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| ID | Type | Description | Link |
|---|---|---|---|
| B4Z-SB-LYDV | Other Identifier | Eli Lilly and Company |
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This is a two-arm, parallel, randomized, double-blind, placebo-controlled Phase 4 multicenter trial to compare the whole day efficacy of atomoxetine versus placebo in children aged 6 through 12 years with Attention-Deficit/Hyperactivity Disorder (ADHD) treated in an inpatient, day-patient and outpatient setting in Germany. Core symptoms will be measured during once or bi-weekly visits, three times per visit-day, by a computer based Continuous Performance Test. Following an initial 3-28-day screening and washout phase, patients will be assigned to double-blind treatment with atomoxetine or placebo. In the verum arm, a one-week atomoxetine treatment period with the 0.5 mg/kg per day lead-in dose will be succeeded by a 7 week period at the target dose of 1.2 mg/kg per day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atomoxetine | Experimental | 0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose. |
|
| Placebo | Placebo Comparator | Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atomoxetine | Drug | A one-week atomoxetine treatment period with the 0.5 mg/kg per day lead-in dose will be succeeded by a 7 week period at the target dose of 1.2 mg/kg per day. 3 capsules of study medication have to be taken once daily in the morning, with or without food. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | Infra-red camera tracks movement of head reflector on patient performing computer test. Hyperactivity test variables: TA=percent time patient moved>1 centimeter (cm)/second; DIS=path of movement (m); AR=total area (cm2) of movements; ME=number of position changes>1 mm; MS=degree (percent) of directional changes. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation (SD)=1 in general population, expressing the probability determined by the Gamma function in terms of SD of Gaussian density). Higher scores reflect more severe symptoms. | Baseline, 8 weeks (W8) |
| Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | Computer test. Patient is to press button if target appears, but not at non-target. Inattention test variables: mRT=average time (ms) from target presentation to response; RTV=standard deviation of mRT; nVRT=RTV expressed in terms of RT (variation as a percent of mean value); OE= percent of omitted targets. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and SD=1 in the general population, expressing the probability determined by the Gamma function in terms of SD of Gaussian density). Higher scores reflect more severe symptoms. | Baseline, 8 weeks |
| Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8 | Computer test. Patient is to press button if target appears, but not at non-target. Impulsivity variables during test: CE=percent of response to non-target; ANT=percent of responses prior to target presentation. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation=1 in the general population, expressing the probability determined by the Gamma function in terms of standard deviation of Gaussian density). Higher scores reflect more severe symptoms. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered And Scored (ADHDRS-IV-Parent:Inv) Total Score At Week 8 | Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 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. | Berlin | 12589 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25019647 | Derived | Bangs ME, Wietecha LA, Wang S, Buchanan AS, Kelsey DK. Meta-analysis of suicide-related behavior or ideation in child, adolescent, and adult patients treated with atomoxetine. J Child Adolesc Psychopharmacol. 2014 Oct;24(8):426-34. doi: 10.1089/cap.2014.0005. Epub 2014 Jul 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Atomoxetine | 0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose. |
| FG001 | Placebo | Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | 3 capsules of placebo have to be taken once daily in the morning, with or without food. |
|
| Baseline, 8 weeks |
| Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8 | Computer test. Patient is to press button if target appears, but not at non-target. Other variables during test: ER=percent of overall incorrect responses (CE and OE); MR=percent of multiple responses per presentation of target (patient responds more than once to target). Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation=1 in the general population, expressing the probability determined by the Gamma function in terms of standard deviation of Gaussian density). Higher scores reflect more severe symptoms. | Baseline, 8 weeks |
| Baseline, 8 weeks |
| Change From Baseline Clinical Global Impressions-Severity of ADHD (CGI-S-ADHD) Score at Week 8 | CGI-S-ADHD 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, 8 weeks |
| Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8 | Weekly Rating Of Evening & Morning Behavior-Revised-Investigator Rated (WREMB-R-Inv) measures the level of difficulty of 11 common morning or evening behaviors (e.g. getting out of bed, doing homework, sitting through dinner). Possible scores for each item range from 0 (no difficulty) to 3 (a lot of difficulty) with a Total score (maximum score=33), Morning subscore (maximum score=9), Evening subscore (maximum score=24), and Item 11 score which pertains to degree of difficulty falling asleep (maximum score=3). | Baseline, 8 weeks |
| 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. | Cologne | D-50931 | 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. | Datteln | 45711 | 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. | Dorsten | 46282 | 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. | Düsseldorf | 40215 | 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. | Eberswalde | 16225 | 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. | Freiburg im Breisgau | 79104 | 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. | Fulda | 36037 | 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. | Giessen | 35390 | 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. | Hagen | 58093 | 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. | Hanover | 30449 | 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. | Kehl | 77694 | 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. | München | 80639 | 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. | Solingen | 42719 | 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. | Wolfenbüttel | 38300 | Germany |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Atomoxetine | 0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose. |
