We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00282984
First Posted: January 27, 2006
Last Update Posted: April 5, 2017
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.
Information provided by:
Pfizer
January 26, 2006
January 27, 2006
February 13, 2009
April 29, 2009
April 5, 2017
February 2006
November 2007   (Final data collection date for 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 ]
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.
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.
Complete list of historical versions of study NCT00282984 on ClinicalTrials.gov Archive Site
  • 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.
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.
Not Provided
Not Provided
 
Efficacy and Safety of Varenicline in Smokers With Cardiovascular Disease Who Wish to Quit Smoking
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Smoking Cessation
  • 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
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
  • Experimental: varenicline
    Intervention: Drug: Varenicline
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.
 
Completed
714
August 2008
November 2007   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
35 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Brazil,   Canada,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Korea, Republic of,   Mexico,   Netherlands,   Taiwan,   United Kingdom,   United States
 
 
NCT00282984
A3051049
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2017

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