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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 October 16, 2014