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

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ClinicalTrials.gov Identifier: NCT00483002
Recruitment Status : Completed
First Posted : June 6, 2007
Results First Posted : May 11, 2012
Last Update Posted : May 11, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment
Smoking Cessation Drug: varenicline

Detailed Description:
No sampling method will be applied to this study.

Study Type : Observational
Actual Enrollment : 3719 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post Marketing Surveillance Study To Observe Safety And Efficacy Of Champix® Tablets
Study Start Date : June 2007
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Healthy smokers Drug: varenicline
As prescribed by physician in usual clinical practice.
Other Name: Champix, Chantix, CP-526,555




Primary Outcome Measures :
  1. Percentage of Participants With 7-day Point Prevalence From Week 3 to Less Than Week 7 [ Time Frame: Week 3 through 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).

  2. Percentage of Participants With 7-day Point Prevalence From Week 7 to Less Than Week 11 [ Time Frame: Week 7 through 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).

  3. Percentage of Participants With 7-day Point Prevalence for at Least Week 11 [ Time Frame: 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Healthy smokers
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00483002


Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00483002     History of Changes
Other Study ID Numbers: A3051083
First Posted: June 6, 2007    Key Record Dates
Results First Posted: May 11, 2012
Last Update Posted: May 11, 2012
Last Verified: April 2012

Keywords provided by Pfizer:
A prospective and observational program to monitor use in real practice including efficacy of Varenicline in Korea.

Additional relevant MeSH terms:
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs