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| ID | Type | Description | Link |
|---|---|---|---|
| B4Z-SB-LYDW | Other Identifier | Eli Lilly and Company |
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A three-arm, randomized, double-blind, placebo-controlled, Phase 4, multicenter study to compare the efficacy and safety of atomoxetine versus placebo in children and adolescents aged 6 through 17 years with attention-deficit/hyperactivity disorder (ADHD) and comorbid oppositional defiant disorder (ODD) who are treated as outpatients in Germany. After an initial 3- to 28-day screening and washout phase, participants will be assigned to double-blind treatment with atomoxetine or placebo. A 2 week up-titration period will be succeeded by a 7 week treatment period at the target dose. The primary efficacy measure will be the Swanson, Nolan and Pelham Rating Scale Revised (SNAP-IV) ODD subscale score.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atomoxetine Fast Titration | Experimental | 0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks |
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| Atomoxetine Slow Titration | Experimental | 0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks |
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| Placebo | Placebo Comparator | matching placebo daily dose taken orally |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atomoxetine | Drug | Dosage form for the atomoxetine fast and slow titration arms consists of 2.5 mg, 10 mg, 20 mg, 25 mg, and 40 mg capsules. Double-blind treatment will consist of 3 capsules taken once per day for approximately 9 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Swanson, Nolan and Pelham Rating Scale Revised (SNAP-IV) Oppositional Defiant Disorder: (ODD) Score | The SNAP-IV, a 26-item scale, includes 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD and 1 item for each of the 8 symptoms contained in the DSM-IV diagnosis of ODD. Each item is scored on a 0 to 3 scale (0=Not at All, 1=Just a Little, 2=Pretty Much, 3=Very Much). The SNAP-IV yields scores in three domains: Inattention (items 1-9: subscore range=0-27), Hyperact-ivity/Impulsivity (items 10-18: subscale range=0-27), and Oppositional (items 19-26: subscale range=0-24). SNAP-IV: ADHD Combined Scale score (inattention + hyperactivity/impulsivity) ranges from 0-54. | 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Combined Score | The SNAP-IV: ADHD Combined Subscale for inattention (items 1-9) and hyperactivity/impulsivity (items 11-19) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 54. | 9 weeks |
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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 | 10789 |
| 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 Fast Titration | 0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks |
| FG001 | Atomoxetine Slow Titration |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| All Randomized Patients |
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| Placebo | Drug | Double-blind treatment will consist of 3 matching placebo capsules taken once per day by mouth for approximately 9 weeks. |
|
| Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Inattention Score | The SNAP-IV: ADHD Inattention Subscale (items 1-9) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 27. | 9 weeks |
| Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): Hyperactivity/Impulsivity Score | The SNAP-IV: ADHD Hyperactivity/Impulsivity Subscale (items 10-18) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 27. | 9 weeks |
| Parent-Rated Attention-Deficit Scale (FBB-HKS), Total Score: Severity | FBB-HKS ("Fremdbeurteilungsbogen fur Hyperkinetische Storungen"), the German, parent-rated scale for attention-deficit, is a 20-item rating scale which describes ADHD symptom criteria of DSM-IV and is grouped based upon the 3 ADHD domains: inattention (items 1-9); hyperactivity (items 10-16); impulsivity (items 17-20). Parents rated symptom severity of each item during the last 7 days on a 0 to 3 scale (0=not at all to 3=very much). The total score was calculated for ADHD overall (sum of ratings for items 1-20, divided by 20). Higher scores indicate higher severity of symptoms. | 9 weeks |
| Parent-Rated Oppositional Defiant/Conduct Disorders Scale (FBB-SSV): Total Score, Severity | FBB-SSV ("Fremdbeurteilungsbogen fur Storungen des Sozialverhaltens"), the German, parent-rated oppositional defiant/conduct disorders scale, covers 23 criteria for ODD and 25 for conduct disorder (CD) in four sections. Parents rated symptom severity of each item during the last 7 days on a 0 to 3 scale (0=not at all to 3=very much). The total score was calculated for ODD/CD overall (sum of ratings for items 1-17, divided by 17). Higher scores indicate higher severity of symptoms. | 9 weeks |
| Investigator-Rated Individual Target Behaviors (ITB-Inv): Intensity Score | ITB-Inv assesses frequency and intensity of individually-defined target behaviors. The investigator defines 3 individual behavior problems based on interviews and additional information. Those most impairing for the child or stressful for the parents will be chosen as target behavior. Intensity during the last 7 days is rated on a 10-point scale (0=no problems to 9=most severe problems) with the lowest possible score of 0 and the highest possible of 27. | 9 weeks |
| Investigator-Rated Individual Target Behaviors (ITB-Inv): Frequency Score | ITB-Inv assesses frequency and intensity of individually-defined target behaviors. The investigator defines 3 individual behavior problems based on interviews and additional information. Those most impairing for the child or stressful for the parents will be chosen as target behavior. Frequency of each target behavior during the last 7 days is rated on a 6-point scale (0=never to 5=always) with 0 as lowest possible score and 15 the highest possible score. | 9 weeks |
| Impact on Family Scale (FaBel), Total Impact Score | Family burden is assessed by the FaBel questionnaire (German version of the Impact on Family Scale). Questionnaire is answered by participant's caregiver and contains 33 Likert-scaled items to assess general negative impact (of a disability, disorder, disease) on parents, description of social relationships, concern for siblings, financial impact, problems in coping as well as a total score. Each item is rated on a 4-point scale (1=fully applies, 4=applies not at all). Total scores range from 24-96. Higher scores correspond to higher family burden. | 9 weeks |
| Clinical Global Impressions - Severity (CGI-S): ADHD Score | The physician-rated CGI-S ADHD measures the participant's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients) during the last 7 days. | 9 weeks |
| Clinical Global Impressions - Severity (CGI-S): ODD Score | The physician-rated CGI-S ODD measures the participant's overall severity of ODD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients) during the last 7 days. | 9 weeks |
| Clinical Global Impressions - Severity (CGI-S): Combined ADHD and ODD Scores | The physician-rated CGI-S Combined ADHD and ODD measures the participant's overall severity of both ADHD and ODD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients) during the last 7 days. | 9 weeks |
| German Revised Children's Quality of Life Questionnaire (KINDL-R): Total Quality of Life Score | KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score in the Total QOL score is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher score indicates better QOL. | 9 weeks |
| German Revised Children's Quality of Life Questionnaire (KINDL-R): Physical Well-Being Score | KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the Physical Well-Being subscale is 0; highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL. | 9 weeks |
| German Revised Children's Quality of Life Questionnaire (KINDL-R): Emotional Well-Being Score | KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time).The lowest possible score for the Emotional Well-Being subscale is 0; highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL. | 9 weeks |
| German Revised Children's Quality of Life Questionnaire (KINDL-R): Self Esteem Score | KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the Self Esteem subscale is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL. | 9 weeks |
| German Revised Children's Quality of Life Questionnaire (KINDL-R): Family Score | KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1=never; 5=all the time). The lowest possible score on the Family subscale is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL. | 9 weeks |
| German Revised Children's Quality of Life Questionnaire (KINDL-R): Friends Score | KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the Friends subscale is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL. | 9 weeks |
| German Revised Children's Quality of Life Questionnaire (KINDL-R): School Score | KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the School subscore is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL. | 9 weeks |
| Number of Participants Discontinuing Treatment | Originally, time to treatment discontinuation was analyzed, deeming participants 'censored' if they reached the end of the observation period, were lost to followup, or withdrew informed consent. Because the median was not reached, the number of participants who discontinued (i.e., those who were not censored) is reported here. | 9 weeks |
| Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Initial Three Weeks of Study Treatment | Number of participants who experienced pre-specified categories of clinically relevant adverse events during the initial three-weeks of study treatment. NOTE: this is a subset of the overall adverse events which are reported by participant and event. | 3 weeks |
| Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Nine-Week Study Treatment Period | Number of participants who experienced pre-specified categories of clinically relevant adverse events during the nine-week study treatment period. NOTE: this is a subset of the overall adverse events which are reported by participant and event. | 9 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. | 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. | 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. | Hamburg | 22459 | 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. | Heppenheim an der Bergstrasse | 64646 | 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 |
0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
| FG002 | Placebo | matching placebo daily dose taken orally |
| COMPLETED |
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| NOT COMPLETED |
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| All Randomized and Treated Patients |
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| ID | Title | Description |
|---|---|---|
| BG000 | Atomoxetine Fast Titration | 0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks |
| BG001 | Atomoxetine Slow Titration | 0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks |
| BG002 | Placebo | matching placebo daily dose taken orally |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Prior Therapy: Attention-Deficit/Hyperactive Disorder (ADHD), Oppositional Defiant Disorder (ODD) | Summarizes number of participants who received previous attention-deficit/hyperactive disorder (ADHD) and/or oppositional defiant disorder (ODD) therapy, by medication and non-medication categories. NOTE: Because some participants may have received one or more types of ADHD and/or ODD therapies while others may not, the breakdown of prior therapies by treatment group does not equal the number of participants in each treatment group. | Number | participants |
