
         occurrences all number
    3
    0
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    11 / 57 (19.30%)
    12 / 54 (22.22%)
         occurrences all number
    12
    19

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Nov 2008
    Changes to exclusion criteria.

    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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