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A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline for the Maintenance of Smoking Cessation

NCT ID: NCT00143286

Last Updated: 2007-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2005-03-31

Brief Summary

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The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52.

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

DOUBLE

Interventions

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varenicline (CP-526,555)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.

Exclusion Criteria

* Subjects with clinically significant cardiovascular disease in the past 6 months.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Santa Ana, California, United States

Site Status

Pfizer Investigational Site

West Palm Beach, Florida, United States

Site Status

Pfizer Investigational Site

Lexington, Kentucky, United States

Site Status

Pfizer Investigational Site

Mogadore, Ohio, United States

Site Status

Pfizer Investigational Site

Dallas, Texas, United States

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Pfizer Investigational Site

Seattle, Washington, United States

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Pfizer Investigational Site

Calgary, Alberta, Canada

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Pfizer Investigational Site

Halifax, Nova Scotia, Canada

Site Status

Pfizer Investigational Site

Ottawa, Ontario, Canada

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Pfizer Investigational Site

Toronto, Ontario, Canada

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Pfizer Investigational Site

Cornwall, Prince Edward Island, Canada

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Pfizer Investigational Site

Sherbrooke, Quebec, Canada

Site Status

Pfizer Investigational Site

Prague, , Czechia

Site Status

Pfizer Investigational Site

Hellerup, Copenhagen, Denmark

Site Status

Pfizer Investigational Site

Aarhus C, , Denmark

Site Status

Pfizer Investigational Site

Frederikssund, , Denmark

Site Status

Pfizer Investigational Site

Bergen, , Norway

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Pfizer Investigational Site

Hønefoss, , Norway

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Pfizer Investigational Site

Oslo, , Norway

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Pfizer Investigational Site

Gothenburg, , Sweden

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Pfizer Investigational Site

Helsingborg, , Sweden

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Pfizer Investigational Site

Stockholm, , Sweden

Site Status

Pfizer Investigational Site

London, Surrey, United Kingdom

Site Status

Pfizer Investigational Site

London, , United Kingdom

Site Status

Countries

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United States Canada Czechia Denmark Norway Sweden 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)

Hajek P, Tonnesen P, Arteaga C, Russ C, Tonstad S. Varenicline in prevention of relapse to smoking: effect of quit pattern on response to extended treatment. Addiction. 2009 Sep;104(9):1597-602. doi: 10.1111/j.1360-0443.2009.02646.x.

Reference Type DERIVED
PMID: 19686530 (View on PubMed)

Tonstad S, Tonnesen P, Hajek P, Williams KE, Billing CB, Reeves KR; Varenicline Phase 3 Study Group. Effect of maintenance therapy with varenicline on smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):64-71. doi: 10.1001/jama.296.1.64.

Reference Type DERIVED
PMID: 16820548 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3051035&StudyName=A+52%2DWeek+Multicenter+Study+Evaluating+the+Safety+and+Efficacy+of+Varenicline+for+the+Maintenance+of+Smoking+Cessation

To obtain contact information for a study center near you, click here.

Other Identifiers

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A3051035

Identifier Type: -

Identifier Source: org_study_id