Trial Outcomes & Findings for Atomoxetine to Treat Korean Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) (NCT NCT00568685)
NCT ID: NCT00568685
Last Updated: 2010-01-26
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
153 participants
Primary outcome timeframe
Baseline, Day 42
Results posted on
2010-01-26
Participant Flow
Participant milestones
| Measure |
Atomoxetine 0.2 Milligrams Per Kilogram, Per Day (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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
51
|
51
|
51
|
|
Overall Study
COMPLETED
|
41
|
46
|
46
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
5
|
Reasons for withdrawal
| Measure |
Atomoxetine 0.2 Milligrams Per Kilogram, Per Day (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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
7
|
2
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
Baseline Characteristics
Atomoxetine to Treat Korean Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
Baseline characteristics by cohort
| Measure |
Atomoxetine 0.2 mg/kg/Day
n=51 Participants
Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
|
Atomoxetine 0.5 mg/kg/Day
n=51 Participants
Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
|
Atomoxetine 1.2 mg/kg/Day
n=51 Participants
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.
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
8.87 years
INTER_QUARTILE_RANGE 2.774 • n=5 Participants
|
10.06 years
INTER_QUARTILE_RANGE 2.178 • n=7 Participants
|
9.29 years
INTER_QUARTILE_RANGE 2.187 • n=5 Participants
|
9.41 years
INTER_QUARTILE_RANGE 2.382 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
|
Region of Enrollment
Korea, Republic of
|
51 participants
n=5 Participants
|
51 participants
n=7 Participants
|
51 participants
n=5 Participants
|
153 participants
n=4 Participants
|
|
Age-Categorical
6-12 years
|
38 participants
n=5 Participants
|
44 participants
n=7 Participants
|
44 participants
n=5 Participants
|
126 participants
n=4 Participants
|
|
Age-Categorical
13-18 years
|
13 participants
n=5 Participants
|
7 participants
n=7 Participants
|
7 participants
n=5 Participants
|
27 participants
n=4 Participants
|
|
Race/Ethnicity
Korean
|
51 participants
n=5 Participants
|
51 participants
n=7 Participants
|
51 participants
n=5 Participants
|
153 participants
n=4 Participants
|
|
ADHRS-IV-Parent: Inv. Total Scores
|
39.08 units on a scale
STANDARD_DEVIATION 7.896 • n=5 Participants
|
37.67 units on a scale
STANDARD_DEVIATION 7.064 • n=7 Participants
|
36.16 units on a scale
STANDARD_DEVIATION 7.341 • n=5 Participants
|
37.63 units on a scale
STANDARD_DEVIATION 7.489 • n=4 Participants
|
|
ADHD Rating Scale-IV-Parent:Investigator Rated Hyperactivity Subscale Score
|
17.51 units on a scale
STANDARD_DEVIATION 5.825 • n=5 Participants
|
16.61 units on a scale
STANDARD_DEVIATION 5.107 • n=7 Participants
|
15.96 units on a scale
STANDARD_DEVIATION 5.553 • n=5 Participants
|
16.69 units on a scale
STANDARD_DEVIATION 5.504 • n=4 Participants
|
|
ADHRS-IV-Parent: Inv. Inattention Subscale Score
|
21.57 units on a scale
STANDARD_DEVIATION 3.312 • n=5 Participants
|
21.06 units on a scale
STANDARD_DEVIATION 3.630 • n=7 Participants
|
20.20 units on a scale
STANDARD_DEVIATION 3.476 • n=5 Participants
|
20.94 units on a scale
STANDARD_DEVIATION 3.499 • n=4 Participants
|
|
Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder Severity Scale (CGI-ADHD-S)
|
5.35 units on a scale
STANDARD_DEVIATION 0.688 • n=5 Participants
|
5.31 units on a scale
STANDARD_DEVIATION 0.787 • n=7 Participants
|
5.16 units on a scale
STANDARD_DEVIATION 0.703 • n=5 Participants
|
5.27 units on a scale
STANDARD_DEVIATION 0.728 • n=4 Participants
|
|
Weight
|
35.67 kilograms
STANDARD_DEVIATION 12.348 • n=5 Participants
|
35.54 kilograms
STANDARD_DEVIATION 10.647 • n=7 Participants
|
35.48 kilograms
STANDARD_DEVIATION 11.536 • n=5 Participants
|
35.56 kilograms
STANDARD_DEVIATION 11.455 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 42Population: Analysis included all randomized participants (intent-to-treat population)
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).
Outcome measures
| Measure |
Atomoxetine 0.2 mg/kg/Day
n=51 Participants
Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
|
Atomoxetine 0.5 mg/kg/Day
n=51 Participants
Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
|
Atomoxetine 1.2 mg/kg/Day
n=51 Participants
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.
|
|---|---|---|---|
|
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 • Interval -12.03 to -7.07
|
-12.31 units on a scale
95% Confidence Interval 7.064 • Interval -14.76 to -9.85
|
-14.51 units on a scale
95% Confidence Interval 7.216 • Interval -16.99 to -12.04
|
SECONDARY outcome
Timeframe: Baseline, Days 7, 14, 42Population: ITT population; last observation carried forward (LOCF)
Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).
Outcome measures
| Measure |
Atomoxetine 0.2 mg/kg/Day
n=51 Participants
Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
|
Atomoxetine 0.5 mg/kg/Day
n=51 Participants
Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
|
Atomoxetine 1.2 mg/kg/Day
n=51 Participants
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.
|
|---|---|---|---|
|
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 0.480
|
-0.53 units on a scale
Standard Deviation 0.612
|
-0.30 units on a scale
Standard Deviation -.036
|
|
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
|
-0.90 units on a scale
Standard Deviation 0.918
|
-0.92 units on a scale
Standard Deviation 0.786
|
|
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
|
-1.30 units on a scale
Standard Deviation 1.121
|
-1.56 units on a scale
Standard Deviation 1.090
|
|
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 0.750
|
-1.22 units on a scale
Standard Deviation 1.119
|
-1.54 units on a scale
Standard Deviation 1.073
|
SECONDARY outcome
Timeframe: Baseline, Days 7, 14, 42Population: ITT population; LOCF
Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment. (1=very much improved, 7=very much worsened)
Outcome measures
| Measure |
Atomoxetine 0.2 mg/kg/Day
n=51 Participants
Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
|
Atomoxetine 0.5 mg/kg/Day
n=51 Participants
Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
|
Atomoxetine 1.2 mg/kg/Day
n=51 Participants
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.
|
|---|---|---|---|
|
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
|
3.22 units on a scale
Standard Deviation 0.642
|
3.54 units on a scale
Standard Deviation 0.813
|
|
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
|
3.20 units on a scale
Standard Deviation 0.957
|
2.98 units on a scale
Standard Deviation 0.721
|
|
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 0.970
|
3.09 units on a scale
Standard Deviation 0.952
|
2.77 units on a scale
Standard Deviation 0.973
|
|
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
|
3.16 units on a scale
Standard Deviation 0.946
|
2.80 units on a scale
Standard Deviation 0.969
|
SECONDARY outcome
Timeframe: Baseline to Day 42Population: As-treated population
Adverse Events (Preferred Term) leading to discontinuation by decreasing frequency
Outcome measures
| Measure |
Atomoxetine 0.2 mg/kg/Day
n=51 Participants
Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
|
Atomoxetine 0.5 mg/kg/Day
n=54 Participants
Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
|
Atomoxetine 1.2 mg/kg/Day
n=48 Participants
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.
|
|---|---|---|---|
|
Adverse Events Leading to Discontinuation
Appendicitis
|
0 events
|
1 events
|
0 events
|
|
Adverse Events Leading to Discontinuation
Dizziness
|
0 events
|
1 events
|
0 events
|
|
Adverse Events Leading to Discontinuation
Anorexia
|
0 events
|
1 events
|
0 events
|
|
Adverse Events Leading to Discontinuation
Dysphemia
|
0 events
|
0 events
|
1 events
|
|
Adverse Events Leading to Discontinuation
Irritability
|
1 events
|
0 events
|
0 events
|
|
Adverse Events Leading to Discontinuation
Sedation
|
0 events
|
0 events
|
1 events
|
|
Adverse Events Leading to Discontinuation
Decreased appetite
|
0 events
|
1 events
|
0 events
|
SECONDARY outcome
Timeframe: Baseline to Day 42Population: As treated population
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.
