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The purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for children with Attention-Deficit/Hyperactivity Disorder or ADHD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Lowest ABT-089 dose |
|
| 2 | Experimental | Low-medium ABT-089 dose |
|
| 3 | Experimental | Medium-high ABT-089 dose |
|
| 4 | Experimental | Highest ABT-089 dose |
|
| 5 | Active Comparator | atomoxetine |
|
| 6 | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-089 | Drug | Subjects will take 0.5 and 1 and/or 5 and/or 10 mg ABT-089 tablets (actual dose based on weight) once daily for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| ADHD-RS-IV (HV) - Administered by study doctor | Screening, Day -1, Day 7, Day 14, Day 28, Day 42, Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Health Outcomes Measurements | Baseline to Final Evaluation of 8-week treatment period | |
| Clinical Global Impression-ADHD-Severity Scale | Baseline to Final Evaluation of 8-week treatment period | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Gault, MD, PhD, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 5999 | Little Rock | Arkansas | 72205 | United States | ||
| Site Reference ID/Investigator# 5979 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21156272 | Derived | Wilens TE, Gault LM, Childress A, Kratochvil CJ, Bensman L, Hall CM, Olson E, Robieson WZ, Garimella TS, Abi-Saab WM, Apostol G, Saltarelli MD. Safety and efficacy of ABT-089 in pediatric attention-deficit/hyperactivity disorder: results from two randomized placebo-controlled clinical trials. J Am Acad Child Adolesc Psychiatry. 2011 Jan;50(1):73-84.e1. doi: 10.1016/j.jaac.2010.10.001. Epub 2010 Nov 25. |
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| atomoxetine | Drug | Subjects will take 10, and/or 18 and/or 25 mg atomoxetine tablets once daily for 8 weeks. |
|
| placebo | Drug | Subject will take a tablet once daily for 8 weeks |
|
| Parent Rating Scales |
| Baseline to Final Evaluation of 8-week treatment period |
| Teacher Rating Scale | Baseline to Final Evaluation of 8-week treatment period |
| El Centro |
| California |
| 92243 |
| United States |
| Site Reference ID/Investigator# 5986 | Boulder | Colorado | 80304 | United States |
| Site Reference ID/Investigator# 5993 | Bradenton | Florida | 34208 | United States |
| Site Reference ID/Investigator# 5995 | Jacksonville | Florida | 32216 | United States |
| Site Reference ID/Investigator# 5977 | Orlando | Florida | 32806 | United States |
| Site Reference ID/Investigator# 5981 | Northbrook | Illinois | 60062 | United States |
| Site Reference ID/Investigator# 5982 | Overland Park | Kansas | 66212 | United States |
| Site Reference ID/Investigator# 5992 | Omaha | Nebraska | 68198 | United States |
| Site Reference ID/Investigator# 5997 | Las Vegas | Nevada | 89128 | United States |
| Site Reference ID/Investigator# 5987 | Clementon | New Jersey | 08021 | United States |
| Site Reference ID/Investigator# 5996 | Eugene | Oregon | 97401 | United States |
| Site Reference ID/Investigator# 5984 | Portland | Oregon | 97210 | United States |
| Site Reference ID/Investigator# 5980 | Salem | Oregon | 97301 | United States |
| Site Reference ID/Investigator# 5994 | Charleston | South Carolina | 29405 | United States |
| Site Reference ID/Investigator# 5976 | Memphis | Tennessee | 38119 | United States |
| Site Reference ID/Investigator# 6000 | Austin | Texas | 78756 | United States |
| Site Reference ID/Investigator# 5998 | Herndon | Virginia | 20170 | United States |
| Site Reference ID/Investigator# 5978 | Bellevue | Washington | 98007 | United States |
| Site Reference ID/Investigator# 5983 | Middleton | Wisconsin | 53562 | United States |
| 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 |
|---|---|
| C108326 | pozanicline |
| D000069445 | Atomoxetine Hydrochloride |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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