| BG001 | Placebo | Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine |
| BG002 | Total | Total of all reporting groups |
| 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 | Breakdown of participants by race | Number | participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Diagnosis | Breakdown of Attention Deficit/Hyperactivity Disorder (ADHD) diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) | Number | participants |
| |||||||||||||||
| Number of Participants with Family History of ADHD | Number of participants with at least one biological relative (mother, father, sibling [brother, sister] or grandparent) with ADHD. | Number | participants |
| |||||||||||||||
| Number of Participants with Prior Therapy For Attention-Deficit/Hyperactive Disorder (ADHD) | Summarizes number of participants who received previous medication and non-medication attention-deficit/hyperactive disorder (ADHD) therapy. | Number | participants |
| |||||||||||||||
| Number of Participants with Psychiatric Comorbidities | Summarizes the psychologic comorbidities of participants. Because some participants may have one or more comorbidities while others may not, the breakdown of psychiatric comorbidities by treatment group does not equal the overall baseline number of participants in each treatment group. | Number | participants |
| |||||||||||||||
| Summary Of Participants' Living Arrangements | Summarizes the participants' living arrangements according to where they live most of the time. | Number | participants |
| |||||||||||||||
| ADHD Rating Scale-IV Parent Version: Investigator Administered & Scored, Total Score | ADHD Rating Scale-IV Parent Version: Investigator Administered & Scored (ADHD-RS-IV-PV:IR) measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Clinical Global Impressions - Severity Of Attention Deficit Hyperactive Disorder Score | Clinical Global Impressions- Severity Of Attention Deficit Hyperactive Disorder (CGI-S-ADHD) measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Time Since Initial Diagnosis Of ADHD | Mean | Standard Deviation | years |
| |||||||||||||||
| Time Since Onset Of ADHD Symptoms | Mean | Standard Deviation | years |
| |||||||||||||||
| Weekly Rating Of Evening & Morning Behavior-Revised-Investigator Rated, Total & Subscores | Weekly Rating Of Evening & Morning Behavior-Revised-Investigator Rated (WREMB-R-Inv) measures the level of difficulty of 11 common morning or evening behaviors (e.g. getting out of bed, doing homework, sitting through dinner). Possible scores for each item range from 0 (no difficulty) to 3 (a lot of difficulty) with a Total score (maximum score=33), Morning subscore (maximum score=9), Evening subscore (maximum score=24), and Item 11 score which pertains to degree of difficulty falling asleep (maximum score=3). | Mean | Standard Deviation | units on a scale |
|
| 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 | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | Infra-red camera tracks movement of head reflector on patient performing computer test. Hyperactivity test variables: TA=percent time patient moved>1 centimeter (cm)/second; DIS=path of movement (m); AR=total area (cm2) of movements; ME=number of position changes>1 mm; MS=degree (percent) of directional changes. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation (SD)=1 in general population, expressing the probability determined by the Gamma function in terms of SD of Gaussian density). Higher scores reflect more severe symptoms. | Full analysis population (N=125) including all randomized participants taking at least one dose of study medication. | Posted | Mean | Standard Deviation | Q-scores | Baseline, 8 weeks (W8) |
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| Secondary | Change From Baseline Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered And Scored (ADHDRS-IV-Parent:Inv) Total Score At Week 8 | Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. | Full analysis population (N=125) including all randomized participants taking at least one dose of study medication. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 8 weeks |
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| Secondary | Change From Baseline Clinical Global Impressions-Severity of ADHD (CGI-S-ADHD) Score at Week 8 | CGI-S-ADHD measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients). | Full analysis population (N=125) including all randomized participants taking at least one dose of study medication. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 8 weeks |
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| Secondary | Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8 | Weekly Rating Of Evening & Morning Behavior-Revised-Investigator Rated (WREMB-R-Inv) measures the level of difficulty of 11 common morning or evening behaviors (e.g. getting out of bed, doing homework, sitting through dinner). Possible scores for each item range from 0 (no difficulty) to 3 (a lot of difficulty) with a Total score (maximum score=33), Morning subscore (maximum score=9), Evening subscore (maximum score=24), and Item 11 score which pertains to degree of difficulty falling asleep (maximum score=3). | Full analysis population (N=125) including all randomized participants taking at least one dose of study medication. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 8 weeks |
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| Primary | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | Computer test. Patient is to press button if target appears, but not at non-target. Inattention test variables: mRT=average time (ms) from target presentation to response; RTV=standard deviation of mRT; nVRT=RTV expressed in terms of RT (variation as a percent of mean value); OE= percent of omitted targets. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and SD=1 in the general population, expressing the probability determined by the Gamma function in terms of SD of Gaussian density). Higher scores reflect more severe symptoms. | Full analysis population (N=125) including all randomized participants taking at least one dose of study medication. | Posted | Mean | Standard Deviation | Q-scores | Baseline, 8 weeks |
