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A Multi-National Study To Assess How Effective And Safe The Smoking Cessation Medicine Varenicline Is In Smokers Who Have Already Tried Varenicline In The Past As A Prescription Medicine From Their Usual Healthcare Provider

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Ronald Reagan University of California Los Angeles Medical Center
Los Angeles, California, 90095-6984 United States
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+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Smokers aged 18 years or above and wanting to stop smoking

- Smokers who have smoked an average of at least 10 cigarettes per day over the last 4
weeks

- Smokers who have tried before to stop smoking at least once with varenicline, and who
took varenicline for at least 2 weeks

- The last attempt to stop smoking must be at least 3 months before entering the study

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

- Individuals who have not tolerated varenicline well previously, or who have a current
or prior medical or psychiatric history that would make entry into the trial
inadvisable

- Individuals who have previously participated in clinical trials of varenicline

- Individuals who have been participating in another smoking cessation trial within the
last 3 months, or other drug trial within the last 30 days

NCT01244061
Pfizer
Completed
A Multi-National Study To Assess How Effective And Safe The Smoking Cessation Medicine Varenicline Is In Smokers Who Have Already Tried Varenicline In The Past As A Prescription Medicine From Their Usual Healthcare Provider

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A Multi-National Study To Assess How Effective And Safe The Smoking Cessation Medicine Varenicline Is In Smokers Who Have Already Tried Varenicline In The Past As A Prescription Medicine From Their Usual Healthcare Provider
A Phase 4 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating The Efficacy And Safety Of Re-Treatment With Varenicline In Subjects Who Are Currently Smoking, And Who Have Previously Taken Varenicline
The main purpose of this study is to compare the effectiveness and safety of the re-treatment of smokers with varenicline with placebo for smoking cessation during the last 4 weeks of a 12 week course of treatment. The study will also assess whether smokers remain abstinent at Week 24 (12 weeks after the end of treatment) and Week 52 (40 weeks after the end of treatment).
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Smoking Cessation
  • Drug: Varenicline
    Varenicline 1mg twice daily
  • Drug: Placebo
    Matched placebo twice daily
  • Experimental: Varenicline
    Intervention: Drug: Varenicline
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Gonzales D, Hajek P, Pliamm L, Nackaerts K, Tseng LJ, McRae TD, Treadow J. Retreatment with varenicline for smoking cessation in smokers who have previously taken varenicline: a randomized, placebo-controlled trial. Clin Pharmacol Ther. 2014 Sep;96(3):390-6. doi: 10.1038/clpt.2014.124. Epub 2014 Jun 9.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
498
November 2012
November 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Smokers aged 18 years or above and wanting to stop smoking
  • Smokers who have smoked an average of at least 10 cigarettes per day over the last 4 weeks
  • Smokers who have tried before to stop smoking at least once with varenicline, and who took varenicline for at least 2 weeks
  • The last attempt to stop smoking must be at least 3 months before entering the study

Exclusion Criteria:

  • Individuals who have not tolerated varenicline well previously, or who have a current or prior medical or psychiatric history that would make entry into the trial inadvisable
  • Individuals who have previously participated in clinical trials of varenicline
  • Individuals who have been participating in another smoking cessation trial within the last 3 months, or other drug trial within the last 30 days
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Canada,   Czech Republic,   France,   Germany,   United Kingdom,   United States
 
 
NCT01244061
A3051139
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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