| 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 | 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. | 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. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 10 weeks | | | | ID | Title | Description |
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| OG000 | Slow Switching Group | 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. | | OG001 | Fast Switching Group | 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. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-14.3± 1.2
- OG001-15.0± 1.2
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Mixed Models Analysis | | 0.692 | | Least square mean differences at week 10 | -0.7 | Standard Error of the Mean | 1.7 | 2-Sided | 95 | -4.0 | 2.6 | | | | No | Superiority or Other | | |
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| Secondary | Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale - Patient Total Score at Week 10 Endpoint | 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. | 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. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 10 weeks | | | | ID | Title | Description |
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| OG000 | Slow Switching Group | 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. | | OG001 | Fast Switching Group | 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. |
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| Secondary | Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Parent Total Score at Week 10 Endpoint | 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. | 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. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 10 weeks | | | | ID | Title | Description |
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| OG000 | Slow Switching Group | 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. | | OG001 | Fast Switching Group | 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. |
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| Secondary | Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Investigator Total Score at Week 10 Endpoint | 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. | 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. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 10 weeks | | | | ID | Title | Description |
|---|
| OG000 | Slow Switching Group | 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. | | OG001 | Fast Switching Group | 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. |
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| Secondary | Change From Baseline in Clinical Global Impression Severity (CGI-S) Rating Scale - Total Score at Week 10 Endpoint | 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. | 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. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 10 weeks | | | | ID | Title | Description |
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| OG000 | Slow Switching Group | 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. | | OG001 | Fast Switching Group | 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. |
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| Secondary | Change From Baseline in Child Health and Illness Profile Child Edition-Parent Report Form (CHIP-CE-PRF) - Domain Scores at Week 10 Endpoint | 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. | 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. | Posted | | Least Squares Mean | Standard Error | standard deviation units | | Baseline, 10 weeks | | | | ID | Title | Description |
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| OG000 | Slow Switching Group | 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. | | OG001 | Fast Switching Group | 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. |
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| Secondary | Change From Baseline in Treatment Satisfaction Preference Survey Mean Score at Week 10 Endpoint | 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. | 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). | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 10 weeks | | | | ID | Title | Description |
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| OG000 | Slow Switching Group | 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. | | OG001 | Fast Switching Group | 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. |
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| Secondary | Change From Baseline in Blood Pressure (BP) at Week 6 and Week 14 Endpoint | | 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. | Posted | | Mean | Standard Deviation | mmHg | | Baseline, 6 weeks, 14 weeks | | | | ID | Title | Description |
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| OG000 | Slow Switching Group | 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. | | OG001 | Fast Switching Group | 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. |
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| Secondary | Change From Baseline in Pulse Rate at Week 6 and Week 14 Endpoint | | 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. | Posted | | Mean | Standard Deviation | beats per minute | | Baseline, 6 weeks, 14 weeks | | | | ID | Title | Description |
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| OG000 | Slow Switching Group | 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. | | OG001 | Fast Switching Group | 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. |
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| Primary | Change From Baseline in ADHD-RS-IV Parent Version: Investigator Administered and Scored - Total Score at Week 2 Endpoint | 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. | 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. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, 2 weeks | | | | ID | Title | Description |
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| OG000 | Slow Switching Group | 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. | | OG001 | Fast Switching Group | 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. |
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| Secondary | Change From Baseline in Body Weight at Week 6 and Week 14 Endpoint | | 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. | Posted | | Mean | Standard Deviation | kilogram | | Baseline, 6 weeks, 14 weeks | | | | ID | Title | Description |
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| OG000 | Slow Switching Group | 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. | | OG001 | Fast Switching Group | 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. |
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| Secondary | Number of Participants With Suicidal Behaviors and Ideations | 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. | 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. | Posted | | Number | | participants | | Baseline through 14 weeks | | | | ID | Title | Description |
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| OG000 | Slow Switching Group | 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. | | OG001 | Fast Switching Group | 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. |
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