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

January 3, 2008
July 14, 2010
April 2008
June 2009   (final data collection date for primary outcome measure)
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
The primary endpoint is the 4-week continuous abstinence rate (CAR) for Weeks 9-12. [ Time Frame: 9-12 weeks ]
Complete list of historical versions of study NCT00594204 on ClinicalTrials.gov Archive Site
  • 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
  • Continuous abstinence rate (CAR) from Week 9 through Week 24. [ Time Frame: week 9-24 ]
  • Seven-day point prevalence of nonsmoking at Weeks 12 and 24. [ Time Frame: week 12-24 ]
  • Incidence rate of adverse events, premature discontinuations during the study, and changes in vital signs. [ Time Frame: through 24 weeks ]
Not Provided
Not Provided
 
Assessment of Safety and Efficacy of Varenicline in Patients That Wish to Stop Smoking
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)

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Smoking Cessation
  • 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
  • Drug: Placebo
    matching placebo 1 tablet twice a day for 12 weeks
  • Active Comparator: varenicline
    Intervention: Drug: varenicline tartrate (CP-526, 555-18)
  • Placebo Comparator: placebo
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
593
August 2009
June 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Colombia,   Costa Rica,   Egypt,   Jordan,   Lebanon,   Mexico,   Saudi Arabia,   South Africa,   United Arab Emirates,   Venezuela
 
NCT00594204
A3051080
No
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP