Attention Deficit Hyperactivity Disorder
Conditions
Brief summary
The purpose of this study is to provide information regarding the relative effectiveness of three different atomoxetine doses in the treatment of Korean children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD)
Interventions
DRUGAtomoxetine Hydrochloride
Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period
DRUGAtomoxetine hydrochloride
Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Patients will be outpatients who are aged 6 to 18 years old at the initial screening visit. * Patients must have ADHD, based on the accepted criteria for that disease * Patients must not have taken any medication used to treat ADHD for at least two weeks prior to beginning study treatment; and at least one week prior to the study screening visit during which initial ADHD assessments were made * Patients must be able to swallow capsules * Patients and parents (or legal guardians) must be judged by the study investigator to be reliable to keep appointments for clinic visits and all tests, including blood tests and any other required examinations
Exclusion criteria
* Patients must not have received any treatment within the last 30 days with a drug that has not been approved by their country's appropriate government agency * Patients will not be included in the study if they have previously experienced any unwanted effects or serious medical events during atomoxetine treatment * Patients will not be included in the study if they are judged by the study investigator to be at serious suicidal risk * Patients will not be included in the study if they have cardiovascular disease or other conditions that could be worsened by an increased heart rate or increased blood pressure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Day 42 Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score | Baseline, Day 42 | Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 none/never or rarely) to 3 (severe/very often). Total scores range from 0 (no symptoms) to 54 (highly symptomatic). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint | Baseline, Days 7, 14, 42 | Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment. (1=very much improved, 7=very much worsened) |
| Adverse Events Leading to Discontinuation | Baseline to Day 42 | Adverse Events (Preferred Term) leading to discontinuation by decreasing frequency |
| Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary | Baseline to Day 42 | Columbia Suicide-Severity Rating Scale (C-SSRS) captures occurrence, severity & frequency of suicide-related thoughts & behaviors, via questions designed to solicit information to determine if a suicide-related thought or behavior occurred. The C-SSRS is not scored; recorded incidents are counted. C-SSRS was only required if an adverse event was reported that the investigator suspected to represent a suicidal thought or behavior. If the C-SSR was completed at a visit, the Self-Harm Supplement was also required. If a self-harm event was reported, the Self-Harm Follow-Up form was also required. |
| Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint | Baseline, Days 7, 14, 42 | Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients). |
| Temperature Change From Baseline to Day 42 Endpoint | Baseline, Day 42 | — |
| Blood Pressure Change From Baseline to Day 42 Endpoint | Baseline, Day 42 | — |
| Weight Change From Baseline to Day 42 Endpoint | Baseline, Day 42 | — |
| Heart Rate Change From Baseline to Day 42 Endpoint | Baseline, Day 42 | — |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Atomoxetine 0.2 mg/kg/Day Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period. | 51 |