Outcome measures
| Measure |
Atomoxetine 0.2 mg/kg/Day
n=51 Participants
Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
|
Atomoxetine 0.5 mg/kg/Day
n=54 Participants
Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
|
Atomoxetine 1.2 mg/kg/Day
n=48 Participants
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.
|
|---|---|---|---|
|
Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, Day 42Population: ITT population
Outcome measures
| Measure |
Atomoxetine 0.2 mg/kg/Day
n=51 Participants
Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
|
Atomoxetine 0.5 mg/kg/Day
n=51 Participants
Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
|
Atomoxetine 1.2 mg/kg/Day
n=51 Participants
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.
|
|---|---|---|---|
|
Heart Rate Change From Baseline to Day 42 Endpoint
Baseline
|
87.86 beats per minute (bpm)
Standard Deviation 12.324
|
85.78 beats per minute (bpm)
Standard Deviation 10.769
|
90.10 beats per minute (bpm)
Standard Deviation 12.852
|
|
Heart Rate Change From Baseline to Day 42 Endpoint
Day 42
|
90.43 beats per minute (bpm)
Standard Deviation 10.278
|
90.35 beats per minute (bpm)
Standard Deviation 11.028
|
93.89 beats per minute (bpm)
Standard Deviation 13.287
|
|
Heart Rate Change From Baseline to Day 42 Endpoint
Change at endpoint
|
2.59 beats per minute (bpm)
Standard Deviation 13.041
|
5.24 beats per minute (bpm)
Standard Deviation 13.621
|
4.98 beats per minute (bpm)
Standard Deviation 14.649
|
SECONDARY outcome
Timeframe: Baseline, Day 42Population: ITT population
Outcome measures
| Measure |
Atomoxetine 0.2 mg/kg/Day
n=51 Participants
Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
|
Atomoxetine 0.5 mg/kg/Day
n=51 Participants
Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
|
Atomoxetine 1.2 mg/kg/Day
n=51 Participants
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.
|
|---|---|---|---|
|
Temperature Change From Baseline to Day 42 Endpoint
Baseline
|
36.63 degrees Celsius
Standard Deviation 0.260
|
36.56 degrees Celsius
Standard Deviation 0.397
|
36.50 degrees Celsius
Standard Deviation 0.400
|
|
Temperature Change From Baseline to Day 42 Endpoint
Day 42
|
36.58 degrees Celsius
Standard Deviation 0.331
|
36.55 degrees Celsius
Standard Deviation 0.332
|
36.59 degrees Celsius
Standard Deviation 0.270
|
|
Temperature Change From Baseline to Day 42 Endpoint
Change at endpoint
|
-0.05 degrees Celsius
Standard Deviation 0.343
|
-0.02 degrees Celsius
Standard Deviation 0.339
|
0.07 degrees Celsius
Standard Deviation 0.327
|
SECONDARY outcome
Timeframe: Baseline, Day 42Population: ITT population
Outcome measures
| Measure |
Atomoxetine 0.2 mg/kg/Day
n=51 Participants
Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
|
Atomoxetine 0.5 mg/kg/Day
n=51 Participants
Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
|
Atomoxetine 1.2 mg/kg/Day
n=51 Participants
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.
