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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002731-28 | EudraCT Number |
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Clinical study which aim is to assess in heavy smokers willing to quit smoking the efficacy and the safety profile of BP1.4979 for smoking cessation on the total abstinence measured by subject diary and confirmed by exhaled CO (abstinent < 10 ppm).
BP1.4979 is a novel compound with promising efficacy on smoker which have been assessed on phase I studies.
This is a multicenter,randomized, double blind, placebo controlled, phase IIb trial with parallel group to assess safety and efficacy of BP1.4979 in smoker.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BP1.4979 3mg | Experimental | BP1.4979 3mg during 3 months |
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| BP1.4979 10mg | Experimental | BP1.4979 10mg during 3 months |
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| BP1.4979 15mg | Experimental | BP1.4979 15mg during 3 months |
|
| Placebo | Placebo Comparator | Placebo during 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BP1.4979 | Drug | BP1.4979 at 3mg, 10mg, 15mg or placebo during 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 4-week prolonged abstinence from smoking cigarettes | The primary measure of efficacy will be 4-week prolonged abstinence from smoking cigarettes at the end of 12-week double-blind treatment phase (i.e. from V3 to V4). The continuous abstinence measured by subject diary and verified by exhaled CO (abstinent < 10 ppm) will define response to the treatment. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 7-day tobacco Point Prevalence Abstinence (PPA) | 7-day tobacco Point Prevalence Abstinence (PPA) will be assessed at each visit by analysis of cigarettes consumption using self-report diaries and measurement of exhaled CO | 7 days |
| Number of adverse events |
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Main inclusion Criteria:
Main exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henri-Jean AUBIN, MD, Ph.D | Hôpital Paul Brousse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Paul Brousse | Villejuif | Île-de-France Region | 94800 | France |
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| Placebo | Drug |
|
Assessment of safety thanks to the number and clinical evaluation of the adverse events. |
| 26 weeks |
| Vital signs measures | Vital signs (measurement of heart rate, blood pressure, and body weight) will be assessed at each study visit, thanks to physical examinations (V0 and V4), ECG and laboratory tests (blood chemistry, haematology, urinanalysis tests, prolactin dosage) at screening (V0), after 4-week treatment (V2) and at V4. | 26 weeks |