| Atomoxetine 0.5 mg/kg/Day Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period. | 51 |
| Atomoxetine 1.2 mg/kg/Day Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days. | 51 |
| Total | 153 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 3 | 3 |
| Overall Study | Protocol Violation | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 7 | 2 | 2 |
Baseline characteristics
| Characteristic | Atomoxetine 0.2 mg/kg/Day | Atomoxetine 0.5 mg/kg/Day | Atomoxetine 1.2 mg/kg/Day | Total |
|---|---|---|---|---|
| ADHD Rating Scale-IV-Parent:Investigator Rated Hyperactivity Subscale Score | 17.51 units on a scale STANDARD_DEVIATION 5.825 | 16.61 units on a scale STANDARD_DEVIATION 5.107 | 15.96 units on a scale STANDARD_DEVIATION 5.553 | 16.69 units on a scale STANDARD_DEVIATION 5.504 |
| ADHRS-IV-Parent: Inv. Inattention Subscale Score | 21.57 units on a scale STANDARD_DEVIATION 3.312 | 21.06 units on a scale STANDARD_DEVIATION 3.63 | 20.20 units on a scale STANDARD_DEVIATION 3.476 | 20.94 units on a scale STANDARD_DEVIATION 3.499 |
| ADHRS-IV-Parent: Inv. Total Scores | 39.08 units on a scale STANDARD_DEVIATION 7.896 | 37.67 units on a scale STANDARD_DEVIATION 7.064 | 36.16 units on a scale STANDARD_DEVIATION 7.341 | 37.63 units on a scale STANDARD_DEVIATION 7.489 |
| Age-Categorical 13-18 years | 13 participants | 7 participants | 7 participants | 27 participants |
| Age-Categorical 6-12 years | 38 participants | 44 participants | 44 participants | 126 participants |
| Age Continuous | 8.87 years INTER_QUARTILE_RANGE 2.774 | 10.06 years INTER_QUARTILE_RANGE 2.178 | 9.29 years INTER_QUARTILE_RANGE 2.187 | 9.41 years INTER_QUARTILE_RANGE 2.382 |
| Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder Severity Scale (CGI-ADHD-S) | 5.35 units on a scale STANDARD_DEVIATION 0.688 | 5.31 units on a scale STANDARD_DEVIATION 0.787 | 5.16 units on a scale STANDARD_DEVIATION 0.703 | 5.27 units on a scale STANDARD_DEVIATION 0.728 |
| Race/Ethnicity Korean | 51 participants | 51 participants | 51 participants | 153 participants |
| Region of Enrollment Korea, Republic of | 51 participants | 51 participants | 51 participants | 153 participants |
| Sex: Female, Male Female | 4 Participants | 41 Participants | 40 Participants | 85 Participants |
| Sex: Female, Male Male | 47 Participants | 10 Participants | 11 Participants | 68 Participants |
| Weight | 35.67 kilograms STANDARD_DEVIATION 12.348 | 35.54 kilograms STANDARD_DEVIATION 10.647 | 35.48 kilograms STANDARD_DEVIATION 11.536 | 35.56 kilograms STANDARD_DEVIATION 11.455 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 15 / 51 | 22 / 54 | 27 / 48 |
| serious Total, serious adverse events | 0 / 51 | 1 / 54 | 1 / 48 |
Outcome results
Primary
Change From Baseline to Day 42 Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score
Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 none/never or rarely) to 3 (severe/very often). Total scores range from 0 (no symptoms) to 54 (highly symptomatic).
Time frame: Baseline, Day 42
Population: Analysis included all randomized participants (intent-to-treat population)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Atomoxetine 0.2 mg/kg/Day | Change From Baseline to Day 42 Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score | -9.55 units on a scale | 95% Confidence Interval 7.758 |
| Atomoxetine 0.5 mg/kg/Day | Change From Baseline to Day 42 Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score | -12.31 units on a scale | 95% Confidence Interval 7.064 |
| Atomoxetine 1.2 mg/kg/Day | Change From Baseline to Day 42 Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score | -14.51 units on a scale | 95% Confidence Interval 7.216 |
p-value: 0.024ANCOVA
Secondary
