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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01106430 | Comparison of Lisdexamfetamine Dimesylate With Atomoxetine HCl in Attention-Deficit/Hyperactivity Disorder (ADHD) Subjects With an Inadequate Response to Methylphenidate | PHASE3 | COMPLETED | 267 | — | — | Jun 28, 2010 | Jul 19, 2012 | Jun 11, 2021 | 64 | United States, Belgium +8 |
Time to first response was defined as a Clinical Global Impression-Improvement (CGI-I) value of 1 (very much improved) or 2 (much improved) first recorded following first dose of investigational product. CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
| Arm | Type | Description |
|---|---|---|
| Lisdexamfetamine Dimesylate | EXPERIMENTAL | - |
| Atomoxetine Hydrochloride | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Lisdexamfetamine Dimesylate | DRUG | Oral 30, 50, or 70mg once-daily for 9 weeks |
| Atomoxetine Hydrochloride | DRUG | Oral 10mg to 100mg once-daily for 9 weeks |
Inclusion Criteria: * Subject has had an historical or current inadequate response to methylphenidate (MPH) treatment. Inadequate response includes but is not limited to the presence of some residual symptoms, with associated impairment inadequate duration of action and/or variability of symptom co...