Trial Outcomes & Findings for Long-Term, Open Label Atomoxetine Study (NCT NCT00190684)
NCT ID: NCT00190684
Last Updated: 2011-01-17
Results Overview
Vital signs were assesed categorically using the term high for BP, high and low for pulse and temperature, or decreased for weight. For BP, high was an increase to a value above the 95th percentile of the National Institute of Health (NIH) values. For pulse, high was an increase of at least 25 beats per minute to at least 110, and low was a decrease of at least 20 beats per minute to at most 65 beats per minute. For temperature, high was an increase of at least 1 to 37.7 and low was a decrease of at least 1.3 to at most 35.6. Decrease in weight was marked by a reduction of at least 3.5%.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1553 participants
Primary outcome timeframe
Baseline through 5 years
Results posted on
2011-01-17
Participant Flow
Participant milestones
| Measure |
Atomoxetine
Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
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|---|---|
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Overall Study
STARTED
|
1553
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
1551
|
|
Overall Study
COMPLETED
|
64
|
|
Overall Study
NOT COMPLETED
|
1489
|
Reasons for withdrawal
| Measure |
Atomoxetine
Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
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|---|---|
|
Overall Study
Adverse Event
|
86
|
|
Overall Study
Satisfactory response
|
80
|
|
Overall Study
Lack of efficacy
|
204
|
|
Overall Study
Lost to Follow-up
|
232
|
|
Overall Study
Patient moved
|
60
|
|
Overall Study
Patient Decision
|
432
|
|
Overall Study
Clinical relapse
|
67
|
|
Overall Study
Sponsor's decision
|
17
|
|
Overall Study
Physician Decision
|
84
|
|
Overall Study
Protocol Violation
|
123
|
|
Overall Study
Study Period III Completed
|
103
|
|
Overall Study
Study Period V Completed
|
1
|
Baseline Characteristics
Long-Term, Open Label Atomoxetine Study
Baseline characteristics by cohort
| Measure |
Atomoxetine
n=1553 Participants
Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
|
|---|---|
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Age Continuous
|
11.62 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
338 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1215 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
1317 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African Descent
|
98 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
East/ Southeast Asian
|
9 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Western Asian
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
76 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
52 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1288 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
16 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
11 participants
n=5 Participants
|
|
Region of Enrollment
France
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
22 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
27 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
23 participants
n=5 Participants
|
|
Height
|
147.89 centimeters (cm)
STANDARD_DEVIATION 15.72 • n=5 Participants
|
|
Weight
|
43.73 kilograms (kg)
STANDARD_DEVIATION 16.03 • n=5 Participants
|
|
Attention Deficit Hyperactive Disorder (ADHD) Subtype
Inattentive
|
413 participants
n=5 Participants
|
|
Attention Deficit Hyperactive Disorder (ADHD) Subtype
Hyperactive/Impulsive
|
46 participants
n=5 Participants
|
|
Attention Deficit Hyperactive Disorder (ADHD) Subtype
Combined
|
1016 participants
n=5 Participants
|
|
Attention Deficit Hyperactive Disorder (ADHD) Subtype
Not Applicable
|
72 participants
n=5 Participants
|
|
Attention Deficit Hyperactive Disorder (ADHD) Subtype
Unknown
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through 5 yearsPopulation: For each vital sign, the number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug. Number of subject analyzed for each vital sign is provided.
Vital signs were assesed categorically using the term high for BP, high and low for pulse and temperature, or decreased for weight. For BP, high was an increase to a value above the 95th percentile of the National Institute of Health (NIH) values. For pulse, high was an increase of at least 25 beats per minute to at least 110, and low was a decrease of at least 20 beats per minute to at most 65 beats per minute. For temperature, high was an increase of at least 1 to 37.7 and low was a decrease of at least 1.3 to at most 35.6. Decrease in weight was marked by a reduction of at least 3.5%.
Outcome measures
| Measure |
Atomoxetine
n=1528 Participants
Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
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|---|---|
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Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study
Systolic BP High (N=1431)
|
228 participants
|
|
Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study
Diastolic BP High (N=1458)
|
92 participants
|
|
Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study
Pulse High (N=1528)
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19 participants
|
|
Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study
Pulse Low (N=1528)
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39 participants
|
|
Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study
Temperature High (N=1525)
|
7 participants
|
|
Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study
Temperature Low (N=1525)
|
9 participants
|
|
Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study
Weight Decrease (N=1526)
|
61 participants
|
PRIMARY outcome
Timeframe: baseline, 5 yearsPopulation: The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.