Adverse Events Leading to Discontinuation
Adverse Events (Preferred Term) leading to discontinuation by decreasing frequency
Time frame: Baseline to Day 42
Population: As-treated population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atomoxetine 0.2 mg/kg/Day | Adverse Events Leading to Discontinuation | Appendicitis | 0 events |
| Atomoxetine 0.2 mg/kg/Day | Adverse Events Leading to Discontinuation | Irritability | 1 events |
| Atomoxetine 0.2 mg/kg/Day | Adverse Events Leading to Discontinuation | Dysphemia | 0 events |
| Atomoxetine 0.2 mg/kg/Day | Adverse Events Leading to Discontinuation | Anorexia | 0 events |
| Atomoxetine 0.2 mg/kg/Day | Adverse Events Leading to Discontinuation | Decreased appetite | 0 events |
| Atomoxetine 0.2 mg/kg/Day | Adverse Events Leading to Discontinuation | Sedation | 0 events |
| Atomoxetine 0.2 mg/kg/Day | Adverse Events Leading to Discontinuation | Dizziness | 0 events |
| Atomoxetine 0.5 mg/kg/Day | Adverse Events Leading to Discontinuation | Dysphemia | 0 events |
| Atomoxetine 0.5 mg/kg/Day | Adverse Events Leading to Discontinuation | Anorexia | 1 events |
| Atomoxetine 0.5 mg/kg/Day | Adverse Events Leading to Discontinuation | Appendicitis | 1 events |
| Atomoxetine 0.5 mg/kg/Day | Adverse Events Leading to Discontinuation | Dizziness | 1 events |
| Atomoxetine 0.5 mg/kg/Day | Adverse Events Leading to Discontinuation | Irritability | 0 events |
| Atomoxetine 0.5 mg/kg/Day | Adverse Events Leading to Discontinuation | Sedation | 0 events |
| Atomoxetine 0.5 mg/kg/Day | Adverse Events Leading to Discontinuation | Decreased appetite | 1 events |
| Atomoxetine 1.2 mg/kg/Day | Adverse Events Leading to Discontinuation | Irritability | 0 events |
| Atomoxetine 1.2 mg/kg/Day | Adverse Events Leading to Discontinuation | Appendicitis | 0 events |
| Atomoxetine 1.2 mg/kg/Day | Adverse Events Leading to Discontinuation | Decreased appetite | 0 events |
| Atomoxetine 1.2 mg/kg/Day | Adverse Events Leading to Discontinuation | Sedation | 1 events |
| Atomoxetine 1.2 mg/kg/Day | Adverse Events Leading to Discontinuation | Dysphemia | 1 events |
| Atomoxetine 1.2 mg/kg/Day | Adverse Events Leading to Discontinuation | Dizziness | 0 events |
| Atomoxetine 1.2 mg/kg/Day | Adverse Events Leading to Discontinuation | Anorexia | 0 events |
p-value: 0.45Fisher Exact
Secondary
Blood Pressure Change From Baseline to Day 42 Endpoint
Time frame: Baseline, Day 42
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine 0.2 mg/kg/Day | Blood Pressure Change From Baseline to Day 42 Endpoint | Systolic Day 42 | 107.82 mmHg | Standard Deviation 14.44 |
| Atomoxetine 0.2 mg/kg/Day | Blood Pressure Change From Baseline to Day 42 Endpoint | Diastolic Change at Endpoint | 0.16 mmHg | Standard Deviation 13.201 |
| Atomoxetine 0.2 mg/kg/Day | Blood Pressure Change From Baseline to Day 42 Endpoint | Systolic Baseline | 105.98 mmHg | Standard Deviation 12.888 |
| Atomoxetine 0.2 mg/kg/Day | Blood Pressure Change From Baseline to Day 42 Endpoint | Systolic Change at Endpoint | 0.98 mmHg | Standard Deviation 16.535 |
| Atomoxetine 0.2 mg/kg/Day | Blood Pressure Change From Baseline to Day 42 Endpoint | Diastolic Baseline | 66.53 mmHg | Standard Deviation 10.567 |
| Atomoxetine 0.2 mg/kg/Day | Blood Pressure Change From Baseline to Day 42 Endpoint | Diastolic Day 42 | 67.45 mmHg | Standard Deviation 10.199 |
| Atomoxetine 0.5 mg/kg/Day | Blood Pressure Change From Baseline to Day 42 Endpoint | Diastolic Baseline | 65.39 mmHg | Standard Deviation 11.742 |
| Atomoxetine 0.5 mg/kg/Day | Blood Pressure Change From Baseline to Day 42 Endpoint | Diastolic Day 42 | 68.78 mmHg | Standard Deviation 11.677 |
