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

NCT00594204

Last updated date
Study Location
Pfizer Investigational Site
Porto Alegre, Centro, RS, Brazil
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Smoking Cessation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Assessment of Safety and Efficacy of Varenicline in Patients That Wish to Stop Smoking
Official Title  ICMJE 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)
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: varenicline
    Intervention: Drug: varenicline tartrate (CP-526, 555-18)
  • Placebo Comparator: placebo
    Intervention: Drug: Placebo
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 27, 2010)
593
Original Estimated Enrollment  ICMJE
 (submitted: January 14, 2008)
450
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   Colombia,   Costa Rica,   Egypt,   Jordan,   Lebanon,   Mexico,   Saudi Arabia,   South Africa,   United Arab Emirates,   Venezuela
Removed Location Countries Qatar
 
Administrative Information
NCT Number  ICMJE NCT00594204
Other Study ID Numbers  ICMJE A3051080
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2010

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