|
|---|---|---|---|
|
Blood Pressure Change From Baseline to Day 42 Endpoint
Diastolic Baseline
|
66.53 mmHg
Standard Deviation 10.567
|
65.39 mmHg
Standard Deviation 11.742
|
66.78 mmHg
Standard Deviation 11.524
|
|
Blood Pressure Change From Baseline to Day 42 Endpoint
Diastolic Day 42
|
67.45 mmHg
Standard Deviation 10.199
|
68.78 mmHg
Standard Deviation 11.677
|
70.02 mmHg
Standard Deviation 8.734
|
|
Blood Pressure Change From Baseline to Day 42 Endpoint
Systolic Baseline
|
105.98 mmHg
Standard Deviation 12.888
|
102.49 mmHg
Standard Deviation 11.279
|
106.12 mmHg
Standard Deviation 13.749
|
|
Blood Pressure Change From Baseline to Day 42 Endpoint
Systolic Day 42
|
107.82 mmHg
Standard Deviation 14.440
|
104.98 mmHg
Standard Deviation 10.988
|
108.48 mmHg
Standard Deviation 11.067
|
|
Blood Pressure Change From Baseline to Day 42 Endpoint
Systolic Change at Endpoint
|
0.98 mmHg
Standard Deviation 16.535
|
2.35 mmHg
Standard Deviation 12.122
|
1.72 mmHg
Standard Deviation 13.391
|
|
Blood Pressure Change From Baseline to Day 42 Endpoint
Diastolic Change at Endpoint
|
0.16 mmHg
Standard Deviation 13.201
|
3.65 mmHg
Standard Deviation 12.058
|
2.17 mmHg
Standard Deviation 13.200
|
SECONDARY outcome
Timeframe: Baseline, Day 42Population: ITT population
Outcome measures
| Measure |
Atomoxetine 0.2 mg/kg/Day
n=51 Participants
Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
|
Atomoxetine 0.5 mg/kg/Day
n=51 Participants
Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
|
Atomoxetine 1.2 mg/kg/Day
n=51 Participants
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.
|
|---|---|---|---|
|
Weight Change From Baseline to Day 42 Endpoint
Baseline
|
35.67 kilograms (kg)
Standard Deviation 12.348
|
35.54 kilograms (kg)
Standard Deviation 10.647
|
35.48 kilograms (kg)
Standard Deviation 11.536
|
|
Weight Change From Baseline to Day 42 Endpoint
Day 42
|
36.10 kilograms (kg)
Standard Deviation 12.524
|
35.72 kilograms (kg)
Standard Deviation 11.305
|
36.39 kilograms (kg)
Standard Deviation 11.708
|
|
Weight Change From Baseline to Day 42 Endpoint
Change at Endpoint
|
0.37 kilograms (kg)
Standard Deviation 1.500
|
-0.08 kilograms (kg)
Standard Deviation 1.155
|
-0.15 kilograms (kg)
Standard Deviation 1.093
|
Adverse Events
Atomoxetine 0.00-0.35 mg/kg/Day
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Atomoxetine 0.36-0.85 mg/kg/Day
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Atomoxetine >0.85 mg/kg/Day
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Atomoxetine 0.00-0.35 mg/kg/Day
n=51 participants at risk
Patients who received the actual dose range listed.
|
Atomoxetine 0.36-0.85 mg/kg/Day
n=54 participants at risk
Patients who received the actual dose range listed.
|
Atomoxetine >0.85 mg/kg/Day
n=48 participants at risk
Patients who received the actual dose range listed.
|
|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/51
The participant flow module encompasses the 'intention-to-treat' population. All safety data is reported with 'as-treated' population.
|
1.9%
1/54 • Number of events 1
The participant flow module encompasses the 'intention-to-treat' population. All safety data is reported with 'as-treated' population.
|
0.00%
0/48
The participant flow module encompasses the 'intention-to-treat' population. All safety data is reported with 'as-treated' population.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/51
The participant flow module encompasses the 'intention-to-treat' population. All safety data is reported with 'as-treated' population.
|
0.00%
0/54
The participant flow module encompasses the 'intention-to-treat' population. All safety data is reported with 'as-treated' population.
|
2.1%
1/48 • Number of events 1
The participant flow module encompasses the 'intention-to-treat' population. All safety data is reported with 'as-treated' population.
|
Other adverse events
| Measure |
Atomoxetine 0.00-0.35 mg/kg/Day
n=51 participants at risk
Patients who received the actual dose range listed.
|
Atomoxetine 0.36-0.85 mg/kg/Day
n=54 participants at risk
Patients who received the actual dose range listed.
|
Atomoxetine >0.85 mg/kg/Day
n=48 participants at risk
Patients who received the actual dose range listed.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/51
The participant flow module encompasses the 'intention-to-treat' population. All safety data is reported with 'as-treated' population.
