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| ID | Type | Description | Link |
|---|---|---|---|
| B4Z-MC-LYAI | Other Identifier | Eli Lilly and Company |
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To learn about the safety and any side effects of atomoxetine when given to children and adolescents for about 5 years (long-term) and to learn whether atomoxetine can help children and adolescents with attention-deficit/hyperactivity disorder (ADHD) who take the drug for about 5 years (long-term).
Study participants can be atomoxetine naive, atomoxetine experienced whose therapy has been interrupted or, atomoxetine experienced on a known stable dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atomoxetine | Experimental | Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted with be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| atomoxetine | Drug | 0.5-1.8 mg/kg/day, by mouth (PO), for up to 5 years |
|
| Measure | Description | Time Frame |
|---|---|---|
| Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study | 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%. | Baseline through 5 years |
| Change From Baseline to 5 Year Endpoint in BP | baseline, 5 years | |
| Change From Baseline to 5 Year Endpoint in Pulse | baseline, 5 years | |
| Change From Baseline to 5 Year Endpoint in Body Weight | baseline, 5 years | |
| Change From Baseline to 5 Year Endpoint in Height | baseline, 5 years | |
| Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile | 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. | baseline, 5 years |
| Change From Baseline to 5 Year Endpoint in Electrocardiogram (ECG) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-619-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Birmingham | Alabama | 35233 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17242628 | Derived | Michelson D, Read HA, Ruff DD, Witcher J, Zhang S, McCracken J. CYP2D6 and clinical response to atomoxetine in children and adolescents with ADHD. J Am Acad Child Adolesc Psychiatry. 2007 Feb;46(2):242-51. doi: 10.1097/01.chi.0000246056.83791.b6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| baseline, 5 years |
| Change From Baseline to 5 Year Endpoint in Heart Rate | Patients were assessed for changes in heart rate using electrocardiogram. | baseline, 5 years |
| Number of Patients Meeting Committee for Proprietary Medicinal Products (CPMP) Categorical QTc Interval Criteria Part I (Numerical Increase) | 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. | baseline through 5 years |
| Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint) | 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. | baseline through 5 years |
| Number of Participants With Abnormal Laboratory Analytes During the Study | 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) | baseline through 5 years |
| Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group | 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 year through 5 years |
| baseline, 5 years |
| Change From Baseline to 5 Year Endpoint in Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S) Score | Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients). | baseline, 5 years |
| Change From Baseline to 5 Year Endpoint in Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Subscale Scores | 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. | baseline, 5 years |
| Change From Baseline to 5 Year Endpoint in the Stroop Word Color Test | 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. | baseline, 5 years |
| United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Phoenix | Arizona | 85016 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | El Centro | California | 92243 | United States |
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| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Middleton | Wisconsin | 53562 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Milwaukee | Wisconsin | 53226 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Wallsend | New South Wales | 2287 | Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | South Brisbane | Queensland | 4101 | Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | West Perth | Western Australia | 6005 | Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Antwerp | 2020 | Belgium |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Leuven | 3000 | Belgium |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Edmonton | Alberta | T5G0B7 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Halifax | Nova Scotia | B3J3G9 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Toronto | Ontario | M5G1X8 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Québec | Quebec | G1R2W8 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bordeaux | 33076 | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lyon | 69395 | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Paris | 75019 | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Paris | 75571 | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Heiligenstadt/Ofr | D-91332 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mannheim | 68159 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Holon | 22100 | Israel |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ness Ziona | 70450 | Israel |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Cagliari | 09124 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Pisa | 50018 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Groningen | 9713 GZ | Netherlands |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Utrecht | 3584 CX | Netherlands |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Oslo | 0319 | Norway |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Rio Piedras | 00936 | Puerto Rico |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | San Juan | 00936 | Puerto Rico |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Benmore | Sandown | 2010 | South Africa |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Garsfontein | 0042 | South Africa |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Panorama | 7500 | South Africa |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Gothenburg | 41118 | Sweden |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Glasgow | Scotland | G3 8SJ | United Kingdom |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Sheffield | South Yorkshire | S10 5DD | United Kingdom |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Height | Summary of baseline characteristics is based on 1553 participants, but only 1527 participants have non-missing baseline measurement of height. | Mean | Standard Deviation | centimeters (cm) |
| |||||||||||||||||||||
| Weight | Summary of baseline characteristics is based on 1553 participants, but only 1548 participants have non-missing baseline measurement of weight. | Mean | Standard Deviation | kilograms (kg) |
| |||||||||||||||||||||
