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| ID | Type | Description | Link |
|---|---|---|---|
| B4Z-UT-S003 |
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The primary purpose of this study is to evaluate the tolerability and effectiveness of atomoxetine in the treatment of attention problems, hyperactivity, and impulsivity in children with ASD, and secondarily, to evaluate the possible response to atomoxetine on the core symptoms of ASD
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atomoxetine Hydrochloride | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Test whether atomoxetine is effective in reducing symptoms of inattention and overactivity/impulsivity as measured by the AHDHRS-IV-Parent:Inv scale in pediatric outpatients with ASD accompanied by ADHD behavior problems |
| Measure | Description | Time Frame |
|---|---|---|
| To assess whether atomoxetine will be effective in reducing symptoms of inattention and overactivity/impulsivity | ||
| To assess whether atomoxetine will be effective for improving social functioning and personal sufficiency in children and adolescents with ASD+ADHD |
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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 | Groningen |
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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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| To assess whether atomoxetine has a positive or negative effect on frequently associated symptoms as impulsive aggression, agitation, self-injurious behavior, troublesome repetitive behavior and poor motor coordination |
| To assess whether atomoxetine has a positive or negative effect on neuropsychological functioning |
| To assess the overall influence on functioning and burden on the family |
| To monitor clinical safety and side effects as assessed by adverse events elicited during open-ended questioning |
| Netherlands |