A Multi-National Study To Assess How Effective And Safe The Smoking Cessation Medicine Varenicline Is In Smokers Who Have Already Tried Varenicline In The Past As A Prescription Medicine From Their Usual Healthcare Provider

Pfizer

Status and phase

Completed

Phase 4

Conditions

Smoking Cessation

Treatments

Drug: Varenicline

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01244061

A3051139

Details and patient eligibility

About

The main purpose of this study is to compare the effectiveness and safety of the re-treatment of smokers with varenicline with placebo for smoking cessation during the last 4 weeks of a 12 week course of treatment. The study will also assess whether smokers remain abstinent at Week 24 (12 weeks after the end of treatment) and Week 52 (40 weeks after the end of treatment).

Enrollment

498 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Smokers aged 18 years or above and wanting to stop smoking
Smokers who have smoked an average of at least 10 cigarettes per day over the last 4 weeks
Smokers who have tried before to stop smoking at least once with varenicline, and who took varenicline for at least 2 weeks
The last attempt to stop smoking must be at least 3 months before entering the study

Exclusion criteria

Individuals who have not tolerated varenicline well previously, or who have a current or prior medical or psychiatric history that would make entry into the trial inadvisable
Individuals who have previously participated in clinical trials of varenicline
Individuals who have been participating in another smoking cessation trial within the last 3 months, or other drug trial within the last 30 days