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

Last updated on May 10, 2018

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

NCT00594204
Pfizer
Completed
Assessment of Safety and Efficacy of Varenicline in Patients That Wish to Stop Smoking

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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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
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
Qatar
 
NCT00594204
A3051080
No
Not Provided
Not Provided
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

FOR MORE INFORMATION

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1-800-718-1021

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