Efficacy and Safety of Varenicline in Smokers With Cardiovascular Disease Who Wish to Quit Smoking

A Phase 3 study testing Varenicline in people with Smoking Cessation, run by Pfizer at 39 sites in 15 countries.

Completed

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

Trial summary

The primary purpose of this study is to determine whether or not varenicline will help people with cardiovascular disease quit smoking and to confirm it is safe in these patients. Read more about this study

Who is it for?: Ages 35 to 75 years
Conditions the study is for: Smoking Cessation
What is being tested?: Varenicline
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 714 participants
Where: 39 sitesin 15 countries
Study dates: Feb 2006to Aug 2008
Phase: Phase 3
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 35 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants must have stable, documented cardiovascular disease (including at least one of the following diagnosed > 2 months prior to the Screening visit - angina, myocardial infarction (MI), revascularization, transient ischemic attack (TIA), and peripheral vascular disease (PVD).
Participants that smoke > 10 cigarettes / day.

Who cannot join

Participants with unstable cardiovascular disease
Cardiovascular events in the past 2 months
Moderate or severe chronic obstructive pulmonary disease (COPD)

Trial locations and contacts

39 sites in 15 countries.

Country

City, postcode or hospital

39 sites in 15 countries

Canada4 sites

Pfizer Investigational Site
Drummondville, Quebec, J2B 7T1
Pfizer Investigational Site
London, Ontario, N6C 5J1
Pfizer Investigational Site
Ottawa, Ontario, K1Y 4W7
Pfizer Investigational Site
Québec, Quebec, G1V 4M6

Other trials in Canada

South Korea4 sites

Pfizer Investigational Site
Seoul, Korea, 152-703
Pfizer Investigational Site
Seoul, 110-799
Pfizer Investigational Site
Seoul, 135-720
Pfizer Investigational Site
Seoul, 138-736

Other trials in South Korea

United Kingdom4 sites

Pfizer Investigational Site
Bradford, West Yorkshire, BD9 6RJ
Pfizer Investigational Site
Carshalton, Surrey, SM5 1AA
Pfizer Investigational Site
Leicester, LE1 5WW
Pfizer Investigational Site
Paisley, PA2 9PN

Other trials in United Kingdom

United States3 sites

Pfizer Investigational Site
Boston, Massachusetts, 02114
Pfizer Investigational Site
Hartford, Connecticut, 06102-5037
Pfizer Investigational Site
Madison, Wisconsin, 53711

Other trials in United States

France3 sites

Pfizer Investigational Site
Caen, 14033
Pfizer Investigational Site
Marseille, 13015
Pfizer Investigational Site
Toulouse, 31059

Other trials in France

Germany3 sites

Pfizer Investigational Site
Berlin, 10787
Pfizer Investigational Site
Göttingen, 37075
Pfizer Investigational Site
Tübingen, 72076

Other trials in Germany

Argentina2 sites

Pfizer Investigational Site
Capital Federal, Buenos Aires, 1181
Pfizer Investigational Site
Ciudad de Buenos Aires, Buenos Aires, 1221

Other trials in Argentina

Australia2 sites

Pfizer Investigational Site
Concord, New South Wales, 2139
Pfizer Investigational Site
Herston, Queensland, 4029

Other trials in Australia

Brazil2 sites

Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90610-000
Pfizer Investigational Site
São Paulo, São Paulo, 05403-904

Other trials in Brazil

Czechia2 sites

Pfizer Investigational Site
Brno, 625 00
Pfizer Investigational Site
Prague, 120 00

Other trials in Czechia

Denmark2 sites

Pfizer Investigational Site
Aarhus C, DK-8000
Pfizer Investigational Site
Hellerup, DK-2900

Other trials in Denmark

Greece2 sites

Pfizer Investigational Site
Athens, 11528
Pfizer Investigational Site
Pireaus, 18526

Other trials in Greece

Mexico2 sites

Pfizer Investigational Site
Monterrey, Nuevo León
Pfizer Investigational Site
Tlalpan, Mexico City, 14080

Other trials in Mexico

Netherlands2 sites

Pfizer Investigational Site
Amsterdam, 1066 EC
Pfizer Investigational Site
Zuthpen, 7207 BA

Other trials in Netherlands

Taiwan2 sites

Pfizer Investigational Site
Taipei, Taiwan, 11217
Pfizer Investigational Site
Tau-Yuan Hsien, 333

Other trials in Taiwan

About this study

Official title: A 12-Week, Double-Blind, Placebo-Controlled, Multicenter Study With A 40 Week Follow Up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 Milligram (Mg) Twice Daily (BID) for Smoking Cessation in Subjects With Cardiovascular Disease

The primary purpose of this study is to determine whether or not varenicline will help people with cardiovascular disease quit smoking and to confirm it is safe in these patients.