| Attention Deficit Hyperactive Disorder (ADHD) Subtype | Summary of baseline characteristics is based on 1553 participants, but only 1547 participants have non-missing baseline measurement of ADHD subtype diagnosis. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study | 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%. | 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. | Posted | Number | participants | Baseline through 5 years |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline to 5 Year Endpoint in BP | 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. | Posted | Mean | Standard Deviation | millimeters of Mercury (mmHg) | baseline, 5 years |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline to 5 Year Endpoint in Pulse | 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. | Posted | Mean | Standard Deviation | beats per minute (bpm) | baseline, 5 years |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline to 5 Year Endpoint in Body Weight | 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. | Posted | Mean | Standard Deviation | kilograms (kg) | baseline, 5 years |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline to 5 Year Endpoint in Height | 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. | Posted | Mean | Standard Deviation | centimeters (cm) | baseline, 5 years |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile | 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. | The number of participants analyzed was defined as all patients with a baseline and 5 year endpoint measurement. | Posted | Mean | Standard Deviation | percentiles | baseline, 5 years |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline to 5 Year Endpoint in Electrocardiogram (ECG) | 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. | 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. | Posted | Mean | Standard Deviation | milliseconds (msec) | baseline, 5 years |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline to 5 Year Endpoint in Heart Rate | Patients were assessed for changes in heart rate using electrocardiogram. | 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. | Posted | Mean | Standard Deviation | beats per minute (bpm) | baseline, 5 years |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Patients Meeting Committee for Proprietary Medicinal Products (CPMP) Categorical QTc Interval Criteria Part I (Numerical Increase) | 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. | 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. | Posted | Number | participants | baseline through 5 years |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline, 5 years |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 5 Year Endpoint in Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S) Score | Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients). | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline, 5 years |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 5 Year Endpoint in Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Subscale Scores | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline, 5 years |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 5 Year Endpoint in the Stroop Word Color Test | 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. | There were not enough participants with prior Stroop Word Color tests to analyze the data. | Posted | Mean | Standard Deviation | number of correct answers | baseline, 5 years |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint) | 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. | 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. | Posted | Number | participants | baseline through 5 years |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Abnormal Laboratory Analytes During the Study | 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) | 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. | Posted | Number | participants | baseline through 5 years |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group | 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:
| The analysis population is defined as patients with at least two Tanner measurements. | Posted | Number | participants | 1 year through 5 years |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 92 | 1,551 | 1,372 | 1,551 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Wolff-Parkinson-White syndrome | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Visual disturbance | Eye disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Campylobacter infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Perianal abscess | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Burns first degree | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Burns second degree | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Post concussion syndrome | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Blood glucose decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Blood pressure decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Ketoacidosis | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Bone cyst | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Retrognathia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Glioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Complex partial seizures | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Migraine with aura | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Psychomotor hyperactivity | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Affect lability | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Conduct disorder | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Impulsive behaviour | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Negativism | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Oppositional defiant disorder | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Post-traumatic stress disorder | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pyromania | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Substance abuse | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Suicidal behaviour | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Facial operation | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
| |
| Nasal septal operation | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069445 | Atomoxetine Hydrochloride |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
Not provided
Not provided
| East/ Southeast Asian |
|
| Western Asian |
|
| Hispanic |
|
| Other |
|
| United Kingdom |
|
| Italy |
|
| France |
|
| Canada |
|
| Puerto Rico |
|
| Belgium |
|
| Australia |
|
| South Africa |
|
| Germany |
|
| Netherlands |
|
| Norway |
|
| Sweden |
|
| Spain |
|
| Combined |
|
| Not Applicable |
|
| Unknown |
|
| Title | Measurements |
|---|---|
|
| Pulse Low (N=1528) |
|
| Temperature High (N=1525) |
|
| Temperature Low (N=1525) |
|
| Weight Decrease (N=1526) |
|
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