Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00686933 | Long Term Safety and Tolerability Study of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD) | PHASE2 | COMPLETED | 117 | — | — | May 1, 2008 | Oct 1, 2008 | Jan 21, 2013 | 12 | United States |
| NCT00640185 | Safety, Tolerability and Efficacy Study of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD) | PHASE2 | COMPLETED | 160 | — | — | Mar 1, 2008 | Aug 1, 2008 | Jan 18, 2013 | 12 | United States |
| NCT00640419 | Safety and Tolerability Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) | PHASE2 | COMPLETED | 121 | — | — | Mar 1, 2008 | Jul 1, 2008 | Jan 18, 2013 | 13 | United States |
| NCT00528697 | A Safety and Efficacy Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) | PHASE2 | COMPLETED | 278 | — | — | Sep 1, 2007 | Apr 1, 2008 | Jan 29, 2013 | 20 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | EXPERIMENTAL | - |
| 4 | EXPERIMENTAL | Highest ABT-089 dose |
| 5 | ACTIVE_COMPARATOR | atomoxetine |
| 6 | PLACEBO_COMPARATOR | placebo |
| Name | Type | Description |
|---|---|---|
| ABT-089 | DRUG | Subjects will take up to 80 mg daily for 24 months |
| Placebo | DRUG | Subjects will take one or two placebos once daily for the duration of the study. |
| atomoxetine | DRUG | Subjects will take 10, and/or 18 and/or 25 mg atomoxetine tablets once daily for 8 weeks. |
Inclusion Criteria: * The subject was randomized into Study M10-346 and completed the study. * Female subjects of childbearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements. * Male subjects must agree to ...