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

NCT ID: NCT00282984

Last Updated: 2017-04-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

714 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-08-31

Brief Summary

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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

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Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

1 mg placebo twice daily by mouth for 12 weeks

varenicline

Group Type EXPERIMENTAL

Varenicline

Intervention Type DRUG

1 mg twice daily by mouth for 12 weeks

Interventions

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placebo

1 mg placebo twice daily by mouth for 12 weeks

Intervention Type DRUG

Varenicline

1 mg twice daily by mouth for 12 weeks

Intervention Type DRUG

Other Intervention Names

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Chantix, Champix

Eligibility Criteria

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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)
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Hartford, Connecticut, United States

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Boston, Massachusetts, United States

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Madison, Wisconsin, United States

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Capital Federal, Buenos Aires, Argentina

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Ciudad de Buenos Aires, Buenos Aires, Argentina

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Concord, New South Wales, Australia

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Herston, Queensland, Australia

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Porto Alegre, Rio Grande do Sul, Brazil

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São Paulo, São Paulo, Brazil

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London, Ontario, Canada

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Ottawa, Ontario, Canada

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Drummondville, Quebec, Canada

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Québec, Quebec, Canada

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Brno, , Czechia

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Prague, , Czechia

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Aarhus C, , Denmark

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Hellerup, , Denmark

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Caen, , France

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Marseille, , France

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Toulouse, , France

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Berlin, , Germany

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Göttingen, , Germany

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Tübingen, , Germany

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Athens, , Greece

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Pireaus, , Greece

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Tlalpan, Mexico City, Mexico

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Monterrey, Nuevo León, Mexico

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Amsterdam, , Netherlands

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Zuthpen, , Netherlands

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Seoul, Korea, South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Taipei, Taiwan, Taiwan

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Tau-Yuan Hsien, , Taiwan

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Carshalton, Surrey, United Kingdom

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Bradford, West Yorkshire, United Kingdom

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Leicester, , United Kingdom

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Paisley, , United Kingdom

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Countries

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United States Argentina Australia Brazil Canada Czechia Denmark France Germany Greece Mexico Netherlands South Korea Taiwan United Kingdom

References

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Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

Reference Type DERIVED
PMID: 37142273 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20048210 (View on PubMed)

Related Links

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Other Identifiers

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A3051049

Identifier Type: -

Identifier Source: org_study_id

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