Outcome measures
| Measure |
Atomoxetine
n=1528 Participants
Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
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|---|---|
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Change From Baseline to 5 Year Endpoint in BP
Systolic BP
|
4.7 millimeters of Mercury (mmHg)
Standard Deviation 11.56
|
|
Change From Baseline to 5 Year Endpoint in BP
Diastolic BP
|
1.3 millimeters of Mercury (mmHg)
Standard Deviation 9.04
|
PRIMARY outcome
Timeframe: baseline, 5 yearsPopulation: The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.
Outcome measures
| Measure |
Atomoxetine
n=1528 Participants
Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
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|---|---|
|
Change From Baseline to 5 Year Endpoint in Pulse
|
-1.5 beats per minute (bpm)
Standard Deviation 13.83
|
PRIMARY outcome
Timeframe: baseline, 5 yearsPopulation: The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.
Outcome measures
| Measure |
Atomoxetine
n=1526 Participants
Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
|
|---|---|
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Change From Baseline to 5 Year Endpoint in Body Weight
|
11.0 kilograms (kg)
Standard Deviation 11.66
|
PRIMARY outcome
Timeframe: baseline, 5 yearsPopulation: The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.
Outcome measures
| Measure |
Atomoxetine
n=1476 Participants
Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
|
|---|---|
|
Change From Baseline to 5 Year Endpoint in Height
|
10.9 centimeters (cm)
Standard Deviation 10.41
|
PRIMARY outcome
Timeframe: baseline, 5 yearsPopulation: The number of participants analyzed was defined as all patients with a baseline and 5 year endpoint measurement.
Patients were assessed for changes in weight, height, and BMI. BMI is an estimate of body fat based on body weight divided by height squared.
Outcome measures
| Measure |
Atomoxetine
n=251 Participants
Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
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|---|---|
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Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile
BMI (75th to 100th percentile) (N=101)
|
-7.94 percentiles
Standard Deviation 18.41
|
|
Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile
Weight (0 to 25th percentile) (N=46)
|
18.93 percentiles
Standard Deviation 9.26
|
|
Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile
Weight (25th to 50th percentile) (N=58)
|
14.90 percentiles
Standard Deviation 22.31
|
|
Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile
Weight (50th to 75th percentile) (N=50)
|
-1.33 percentiles
Standard Deviation 20.21
|
|
Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile
Weight (75th to 100th percentile) (N=97)
|
-6.68 percentiles
Standard Deviation 15.50
|
|
Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile
Height (0 to 25th percentile) (N=64)
|
12.06 percentiles
Standard Deviation 21.00
|
|
Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile
Height (25th tp 50th percentile) (N=61)
|
9.53 percentiles
Standard Deviation 21.76
|
|
Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile
Height (50th to 75th percentile) (N=55)
|
-6.28 percentiles
Standard Deviation 22.55
|
|
Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile
Height (75th to 100th percentile) (N=65)
|
-10.92 percentiles
Standard Deviation 20.31
|
|
Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile
BMI (0 to 25th percentile) (N=34)
|
18.71 percentiles
Standard Deviation 24.76
|
|
Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile
BMI (25th to 50th percentile) (N=53)
|
8.52 percentiles
Standard Deviation 28.11
|
|
Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile
BMI (50th to 75th percentile) (N=55)
|
-3.26 percentiles
Standard Deviation 25.69
|
PRIMARY outcome
Timeframe: baseline, 5 yearsPopulation: The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.
Patients were assessed for changes in ECG. The RR interval is the time duration between two consecutive R waves of the ECG. The QRS interval is the beginning of Q to the end of the S wave. The QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate. A corrected QT interval (QTc) has been corrected in order to aid interpretation. QTbz is the QT interval using Bazett's correction formula. QTfr is the QT interval using Fridericia's correction formula.QTdat is the QT interval using a data specific correction method for children.
Outcome measures
| Measure |
Atomoxetine
n=1482 Participants
Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
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|---|---|
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Change From Baseline to 5 Year Endpoint in Electrocardiogram (ECG)
RR Interval
|
27.2 milliseconds (msec)
Standard Deviation 138.78
|
|
Change From Baseline to 5 Year Endpoint in Electrocardiogram (ECG)
QRS Interval
|
2.6 milliseconds (msec)
Standard Deviation 7.19
|
|
Change From Baseline to 5 Year Endpoint in Electrocardiogram (ECG)
QT Bazett (bz) Correction
|
-1.7 milliseconds (msec)
Standard Deviation 17.85
|
|
Change From Baseline to 5 Year Endpoint in Electrocardiogram (ECG)
QT Data (dat) Correction
|
-0.2 milliseconds (msec)
Standard Deviation 15.43
|
|
Change From Baseline to 5 Year Endpoint in Electrocardiogram (ECG)
QT Fridericia (fr) Correction
|
0.5 milliseconds (msec)
Standard Deviation 15.71
|
PRIMARY outcome
Timeframe: baseline, 5 yearsPopulation: The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.
