A Multi-National Study To Assess How Effective And Safe The Smoking Cessation Medicine Varenicline Is In Smokers Who Have Already Tried Varenicline In The Past As A Prescription Medicine From Their Usual Healthcare Provider
NCT ID: NCT01244061
Last Updated: 2014-06-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
498 participants
INTERVENTIONAL
2010-12-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Varenicline
Varenicline
Varenicline 1mg twice daily
Placebo
Placebo
Matched placebo twice daily
Interventions
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Varenicline
Varenicline 1mg twice daily
Placebo
Matched placebo twice daily
Eligibility Criteria
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Inclusion Criteria
* Smokers who have smoked an average of at least 10 cigarettes per day over the last 4 weeks
* Smokers who have tried before to stop smoking at least once with varenicline, and who took varenicline for at least 2 weeks
* The last attempt to stop smoking must be at least 3 months before entering the study
Exclusion Criteria
* Individuals who have previously participated in clinical trials of varenicline
* Individuals who have been participating in another smoking cessation trial within the last 3 months, or other drug trial within the last 30 days
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Ronald Reagan University of California Los Angeles Medical Center
Los Angeles, California, United States
University of California Los Angeles David Geffen School of Medicine
Los Angeles, California, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States
The University of Maryland
College Park, Maryland, United States
The Center for Pharmaceutical Research, PC
Kansas City, Missouri, United States
Oregon Health and Science University
Portland, Oregon, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, United States
Australian Clinical Research Network
Maroubra, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
AusTrials Australia
Sherwood, Queensland, Australia
Emeritus Research
Malvern, Victoria, Australia
Universitair Ziekenhuis Antwerpen, Afdeling Pneumologie
Edegem, , Belgium
Universitaire Ziekenhuizen Leuven/Pneumologie
Leuven, , Belgium
Centre Hospitalier Universitaire de Liege
Liège, , Belgium
Cliniques Universitaires U.C.L. de Mont-Godinne/Laboratoire
Yvoir, , Belgium
Office of Dr. Ronald Collette
Burnaby, British Columbia, Canada
White Hills Medical Clinic
St. John's, Newfoundland and Labrador, Canada
Canadian Phase Onward Inc.
Toronto, Ontario, Canada
Clinique des maladies Lipidiques de Quebec
Québec, Quebec, Canada
Fakultni nemocnice Brno
Brno, , Czechia
Krajska nemocnice Liberec a.s., Plicni oddeleni
Liberec, , Czechia
Mestska nemocnice Ostrava, Plicni oddeleni
Ostrava, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
CHU de la Cavale Blanche
Brest, , France
CHU Côte de Nacre, Unité de Coordination de Tabacologie
Caen, , France
Hopital Arnaud de Villeneuve
Montpellier, , France
Universitaetsklinikum Goettingen Zentrum Innere Medizin Abteilung Kardiologie und Pneumologie
Göttingen, Germany, Germany
Klinische Forschung Berlin
Berlin, , Germany
Klinische Forschung Hamburg GmbH
Hamburg, , Germany
Ludwig Maximilians-Universitaet Muenchen
München, , Germany
FOCUS Clinical Drug Development GmbH
Neuss, , Germany
Synexus Thames Valley Clinical Research Centre
Reading, Berks, United Kingdom
Synexus Lancashire Clinical Research Centre
Chorley, Lancashire, United Kingdom
Synexus Scotland Clinical Research Centre
Glasgow, , United Kingdom
Synexus, Merseyside Clinical Research Centre
Liverpool, , United Kingdom
William Harvey Research Institute,
London, , United Kingdom
Countries
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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.
Gonzales D, Hajek P, Pliamm L, Nackaerts K, Tseng LJ, McRae TD, Treadow J. Retreatment with varenicline for smoking cessation in smokers who have previously taken varenicline: a randomized, placebo-controlled trial. Clin Pharmacol Ther. 2014 Sep;96(3):390-6. doi: 10.1038/clpt.2014.124. Epub 2014 Jun 9.
Related Links
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Other Identifiers
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A3051139
Identifier Type: -
Identifier Source: org_study_id
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