Varenicline Observational Investigation In The Cessation of Smoking

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NCT00669240

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Study Location
Pfizer Investigational Site
Alleur, , 4432, Belgium
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

ClinicalTrials.g[email protected]

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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 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- The patients enrolled should be of legal adult age who regularly smoke and of which the main tobacco product is cigarettes.

- The patients must be willing to make an attempt to stop smoking.

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


- All patients enrolled should meet the usual prescribing criteria for varenicline as
per SmPC and should be entered into the trial at the Investigators discretion.

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Advanced Information
Descriptive Information
Brief Title Varenicline Observational Investigation In The Cessation of Smoking
Official Title Champix Observational Investigation In The Cessation of Smoking
Brief Summary The purpose of this study is to determine the safety and efficacy of varenicline in the real-world environment of smokers attending primary care in routine clinical practice with the addition of being offered behavioral support "Life REWARDS"TM. This is a non-interventional study.
Detailed Description Sampling Method Details: Patients as they come to surgeries for smoking cessation treatment.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

The patients enrolled should be of legal adult age who regularly smoke and of which the main tobacco product is cigarettes. The patients must be willing to make an attempt to stop smoking.

All patients enrolled should meet the usual prescribing criteria for varenicline as per SmPC and should be entered into the trial at the Investigators discretion.

Condition Smoking Cessation
Intervention Drug: Varenicline
According to the approved Summary of Product Characteristics (SmPC), patients will be required to orally take 0.5 mg once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4 - 7. From day 8 to the end of treatment patients should take 1 mg twice daily. Patients who cannot tolerate adverse effects of Champix may have the dose lowered temporarily or permanently to 0.5 mg twice daily. Patients should be treated for 12 weeks. Treatment should start 1 - 2 weeks prior to quitting smoking.
Other Name: Champix, Chantix, CP-526,555
Study Groups/Cohorts 1. Non-interventional
Patients prescribed varenicline in a non interventional manner.
Intervention: Drug: Varenicline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 7, 2010)		567
Original Estimated Enrollment
 (submitted: April 25, 2008)		1000
Actual Study Completion Date August 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • The patients enrolled should be of legal adult age who regularly smoke and of which the main tobacco product is cigarettes.
  • The patients must be willing to make an attempt to stop smoking.

Exclusion Criteria:

  • All patients enrolled should meet the usual prescribing criteria for varenicline as per SmPC and should be entered into the trial at the Investigators discretion.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium,   Greece,   Hungary,   Slovenia
Removed Location Countries  
 
Administrative Information
NCT Number NCT00669240
Other Study ID Numbers A3051085
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2015