| Atomoxetine 0.5 mg/kg/Day | Blood Pressure Change From Baseline to Day 42 Endpoint | Systolic Day 42 | 104.98 mmHg | Standard Deviation 10.988 |
| Atomoxetine 0.5 mg/kg/Day | Blood Pressure Change From Baseline to Day 42 Endpoint | Systolic Change at Endpoint | 2.35 mmHg | Standard Deviation 12.122 |
| Atomoxetine 0.5 mg/kg/Day | Blood Pressure Change From Baseline to Day 42 Endpoint | Diastolic Change at Endpoint | 3.65 mmHg | Standard Deviation 12.058 |
| Atomoxetine 0.5 mg/kg/Day | Blood Pressure Change From Baseline to Day 42 Endpoint | Systolic Baseline | 102.49 mmHg | Standard Deviation 11.279 |
| Atomoxetine 1.2 mg/kg/Day | Blood Pressure Change From Baseline to Day 42 Endpoint | Diastolic Change at Endpoint | 2.17 mmHg | Standard Deviation 13.2 |
| Atomoxetine 1.2 mg/kg/Day | Blood Pressure Change From Baseline to Day 42 Endpoint | Systolic Day 42 | 108.48 mmHg | Standard Deviation 11.067 |
| Atomoxetine 1.2 mg/kg/Day | Blood Pressure Change From Baseline to Day 42 Endpoint | Systolic Change at Endpoint | 1.72 mmHg | Standard Deviation 13.391 |
| Atomoxetine 1.2 mg/kg/Day | Blood Pressure Change From Baseline to Day 42 Endpoint | Diastolic Baseline | 66.78 mmHg | Standard Deviation 11.524 |
| Atomoxetine 1.2 mg/kg/Day | Blood Pressure Change From Baseline to Day 42 Endpoint | Diastolic Day 42 | 70.02 mmHg | Standard Deviation 8.734 |
| Atomoxetine 1.2 mg/kg/Day | Blood Pressure Change From Baseline to Day 42 Endpoint | Systolic Baseline | 106.12 mmHg | Standard Deviation 13.749 |
p-value: 0.9761ANOVA
p-value: 0.6419ANOVA
Secondary
Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint
Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment. (1=very much improved, 7=very much worsened)
Time frame: Baseline, Days 7, 14, 42
Population: ITT population; LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine 0.2 mg/kg/Day | Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint | Day 7 | 3.57 units on a scale | Standard Deviation 0.645 |
| Atomoxetine 0.2 mg/kg/Day | Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint | Day 14 | 3.25 units on a scale | Standard Deviation 0.729 |
| Atomoxetine 0.2 mg/kg/Day | Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint | LOCF Endpoint | 3.29 units on a scale | Standard Deviation 0.957 |
| Atomoxetine 0.2 mg/kg/Day | Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint | Day 42 | 3.24 units on a scale | Standard Deviation 0.97 |
| Atomoxetine 0.5 mg/kg/Day | Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint | Day 14 | 3.20 units on a scale | Standard Deviation 0.957 |
| Atomoxetine 0.5 mg/kg/Day | Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint | Day 42 | 3.09 units on a scale | Standard Deviation 0.952 |
| Atomoxetine 0.5 mg/kg/Day | Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint | Day 7 | 3.22 units on a scale | Standard Deviation 0.642 |
| Atomoxetine 0.5 mg/kg/Day | Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint | LOCF Endpoint | 3.16 units on a scale | Standard Deviation 0.946 |
| Atomoxetine 1.2 mg/kg/Day | Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint | LOCF Endpoint | 2.80 units on a scale | Standard Deviation 0.969 |
| Atomoxetine 1.2 mg/kg/Day | Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint | Day 14 | 2.98 units on a scale | Standard Deviation 0.721 |
| Atomoxetine 1.2 mg/kg/Day | Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint | Day 7 | 3.54 units on a scale | Standard Deviation 0.813 |
| Atomoxetine 1.2 mg/kg/Day | Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint | Day 42 | 2.77 units on a scale | Standard Deviation 0.973 |
p-value: 0.0153Mixed Models Analysis
Secondary
Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint
Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).