Conditions: Smoking Cessation
Being tested: placebo, Varenicline
Medical subject headings: Smoking Cessation

What participants receive

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

placeboDrug
1 mg placebo twice daily by mouth for 12 weeks
VareniclineDrug
Also called Chantix, Champix
1 mg twice daily by mouth for 12 weeks

Study groups in NCT00282984
Study group	Role	What they receive
placebo	Placebo comparator	Not described Receives: Drug: placebo
varenicline	Experimental	Not described Receives: Drug: Varenicline

What is being measured

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

Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt)
Participants considered Responders (4-week CQR <=10 parts per million <ppm>) through reports of cigarette or other nicotine use since last study visit, confirmed by measurement of end-expiratory exhaled carbon monoxide (CO). If any CO measurement at a particular timepoint was >10 ppm, subject was considered to be Non-Responder at that timepoint.
Measured: weeks 9 through 12

Secondary outcomes (9)

Number of Responders With Continuous Abstinence (CA) Through Week 52
Responders: participants who remained abstinent based on 'since the last contact' question in Nicotine Use Inventory 1) "Has participant smoked any cigarettes (even a puff) since last contact?" = No AND 2) "Has participant used any other tobacco products… since last contact?" = No. Participant a non-responder if expired CO > 10 ppm.
Measured: Week 9 through Week 52
Number of Long-Term Quit Responders
Responders: participants were considered Long Term Quit responders if 1) they were responders for the primary endpoint (the 4-week CQR for Weeks 9-12) and 2) had no more than 6 days of smoking from Week 12 through the given visit.
Measured: Week 9 through Week 52
Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 12
Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) "Has the participant smoked any cigarettes in the last 7 days?" = No AND 2) "Has the participant used any other tobacco products in the last 7 days?" = No. Participant a non-responder if expired CO > 10 ppm.
Measured: Week 12
Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 24
Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) "Has the participant smoked any cigarettes in the last 7 days?" = No AND 2) "Has the participant used any other tobacco products in the last 7 days?" = No. Participant a non-responder if expired CO > 10 ppm.
Measured: Week 24
Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 52
Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) "Has the participant smoked any cigarettes in the last 7 days?" = No AND 2) "Has the participant used any other tobacco products in the last 7 days?" = No. Participant a non-responder if expired CO > 10 ppm.
Measured: Week 52
Number of Participants With a 4 Week Point Prevalence of Smoking Cessation
Responders: participants with abstinence during the last 4 weeks of non-treatment based on answering 'no' to both of the two 'last 4 week' questions in the Nicotine Use Inventory (NUI). NUI collected information of cigarette or other nicotine use during the study.
Measured: Week 48 through Week 52 (final 4 weeks of non-treatment period [pd])
Number of Responders With Continuous Abstinence (CA) Through Week 24
Responders: participants who remained abstinent based on 'since the last contact' question in Nicotine Use Inventory 1) "Has participant smoked any cigarettes (even a puff) since the last contact?" = No AND 2) "Has participant used any other tobacco products… since the last contact?" = No. Non- responder if the expired CO > 10 ppm at any given timepoint.
Measured: Week 9 through Week 24
Cigarettes Smoked Per Day
Cigarettes smoked each day during the first 3 weeks of the treatment phase.
Measured: Day 21
Number of Long-Term Quit Responders From Week 9 Through Week 24
Responders: participants were considered Long Term Quit Responders if 1) they were responders for the primary endpoint (the 4-week CQR for Weeks 9-12) and 2) had no more than 6 days of smoking from Week 12 through the given visit.
Measured: Week 9 through Week 24

Timeline

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

Feb 2006Aug 2008

First posted27 Jan 2006 (estimated)
Study startFeb 2006
Primary completionNov 2007
Study completionAug 2008

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 (2)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: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 714 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00282984
Sponsor's protocol ID: A3051049
Status last verified: Mar 2017
First submitted: 26 Jan 2006
Last updated: 5 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
PubMed 37142273
Rigotti NA, Pipe AL, Benowitz NL, Arteaga C, Garza D, Tonstad S. Efficacy and safety of varenicline for smoking cessation in patients with cardiovascular disease: a randomized trial. Circulation. 2010 Jan 19;121(2):221-9. doi: 10.1161/CIRCULATIONAHA.109.869008. Epub 2010 Jan 4.
PubMed 20048210

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?

See locations

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 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 12-Week, Double-Blind, Placebo-Controlled, Multicenter Study With A 40 Week Follow Up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 Milligram (Mg) Twice Daily (BID) for Smoking Cessation in Subjects With Cardiovascular Disease
ClinicalTrials.gov ID: NCT00282984
Acronym / sponsor ID: A3051049
Conditions: Smoking Cessation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 714 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Feb 2006
Primary completion: Nov 2007 (actual)
Study completion: Aug 2008 (actual)
First posted: 27 Jan 2006 (estimated)
Results: Posted 29 Apr 2009

Clinical summary

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

The primary purpose of this study is to determine whether or not varenicline will help people with cardiovascular disease quit smoking and to confirm it is safe in these patients.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
placebo	Placebo comparator	Drug: placebo
varenicline	Experimental	Drug: Varenicline

Who may qualify

Ages: 35 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Participants must have stable, documented cardiovascular disease (including at least one of the following diagnosed > 2 months prior to the Screening visit - angina, myocardial infarction (MI), revascularization, transient ischemic attack (TIA), and peripheral vascular disease (PVD).
Participants that smoke > 10 cigarettes / day.

Key exclusion criteria (3 listed)

Participants with unstable cardiovascular disease
Cardiovascular events in the past 2 months
Moderate or severe chronic obstructive pulmonary disease (COPD)

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
placebo1 mg placebo twice daily by mouth for 12 weeks	Drug	placebo
VareniclineAlso: Chantix, Champix1 mg twice daily by mouth for 12 weeks	Drug	varenicline

Primary outcome

Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt)
Time frame: weeks 9 through 12
Participants considered Responders (4-week CQR <=10 parts per million <ppm>) through reports of cigarette or other nicotine use since last study visit, confirmed by measurement of end-expiratory exhaled carbon monoxide (CO). If any CO measurement at a particular timepoint was >10 ppm, subject was considered to be Non-Responder at that timepoint.

9 secondary outcomes

Number of Responders With Continuous Abstinence (CA) Through Week 52
Time frame: Week 9 through Week 52
Number of Long-Term Quit Responders
Time frame: Week 9 through Week 52
Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 12
Time frame: Week 12
Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 24
Time frame: Week 24
Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 52
Time frame: Week 52
Number of Participants With a 4 Week Point Prevalence of Smoking Cessation
Time frame: Week 48 through Week 52 (final 4 weeks of non-treatment period [pd])
Number of Responders With Continuous Abstinence (CA) Through Week 24
Time frame: Week 9 through Week 24
Cigarettes Smoked Per Day
Time frame: Day 21
Number of Long-Term Quit Responders From Week 9 Through Week 24
Time frame: Week 9 through Week 24

Results and safety

Results posted to the registry on 29 Apr 2009, 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 (Var)	353	302
Placebo (Pbo)	350	289

Primary outcome: Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt)

Time frame: weeks 9 through 12. Number. Unit: participants

Measure	Varenicline (Var) n = 353	Placebo (Pbo) n = 350
responders	167	50
non-responders	186	300

Varenicline (Var) vs Placebo (Pbo): Odds Ratio (OR): 6.05 (95% CI 4.13 to 8.86), p <0.0001, Regression, Logistic

Population analysed: Primary analysis population (Modified Intent-to-Treat) included all participants who took at least 1 dose randomized study medication. Participants who discontinued study were assumed smokers from timepoint of discontinuation through end of study. Modified Intent-to-Treat population is referred to as "All Participants" population in this report.

9 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Varenicline (Var)	23 of ?	253 of ?	Not reported
Placebo (Pbo)	21 of ?	179 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37142273Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
Derived from this study: PubMed 20048210Rigotti NA, Pipe AL, Benowitz NL, Arteaga C, Garza D, Tonstad S. Efficacy and safety of varenicline for smoking cessation in patients with cardiovascular disease: a randomized trial. Circulation. 2010 Jan 19;121(2):221-9. doi: 10.1161/CIRCULATIONAHA.109.869008. Epub 2010 Jan 4.
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

39 sites in 15 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Varenicline in people with Smoking Cessation, run by Pfizer at 39 sites in 15 countries.

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 2 inclusion and 3 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 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in Canada, South Korea, United Kingdom, United States, France and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Apr 2009). 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?

Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) (time frame: weeks 9 through 12). 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 NCT00282984, which also lists 2 linked publications.

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 5 Apr 2017.