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Varenicline Observational Investigation In The Cessation of Smoking

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NCT00669240

Last updated on November 11, 2019
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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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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.

NCT00669240
Pfizer
Completed
Varenicline Observational Investigation In The Cessation of Smoking

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Descriptive Information
Brief TitleVarenicline Observational Investigation In The Cessation of Smoking
Official TitleChampix Observational Investigation In The Cessation of Smoking
Brief SummaryThe 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 DescriptionSampling Method Details: Patients as they come to surgeries for smoking cessation treatment.
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-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.

ConditionSmoking Cessation
InterventionDrug: 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/Cohorts1. 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 StatusCompleted
Actual Enrollment
 (submitted: June 7, 2010)		567
Original Estimated Enrollment
 (submitted: April 25, 2008)		1000
Actual Study Completion DateAugust 2009
Actual Primary Completion DateJune 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
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesBelgium,   Greece,   Hungary,   Slovenia
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00669240
Other Study ID NumbersA3051085
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 2015

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