Efficacy and Safety of Varenicline in Smokers With Cardiovascular Disease Who Wish to Quit Smoking
- Registration Number
- NCT00282984
- Lead Sponsor
- Pfizer
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 714
- 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.
- Participants with unstable cardiovascular disease
- Cardiovascular events in the past 2 months
- Moderate or severe chronic obstructive pulmonary disease (COPD)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo - varenicline Varenicline -
- Primary Outcome Measures
Name Time Method Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) 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
Name Time Method Number of Responders With Continuous Abstinence (CA) Through Week 52 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 Participants With a Seven-Day Point Prevalence of Abstinence at Week 12 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 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 4 Week Point Prevalence of Smoking Cessation 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 Long-Term Quit Responders 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 52 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 Responders With Continuous Abstinence (CA) Through Week 24 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 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 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.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇬🇧Paisley, United Kingdom