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| Summary of ADHD Diagnosis | Breakdown of ADHD diagnosis in accordance with the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). | Number | participants |
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| Summary of ODD Diagnosis | Breakdown of ODD diagnosis in accordance with the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). | Number | participants |
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| Clinical Global Impressions - Severity (CGI-S): ADHD Score | The physician-rated CGI-S ADHD subscale measures the participant's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients) during the last 7 days. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Clinical Global Impressions - Severity (CGI-S): Combined ADHD and ODD Scores | The physician-rated CGI-S Combined ADHD and ODD subscale measures the participant's overall severity of both ADHD and ODD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients) during the last 7 days. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Clinical Global Impressions - Severity (CGI-S): ODD Score | The physician-rated CGI-S ODD subscale measures the participant's overall severity of ODD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients) during the last 7 days. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| German Revised Children's Quality of Life Questionnaire (KINDL-R): Emotional Well-Being Score | KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1=never; 5=all the time). Lowest possible score for the Emotional Well-Being subscale is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| German Revised Children's Quality of Life Questionnaire (KINDL-R): Family Score | KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1=never; 5=all the time). The lowest possible score on the Family subscale is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL. | Mean | Standard Deviation | units on a scale |
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| German Revised Children's Quality of Life Questionnaire (KINDL-R): Friends Score | KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the Friends subscale is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL. | Mean | Standard Deviation | units on a scale |
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| German Revised Children's Quality of Life Questionnaire (KINDL-R): Physical Well-Being Score | KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the Physical Well-Being subscale is 0; highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL. | Mean | Standard Deviation | units on a scale |
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| German Revised Children's Quality of Life Questionnaire (KINDL-R): School Score | KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the School subscale is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| German Revised Children's Quality of Life Questionnaire (KINDL-R): Self Esteem Score | KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the Self Esteem subscale is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL. | Mean | Standard Deviation | units on a scale |
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| German Revised Children's Quality of Life Questionnaire (KINDL-R): Total Quality of Life Score | KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score in the Total QOL score is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Impact on Family Scale (FaBel): Total Impact Score | Family burden is assessed by the FaBel questionnaire (German version of the Impact on Family Scale). Questionnaire is answered by participant's caregiver and contains 33 Likert-scaled items to assess general negative impact (of a disability, disorder, disease) on parents, description of social relationships, concern for siblings, financial impact, problems in coping as well as a total score. Each item is rated on a 4-point scale (1=fully applies, 4=applies not at all). Total scores range from 24-96. Higher scores correspond to higher family burden. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Investigator-Rated Individual Target Behaviors (ITB-Inv): Frequency Score | ITB-Inv assesses frequency and intensity of individually-defined target behaviors. The investigator defines 3 individual behavior problems based on interviews & additional information. Those most impairing for the child or stressful for the parents will be chosen as target behavior. Frequency of each target behavior during the last 7 days is rated on a 6-point scale (0=never to 5=always) with 0 as lowest possible score and 15 the highest possible score. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Investigator-Rated Individual Target Behaviors (ITB-Inv): Intensity Score | ITB-Inv assesses frequency and intensity of individually-defined target behaviors. The investigator defines 3 individual behavior problems based on interviews & additional information. Those most impairing for the child or stressful for the parents will be chosen as target behavior. Intensity during the last 7 days is rated on a 10-point scale (0=no problems to 9=most severe problems) with the lowest possible score of 0 and the highest possible of 27. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Parent-Rated Attention-Deficit Scale (FBB-HKS): Total Score, Severity | FBB-HKS ("Fremdbeurteilungsbogen fur Hyperkinetische Storungen"), the German, parent-rated scale for attention-deficit, is a 20-item rating scale which describes ADHD symptom criteria of DSM-IV and is grouped based upon the 3 ADHD domains: inattention (items 1-9); hyperactivity (items 10-16); impulsivity (items 17-20). Parents rated symptom severity of each item during the last 7 days on a 0 to 3 scale (0=not at all to 3=very much). The total score was calculated for ADHD overall (sum of ratings for items 1-20, divided by 20). High scores indicate high severity of symptoms. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Parent-Rated Oppositional Defiant/Conduct Disorders Scale (FBB-SSV): Total Score, Severity | FBB-SSV ("Fremdbeurteilungsbogen fur Storungen des Sozialverhaltens"), the German, parent-rated oppositional defiant/conduct disorders scale, covers 23 criteria for ODD and 25 for conduct disorder (CD) in four sections. Parents rated symptom severity of each item during the last 7 days on a 0 to 3 scale (0=not at all to 3=very much). The total score was calculated for ODD/CD overall (sum of ratings for items 1-17, divided by 17). Higher scores indicate higher severity of symptoms. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Inattention Subscale Score | The SNAP-IV, ADHD Inattention subscale (items 1-9) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 27. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): Hyperactivity/Impulsivity Score | The SNAP-IV, ADHD Hyperactivity/Impulsivity subscale (items 10-18) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 27. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ODD Score | The SNAP-IV, ODD subscale (items 19-26) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 24. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Swanson, Nolan & Pelham Rating Scale-Revised (SNAP-IV): ADHD Combined Score | SNAP-IV is a 26-item scale that includes 1 item for each of 18 symptoms in the DSM-IV diagnosis of ADHD and 1 item for each of 8 symptoms in the DSM-IV diagnosis of ODD. Each item is scored on a 0 to 3 scale (0=Not at All, 1=Just a Little, 2=Pretty Much, 3=Very Much). SNAP-IV yields scores in 3 domains: Inattention (items 1-9: subscore range=0-27), Hyperactivity/impulsivity (items 10-18: subscale range=0-27), and Oppositional (items 19-26: subscale range=0-24). SNAP-IV ADHD combined score (inattention + hyperactivity/impulsivity) range=0-54. | Mean | Standard Deviation | units on a scale |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Swanson, Nolan and Pelham Rating Scale Revised (SNAP-IV) Oppositional Defiant Disorder: (ODD) Score | The SNAP-IV, a 26-item scale, includes 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD and 1 item for each of the 8 symptoms contained in the DSM-IV diagnosis of ODD. Each item is scored on a 0 to 3 scale (0=Not at All, 1=Just a Little, 2=Pretty Much, 3=Very Much). The SNAP-IV yields scores in three domains: Inattention (items 1-9: subscore range=0-27), Hyperact-ivity/Impulsivity (items 10-18: subscale range=0-27), and Oppositional (items 19-26: subscale range=0-24). SNAP-IV: ADHD Combined Scale score (inattention + hyperactivity/impulsivity) ranges from 0-54. | All participants randomized and receiving at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | units on a scale | 9 weeks |
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| Secondary | Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Combined Score | The SNAP-IV: ADHD Combined Subscale for inattention (items 1-9) and hyperactivity/impulsivity (items 11-19) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 54. | All participants randomized and receiving at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | units on a scale | 9 weeks |
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| Secondary | Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Inattention Score | The SNAP-IV: ADHD Inattention Subscale (items 1-9) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 27. | All participants randomized and receiving at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | units on a scale | 9 weeks |
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| Secondary | Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): Hyperactivity/Impulsivity Score | The SNAP-IV: ADHD Hyperactivity/Impulsivity Subscale (items 10-18) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 27. | All participants randomized and receiving at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | units on a scale | 9 weeks |
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| Secondary | Parent-Rated Attention-Deficit Scale (FBB-HKS), Total Score: Severity | FBB-HKS ("Fremdbeurteilungsbogen fur Hyperkinetische Storungen"), the German, parent-rated scale for attention-deficit, is a 20-item rating scale which describes ADHD symptom criteria of DSM-IV and is grouped based upon the 3 ADHD domains: inattention (items 1-9); hyperactivity (items 10-16); impulsivity (items 17-20). Parents rated symptom severity of each item during the last 7 days on a 0 to 3 scale (0=not at all to 3=very much). The total score was calculated for ADHD overall (sum of ratings for items 1-20, divided by 20). Higher scores indicate higher severity of symptoms. | All participants randomized and receiving at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | units on a scale | 9 weeks |
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| Secondary | Parent-Rated Oppositional Defiant/Conduct Disorders Scale (FBB-SSV): Total Score, Severity | FBB-SSV ("Fremdbeurteilungsbogen fur Storungen des Sozialverhaltens"), the German, parent-rated oppositional defiant/conduct disorders scale, covers 23 criteria for ODD and 25 for conduct disorder (CD) in four sections. Parents rated symptom severity of each item during the last 7 days on a 0 to 3 scale (0=not at all to 3=very much). The total score was calculated for ODD/CD overall (sum of ratings for items 1-17, divided by 17). Higher scores indicate higher severity of symptoms. | All participants randomized and receiving at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | units on a scale | 9 weeks |
