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

March 7, 2017 updated by: Pfizer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

714

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, 1181
        • Pfizer Investigational Site
      • Ciudad de Buenos Aires, Buenos Aires, Argentina, 1221
        • Pfizer Investigational Site
  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Pfizer Investigational Site
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Pfizer Investigational Site
  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90610-000
        • Pfizer Investigational Site
    • SP
      • São Paulo, SP, Brazil, 05403-904
        • Pfizer Investigational Site
  • Canada
      • Quebec, Canada, G1V 4M6
        • Pfizer Investigational Site
    • Ontario
      • London, Ontario, Canada, N6C 5J1
        • Pfizer Investigational Site
      • Ottawa, Ontario, Canada, K1Y 4W7
        • Pfizer Investigational Site
    • Quebec
      • Drummondville, Quebec, Canada, J2B 7T1
        • Pfizer Investigational Site
  • Czech Republic
      • Brno, Czech Republic, 625 00
        • Pfizer Investigational Site
      • Praha 2, Czech Republic, 120 00
        • Pfizer Investigational Site
  • Denmark
      • Aarhus C, Denmark, DK-8000
        • Pfizer Investigational Site
      • Hellerup, Denmark, DK-2900
        • Pfizer Investigational Site
  • France
      • Caen, France, 14033
        • Pfizer Investigational Site
      • Marseille, France, 13015
        • Pfizer Investigational Site
      • Toulouse Cedex, France, 31059
        • Pfizer Investigational Site
  • Germany
      • Berlin, Germany, 10787
        • Pfizer Investigational Site
      • Goettingen, Germany, 37075
        • Pfizer Investigational Site
      • Tuebingen, Germany, 72076
        • Pfizer Investigational Site
  • Greece
      • Athens, Greece, 11528
        • Pfizer Investigational Site
      • Pireaus, Greece, 18526
        • Pfizer Investigational Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 110-799
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 135-720
        • Pfizer Investigational Site
    • Korea
      • Seoul, Korea, Korea, Republic of, 152-703
        • Pfizer Investigational Site
  • Mexico
    • Mexico D.F.
      • Tlalpan, Mexico D.F., Mexico, 14080
        • Pfizer Investigational Site
    • Nuevo León
      • Monterrey, Nuevo León, Mexico
        • Pfizer Investigational Site
  • Netherlands
      • Amsterdam, Netherlands, 1066 EC
        • Pfizer Investigational Site
      • Zuthpen, Netherlands, 7207 BA
        • Pfizer Investigational Site
  • Taiwan
      • Taipei, Taiwan, 11217
        • Pfizer Investigational Site
      • Tau-Yuan Hsien, Taiwan, 333
        • Pfizer Investigational Site
  • United Kingdom
      • Leicester, United Kingdom, LE1 5WW
        • Pfizer Investigational Site
      • Paisley, United Kingdom, PA2 9PN
        • Pfizer Investigational Site
    • Surrey
      • Carshalton, Surrey, United Kingdom, SM5 1AA
        • Pfizer Investigational Site
    • West Yorkshire
      • Bradford, West Yorkshire, United Kingdom, BD9 6RJ
        • Pfizer Investigational Site
  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06102-5037
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Pfizer Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53711
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: placebo
1 mg placebo twice daily by mouth for 12 weeks
Experimental: varenicline
Drug: Varenicline
1 mg twice daily by mouth for 12 weeks
Other Names:
  • Chantix, Champix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
weeks 9 through 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Responders With Continuous Abstinence (CA) Through Week 52
Time Frame: Week 9 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.
Week 9 through Week 52
Number of Long-Term Quit Responders
Time Frame: Week 9 through Week 52
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.
Week 9 through Week 52
Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 12
Time Frame: 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.
Week 12
Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 24
Time Frame: 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.
Week 24
Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 52
Time Frame: 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.
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])
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.
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
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.
Week 9 through Week 24
Cigarettes Smoked Per Day
Time Frame: Day 21
Cigarettes smoked each day during the first 3 weeks of the treatment phase.
Day 21
Number of Long-Term Quit Responders From Week 9 Through Week 24
Time Frame: 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.
Week 9 through Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

January 26, 2006

First Submitted That Met QC Criteria

January 26, 2006

First Posted (Estimate)

January 27, 2006

Study Record Updates

Last Update Posted (Actual)

April 5, 2017

Last Update Submitted That Met QC Criteria

March 7, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3051049

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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