Phase 4
Completed N=659
Randomized Study Comparing the Efficacy and Safety of Varenicline Tartrate to Placebo in Smoking Cessation When Subjects Are Allowed to Set Their Own Quit Date
Source: ClinicalTrials.gov NCT00691483 ↗Enrolled (actual)
659
Serious AEs
1.1%
Results posted
Sep 2010
Primary outcomePrimary: Percentage of Participants With 4-week Continuous Abstinence (CA) — 53.9; 19.4 Percentage of participants — p=<0.0001
Summary
The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With 4-week Continuous Abstinence (CA) |
53.9; 19.4 | <0.0001 sig |
| SECONDARY Percentage of Participants With Continuous Abstinence (CA) From Smoking Weeks 9-24 |
35.2; 12.7 | <0.0001 sig |
| SECONDARY Percentage of Participants With Long Term Quit Through Week 24 |
40.7; 14.6 | <0.0001 sig |
| SECONDARY Percentage of Participants With 7-day Point Prevalence of Nonsmoking (Smoking Cessation) |
59.5; 24.2; 43.0; 17.6 | <0.0001 sig |
| SECONDARY Percentage of Participants With 4-week Point Prevalence of Nonsmoking |
42.0; 17.0 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Men and women
- 18 to 75 yrs old
- Motivated to stop smoking
- Smoke at least 10 cigarettes/day
Exclusion Criteria
- Active psychiatric disease
- Severe or unstable cardiovascular or pulmonary disease
- Current or recent treatment to stop smoking
- Previous use of varenicline
Data sourced from ClinicalTrials.gov (NCT00691483). 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.