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| Secondary | Investigator-Rated Individual Target Behaviors (ITB-Inv): Intensity Score | ITB-Inv assesses frequency and intensity of individually-defined target behaviors. The investigator defines 3 individual behavior problems based on interviews and additional information. Those most impairing for the child or stressful for the parents will be chosen as target behavior. Intensity during the last 7 days is rated on a 10-point scale (0=no problems to 9=most severe problems) with the lowest possible score of 0 and the highest possible of 27. | All participants randomized and receiving at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | units on a scale | 9 weeks |
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| Secondary | Investigator-Rated Individual Target Behaviors (ITB-Inv): Frequency Score | ITB-Inv assesses frequency and intensity of individually-defined target behaviors. The investigator defines 3 individual behavior problems based on interviews and additional information. Those most impairing for the child or stressful for the parents will be chosen as target behavior. Frequency of each target behavior during the last 7 days is rated on a 6-point scale (0=never to 5=always) with 0 as lowest possible score and 15 the highest possible score. | All participants randomized and receiving at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | units on a scale | 9 weeks |
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| Secondary | Impact on Family Scale (FaBel), Total Impact Score | Family burden is assessed by the FaBel questionnaire (German version of the Impact on Family Scale). Questionnaire is answered by participant's caregiver and contains 33 Likert-scaled items to assess general negative impact (of a disability, disorder, disease) on parents, description of social relationships, concern for siblings, financial impact, problems in coping as well as a total score. Each item is rated on a 4-point scale (1=fully applies, 4=applies not at all). Total scores range from 24-96. Higher scores correspond to higher family burden. | All participants randomized and receiving at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | units on a scale | 9 weeks |
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| Secondary | Clinical Global Impressions - Severity (CGI-S): ADHD Score | The physician-rated CGI-S ADHD measures the participant's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients) during the last 7 days. | All participants randomized and receiving at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | units on a scale | 9 weeks |
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| Secondary | Clinical Global Impressions - Severity (CGI-S): ODD Score | The physician-rated CGI-S ODD measures the participant's overall severity of ODD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients) during the last 7 days. | All participants randomized and receiving at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | units on a scale | 9 weeks |
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| Secondary | Clinical Global Impressions - Severity (CGI-S): Combined ADHD and ODD Scores | The physician-rated CGI-S Combined ADHD and ODD measures the participant's overall severity of both ADHD and ODD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients) during the last 7 days. | All participants randomized and receiving at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | units on a scale | 9 weeks |
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| Secondary | German Revised Children's Quality of Life Questionnaire (KINDL-R): Total Quality of Life Score | KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score in the Total QOL score is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher score indicates better QOL. | All participants randomized and receiving at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | units on a scale | 9 weeks |
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| Secondary | German Revised Children's Quality of Life Questionnaire (KINDL-R): Physical Well-Being Score | KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the Physical Well-Being subscale is 0; highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL. | All participants randomized and receiving at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | units on a scale | 9 weeks |
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| Secondary | German Revised Children's Quality of Life Questionnaire (KINDL-R): Emotional Well-Being Score | KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time).The lowest possible score for the Emotional Well-Being subscale is 0; highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL. | All participants randomized and receiving at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | units on a scale | 9 weeks |
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| Secondary | German Revised Children's Quality of Life Questionnaire (KINDL-R): Self Esteem Score | KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the Self Esteem subscale is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL. | All participants randomized and receiving at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | units on a scale | 9 weeks |
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| Secondary | German Revised Children's Quality of Life Questionnaire (KINDL-R): Family Score | KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1=never; 5=all the time). The lowest possible score on the Family subscale is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL. | All participants randomized and receiving at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | units on a scale | 9 weeks |
