NCT01785147

Efficacy and Safety of BP1.4979 in Smoking Cessation

Randomized Placebo Controlled Trial Assessing the Efficacy and Safety of BP1.4979 in Smoking Cessation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 219 (actual)
• Sponsor: Bioprojet · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Tobacco Addiction

Interventions

Type	Name	Description
DRUG	BP1.4979	BP1.4979 at 3mg, 10mg, 15mg or placebo during 3 months.
DRUG	Placebo

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-07-01
• Completion: 2014-10-01
• First posted: 2013-02-07
• Last updated: 2015-01-21

Locations

1 site across 1 country: France