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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00738595 | Phase II Study to Evaluate the Effectiveness of EVT 302 in Smoking Cessation. | PHASE2 | COMPLETED | 400 | — | — | Aug 1, 2008 | May 1, 2009 | May 29, 2009 | 9 | Germany |
| NCT00622752 | Effects of EVT 302 With or Without NRT on Craving and Withdrawal in Healthy Male Smokers Deprived of Cigarettes | PHASE2 | COMPLETED | 90 | — | — | Feb 1, 2008 | May 1, 2008 | Jun 17, 2008 | 1 | Germany |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | EVT 302, 5 mg once Daily |
| 2 | PLACEBO_COMPARATOR | Placebo once daily |
| 3 | EXPERIMENTAL | EVT 302 plus open label Nicotine replacement |
| 4 | ACTIVE_COMPARATOR | Placebo plus nicotine replacement therapy |
| Name | Type | Description |
|---|---|---|
| EVT 302 | DRUG | EVT 302 5 mg once daily |
| Placebo | DRUG | Placebo to match EVT 302, 5 mg |
| EVT 302 plus open label Nicotine replacement | DRUG | Double-blind EVT 302 plus open label nicotine replacement |
| Placebo plus open label Nicotine Replacement | DRUG | Double-blind placebo plus open label Nicotine replacement patch 21 mg once daily. |
| EVT 302, 10 mg | DRUG | 2 X EVT 302, 5 mg tablets |
| Nicotine replacement therapy (NRT) | DRUG | NRT patch containing 21 mg of nicotine |
| NRT placebo | DEVICE | Medically inert plaster cut to match the NRT plaster |
Inclusion Criteria: * Smoker of at least 10 cigarettes daily * Motivated to quit smoking * Reports at least one unsuccessful attempt to quit in the last 2 years * In generally good health * Provides written informed consent to participate in the sudy Exclusion Criteria: * Pregnant or nursing fema...