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| ID | Type | Description | Link |
|---|---|---|---|
| B4Z-JE-LYEK | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to assess long-term safety and tolerability in adult patients who have completed a previous atomoxetine study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atomoxetine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atomoxetine | Drug | 40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events Leading to Discontinuation | Baseline through 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline to 48 Weeks Endpoint in the Conners' Adult Attention-Deficit Hyperactivity Disorder Rating Scale-Investigator Rated: Screening Version-Japanese (CAARS-Inv:SV-J) | CAARS-Inv:SV-J is a 30-item scale containing 3 subscales: inattention (9 items), hyperactivity/impulsivity (9 items), and attention deficit hyperactivity disorder (ADHD) Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention subscales (scores range from 0-27) and hyperactivity/impulsivity subscales (scores range from 0-27) with a total score range of 0-54. The ADHD Index scores range from 0-36. Higher scores indicate greater impairment. |
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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. | Aichi | 466-8560 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Atomoxetine | 40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Atomoxetine | 40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Number of Participants With Adverse Events Leading to Discontinuation | All participants who received at least one dose of study drug. | Posted | Number | participant | Baseline through 48 weeks |
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|
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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 | 40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaphylactic reaction | Immune system disorders | MedDRA 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| 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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| Baseline, 48 weeks |
| Mean Change From Baseline to 48 Weeks Endpoint in the Adult Attention-Deficit/Hyperactivity Disorder Quality of Life (AAQoL)-29 Scores | AAQoL is a 29 items participant completed questionnaire rated on a 5-point Likert scale from 1 (Not at all/ Never) to 5 (Extremely/Very Often). AAQoL total (all 29 items) and 4 subscale scores: Life Productivity (11 items); Psychological Health (6 items); Life Outlook (7 items); Relationships (5 items). Total score is computed by (1) reversing scores for all items except the 7 items in the Life Outlook subscale; (2) transforming scores to 0-100 scale (1=0; 2=25; 3=50; 4=75; 5=100); (3) summing item scores and dividing by the item count. Higher total scores indicate better quality of life. | Baseline, 48 weeks |
| Mean Change From Baseline to 48 Weeks Endpoint in the Behavior Rating Inventory of Executive Function -Adult (BRIEF-A) Version: Self Report (BRIEF-A:Self Report ) | A 75-item standardized self-reported measure comprised of 3 subscales. Each item is rated on a 3-point Likert scale: 1 (behavior never observed) to 3 (behavior often observed). Global executive composite (GEC) subscale rates participant's GEC in everyday environment (75- 225 total score). Behavioral regulation subscale measures participant's control over behavior (30-90 total score). Metacognition subscale assesses systematic problem-solving ability while sustaining these task-completion efforts in active working memory (40-120 total score). Higher subscale ratings indicate greater perceived impairment. | Baseline, 48 weeks |
| Mean Change From Baseline to 48 Weeks Endpoint in Comorbid, Anxiety Symptoms, as Measured by Hamilton Anxiety Rating Scale-14 (HAMA-14) Items | The HAMA-14 instrument consists of 14 items that provide an overall measure of general anxiety, including psychic anxiety and somatic anxiety. This instrument is completed by the clinician based on his or her assessment of the participant. Each item is rated on a 5-point scale of 0 (absent) to 4 (very severe). Total score is the sum of the 14 items and ranges from 0 (normal) to 56 (severe). Higher scores indicate greater anxiety. | Baseline, 48 weeks |
| Mean Change From Baseline to 48 Weeks Endpoint in Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S) | The CGI-ADHD-S is a single-item rating of the clinician's assessment of the overall severity of the participant's ADHD symptoms in relation to the clinician's total experience with ADHD participants. CGI-ADHD-S measures severity of the participant's overall severity of ADHD symptoms: 1 (normal, not at all ill) to 7 (among the most extremely ill participants). | Baseline, 48 weeks |