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| Primary | Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8 | Computer test. Patient is to press button if target appears, but not at non-target. Impulsivity variables during test: CE=percent of response to non-target; ANT=percent of responses prior to target presentation. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation=1 in the general population, expressing the probability determined by the Gamma function in terms of standard deviation of Gaussian density). Higher scores reflect more severe symptoms. | Full analysis population (N=125) including all randomized participants taking at least one dose of study medication. | Posted | Mean | Standard Deviation | Q-scores | Baseline, 8 weeks |
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| Primary | Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8 | Computer test. Patient is to press button if target appears, but not at non-target. Other variables during test: ER=percent of overall incorrect responses (CE and OE); MR=percent of multiple responses per presentation of target (patient responds more than once to target). Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation=1 in the general population, expressing the probability determined by the Gamma function in terms of standard deviation of Gaussian density). Higher scores reflect more severe symptoms. | Full analysis population (N=125) including all randomized participants taking at least one dose of study medication. | Posted | Mean | Standard Deviation | Q-scores | Baseline, 8 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atomoxetine | 0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose. | 0 | 63 | 32 | 63 | ||
| EG001 | Placebo | Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine | 0 | 62 | 27 | 62 |
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| 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 |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Aggression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| 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 |
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| ID | Term |
|---|---|
| D000069445 | Atomoxetine Hydrochloride |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Male |
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| African |
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| ADHD-Predominantly Inattentive Type |
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| ADHD- Predominantly Hyperactive-Impulsive Type |
|
| None or missing |
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| None or missing |
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| None or missing |
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| Single Mother |
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| Step Parent (One Biologic and one step parent) |
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| Morning Subscore |
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| Evening Subscore |
|
| Item 11 Subscore |
|
| Baseline: TA- Evening |
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| W8 Change: TA- Morning |
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| W8 Change: TA- Noon |
|
| W8 Change: TA- Evening |
|
| Baseline: DIS- Morning |
|
| Baseline: DIS- Noon |
|
| Baseline: DIS- Evening |
|
| W8 Change: DIS- Morning |
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| W8 Change: DIS- Noon |
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| W8 Change: DIS- Evening |
|
| Baseline: AR- Morning |
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| Baseline: AR- Noon |
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| Baseline: AR- Evening |
|
| W8 Change: AR- Morning |
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| W8 Change: AR- Noon |
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| W8 Change: AR- Evening |
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| Baseline: ME- Morning |
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| Baseline: ME- Noon |
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| Baseline: ME- Evening |
|
| W8 Change: ME- Morning |
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| W8 Change: ME- Noon |
|
| W8 Change: ME- Evening |
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| Baseline: MS- Morning |
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| Baseline: MS- Noon |
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| Baseline: MS- Evening |
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| W8 Change: MS- Morning |
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| W8 Change: MS- Noon |
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| W8 Change: MS- Evening |
|
| Mixed Models Analysis |
Positive values for the mean difference are in favor of the atomoxetine arm. |
| <0.001 |
P-value is for Distance overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Distance was tested at rank 5. |
| Mean Difference (Final Values) |
| 1.27 |
| 2-Sided |
| 95 |
| 0.98 |
| 1.57 |
| No |
| Superiority or Other |
| Mixed Models Analysis | Positive values for the mean difference are in favor of the atomoxetine arm. | <0.001 | P-value is for Area overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Area was tested at rank 6. | Mean Difference (Final Values) | 1.08 | 2-Sided | 95 | 0.81 | 1.35 | No | Superiority or Other |
| Mixed Models Analysis | Positive values for the mean difference are in favor of the atomoxetine arm. | <0.001 | P-value is for Microevents overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Microevents was tested at rank 3. | Mean Difference (Final Values) | 1.00 | 2-Sided | 95 | 0.78 | 1.22 | No | Superiority or Other |
| Mixed Models Analysis | Positive values for the mean difference are in favor of the atomoxetine arm. | <0.001 | P-value is for Motion Simplicity overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Motion Simplicity was tested at rank 9. | Mean Difference (Final Values) | 0.38 | 2-Sided | 95 | 0.18 | 0.58 | No | Superiority or Other |
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