Patients were assessed for changes in heart rate using electrocardiogram.
Outcome measures
| Measure |
Atomoxetine
n=1482 Participants
Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
|
|---|---|
|
Change From Baseline to 5 Year Endpoint in Heart Rate
|
-2.5 beats per minute (bpm)
Standard Deviation 14.45
|
PRIMARY outcome
Timeframe: baseline through 5 yearsPopulation: The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.
QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate. A corrected QT interval (QTc) has been corrected in order to aid interpretation. QTbz is the QT interval using Bazett's correction formula. QTfr is the QT interval using Fridericia's correction formula. QTdat is the QT interval using a data specific correction method for children.
Outcome measures
| Measure |
Atomoxetine
n=1482 Participants
Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
|
|---|---|
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Number of Patients Meeting Committee for Proprietary Medicinal Products (CPMP) Categorical QTc Interval Criteria Part I (Numerical Increase)
QTc (bz) Increase of at least 30 milliseconds (ms)
|
68 participants
|
|
Number of Patients Meeting Committee for Proprietary Medicinal Products (CPMP) Categorical QTc Interval Criteria Part I (Numerical Increase)
QTc (bz) Increase of at least 60 ms
|
2 participants
|
|
Number of Patients Meeting Committee for Proprietary Medicinal Products (CPMP) Categorical QTc Interval Criteria Part I (Numerical Increase)
QTc (bz) Increase to values >500 ms
|
0 participants
|
|
Number of Patients Meeting Committee for Proprietary Medicinal Products (CPMP) Categorical QTc Interval Criteria Part I (Numerical Increase)
QTc (dat) Increase of at least 30 ms
|
50 participants
|
|
Number of Patients Meeting Committee for Proprietary Medicinal Products (CPMP) Categorical QTc Interval Criteria Part I (Numerical Increase)
QTc (dat) Increase of at least 60 ms
|
2 participants
|
|
Number of Patients Meeting Committee for Proprietary Medicinal Products (CPMP) Categorical QTc Interval Criteria Part I (Numerical Increase)
QTc (dat) Increase to values >500 ms
|
0 participants
|
|
Number of Patients Meeting Committee for Proprietary Medicinal Products (CPMP) Categorical QTc Interval Criteria Part I (Numerical Increase)
QTc (fr) Increase of at least 30 ms
|
56 participants
|
|
Number of Patients Meeting Committee for Proprietary Medicinal Products (CPMP) Categorical QTc Interval Criteria Part I (Numerical Increase)
QTc (fr) Increase of at least 60 ms
|
2 participants
|
|
Number of Patients Meeting Committee for Proprietary Medicinal Products (CPMP) Categorical QTc Interval Criteria Part I (Numerical Increase)
QTc (fr) Increase to values >500 ms
|
0 participants
|
PRIMARY outcome
Timeframe: baseline through 5 yearsPopulation: The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.
QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate. A corrected QT interval (QTc) has been corrected in order to aid interpretation. QTbz is the QT interval using Bazett's correction formula. QTfr is the QT interval using Fridericia's correction formula. QTdat is the QT interval using a data specific correction method for children. For Males: Normal is \<430 ms, Borderline is \>=430 ms and \<450 ms, Prolonged is \>=450 ms. For Females: Normal is \<450 ms, Borderline is \>=450 ms and \<470 ms, Prolonged is \>=470 ms.