| Mean Change From Baseline to 48 Weeks Endpoint in the Behavior Rating Inventory of Executive Function-Adult (BRIEF-A) Version: Informant Scores (BRIEF-A:Informant Scores) | Third-party observer of participant completes 75-item scale. Comprised of 3 subscales. Each item rated on 3-point Likert scale: 1 (behavior never observed) to 3 (behavior often observed). Global executive composite (GEC) subscale rates participant's GEC in everyday environment (75-225 total score). Behavioral regulation subscale measures participant's control over behavior (30-90 total score). Metacognition subscale assesses systematic problem-solving ability while sustaining these task-completion efforts in active working memory (40-120 total score). Higher subscale ratings indicate greater perceived impairment. | Baseline, 48 weeks |
| Mean Change From Baseline to 48 Weeks Endpoint in Comorbid, Depressive Symptoms, as Measured by Hamilton Depression Rating Scale-17 (HAMD-17) Items | The HAMD-17 instrument consists of 17 items used to assess the severity of depression and its improvement during the course of therapy. This instrument is completed by the clinician based on his or her assessment of the participant. Each item was evaluated and scored using either a 5-point scale of 0 (not present) to 4 (very severe) or a 3-point scale of 0 (not present) to 2 (marked). The total score is the sum of the scores from HAMD-17 Items 1 through 17 and ranges from 0 (not at all depressed) to 52 (severely depressed). Higher scores indicate greater symptom severity. | Baseline, 48 weeks |
| Japan |
| 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. | Chiba | 260-0842 | Japan |
| 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. | Fukushima | 960-1295 | Japan |
| 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. | Hokkaido | 060-0814 | Japan |
| 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. | Hyōgo | 661-0002 | Japan |
| 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. | Kanagawa | 259-1193 | Japan |
| 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. | Kumamoto | 862-0920 | Japan |
| 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. | Kyoto | 606-8397 | Japan |
| 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. | Nara | 634-8522 | Japan |
| 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. | Osaka | 590-0947 | Japan |
| 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. | Saitama | 330-0081 | Japan |
| 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. | Tokyo | 170-0002 | Japan |
| Lost to Follow-up |
|
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Mean Change From Baseline to 48 Weeks Endpoint in the Conners' Adult Attention-Deficit Hyperactivity Disorder Rating Scale-Investigator Rated: Screening Version-Japanese (CAARS-Inv:SV-J) | CAARS-Inv:SV-J is a 30-item scale containing 3 subscales: inattention (9 items), hyperactivity/impulsivity (9 items), and attention deficit hyperactivity disorder (ADHD) Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention subscales (scores range from 0-27) and hyperactivity/impulsivity subscales (scores range from 0-27) with a total score range of 0-54. The ADHD Index scores range from 0-36. Higher scores indicate greater impairment. | All participants who received at least one dose of study drug, and had a baseline and at least one post-baseline CAARS measurement. Last observation carried forward (LOCF) principle was used. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 48 weeks |
|
|
|
|
| Secondary | Mean Change From Baseline to 48 Weeks Endpoint in the Adult Attention-Deficit/Hyperactivity Disorder Quality of Life (AAQoL)-29 Scores | AAQoL is a 29 items participant completed questionnaire rated on a 5-point Likert scale from 1 (Not at all/ Never) to 5 (Extremely/Very Often). AAQoL total (all 29 items) and 4 subscale scores: Life Productivity (11 items); Psychological Health (6 items); Life Outlook (7 items); Relationships (5 items). Total score is computed by (1) reversing scores for all items except the 7 items in the Life Outlook subscale; (2) transforming scores to 0-100 scale (1=0; 2=25; 3=50; 4=75; 5=100); (3) summing item scores and dividing by the item count. Higher total scores indicate better quality of life. | All participants who received at least one dose of study drug, and had a baseline and at least one post-baseline AAQoL measurement. Last observation carried forward (LOCF) principle was used. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 48 weeks |
|
|
|
|
| Secondary | Mean Change From Baseline to 48 Weeks Endpoint in the Behavior Rating Inventory of Executive Function -Adult (BRIEF-A) Version: Self Report (BRIEF-A:Self Report ) | A 75-item standardized self-reported measure comprised of 3 subscales. Each item is rated on a 3-point Likert scale: 1 (behavior never observed) to 3 (behavior often observed). Global executive composite (GEC) subscale rates participant's GEC in everyday environment (75- 225 total score). Behavioral regulation subscale measures participant's control over behavior (30-90 total score). Metacognition subscale assesses systematic problem-solving ability while sustaining these task-completion efforts in active working memory (40-120 total score). Higher subscale ratings indicate greater perceived impairment. | All participants who received at least one dose of study drug, and had a baseline and at least one post-baseline BRIEF-A self report measurement. Last observation carried forward (LOCF) principle was used. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 48 weeks |
