Phase 3
Completed N=703
Efficacy and Safety of Varenicline in Smokers With Cardiovascular Disease Who Wish to Quit Smoking
Source: ClinicalTrials.gov NCT00282984 ↗Enrolled (actual)
703
Serious AEs
—
Results posted
Apr 2009
Primary outcomePrimary: Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) — 167; 50; 186; 300 participants — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) |
167; 50; 186; 300 | <0.0001 sig |
| SECONDARY Number of Responders With Continuous Abstinence (CA) Through Week 52 |
70; 26; 283; 324 | <0.0001 sig |
| SECONDARY Number of Long-Term Quit Responders |
80; 34; 273; 316 | <0.0001 sig |
| SECONDARY Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 12 |
192; 65; 161; 285 | <0.0001 sig |
| SECONDARY Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 24 |
124; 57; 229; 293 | <0.0001 sig |
| SECONDARY Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 52 |
102; 62; 251; 288 | 0.0003 sig |
| SECONDARY Number of Participants With a 4 Week Point Prevalence of Smoking Cessation |
99; 57 | 0.0001 sig |
| SECONDARY Number of Responders With Continuous Abstinence (CA) Through Week 24 |
100; 34 | <0.0001 sig |
| SECONDARY Cigarettes Smoked Per Day |
22.2; 22.9; 17.6; 19.1; 16.8; 18.4 | — |
| SECONDARY Number of Long-Term Quit Responders From Week 9 Through Week 24 |
117; 42; 236; 308 | <0.0001 sig |
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT00282984). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.