Outcome measures
| Measure |
Atomoxetine
n=1482 Participants
Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
|
|---|---|
|
Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)
QTc (bz) Normal Baseline/Normal Endpoint
|
1069 participants
|
|
Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)
QTc (bz) Normal Baseline/Borderline Endpoint
|
156 participants
|
|
Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)
QTc (bz) Normal Baseline/Prolonged Endpoint
|
11 participants
|
|
Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)
QTc (bz) Borderline Baseline/Normal Endpoint
|
180 participants
|
|
Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)
QTc (bz) Borderline Baseline/Borderline Endpoint
|
49 participants
|
|
Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)
QTc (bz) Borderline Baseline/Prolonged Endpoint
|
6 participants
|
|
Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)
QTc (bz) Prolonged Baseline/Normal Endpoint
|
6 participants
|
|
Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)
QTc (bz) Prolonged Baseline/Borderline Endpoint
|
5 participants
|
|
Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)
QTc (bz) Prolonged Baseline/Prolonged Endpoint
|
0 participants
|
|
Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)
QTc (dat) Normal Baseline/Normal Endpoint
|
1433 participants
|
|
Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)
QTc (dat) Normal Baseline/Borderline Endpoint
|
26 participants
|
|
Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)
QTc (dat) Normal Baseline/Prolonged Endpoint
|
1 participants
|
|
Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)
QTc (dat) Borderline Baseline/Normal Endpoint
|
16 participants
|
|
Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)
QTc (dat) Borderline Baseline/Borderline Endpoint
|
3 participants
|
|
Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)
QTc (dat) Borderline Baseline/Prolonged Endpoint
|
1 participants
|
|
Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)
QTc (dat) Prolonged Baseline/Normal Endpoint
|
2 participants
|
|
Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)
QTc (dat) Prolonged Baseline/Borderline Endpoint
|
0 participants
|
|
Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)
QTc (dat) Prolonged Baseline/Prolonged Endpoint
|
0 participants
|
|
Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)
QTc (fr) Normal Baseline/Normal Endpoint
|
1454 participants
|
|
Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)
QTc (fr) Normal Baseline/Borderline Endpoint
|
16 participants
|
|
Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)
QTc (fr) Normal Baseline/Prolonged Endpoint
|
2 participants
|
|
Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)
QTc (fr) Borderline Baseline/Normal Endpoint
|
7 participants
|
|
Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)
QTc (fr) Borderline Baseline/Borderline Endpoint
|
0 participants
|
|
Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)
QTc (fr) Borderline Baseline/Prolonged Endpoint
|
1 participants
|
|
Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)
QTc (fr) Prolonged Baseline/Normal Endpoint
|
2 participants
|
|
Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)
QTc (fr) Prolonged Baseline/Borderline Endpoint
|
0 participants
|
|
Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)
QTc (fr) Prolonged Baseline/Prolonged Endpoint
|
0 participants
|
PRIMARY outcome
Timeframe: baseline through 5 yearsPopulation: The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.
Standard reference ranges from Covance Laboratories were used in the determination of abnormal high and low values based on age and gender, where appropriate. Aspartate aminotransferase (AST); serum glutamic oxaloacetic transaminase (SGOT); units/liter (U/L); alanine aminotransferase (ALT); serum glutamic pyruvic transaminase (SGPT); millimoles/liter (mmol/L); grams/liter (g/L); micromoles/liter (umol/L); millimoles/liter-iron (mmol/L-Fe); trillion/liter (TI/L)or 10\^12 units/liter; Giga/liter (GI/L)or 10\^9 units/liter; femtoliters (fL); urinalysis (UA)
Outcome measures
| Measure |
Atomoxetine
n=1487 Participants
Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
|
|---|---|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Glucose, Non-Fasting/Random (mmol/L) High (N=1486)
|
1 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
AST/SGOT (U/L) Low (N=1484)
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
AST/SGOT (U/L) High (N=1484)
|
27 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
ALT/SGPT (U/L) Low (N=1486)
|
2 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
ALT/SGPT (U/L) High (N=1486)
|
38 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Creatine Phosphokinase (U/L) Low (N=1485)
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Creatine Phosphokinase (U/L) High (N=1485)
|
57 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Alkaline Phosphatase (U/L) Low (N=1486)
|
67 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Alkaline Phosphatase (U/L) High (N=1486)
|
83 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Gamma Glutamyltransferase (U/L) Low (N=1486)
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Gamma Glutamyltransferase (U/L) High (N=1486)
|
17 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Urea Nitrogen (mmol/L) Low (N=1487)
|
1 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Urea Nitrogen (mmol/L) High (N=1487)
|
2 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Calcium (mmol/L) Low (N=1487)
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Calcium (mmol/L) High (N=1487)
|
117 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Inorganic Phosphorus (mmol/L) Low (N=1485)
|
10 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Inorganic Phosphorus (mmol/L) High (N=1485)
|
31 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Total Protein (g/L) Low (N=1487)
|
2 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Total Protein (g/L) High (N=1487)
|
5 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Albumin (g/L) Low (N=1487)
|
1 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Albumin (g/L) High (N=1487)
|
113 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Glucose, Non-Fasting/Random (mmol/L) Low (N=1486)
|
20 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Uric Acid (umol/L) Low (N=1487)
|
6 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Uric Acid (umol/L) High (N=1487)
|
130 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Cholesterol (mmol/L) Low (N=1487)
|
87 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Cholesterol (mmol/L) High (N=1487)
|
72 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Creatinine (umol/L) Low (N=1487)
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Creatinine (umol/L) High (N=1487)
|
285 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Total Bilirubin (umol/L) Low (N=1458)
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Total Bilirubin (umol/L) High (N=1458)
|
38 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Hematocrit (1) Low (N=1482)
|
24 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Hematocrit (1) High (N=1482)
|
85 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Hemoglobin (mmL/L-Fe) Low (N=1482)
|
14 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Hemoglobin (mmL/L-Fe) High (N=1482)
|
30 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Erythrocyte Count (TI/L) Low (N=1482)
|
8 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Erythrocyte Count (TI/L) High (N=1482)
|
3 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Leukocyte Count (GI/L) Low (N=1482)
|
63 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Leukocyte Count (GI/L) High (N=1482)
