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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00483002
First received: June 5, 2007
Last updated: April 11, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention
Smoking Cessation
Drug: varenicline

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post Marketing Surveillance Study To Observe Safety And Efficacy Of Champix® Tablets

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With 7-day Point Prevalence From Week 3 to Less Than Week 7 [ Time Frame: Week 3 through Week 7 ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants With 7-day Point Prevalence From Week 7 to Less Than Week 11 [ Time Frame: Week 7 through Week 11 ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants With 7-day Point Prevalence for at Least Week 11 [ Time Frame: At least Week 11 ] [ Designated as safety issue: No ]
    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).


Enrollment: 3719
Study Start Date: June 2007
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy smokers Drug: varenicline
As prescribed by physician in usual clinical practice.
Other Name: Champix, Chantix, CP-526,555

Detailed Description:

No sampling method will be applied to this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00483002

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00483002     History of Changes
Other Study ID Numbers: A3051083
Study First Received: June 5, 2007
Results First Received: April 11, 2012
Last Updated: April 11, 2012
Health Authority: Korea: Food and Drug Administration

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:
Smoking
Habits
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014