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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00282984
First received: January 26, 2006
Last updated: August 27, 2009
Last verified: August 2009

January 26, 2006
August 27, 2009
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Number of Long-Term Quit Responders [ Time Frame: Week 9 through Week 52 ] [ Designated as safety issue: No ]
  • Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • 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]) ] [ Designated as safety issue: No ]
  • Number of Responders With Continuous Abstinence (CA) Through Week 24 [ Time Frame: Week 9 through Week 24 ] [ Designated as safety issue: No ]
  • Cigarettes Smoked Per Day [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
  • Number of Long-Term Quit Responders From Week 9 Through Week 24 [ Time Frame: Week 9 through Week 24 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)
Both
35 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Brazil,   Canada,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Korea, Republic of,   Mexico,   Netherlands,   Taiwan,   United Kingdom
 
NCT00282984
A3051049
Yes
Director, Clinical Trial Disclosure Group, Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2009

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