|
8 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Bands (GI/L) Low (N=1482)
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Bands (GI/L) High (N=1482)
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Neutrophils, Segmented (GI/L) Low (N=1482)
|
20 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Neutrophils, Segmented (GI/L) High (N=1482)
|
23 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Lymphocytes (GI/L) Low (N=1482)
|
6 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Lymphocytes (GI/L) High (N=1482)
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Monocytes (GI/L) Low (N=1482)
|
62 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Monocytes (GI/L) High (N=1482)
|
12 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Eosinophils (GI/L) Low (N=1482)
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Eosinophils (GI/L) High (N=1482)
|
54 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Basophils (GI/L) Low (N=1482)
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Basophils (GI/L) High (N=1482)
|
3 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Mean Cell Volume (fL) Low (N=1482)
|
26 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Mean Cell Volume (fL) High (N=1482)
|
10 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Platelet Count (GI/L) Low (N=1479)
|
1 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Platelet Count (GI/L) High (N=1479)
|
63 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Sodium (mmol/L) Low (N=1486)
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Sodium (mmol/L) High (N=1486)
|
2 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Potassium (mmol/L) Low (N=1484)
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Potassium (mmol/L) High (N=1484)
|
8 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Chloride (mmol/L) Low (N=1486)
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Chloride (mmol/L) High (N=1486)
|
2 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Bicarbonate (mmol/L) Low (N=1486)
|
7 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Bicarbonate (mmol/L) High (N=1486)
|
6 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
UA-Specific Gravity (no units) Low (N=1486)
|
39 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
UA-Specific Gravity (no units) High (N=1486)
|
73 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Lymphocytes, Atypical (GI/L) Low (N=52)
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Analytes During the Study
Lymphocytes, Atypical (GI/L) High (N=52)
|
52 participants
|
PRIMARY outcome
Timeframe: 1 year through 5 yearsPopulation: The analysis population is defined as patients with at least two Tanner measurements.
Tanner Stage: I: no pubic hair at all (prepubertal Dominic state) II: small amount of long, downy hair with slight pigmentation at the base of the penis and scrotum (males) or on the labia majora (females) III: hair becomes more coarse and curly, and begins to extend laterally IV: adult-like hair quality, extending across pubis but sparing medial thighs V: hair extends to medial surface of the thighs Age Groups: 1. age\<11.0 (female) and age\<12 (male) 2. 11=\<age\<12 (female) or 12\<=age\<13 (male) 3. 12=\<age\<15 (female) or 13=\<age\<15 (male) 4. age\>=15 (female and male)
Outcome measures
| Measure |
Atomoxetine
n=93 Participants
Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
|
|---|---|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
First Tanner, Age Group 1, Tanner I (N=7)
|
2 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
First Tanner, Age Group 1, Tanner II (N=7)
|
2 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
First Tanner, Age Group 1, Tanner III (N=7)
|
2 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
First Tanner, Age Group 1, Tanner IV (N=7)
|
1 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
First Tanner, Age Group 1, Tanner V (N=7)
|
0 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
First Tanner, Age Group 2, Tanner I (N=14)
|
4 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
First Tanner, Age Group 2, Tanner II (N=14)
|
6 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
First Tanner, Age Group 2, Tanner III (N=14)
|
2 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
First Tanner, Age Group 2, Tanner IV (N=14)
|
2 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
First Tanner, Age Group 2, Tanner V (N=14)
|
0 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
First Tanner, Age Group 3, Tanner I (N=37)
|
0 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
First Tanner, Age Group 3, Tanner II (N=37)
|
2 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
First Tanner, Age Group 3, Tanner III (N=37)
|
13 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
First Tanner, Age Group 3, Tanner IV (N=37)
|
15 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
First Tanner, Age Group 3, Tanner V (N=37)
|
7 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
First Tanner, Age Group 4, Tanner I (N=35)
|
0 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
First Tanner, Age Group 4, Tanner II (N=35)
|
0 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
First Tanner, Age Group 4, Tanner III (N=35)
|
2 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
First Tanner, Age Group 4, Tanner IV (N=35)
|
11 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
First Tanner, Age Group 4, Tanner V (N=35)
|
22 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
Endpoint Tanner, Age Group 1, Tanner I (N=2)
|
1 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
Endpoint Tanner, Age Group 1, Tanner II (N=2)
|
1 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
Endpoint Tanner, Age Group 1, Tanner III (N=2)
|
0 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
Endpoint Tanner, Age Group 1, Tanner IV (N=2)
|
0 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
Endpoint Tanner, Age Group 1, Tanner V (N=2)
|
0 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
Endpoint Tanner, Age Group 2, Tanner I (N=4)
|
0 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
Endpoint Tanner, Age Group 2, Tanner II (N=4)
|
1 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
Endpoint Tanner, Age Group 2, Tanner III (N=4)
|
2 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
Endpoint Tanner, Age Group 2, Tanner IV (N=4)
|
1 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
Endpoint Tanner, Age Group 2, Tanner V (N=4)
|
0 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
Endpoint Tanner, Age Group 3, Tanner I (N=32)
|
0 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
Endpoint Tanner, Age Group 3, Tanner II (N=32)
|
5 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
Endpoint Tanner, Age Group 3, Tanner III (N=32)
|
8 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
Endpoint Tanner, Age Group 3, Tanner IV (N=32)
|
14 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
Endpoint Tanner, Age Group 3, Tanner V (N=32)
|
5 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
Endpoint Tanner, Age Group 4, Tanner I (N=55)
|
0 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
Endpoint Tanner, Age Group 4, Tanner II (N=55)
|
0 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
Endpoint Tanner, Age Group 4, Tanner III (N=55)
|
3 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
Endpoint Tanner, Age Group 4, Tanner IV (N=55)
|
19 participants
|
|
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
Endpoint Tanner, Age Group 4, Tanner V (N=55)
|
33 participants
|
SECONDARY outcome
Timeframe: baseline, 5 yearsPopulation: The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.
