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

Last updated on December 11, 2019

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Study Location
Pfizer Investigational Site
Hartford, Connecticut, 06102-5037 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Smoking Cessation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
35-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Participants with unstable cardiovascular disease

- Cardiovascular events in the past 2 months

- Moderate or severe chronic obstructive pulmonary disease (COPD)

NCT00282984
Pfizer
Completed
Efficacy and Safety of Varenicline in Smokers With Cardiovascular Disease Who Wish to Quit Smoking

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Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Varenicline in Smokers With Cardiovascular Disease Who Wish to Quit Smoking
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
  • Experimental: varenicline
    Intervention: Drug: Varenicline
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 17, 2009)
714
Original Enrollment  ICMJE
 (submitted: January 26, 2006)
700
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Brazil,   Canada,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Korea, Republic of,   Mexico,   Netherlands,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00282984
Other Study ID Numbers  ICMJE A3051049
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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