Time frame: Baseline, Days 7, 14, 42
Population: ITT population; last observation carried forward (LOCF)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine 0.2 mg/kg/Day | Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint | Day 7 | -0.24 units on a scale | Standard Deviation 0.48 |
| Atomoxetine 0.2 mg/kg/Day | Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint | Day 14 | -0.73 units on a scale | Standard Deviation 0.736 |
| Atomoxetine 0.2 mg/kg/Day | Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint | Day 42 | -1.04 units on a scale | Standard Deviation 0.729 |
| Atomoxetine 0.2 mg/kg/Day | Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint | LOCF Endpoint | -0.98 units on a scale | Standard Deviation 0.75 |
| Atomoxetine 0.5 mg/kg/Day | Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint | LOCF Endpoint | -1.22 units on a scale | Standard Deviation 1.119 |
| Atomoxetine 0.5 mg/kg/Day | Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint | Day 7 | -0.53 units on a scale | Standard Deviation 0.612 |
| Atomoxetine 0.5 mg/kg/Day | Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint | Day 42 | -1.30 units on a scale | Standard Deviation 1.121 |
| Atomoxetine 0.5 mg/kg/Day | Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint | Day 14 | -0.90 units on a scale | Standard Deviation 0.918 |
| Atomoxetine 1.2 mg/kg/Day | Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint | LOCF Endpoint | -1.54 units on a scale | Standard Deviation 1.073 |
| Atomoxetine 1.2 mg/kg/Day | Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint | Day 14 | -0.92 units on a scale | Standard Deviation 0.786 |
| Atomoxetine 1.2 mg/kg/Day | Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint | Day 42 | -1.56 units on a scale | Standard Deviation 1.09 |
| Atomoxetine 1.2 mg/kg/Day | Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint | Day 7 | -0.30 units on a scale | Standard Deviation -0.036 |
p-value: 0.0048Mixed Models Analysis
Secondary
Heart Rate Change From Baseline to Day 42 Endpoint
Time frame: Baseline, Day 42
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine 0.2 mg/kg/Day | Heart Rate Change From Baseline to Day 42 Endpoint | Day 42 | 90.43 beats per minute (bpm) | Standard Deviation 10.278 |
| Atomoxetine 0.2 mg/kg/Day | Heart Rate Change From Baseline to Day 42 Endpoint | Baseline | 87.86 beats per minute (bpm) | Standard Deviation 12.324 |
| Atomoxetine 0.2 mg/kg/Day | Heart Rate Change From Baseline to Day 42 Endpoint | Change at endpoint | 2.59 beats per minute (bpm) | Standard Deviation 13.041 |
| Atomoxetine 0.5 mg/kg/Day | Heart Rate Change From Baseline to Day 42 Endpoint | Day 42 | 90.35 beats per minute (bpm) | Standard Deviation 11.028 |
| Atomoxetine 0.5 mg/kg/Day | Heart Rate Change From Baseline to Day 42 Endpoint | Baseline | 85.78 beats per minute (bpm) | Standard Deviation 10.769 |
| Atomoxetine 0.5 mg/kg/Day | Heart Rate Change From Baseline to Day 42 Endpoint | Change at endpoint | 5.24 beats per minute (bpm) | Standard Deviation 13.621 |
| Atomoxetine 1.2 mg/kg/Day | Heart Rate Change From Baseline to Day 42 Endpoint | Baseline | 90.10 beats per minute (bpm) | Standard Deviation 12.852 |
| Atomoxetine 1.2 mg/kg/Day | Heart Rate Change From Baseline to Day 42 Endpoint | Change at endpoint | 4.98 beats per minute (bpm) | Standard Deviation 14.649 |
| Atomoxetine 1.2 mg/kg/Day | Heart Rate Change From Baseline to Day 42 Endpoint | Day 42 | 93.89 beats per minute (bpm) | Standard Deviation 13.287 |
p-value: 0.8005ANOVA
Secondary
Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary
Columbia Suicide-Severity Rating Scale (C-SSRS) captures occurrence, severity & frequency of suicide-related thoughts & behaviors, via questions designed to solicit information to determine if a suicide-related thought or behavior occurred. The C-SSRS is not scored; recorded incidents are counted. C-SSRS was only required if an adverse event was reported that the investigator suspected to represent a suicidal thought or behavior. If the C-SSR was completed at a visit, the Self-Harm Supplement was also required. If a self-harm event was reported, the Self-Harm Follow-Up form was also required.