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. Hyperactive/Impulsive and Inattention Subscales consisted of 9 items each, for total subscale score range of 0 to 27. ADHD Index Subscale consisted of 12 items, for total score range of 0 to 36.
Outcome measures
| Measure |
Atomoxetine
n=1135 Participants
Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
|
|---|---|
|
Change From Baseline to 5 Year Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score and Subscale Scores
Total Score
|
3.5 units on a scale
Standard Deviation 9.62
|
|
Change From Baseline to 5 Year Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score and Subscale Scores
Inattentive Subscale Score
|
2.6 units on a scale
Standard Deviation 6.00
|
|
Change From Baseline to 5 Year Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score and Subscale Scores
Hyperactive Subscale Score
|
0.9 units on a scale
Standard Deviation 4.73
|
SECONDARY outcome
Timeframe: baseline, 5 yearsPopulation: The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.
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
n=1136 Participants
Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
|
|---|---|
|
Change From Baseline to 5 Year Endpoint in Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S) Score
|
0.523 units on a scale
Standard Deviation 1.149
|
SECONDARY outcome
Timeframe: baseline, 5 yearsPopulation: The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.
A 27-item rating scale (0 \[not at all/never\] to 3 \[very much true/very often\]) completed by the parent to assess problem behaviors related to ADHD. Subscales: Oppositional, Cognitive Problems, Hyperactivity, and ADHD Index. Subscale total scores range from 0 to 18 for all subscales except ADHD Index which ranges from 0 to 36.
Outcome measures
| Measure |
Atomoxetine
n=1059 Participants
Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
|
|---|---|
|
Change From Baseline to 5 Year Endpoint in Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Subscale Scores
CPRS ADHD Index Subscale (n=1056)
|
2.411 units on a scale
Standard Deviation 7.785
|
|
Change From Baseline to 5 Year Endpoint in Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Subscale Scores
CPRS Cognitive Subscale (n=1056)
|
1.500 units on a scale
Standard Deviation 4.777
|
|
Change From Baseline to 5 Year Endpoint in Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Subscale Scores
CPRS Hyperactive Subscale (n=1057)
|
0.325 units on a scale
Standard Deviation 3.287
|
|
Change From Baseline to 5 Year Endpoint in Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Subscale Scores
CPRS Oppositional Subscale (n=1059)
|
1.357 units on a scale
Standard Deviation 4.287
|
SECONDARY outcome
Timeframe: baseline, 5 yearsPopulation: There were not enough participants with prior Stroop Word Color tests to analyze the data.
Only patients who took the Stroop Color Word Test in a previous atomoxetine study were required to complete the Stroop in this study. Stroop measures inhibition of dominant response and interference control. Patients were given tasks of recognition (colors), reading (where a word represents a color), and interference (reading words written in different colors). There were 100 items for each of the three categories and if they made it through 100 words with time remaining, they would repeat the list. Only a small number of patients had Stroop tests in this study, so no analysis was done.
