Post Marketing Surveillance Study To Observe Safety And Efficacy Of Champix® Tablets

Smoking Cessation Clinical Trial

Official title:

Post Marketing Surveillance Study To Observe Safety And Efficacy Of Champix® Tablets

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00483002
• Other study ID #: A3051083
• Status: Completed
• Phase: N/A
• First received: June 5, 2007
• Last updated: April 11, 2012
• Start date: June 2007
• Est. completion date: May 2011

Study information

• Verified date: April 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

To monitor use in real practice including safety and efficacy of Champix tablets 0.5mg, 1mg medication for 12 weeks in smokers

Description:

No sampling method will be applied to this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3719
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects selected for this study are those who would have been prescribed Champix tablets by the physician according to the subject's condition in usual clinical practice.

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• varenicline
As prescribed by physician in usual clinical practice.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With 7-day Point Prevalence From Week 3 to Less Than Week 7	Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No).	Week 3 through Week 7	No
Primary	Percentage of Participants With 7-day Point Prevalence From Week 7 to Less Than Week 11	Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No).	Week 7 through Week 11	No
Primary	Percentage of Participants With 7-day Point Prevalence for at Least Week 11	Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No).	At least Week 11	No

External Links

•   To obtain contact information for a study center near you, click here.