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

Last updated on May 11, 2018

FOR MORE INFORMATION
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.
Show details

- 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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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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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)
Sexes Eligible for Study: All
35 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Brazil,   Canada,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Korea, Republic of,   Mexico,   Netherlands,   Taiwan,   United Kingdom,   United States
 
 
NCT00282984
A3051049
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2017

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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