Outcome measures
Outcome data not reported
Adverse Events
Atomoxetine
Serious events: 92 serious events
Other events: 1372 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Atomoxetine
n=1551 participants at risk
Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.06%
1/1551 • Number of events 1
|
|
Cardiac disorders
Pericarditis
|
0.06%
1/1551 • Number of events 1
|
|
Cardiac disorders
Wolff-Parkinson-White syndrome
|
0.06%
1/1551 • Number of events 1
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.06%
1/1551 • Number of events 1
|
|
Endocrine disorders
Hyperthyroidism
|
0.06%
1/1551 • Number of events 1
|
|
Eye disorders
Visual disturbance
|
0.06%
1/1551 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.19%
3/1551 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.06%
1/1551 • Number of events 1
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.06%
1/1551 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.06%
1/1551 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.06%
1/1551 • Number of events 1
|
|
General disorders
Pain
|
0.06%
1/1551 • Number of events 1
|
|
General disorders
Pyrexia
|
0.06%
1/1551 • Number of events 1
|
|
Infections and infestations
Appendicitis
|
0.64%
10/1551 • Number of events 10
|
|
Infections and infestations
Campylobacter infection
|
0.06%
1/1551 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.06%
1/1551 • Number of events 1
|
|
Infections and infestations
Dengue fever
|
0.06%
1/1551 • Number of events 1
|
|
Infections and infestations
Enterocolitis infectious
|
0.06%
1/1551 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.19%
3/1551 • Number of events 4
|
|
Infections and infestations
Gastroenteritis viral
|
0.06%
1/1551 • Number of events 1
|
|
Infections and infestations
Meningitis viral
|
0.06%
1/1551 • Number of events 1
|
|
Infections and infestations
Oral candidiasis
|
0.06%
1/1551 • Number of events 1
|
|
Infections and infestations
Osteomyelitis
|
0.06%
1/1551 • Number of events 1
|
|
Infections and infestations
Otitis media
|
0.06%
1/1551 • Number of events 1
|
|
Infections and infestations
Perianal abscess
|
0.06%
1/1551 • Number of events 1
|
|
Infections and infestations
Periorbital cellulitis
|
0.06%
1/1551 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.26%
4/1551 • Number of events 5
|
|
Infections and infestations
Sinusitis
|
0.13%
2/1551 • Number of events 2
|
|
Infections and infestations
Staphylococcal infection
|
0.06%
1/1551 • Number of events 1
|
|
Infections and infestations
Viral infection
|
0.13%
2/1551 • Number of events 3
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.06%
1/1551 • Number of events 1
|
|
Injury, poisoning and procedural complications
Burns first degree
|
0.06%
1/1551 • Number of events 1
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.06%
1/1551 • Number of events 1
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.06%
1/1551 • Number of events 1
|
|
Injury, poisoning and procedural complications
Concussion
|
0.26%
4/1551 • Number of events 4
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.06%
1/1551 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.13%
2/1551 • Number of events 2
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.13%
2/1551 • Number of events 2
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.06%
1/1551 • Number of events 1
|
|
Injury, poisoning and procedural complications
Head injury
|
0.06%
1/1551 • Number of events 1
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.06%
1/1551 • Number of events 1
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.06%
1/1551 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.06%
1/1551 • Number of events 1
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.06%
1/1551 • Number of events 1
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.06%
1/1551 • Number of events 1
|
|
Injury, poisoning and procedural complications
Overdose
|
0.06%
1/1551 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post concussion syndrome
|
0.06%
1/1551 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.06%
1/1551 • Number of events 1
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.26%
4/1551 • Number of events 4
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.06%
1/1551 • Number of events 1
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.13%
2/1551 • Number of events 2
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.06%
1/1551 • Number of events 1
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.13%
2/1551 • Number of events 2
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.13%
2/1551 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
0.06%
1/1551 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
0.06%
1/1551 • Number of events 1
|
|
Investigations
Blood glucose decreased
|
0.06%
1/1551 • Number of events 1
|
|
Investigations
Blood glucose increased
|
0.06%
1/1551 • Number of events 5
|
|
Investigations
Blood pressure decreased
|
0.06%
1/1551 • Number of events 1
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.06%
1/1551 • Number of events 1
|
|
Investigations
Weight decreased
|
0.13%
2/1551 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
0.19%
3/1551 • Number of events 3
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.06%
1/1551 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.06%
1/1551 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.06%
