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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00282984
Recruitment Status : Completed
First Posted : January 27, 2006
Results First Posted : April 29, 2009
Last Update Posted : April 5, 2017
Sponsor:
Information provided by:
Pfizer

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: placebo Drug: Varenicline Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 714 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : February 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Chantix, Champix


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Cigarettes Smoked Per Day [ Time Frame: Day 21 ]
    Cigarettes smoked each day during the first 3 weeks of the treatment phase.

  9. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00282984


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov Identifier: NCT00282984    
Other Study ID Numbers: A3051049
First Posted: January 27, 2006    Key Record Dates
Results First Posted: April 29, 2009
Last Update Posted: April 5, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Cardiovascular Diseases
Varenicline
Nicotinic Agonists
Cholinergic Agonists
 Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs