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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00594204
First received: January 3, 2008
Last updated: July 14, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Smoking Cessation
Drug: varenicline tartrate (CP-526, 555-18)
Drug: Placebo
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With 4-week Continuous Abstinence [ Time Frame: Weeks 9 through 12 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Number of Participants With Continuous Abstinence [ Time Frame: Weeks 9 through 24 ] [ Designated as safety issue: No ]
    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

  • Number of Participants With Seven-day Point Prevalence of Abstinence [ Time Frame: Week 12 and 24 ] [ Designated as safety issue: No ]
    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


Enrollment: 593
Study Start Date: April 2008
Study Completion Date: August 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: varenicline Drug: varenicline tartrate (CP-526, 555-18)
1 mg twice a day for 12 weeks, starting with a 1-week titration period.
Other Name: Chantix, Champix
Placebo Comparator: placebo Drug: Placebo
matching placebo 1 tablet twice a day for 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594204

  Hide Study Locations
Locations
Brazil
Pfizer Investigational Site
Porto Alegre, Centro, Brazil, RS
Pfizer Investigational Site
Fortaleza, CE, Brazil, 60864-190
Pfizer Investigational Site
Juiz de Fora, MG, Brazil, 36036-110
Pfizer Investigational Site
Botucatu, SP, Brazil, 18618-000
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 04012-909
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 05019-010
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 04032-060
Colombia
Pfizer Investigational Site
Medellin, Antioquia, Colombia, 0
Pfizer Investigational Site
Barranquilla, Atlantico, Colombia, 0
Costa Rica
Pfizer Investigational Site
San Pedro de Montes de Oca, San Jose, Costa Rica
Egypt
Pfizer Investigational Site
Cairo, Egypt
Jordan
Pfizer Investigational Site
Amman, Jordan
Lebanon
Pfizer Investigational Site
Beirut, Lebanon
Pfizer Investigational Site
Beirut Lebanon, Lebanon, 00000
Mexico
Pfizer Investigational Site
Mexico, D.f., Mexico, 14000
Pfizer Investigational Site
Morelia, Michoacan, Mexico, 58249
Pfizer Investigational Site
Monterrey, Nuevo Leon, Mexico, 64460
Saudi Arabia
Pfizer Investigational Site
Jeddah, Saudi Arabia, 21499
Pfizer Investigational Site
Riyadh, Saudi Arabia, 11211
South Africa
Pfizer Investigational Site
Tygerberg, Cape Town, South Africa, 7505
Pfizer Investigational Site
Bloemfontein, Free State, South Africa, 9300
Pfizer Investigational Site
Benoni, Gauteng, South Africa, 1501
Pfizer Investigational Site
Midrand, Gauteng, South Africa, 1685
Pfizer Investigational Site
Tshwane, Gauteng, South Africa
Pfizer Investigational Site
Soweto, Johannesburg, South Africa
Pfizer Investigational Site
Durban, Kwazulu-Natal, South Africa, 4001
Pfizer Investigational Site
Sydenham, Durban, Kwazulu-natal, South Africa, 4091
Pfizer Investigational Site
Hillcrest, Pretoria, South Africa, 0083
Pfizer Investigational Site
Cape Town, Western Cape, South Africa, 7764
Pfizer Investigational Site
Paarl, Cape Town, Western Cape, South Africa, 7647
Pfizer Investigational Site
Durban, South Africa, 4091
Pfizer Investigational Site
Lyttelton, South Africa, 0140
United Arab Emirates
Pfizer Investigational Site
Abu Dhabi, United Arab Emirates
Pfizer Investigational Site
Al Ain, United Arab Emirates, 0
Pfizer Investigational Site
Dubai, United Arab Emirates, 0
Pfizer Investigational Site
Jumeirah/Dubai, United Arab Emirates, 0
Pfizer Investigational Site
Ras Al Khaima, United Arab Emirates, 0
Venezuela
Pfizer Investigational Site
Caracas, Distrito Capital, Venezuela, 1011
Pfizer Investigational Site
Barquisimeto, Lara, Venezuela, 3002
Pfizer Investigational Site
Gran Caracas, Miranda, Venezuela, 1060
Pfizer Investigational Site
Caracas, Venezuela
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00594204     History of Changes
Other Study ID Numbers: A3051080
Study First Received: January 3, 2008
Results First Received: May 27, 2010
Last Updated: July 14, 2010
Health Authority: Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Smoking
Habits
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014