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).
The subjects have been retreated with varenicline within 52 weeks, and subjects have been enrolled to varenicline Drug Use Investigation protocol A3051109.
Study Type
OBSERVATIONAL
Enrollment
20
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.
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.
Time frame: 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.
Time frame: 24 weeks
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.
Time frame: 24 weeks
Number of Participants With Risk Factors Likely to Affect the Frequency of Treatment-Related Adverse Events (AEs)
Time frame: 24 weeks
Number of Participants With Risk Factors Likely to Affect the Proportion of Responders
Time frame: 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.