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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00880217 | A Study to Evaluate 3 Different Doses of JNJ-31001074 in the Treatment of Adults With Attention-Deficit/Hyperactivity Disorder (ADHD) | PHASE2 | COMPLETED | 430 | — | — | May 1, 2009 | Jan 1, 2010 | Mar 4, 2013 | 35 | United States |
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | JNJ-31001074 1 mg/d 1-mg capsule once daily for 42 days |
| 002 | EXPERIMENTAL | JNJ-31001074 3 mg/d 3-mg capsule once daily for 42 days |
| 003 | EXPERIMENTAL | JNJ-31001074 10 mg/d 10-mg capsule once daily for 42 days |
| 004 | ACTIVE_COMPARATOR | Atomoxetine 80 mg/d 40-mg capsule for 3 days followed by 80-mg capsule once daily for 39 days |
| 005 | ACTIVE_COMPARATOR | OROS methylphenidate HCl 54 mg/d 36-mg capsule for 3 days followed by 54-mg capsule once daily for 39 days |
| 006 | PLACEBO_COMPARATOR | Placebo capsule once daily for 42 days |
| Name | Type | Description |
|---|---|---|
| Atomoxetine 80 mg/d | DRUG | 40-mg capsule for 3 days, followed by 80-mg capsule once daily for 39 days |
| Placebo | DRUG | Placebo capsule once daily for 42 days |
| OROS methylphenidate HCl 54 mg/d | DRUG | 36-mg capsule for 3 days, followed by 54-mg capsule once daily for 39 days |
| JNJ-31001074 3 mg/d | DRUG | 3-mg capsule once daily for 42 days |
| JNJ-31001074 1 mg/d | DRUG | 1-mg capsule once daily for 42 days |
| JNJ-31001074 10 mg/d | DRUG | 10-mg capsule once daily for 42 days |
Inclusion Criteria: * Patients diagnosed with ADHD, confirmed with the Conners Adult ADHD Diagnostic Interview for Diagnostic and Statistical Manual, 4th edition (DSM-IV) (CAADID) * Patients who meet the cutoff scores for the Conners Adult ADHD Rating Scale (CAARS-S:SV) * Patients with a Clinical G...