Post Marketing Surveillance Study To Observe Safety And Efficacy Of Champix® Tablets
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00483002
First received: June 5, 2007
Last updated: April 11, 2012
Last verified: April 2012
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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 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 May 23, 2013