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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

Tracking Information
First Submitted Date  ICMJE January 26, 2006
First Posted Date  ICMJE January 27, 2006
Results First Submitted Date  ICMJE February 13, 2009
Results First Posted Date  ICMJE April 29, 2009
Last Update Posted Date April 5, 2017
Study Start Date  ICMJE February 2006
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2009)		 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 26, 2006)		 The primary outcome is the comparison of 12 weeks of treatment with varenicline to placebo for smoking cessation in subjects with cardiovascular disease. Continuous abstinence from weeks 9 to 52 will also be compared.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2009)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Cigarettes Smoked Per Day [ Time Frame: Day 21 ]
    Cigarettes smoked each day during the first 3 weeks of the treatment phase.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2006)		 Secondary outcomes include other short and long-term efficacy endpoints and safety data in subjects with cardiovascular disease treated for 12 weeks with varenicline or placebo and followed for a 40 week nontreatment period.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Varenicline in Smokers With Cardiovascular Disease Who Wish to Quit Smoking
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • Drug: placebo
    1 mg placebo twice daily by mouth for 12 weeks
  • Drug: Varenicline
    1 mg twice daily by mouth for 12 weeks
    Other Name: Chantix, Champix
Study Arms  ICMJE
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
  • Experimental: varenicline
    Intervention: Drug: Varenicline
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 17, 2009)		 714
Original Enrollment  ICMJE
 (submitted: January 26, 2006)		 700
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Brazil,   Canada,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Korea, Republic of,   Mexico,   Netherlands,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00282984
Other Study ID Numbers  ICMJE A3051049
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Director, Clinical Trial Disclosure Group, Pfizer
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Pfizer
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP