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

An observational study of Smoking Cessation, run by Pfizer.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Smoking Cessation
What is being tested?: varenicline
How many people: 3,719 participants
Where: No sites listed yet
Study dates: Jun 2007to May 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Healthy smokers

Who may be able to join

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.

Who cannot join

None

About this study

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

Read the detailed description

No sampling method will be applied to this study.

Conditions: Smoking Cessation
Being tested: varenicline
Keywords: A prospective and observational program to monitor use in real practice including efficacy of Varenicline in Korea.
Medical subject headings: Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

vareniclineDrug
Also called Champix, Chantix, CP-526,555
As prescribed by physician in usual clinical practice.

Study groups in NCT00483002
Study group	Role	What they receive
Healthy smokers		Not described Receives: Drug: varenicline

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Week 3 through Week 7
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).
Measured: Week 7 through Week 11
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).
Measured: At least Week 11

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2007May 2011

First posted6 Jun 2007 (estimated)
Study startJun 2007
Primary completionMay 2011
Study completionMay 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Smoking CessationStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 3,719 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00483002
Sponsor's protocol ID: A3051083
Status last verified: Apr 2012
First submitted: 5 Jun 2007
Last updated: 11 May 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Ock M, Shin JS, Ra SW. Safety and Effectiveness of Varenicline in Korean Smokers: A Nationwide Post-Marketing Surveillance Study. Patient Prefer Adherence. 2022 Feb 15;16:413-426. doi: 10.2147/PPA.S344757. eCollection 2022.
PubMed 35210758

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation

All Smoking Cessation trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post Marketing Surveillance Study To Observe Safety And Efficacy Of Champix® Tablets
ClinicalTrials.gov ID: NCT00483002
Acronym / sponsor ID: A3051083
Conditions: Smoking Cessation
Keywords: A prospective and observational program to monitor use in real practice including efficacy of Varenicline in Korea.
Study type: Observational
Recruitment status: Completed
Enrolment: 3,719 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jun 2007
Primary completion: May 2011 (actual)
Study completion: May 2011 (actual)
First posted: 6 Jun 2007 (estimated)
Results: Posted 11 May 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

No sampling method will be applied to this study.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Healthy smokers	–	Drug: varenicline

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Healthy smokers

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
vareniclineAlso: Champix, Chantix, CP-526,555As prescribed by physician in usual clinical practice.	Drug	Healthy smokers

Primary outcome

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).
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).
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).

Results and safety

Results posted to the registry on 11 May 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Varenicline	3,719	1,165

Primary outcome: Percentage of Participants With 7-day Point Prevalence From Week 3 to Less Than Week 7

Time frame: Week 3 through Week 7. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Varenicline n = 2922
Value	59.55 (57.77 to 61.33)

Population analysed: Study population included all those participants who received the study medication more than once and were available for follow up. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.

Primary outcome: Percentage of Participants With 7-day Point Prevalence From Week 7 to Less Than Week 11

Time frame: Week 7 through Week 11. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Varenicline n = 1520
Value	73.29 (71.07 to 75.51)

Primary outcome: Percentage of Participants With 7-day Point Prevalence for at Least Week 11

Time frame: At least Week 11. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Varenicline n = 1449
Value	77.02 (74.85 to 79.18)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Varenicline	4 of 3,719 (0.1%)	342 of 3,719 (9.2%)	Not reported

Limitations and caveats (from the sponsor): Planned observation time points at 4, 8 and 12 weeks were reported as from week 3 to less than week 7, from week 7 to less than week 11, at least week 11. As this is non-interventional study it is likely that adverse events had been under reported.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35210758Ock M, Shin JS, Ra SW. Safety and Effectiveness of Varenicline in Korean Smokers: A Nationwide Post-Marketing Surveillance Study. Patient Prefer Adherence. 2022 Feb 15;16:413-426. doi: 10.2147/PPA.S344757. eCollection 2022.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Smoking Cessation

Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

Questions about this trial

What is this clinical trial studying?

An observational study of Smoking Cessation, run by Pfizer.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2012. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With 7-day Point Prevalence From Week 3 to Less Than Week 7 (time frame: Week 3 through Week 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00483002, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2012.