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

Smoking Cessation Clinical Trial

Official title:

A 12-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study With Follow-Up Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555-18) 1 Mg Bid For Smoking Cessation (Protocol A3051080)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00594204
• Other study ID #: A3051080
• Status: Completed
• Phase: Phase 4
• First received: January 3, 2008
• Last updated: July 14, 2010
• Start date: April 2008
• Est. completion date: August 2009

Study information

• Verified date: July 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in ResearchBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 593
• Est. completion date: August 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• varenicline tartrate (CP-526, 555-18)
1 mg twice a day for 12 weeks, starting with a 1-week titration period.
• Placebo
matching placebo 1 tablet twice a day for 12 weeks

Locations

Country	Name	City	State
Brazil	Pfizer Investigational Site	Botucatu	SP
Brazil	Pfizer Investigational Site	Fortaleza	CE
Brazil	Pfizer Investigational Site	Juiz de Fora	MG
Brazil	Pfizer Investigational Site	Porto Alegre	Centro
Brazil	Pfizer Investigational Site	Sao Paulo	SP
Brazil	Pfizer Investigational Site	Sao Paulo	SP
Brazil	Pfizer Investigational Site	Sao Paulo	SP
Colombia	Pfizer Investigational Site	Barranquilla	Atlantico
Colombia	Pfizer Investigational Site	Medellin	Antioquia
Costa Rica	Pfizer Investigational Site	San Pedro de Montes de Oca	San Jose
Egypt	Pfizer Investigational Site	Cairo
Jordan	Pfizer Investigational Site	Amman
Lebanon	Pfizer Investigational Site	Beirut
Lebanon	Pfizer Investigational Site	Beirut Lebanon
Mexico	Pfizer Investigational Site	Mexico	D.f.
Mexico	Pfizer Investigational Site	Monterrey	Nuevo Leon
Mexico	Pfizer Investigational Site	Morelia	Michoacan
Saudi Arabia	Pfizer Investigational Site	Jeddah
Saudi Arabia	Pfizer Investigational Site	Riyadh
South Africa	Pfizer Investigational Site	Benoni	Gauteng
South Africa	Pfizer Investigational Site	Bloemfontein	Free State
South Africa	Pfizer Investigational Site	Cape Town	Western Cape
South Africa	Pfizer Investigational Site	Durban	Kwazulu-Natal
South Africa	Pfizer Investigational Site	Durban
South Africa	Pfizer Investigational Site	Hillcrest	Pretoria
South Africa	Pfizer Investigational Site	Lyttelton
South Africa	Pfizer Investigational Site	Midrand	Gauteng
South Africa	Pfizer Investigational Site	Paarl, Cape Town	Western Cape
South Africa	Pfizer Investigational Site	Soweto	Johannesburg
South Africa	Pfizer Investigational Site	Sydenham, Durban	Kwazulu-natal
South Africa	Pfizer Investigational Site	Tshwane	Gauteng
South Africa	Pfizer Investigational Site	Tygerberg	Cape Town
United Arab Emirates	Pfizer Investigational Site	Abu Dhabi
United Arab Emirates	Pfizer Investigational Site	Al Ain
United Arab Emirates	Pfizer Investigational Site	Dubai
United Arab Emirates	Pfizer Investigational Site	Jumeirah/Dubai
United Arab Emirates	Pfizer Investigational Site	Ras Al Khaima
Venezuela	Pfizer Investigational Site	Barquisimeto	Lara
Venezuela	Pfizer Investigational Site	Caracas
Venezuela	Pfizer Investigational Site	Caracas	Distrito Capital
Venezuela	Pfizer Investigational Site	Gran Caracas	Miranda

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With 4-week Continuous Abstinence	The number of participants who, at each visit from Week 9 through 12 (inclusive), reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) > 10 parts per milion (ppm) at any of these visits	Weeks 9 through 12	No
Secondary	Number of Participants With Continuous Abstinence	The number of participants who, at each contact from Week 9 through the given timepoint, reported no smoking and no use of other nicotine-containing products (Treatment Phase) or tobacco products (Nontreatment Phase) since the last study contact(on the Nicotine Use Inventory) and who did not have CO > 10 ppm	Weeks 9 through 24	No
Secondary	Number of Participants With Seven-day Point Prevalence of Abstinence	Number of participants who, at the given visit or telephone contact, reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) in the last 7 days and who did not have CO >10 ppm on that day	Week 12 and 24	No

External Links

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