|
9.3%
5/54 • Number of events 5
The participant flow module encompasses the 'intention-to-treat' population. All safety data is reported with 'as-treated' population.
|
8.3%
4/48 • Number of events 5
The participant flow module encompasses the 'intention-to-treat' population. All safety data is reported with 'as-treated' population.
|
|
Gastrointestinal disorders
Nausea
|
3.9%
2/51 • Number of events 2
The participant flow module encompasses the 'intention-to-treat' population. All safety data is reported with 'as-treated' population.
|
5.6%
3/54 • Number of events 3
The participant flow module encompasses the 'intention-to-treat' population. All safety data is reported with 'as-treated' population.
|
4.2%
2/48 • Number of events 2
The participant flow module encompasses the 'intention-to-treat' population. All safety data is reported with 'as-treated' population.
|
|
General disorders
Irritability
|
3.9%
2/51 • Number of events 2
The participant flow module encompasses the 'intention-to-treat' population. All safety data is reported with 'as-treated' population.
|
3.7%
2/54 • Number of events 2
The participant flow module encompasses the 'intention-to-treat' population. All safety data is reported with 'as-treated' population.
|
8.3%
4/48 • Number of events 5
The participant flow module encompasses the 'intention-to-treat' population. All safety data is reported with 'as-treated' population.
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
3/51 • Number of events 3
The participant flow module encompasses the 'intention-to-treat' population. All safety data is reported with 'as-treated' population.
|
7.4%
4/54 • Number of events 4
The participant flow module encompasses the 'intention-to-treat' population. All safety data is reported with 'as-treated' population.
|
4.2%
2/48 • Number of events 2
The participant flow module encompasses the 'intention-to-treat' population. All safety data is reported with 'as-treated' population.
|
|
Metabolism and nutrition disorders
Anorexia
|
3.9%
2/51 • Number of events 2
The participant flow module encompasses the 'intention-to-treat' population. All safety data is reported with 'as-treated' population.
|
3.7%
2/54 • Number of events 2
The participant flow module encompasses the 'intention-to-treat' population. All safety data is reported with 'as-treated' population.
|
12.5%
6/48 • Number of events 6
The participant flow module encompasses the 'intention-to-treat' population. All safety data is reported with 'as-treated' population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.0%
1/51 • Number of events 1
The participant flow module encompasses the 'intention-to-treat' population. All safety data is reported with 'as-treated' population.
|
7.4%
4/54 • Number of events 4
The participant flow module encompasses the 'intention-to-treat' population. All safety data is reported with 'as-treated' population.
|
12.5%
6/48 • Number of events 8
The participant flow module encompasses the 'intention-to-treat' population. All safety data is reported with 'as-treated' population.
|
|
Nervous system disorders
Dizziness
|
2.0%
1/51 • Number of events 1
The participant flow module encompasses the 'intention-to-treat' population. All safety data is reported with 'as-treated' population.
|
5.6%
3/54 • Number of events 3
The participant flow module encompasses the 'intention-to-treat' population. All safety data is reported with 'as-treated' population.
|
0.00%
0/48
The participant flow module encompasses the 'intention-to-treat' population. All safety data is reported with 'as-treated' population.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/51
The participant flow module encompasses the 'intention-to-treat' population. All safety data is reported with 'as-treated' population.
|
1.9%
1/54 • Number of events 1
The participant flow module encompasses the 'intention-to-treat' population. All safety data is reported with 'as-treated' population.
|
8.3%
4/48 • Number of events 4
The participant flow module encompasses the 'intention-to-treat' population. All safety data is reported with 'as-treated' population.
|
|
Psychiatric disorders
Sleep disorder
|
7.8%
4/51 • Number of events 4
The participant flow module encompasses the 'intention-to-treat' population. All safety data is reported with 'as-treated' population.
|
0.00%
0/54
The participant flow module encompasses the 'intention-to-treat' population. All safety data is reported with 'as-treated' population.
|
2.1%
1/48 • Number of events 1
The participant flow module encompasses the 'intention-to-treat' population. All safety data is reported with 'as-treated' population.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 1-800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60