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

Study Overview
=================
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.

Official Title
-----------------
Champix Tablets Special Investigation -Retrospective Survey For Subjects Who Have Been Retreated With Champix.-(Regulatory Post Marketing Commitment Plan).

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Drug: varenicline


Participation Criteria
=================
Eligibility Criteria
-----------------
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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| varenicline (Champix®)<br>Subjects who have been retreated with varenicline within 52 weeks and have been enrolled to varenicline protocol A3051109. | Drug: varenicline<br>* Dosage form: tablet 0.5mg, tablet 1mg. The usual adult dosage for oral use is 0.5 mg once daily after eating on Days 1 to 3; 0.5 mg twice daily after eating in the morning and evening on Days 4 to 7, and 1 mg twice daily after eating in the morning and evening on Day 8 and thereafter. The drug should be administered to subjects for 12 weeks.<br>* Other names: Chantix, Champix;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-Related Adverse Events (AEs) | 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. | 24 weeks | 
| Number of Responders to Varenicline Treatment | Number of participants who succeeded in smoking cessation from 12 weeks through 24 weeks of the observation period. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Treatment-Related Adverse Events (AEs) Unlisted in Japanese Package Insert | 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. | 24 weeks | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Smoking, smoking cessation, Japanese, varenicline, retreatment, Regulatory Post Marketing Commitment Plan