1/1551 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.06%
1/1551 • Number of events 1
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.06%
1/1551 • Number of events 10
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.13%
2/1551 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Bone cyst
|
0.06%
1/1551 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.06%
1/1551 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Retrognathia
|
0.06%
1/1551 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioma
|
0.06%
1/1551 • Number of events 1
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.06%
1/1551 • Number of events 1
|
|
Nervous system disorders
Complex partial seizures
|
0.06%
1/1551 • Number of events 1
|
|
Nervous system disorders
Depressed level of consciousness
|
0.06%
1/1551 • Number of events 1
|
|
Nervous system disorders
Migraine
|
0.13%
2/1551 • Number of events 2
|
|
Nervous system disorders
Migraine with aura
|
0.06%
1/1551 • Number of events 1
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.06%
1/1551 • Number of events 1
|
|
Psychiatric disorders
Affect lability
|
0.06%
1/1551 • Number of events 1
|
|
Psychiatric disorders
Aggression
|
0.19%
3/1551 • Number of events 5
|
|
Psychiatric disorders
Agitation
|
0.06%
1/1551 • Number of events 1
|
|
Psychiatric disorders
Conduct disorder
|
0.06%
1/1551 • Number of events 1
|
|
Psychiatric disorders
Confusional state
|
0.06%
1/1551 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.32%
5/1551 • Number of events 5
|
|
Psychiatric disorders
Impulsive behaviour
|
0.06%
1/1551 • Number of events 1
|
|
Psychiatric disorders
Major depression
|
0.13%
2/1551 • Number of events 2
|
|
Psychiatric disorders
Mental status changes
|
0.06%
1/1551 • Number of events 1
|
|
Psychiatric disorders
Mood altered
|
0.06%
1/1551 • Number of events 1
|
|
Psychiatric disorders
Negativism
|
0.06%
1/1551 • Number of events 1
|
|
Psychiatric disorders
Oppositional defiant disorder
|
0.06%
1/1551 • Number of events 2
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.06%
1/1551 • Number of events 1
|
|
Psychiatric disorders
Psychotic disorder
|
0.06%
1/1551 • Number of events 1
|
|
Psychiatric disorders
Pyromania
|
0.06%
1/1551 • Number of events 1
|
|
Psychiatric disorders
Substance abuse
|
0.06%
1/1551 • Number of events 1
|
|
Psychiatric disorders
Suicidal behaviour
|
0.06%
1/1551 • Number of events 1
|
|
Psychiatric disorders
Suicidal ideation
|
0.58%
9/1551 • Number of events 9
|
|
Psychiatric disorders
Suicide attempt
|
0.13%
2/1551 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.13%
2/1551 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.06%
1/1551 • Number of events 1
|
|
Surgical and medical procedures
Facial operation
|
0.06%
1/1551 • Number of events 1
|
|
Surgical and medical procedures
Nasal septal operation
|
0.06%
1/1551 • Number of events 1
|
|
Vascular disorders
Haematoma
|
0.06%
1/1551 • Number of events 1
|
Other adverse events
| Measure |
Atomoxetine
n=1551 participants at risk
Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
82/1551 • Number of events 100
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.8%
260/1551 • Number of events 353
|
|
Gastrointestinal disorders
Diarrhoea
|
8.1%
125/1551 • Number of events 166
|
|
Gastrointestinal disorders
Nausea
|
13.5%
210/1551 • Number of events 285
|
|
Gastrointestinal disorders
Vomiting
|
18.4%
285/1551 • Number of events 451
|
|
General disorders
Fatigue
|
9.5%
147/1551 • Number of events 186
|
|
General disorders
Irritability
|
9.7%
151/1551 • Number of events 168
|
|
General disorders
Pyrexia
|
16.0%
248/1551 • Number of events 386
|
|
Immune system disorders
Seasonal allergy
|
5.7%
89/1551 • Number of events 98
|
|
Infections and infestations
Ear infection
|
5.1%
79/1551 • Number of events 108
|
|
Infections and infestations
Gastroenteritis viral
|
7.9%
122/1551 • Number of events 152
|
|
Infections and infestations
Influenza
|
13.2%
205/1551 • Number of events 287
|
|
Infections and infestations
Nasopharyngitis
|
20.3%
315/1551 • Number of events 515
|
|
Infections and infestations
Pharyngitis streptococcal
|
8.3%
129/1551 • Number of events 177
|
|
Infections and infestations
Sinusitis
|
8.1%
125/1551 • Number of events 176
|
|
Infections and infestations
Upper respiratory tract infection
|
17.0%
263/1551 • Number of events 430
|
|
Infections and infestations
Viral infection
|
5.0%
78/1551 • Number of events 106
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.5%
163/1551 • Number of events 178
|
|
Nervous system disorders
Dizziness
|
5.4%
83/1551 • Number of events 103
|
|
Nervous system disorders
Headache
|
34.4%
534/1551 • Number of events 1063
|
|
Psychiatric disorders
Depression
|
5.2%
81/1551 • Number of events 84
|
|
Psychiatric disorders
Insomnia
|
6.8%
106/1551 • Number of events 120
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.1%
297/1551 • Number of events 445
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.1%
79/1551 • Number of events 97
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.8%
168/1551 • Number of events 263
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
17.2%
267/1551 • Number of events 414
|
|
Skin and subcutaneous tissue disorders
Acne
|
6.8%
105/1551 • Number of events 110
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.2%
80/1551 • Number of events 90
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60