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An Open Label Study That Compares Varenicline to Transdermal Nicotine Patch for Smoking Cessation

NCT ID: NCT00143325

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

730 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2006-06-30

Brief Summary

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Open-label comparison of standard 12-week regimen of varenicline with standard 10-week regimen of transdermal nicotine patch for smoking cessation.

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 15 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

Palo Alto, California, United States

Site Status

Pfizer Investigational Site

Santa Ana, California, United States

Site Status

Pfizer Investigational Site

Farmington, Connecticut, United States

Site Status

Pfizer Investigational Site

Lexington, Kentucky, United States

Site Status

Pfizer Investigational Site

Worcester, Massachusetts, United States

Site Status

Pfizer Investigational Site

Portland, Oregon, United States

Site Status

Pfizer Investigational Site

Brussels, , Belgium

Site Status

Pfizer Investigational Site

Edegem, , Belgium

Site Status

Pfizer Investigational Site

Ghent, , Belgium

Site Status

Pfizer Investigational Site

Caen, , France

Site Status

Pfizer Investigational Site

Clermont-Ferrand, , France

Site Status

Pfizer Investigational Site

Limeil-Brévannes, , France

Site Status

Pfizer Investigational Site

Metz, , France

Site Status

Pfizer Investigational Site

Paris, , France

Site Status

Pfizer Investigational Site

Vandœuvre-lès-Nancy, , France

Site Status

Pfizer Investigational Site

Amsterdam, , Netherlands

Site Status

Pfizer Investigational Site

Enschede, , Netherlands

Site Status

Pfizer Investigational Site

Maastricht, , Netherlands

Site Status

Pfizer Investigational Site

Zutphen, , Netherlands

Site Status

Pfizer Investigational Site

London, Surrey, United Kingdom

Site Status

Pfizer Investigational Site

London, , United Kingdom

Site Status

Pfizer Investigational Site

Nottingham, , United Kingdom

Site Status

Countries

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United States Belgium France Netherlands 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)

Aubin HJ, Bobak A, Britton JR, Oncken C, Billing CB Jr, Gong J, Williams KE, Reeves KR. Varenicline versus transdermal nicotine patch for smoking cessation: results from a randomised open-label trial. Thorax. 2008 Aug;63(8):717-24. doi: 10.1136/thx.2007.090647. Epub 2008 Feb 8.

Reference Type DERIVED
PMID: 18263663 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3051044&StudyName=An+Open+Label+Study+that+Compares+Varenicline+to+Transdermal+Nicotine+Patch+for+Smoking+Cessation

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Other Identifiers

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A3051044

Identifier Type: -

Identifier Source: org_study_id