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Assessment of Safety and Efficacy of Varenicline in Patients That Wish to Stop Smoking

NCT ID: NCT00594204

Last Updated: 2010-07-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

593 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-08-31

Brief Summary

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The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period will also be evaluated.

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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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varenicline

Group Type ACTIVE_COMPARATOR

varenicline tartrate (CP-526, 555-18)

Intervention Type DRUG

1 mg twice a day for 12 weeks, starting with a 1-week titration period.

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

matching placebo 1 tablet twice a day for 12 weeks

Interventions

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varenicline tartrate (CP-526, 555-18)

1 mg twice a day for 12 weeks, starting with a 1-week titration period.

Intervention Type DRUG

Placebo

matching placebo 1 tablet twice a day for 12 weeks

Intervention Type DRUG

Other Intervention Names

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Chantix, Champix

Eligibility Criteria

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Inclusion Criteria

* Current male or female cigarette smokers who are motivated to stop smoking.
* Smoked an average of 10 cigarettes per day during past year and the month prior to first visit.

Exclusion Criteria

* Patients who have used a nicotine replacement product, bupropion, clonidine or notriptyline within the past 6 months.
* Patients currently with depression or diagnosed with depression in past 12 months.
* Past or present history of psychosis, panic disorder, or bipolar disorder.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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 Inc

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Fortaleza, Ceará, Brazil

Site Status

Pfizer Investigational Site

Porto Alegre, Centro, Brazil

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Pfizer Investigational Site

Juiz de Fora, Minas Gerais, Brazil

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Pfizer Investigational Site

Botucatu, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Medellín, Antioquia, Colombia

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Barranquilla, Atlántico, Colombia

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San Pedro, Provincia de San José, Costa Rica

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Cairo, Egypt, Egypt

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Amman, Jordan, Jordan

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Beirut, Lebanon, Lebanon

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Beirut Lebanon, Lebanon, Lebanon

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México, D.f., Mexico

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Morelia, Michoacán, Mexico

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Monterrey, Nuevo León, Mexico

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Jeddah, , Saudi Arabia

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Riyadh, , Saudi Arabia

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Tygerberg, Cape Town, South Africa

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Bloemfontein, Free State, South Africa

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Benoni, Gauteng, South Africa

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Midrand, Gauteng, South Africa

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Pretoria, Gauteng, South Africa

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Soweto, Johannesburg, South Africa

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Durban, KwaZulu-Natal, South Africa

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Sydenham, Durban, KwaZulu-Natal, South Africa

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Hillcrest, Pretoria, South Africa

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Cape Town, Western Cape, South Africa

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Paarl, Cape Town, Western Cape, South Africa

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Durban, , South Africa

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Lyttelton, , South Africa

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Dubai, United Arab Emirates, United Arab Emirates

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Abu Dhabi, , United Arab Emirates

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Al Ain City, , United Arab Emirates

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Dubai, , United Arab Emirates

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Jumeirah/Dubai, , United Arab Emirates

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Ras Al Khaima, , United Arab Emirates

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Caracas, Distrito Federal, Venezuela

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Barquisimeto, Lara, Venezuela

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Pfizer Investigational Site

Gran Caracas, Miranda, Venezuela

Site Status

Pfizer Investigational Site

Caracas, , Venezuela

Site Status

Countries

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Brazil Colombia Costa Rica Egypt Jordan Lebanon Mexico Saudi Arabia South Africa United Arab Emirates Venezuela

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)

Bolliger CT, Issa JS, Posadas-Valay R, Safwat T, Abreu P, Correia EA, Park PW, Chopra P. Effects of varenicline in adult smokers: a multinational, 24-week, randomized, double-blind, placebo-controlled study. Clin Ther. 2011 Apr;33(4):465-77. doi: 10.1016/j.clinthera.2011.04.013.

Reference Type DERIVED
PMID: 21635992 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3051080&StudyName=Assessment%20of%20safety%20and%20efficacy%20of%20varenicline%20in%20patients%20that%20wish%20to%20stop%20smoking%20

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

Other Identifiers

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A3051080

Identifier Type: -

Identifier Source: org_study_id

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