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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00594204
Other study ID # A3051080
Secondary ID
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


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
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