Varenicline (Champix®) Special Investigation (Regulatory Post Marketing Commitment Plan)

Completed

• Conditions: Smoking Cessation
• Interventions: Drug: varenicline

• Registration Number: NCT01061710
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to collect the efficacy and safety information in subjects who have been retreated with varenicline (Champix®) within 52 weeks of initial treatment for their appropriate use in daily practice and are participants for varenicline Drug Use Investigation protocol A3051109 ((NCT# NCT00772941).

Detailed Description

The subjects have been retreated with varenicline within 52 weeks, and subjects have been enrolled to varenicline Drug Use Investigation protocol A3051109.

Study Timeline

• Study First Submitted: 2010-02-01
• Study First Submitted QC: 2010-02-02
• Study First Posted: 2010-02-03
• Study Start: 2010-07
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2015-01
• Results First Submitted: 2015-01-27
• Results First Submitted QC: 2015-01-27
• Last Update Submitted: 2015-01-27
• Results First Posted: 2015-02-11
• Last Update Posted: 2015-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Male or Female subjects intend to quit tobacco use who are prescribed varenicline (Champix®) by their Physicians
• Subjects who are prescribed varenicline (Champix®) for the second time within 52 weeks of initial treatment.

Exclusion Criteria

Non-participants of varenicline (Champix®) Drug use Investigation protocol A3051109.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
varenicline (Champix®)	varenicline	Subjects who have been retreated with varenicline within 52 weeks and have been enrolled to varenicline protocol A3051109.

Primary Outcome Measures

Name	Time	Method
Number of Responders to Varenicline Treatment	24 weeks	Number of participants who succeeded in smoking cessation from 12 weeks through 24 weeks of the observation period.
Number of Participants With Treatment-Related Adverse Events (AEs)	24 weeks	An AE was any untoward medical occurrence attributed to veranicline in a participant who received veranicline. Treatment related adverse events were evaluated in company with the causal relationship to veranicline.

Secondary Outcome Measures

Name	Time	Method
Number of Treatment-Related Adverse Events (AEs) Unlisted in Japanese Package Insert	24 weeks	An AE was any untoward medical occurrence attributed to varenicline in a participant who received varenicline. Treatment related adverse events were evaluated in company with the causal relationship to veranicline.
Number of Participants With Risk Factors Likely to Affect the Frequency of Treatment-Related Adverse Events (AEs)	24 weeks
Number of Participants With Risk Factors Likely to Affect the Proportion of Responders	24 weeks