|
|
|
|
| Secondary | Mean Change From Baseline to 48 Weeks Endpoint in Comorbid, Anxiety Symptoms, as Measured by Hamilton Anxiety Rating Scale-14 (HAMA-14) Items | The HAMA-14 instrument consists of 14 items that provide an overall measure of general anxiety, including psychic anxiety and somatic anxiety. This instrument is completed by the clinician based on his or her assessment of the participant. Each item is rated on a 5-point scale of 0 (absent) to 4 (very severe). Total score is the sum of the 14 items and ranges from 0 (normal) to 56 (severe). Higher scores indicate greater anxiety. | All participants who received at least one dose of study drug, and had a baseline and at least one post-baseline HAMA-14 measurement. Last observation carried forward (LOCF) principle was used. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 48 weeks |
|
|
|
|
| Secondary | Mean Change From Baseline to 48 Weeks Endpoint in Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S) | The CGI-ADHD-S is a single-item rating of the clinician's assessment of the overall severity of the participant's ADHD symptoms in relation to the clinician's total experience with ADHD participants. CGI-ADHD-S measures severity of the participant's overall severity of ADHD symptoms: 1 (normal, not at all ill) to 7 (among the most extremely ill participants). | All participants who received at least one dose of study drug, and had a baseline and at least one post-baseline CGI-ADHD-S measurement. Last observation carried forward (LOCF) principle was used. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 48 weeks |
|
|
|
|
| Secondary | Mean Change From Baseline to 48 Weeks Endpoint in the Behavior Rating Inventory of Executive Function-Adult (BRIEF-A) Version: Informant Scores (BRIEF-A:Informant Scores) | Third-party observer of participant completes 75-item scale. Comprised of 3 subscales. Each item rated on 3-point Likert scale: 1 (behavior never observed) to 3 (behavior often observed). Global executive composite (GEC) subscale rates participant's GEC in everyday environment (75-225 total score). Behavioral regulation subscale measures participant's control over behavior (30-90 total score). Metacognition subscale assesses systematic problem-solving ability while sustaining these task-completion efforts in active working memory (40-120 total score). Higher subscale ratings indicate greater perceived impairment. | All participants who received at least one dose of study drug, and had a baseline and at least one post-baseline BRIEF-A Informant scores measurement. Last observation carried forward (LOCF) principle was used. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 48 weeks |
|
|
|
|
| Secondary | Mean Change From Baseline to 48 Weeks Endpoint in Comorbid, Depressive Symptoms, as Measured by Hamilton Depression Rating Scale-17 (HAMD-17) Items | The HAMD-17 instrument consists of 17 items used to assess the severity of depression and its improvement during the course of therapy. This instrument is completed by the clinician based on his or her assessment of the participant. Each item was evaluated and scored using either a 5-point scale of 0 (not present) to 4 (very severe) or a 3-point scale of 0 (not present) to 2 (marked). The total score is the sum of the scores from HAMD-17 Items 1 through 17 and ranges from 0 (not at all depressed) to 52 (severely depressed). Higher scores indicate greater symptom severity. | All participants who received at least one dose of study drug, and had a baseline and at least one post-baseline HAMD-17 measurement. Last observation carried forward (LOCF) principle was used. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 48 weeks |
|
|
|
|
| 5 |
| 211 |
| 180 |
| 211 |
| Infectious peritonitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Limb traumatic amputation | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Thirst | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
Not provided
| Title | Measurements |
|---|---|
|
| ADHD Index Subscale Score |
|
P-value is for inattention subscale score.
| 95 |
| No |
| Superiority or Other |
| Paired t-test | <0.001 | P-value is for hyperactivity/impulsivity subscale score. | 95 | No | Superiority or Other |
| Paired t-test | <0.001 | P-value is for ADHD index subscale score. | 95 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
P-value is for behavioral regulation subscale score.
| 95 |
| No |
| Superiority or Other |
| Paired t-test | <0.001 | P-value is for metacognition subscale score. | 95 | No | Superiority or Other |
|
P-value is for behavioral regulation subscale score.
| 95 |
| No |
| Superiority or Other |
| Paired t-test | <0.001 | P-value is for metacognition subscale score. | 95 | No | Superiority or Other |