Time frame: Baseline to Day 42
Population: As treated population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Atomoxetine 0.2 mg/kg/Day | Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary | 0 participants |
| Atomoxetine 0.5 mg/kg/Day | Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary | 0 participants |
| Atomoxetine 1.2 mg/kg/Day | Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary | 0 participants |
Secondary
Temperature Change From Baseline to Day 42 Endpoint
Time frame: Baseline, Day 42
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine 0.2 mg/kg/Day | Temperature Change From Baseline to Day 42 Endpoint | Day 42 | 36.58 degrees Celsius | Standard Deviation 0.331 |
| Atomoxetine 0.2 mg/kg/Day | Temperature Change From Baseline to Day 42 Endpoint | Baseline | 36.63 degrees Celsius | Standard Deviation 0.26 |
| Atomoxetine 0.2 mg/kg/Day | Temperature Change From Baseline to Day 42 Endpoint | Change at endpoint | -0.05 degrees Celsius | Standard Deviation 0.343 |
| Atomoxetine 0.5 mg/kg/Day | Temperature Change From Baseline to Day 42 Endpoint | Day 42 | 36.55 degrees Celsius | Standard Deviation 0.332 |
| Atomoxetine 0.5 mg/kg/Day | Temperature Change From Baseline to Day 42 Endpoint | Baseline | 36.56 degrees Celsius | Standard Deviation 0.397 |
| Atomoxetine 0.5 mg/kg/Day | Temperature Change From Baseline to Day 42 Endpoint | Change at endpoint | -0.02 degrees Celsius | Standard Deviation 0.339 |
| Atomoxetine 1.2 mg/kg/Day | Temperature Change From Baseline to Day 42 Endpoint | Baseline | 36.50 degrees Celsius | Standard Deviation 0.4 |
| Atomoxetine 1.2 mg/kg/Day | Temperature Change From Baseline to Day 42 Endpoint | Change at endpoint | 0.07 degrees Celsius | Standard Deviation 0.327 |
| Atomoxetine 1.2 mg/kg/Day | Temperature Change From Baseline to Day 42 Endpoint | Day 42 | 36.59 degrees Celsius | Standard Deviation 0.27 |
p-value: 0.4128ANOVA
Secondary
Weight Change From Baseline to Day 42 Endpoint
Time frame: Baseline, Day 42
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine 0.2 mg/kg/Day | Weight Change From Baseline to Day 42 Endpoint | Day 42 | 36.10 kilograms (kg) | Standard Deviation 12.524 |
| Atomoxetine 0.2 mg/kg/Day | Weight Change From Baseline to Day 42 Endpoint | Baseline | 35.67 kilograms (kg) | Standard Deviation 12.348 |
| Atomoxetine 0.2 mg/kg/Day | Weight Change From Baseline to Day 42 Endpoint | Change at Endpoint | 0.37 kilograms (kg) | Standard Deviation 1.5 |
| Atomoxetine 0.5 mg/kg/Day | Weight Change From Baseline to Day 42 Endpoint | Day 42 | 35.72 kilograms (kg) | Standard Deviation 11.305 |
| Atomoxetine 0.5 mg/kg/Day | Weight Change From Baseline to Day 42 Endpoint | Baseline | 35.54 kilograms (kg) | Standard Deviation 10.647 |
| Atomoxetine 0.5 mg/kg/Day | Weight Change From Baseline to Day 42 Endpoint | Change at Endpoint | -0.08 kilograms (kg) | Standard Deviation 1.155 |
| Atomoxetine 1.2 mg/kg/Day | Weight Change From Baseline to Day 42 Endpoint | Baseline | 35.48 kilograms (kg) | Standard Deviation 11.536 |
| Atomoxetine 1.2 mg/kg/Day | Weight Change From Baseline to Day 42 Endpoint | Change at Endpoint | -0.15 kilograms (kg) | Standard Deviation 1.093 |
| Atomoxetine 1.2 mg/kg/Day | Weight Change From Baseline to Day 42 Endpoint | Day 42 | 36.39 kilograms (kg) | Standard Deviation 11.708 |
p-value: 0.2213ANOVA