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| Secondary | German Revised Children's Quality of Life Questionnaire (KINDL-R): Friends Score | KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the Friends subscale is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL. | All participants randomized and receiving at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | units on a scale | 9 weeks |
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| Secondary | German Revised Children's Quality of Life Questionnaire (KINDL-R): School Score | KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the School subscore is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL. | All participants randomized and receiving at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | units on a scale | 9 weeks |
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| Secondary | Number of Participants Discontinuing Treatment | Originally, time to treatment discontinuation was analyzed, deeming participants 'censored' if they reached the end of the observation period, were lost to followup, or withdrew informed consent. Because the median was not reached, the number of participants who discontinued (i.e., those who were not censored) is reported here. | All participants randomized and receiving at least one dose of study drug. | Posted | Number | participants | 9 weeks |
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| Secondary | Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Initial Three Weeks of Study Treatment | Number of participants who experienced pre-specified categories of clinically relevant adverse events during the initial three-weeks of study treatment. NOTE: this is a subset of the overall adverse events which are reported by participant and event. | All randomized participants who received at least one dose of study drug. | Posted | Number | participants | 3 weeks |
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| Secondary | Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Nine-Week Study Treatment Period | Number of participants who experienced pre-specified categories of clinically relevant adverse events during the nine-week study treatment period. NOTE: this is a subset of the overall adverse events which are reported by participant and event. | All randomized participants who received at least one dose of study drug. | Posted | Number | participants | 9 weeks |
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Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
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) |
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| EG000 | Atomoxetine Fast Titration | 0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks | 1 | 60 | 48 | 60 | ||
| EG001 | Atomoxetine Slow Titration | 0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks | 1 | 61 | 43 | 61 | ||
| EG002 | Placebo | matching placebo daily dose taken orally | 1 | 59 | 32 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Vertigo | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
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| Mydriasis | Eye disorders | MedDRA 11.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| 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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| Sleep disorder | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal 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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Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 1-800-545-5979 |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D000096865 | Oppositional Defiant Disorder |
| ID | Term |
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| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069445 | Atomoxetine Hydrochloride |
| ID | Term |
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| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Parent/Caregiver Decision |
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| Withdrawal by Subject |
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| Physician Decision |
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| Male |
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| African |
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| Previous psychotropic medication |
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| Previous non-drug treatment |
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| Previous psychotherapy |
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| ADHD - predominantly inattentive type |
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| ADHD - predominantly hyperactive-impulsive type |
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| Oppositional defiant disorder |
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| Disruptive behavior disorder not specified |
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| Adjustment disorder, emotion, conduct disturbance |
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matching placebo daily dose taken orally
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matching placebo daily dose taken orally
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matching placebo daily dose taken orally
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matching placebo daily dose taken orally
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matching placebo daily dose taken orally
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matching placebo daily dose taken orally
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