NCT00669240

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
567

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2007

Geographic Reach
4 countries

52 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 30, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
11 months until next milestone

Results Posted

Study results publicly available

July 7, 2010

Completed
Last Updated

July 23, 2015

Status Verified

June 1, 2015

Enrollment Period

1.6 years

First QC Date

April 25, 2008

Results QC Date

June 7, 2010

Last Update Submit

June 30, 2015

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Non-serious Adverse Events (AEs) or Serious Adverse Events (SAEs)

    Non-serious AEs are any untoward medical occurrence in a clinical investigation (subject administered a product or medical device) observed or volunteered through 7 days after the last dose of study drug regardless of suspected causal relationship; SAEs are any untoward medical occurrence that results in death; is life-threatening; requires hospitalization or prolongation of hospitalization; results in disability or incapacity; congenital anomaly or birth defect observed or volunteered through 28 days after the last dose of study drug, regardless of suspected causal relationship.

    Baseline through Week 12 or Week 24

Secondary Outcomes (10)

  • Number of Participants Whose Smoking Status Was Known at the End of 12 Weeks

    Week 12

  • Number of Participants in Belgium Whose Smoking Status Was Known at the End of 12 Weeks and 24 Weeks

    Week 12 and Week 24

  • Number of Treatment Responders at Week 12

    Week 12

  • Number of Treatment Responders in Belgium at Week 12 and at Week 24

    Week 12 and Week 24

  • Number of Participants With Smoking Cessation Assessments at Weekly Intervals From Week 3 Through Week 11

    Weeks 3, 4, 5, 6, 7, 8, 9, 10, and 11

  • +5 more secondary outcomes

Study Arms (1)

1. Non-interventional

Patients prescribed varenicline in a non interventional manner.

Drug: Varenicline

Interventions

VareniclineDRUG

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.

Also known as: Champix, Chantix, CP-526,555
1. Non-interventional

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (52)

Pfizer Investigational Site

Alleur, 4432, Belgium

Location

Pfizer Investigational Site

Beerse, 2340, Belgium

Location

Pfizer Investigational Site

Braine-le-Comte, 7090, Belgium

Location

Pfizer Investigational Site

Brussels, 1070, Belgium

Location

Pfizer Investigational Site

Brussels, 1081, Belgium

Location

Pfizer Investigational Site

Brussels, 1160, Belgium

Location

Pfizer Investigational Site

Deinze, 9800, Belgium

Location

Pfizer Investigational Site

Edegem, 2650, Belgium

Location

Pfizer Investigational Site

Genk, 3600, Belgium

Location

Pfizer Investigational Site

Ghent, 9000, Belgium

Location

Pfizer Investigational Site

Habay-la-Neuve, 6720, Belgium

Location

Pfizer Investigational Site

Halen, 3545, Belgium

Location

Pfizer Investigational Site

Jette, 1090, Belgium

Location

Pfizer Investigational Site

Kortessem, 3720, Belgium

Location

Pfizer Investigational Site

Leuven, 3000, Belgium

Location

Pfizer Investigational Site

Libramont-Chevigny, 6800, Belgium

Location

Pfizer Investigational Site

Liège, 4000, Belgium

Location

Pfizer Investigational Site

Moerkerke, 8340, Belgium

Location

Pfizer Investigational Site

Monceau-sur-Sambre, 6031, Belgium

Location

Pfizer Investigational Site

Moorsel, 9310, Belgium

Location

Pfizer Investigational Site

Namur, 5000, Belgium

Location

Pfizer Investigational Site

Rijkevorsel, 2310, Belgium

Location

Pfizer Investigational Site

Vedrin, 5020, Belgium

Location

Pfizer Investigational Site

Vilvoorde, 1800, Belgium

Location

Pfizer Investigational Site

Yvoir, B-5530, Belgium

Location

Pfizer Investigational Site

Zedelgem, 8210, Belgium

Location

Pfizer Investigational Site

Cholargós, Athens, 11527, Greece

Location

Pfizer Investigational Site

Ilisia, Athens, 11528, Greece

Location

Pfizer Investigational Site

Marousi, Athens, 15126, Greece

Location

Pfizer Investigational Site

Heraklion, Crete, 71110, Greece

Location

Pfizer Investigational Site

Eksochi, Thessaloniki, 57010, Greece

Location

Pfizer Investigational Site

Alexandroupoli, 68100, Greece

Location

Pfizer Investigational Site

Ioannina, 45500, Greece

Location

Pfizer Investigational Site

Kavala, 65201, Greece

Location

Pfizer Investigational Site

Larissa, 41 110, Greece

Location

Pfizer Investigational Site

Thessaloniki, 56249, Greece

Location

Pfizer Investigational Site

Budapest, 1033, Hungary

Location

Pfizer Investigational Site

Budapest, 1134, Hungary

Location

Pfizer Investigational Site

Eger, 3300, Hungary

Location

Pfizer Investigational Site

Érd, 2030, Hungary

Location

Pfizer Investigational Site

Farkasgyepű, 8582, Hungary

Location

Pfizer Investigational Site

Hatvan, 3000, Hungary

Location

Pfizer Investigational Site

Nyíregyháza, 4400, Hungary

Location

Pfizer Investigational Site

Siófok, 8600, Hungary

Location

Pfizer Investigational Site

Szombathely, 9700, Hungary

Location

Pfizer Investigational Site

Zalaegerszeg, 8900, Hungary

Location

Pfizer Investigational Site

Cerknica, 1380, Slovenia

Location

Pfizer Investigational Site

Domžale, 1230, Slovenia

Location

Pfizer Investigational Site

Jesenice, 4270, Slovenia

Location

Pfizer Investigational Site

Kranj, 4000, Slovenia

Location

Pfizer Investigational Site

Ljubljana, 1000, Slovenia

Location

Pfizer Investigational Site

Maribor, 2000, Slovenia

Location

Related Publications (3)

  • Boudrez H, Hoengenaert JP, Nackaerts K, Messig M, Metcalfe M. Predictors of quit success in Belgian participants of a varenicline observational smoking cessation study. Acta Clin Belg. 2013 Jan-Feb;68(1):37-42. doi: 10.2143/ACB.68.1.2062718.

    PMID: 23627193DERIVED

  • Gratziou C, Gourgoulianis K, Pataka PA, Sykara GD, Messig M, Raju S. Varenicline as a smoking cessation aid in a Greek population: a subanalysis of an observational study. Tob Induc Dis. 2012 Feb 2;10(1):1. doi: 10.1186/1617-9625-10-1.

    PMID: 22300423DERIVED

  • Boudrez H, Gratziou C, Messig M, Metcalfe M. Effectiveness of varenicline as an aid to smoking cessation: results of an inter-European observational study. Curr Med Res Opin. 2011 Apr;27(4):769-75. doi: 10.1185/03007995.2011.557718. Epub 2011 Feb 4.

    PMID: 21294601DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalines

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2008

First Posted

April 30, 2008

Study Start

November 1, 2007

Primary Completion

June 1, 2009

Study Completion

August 1, 2009

Last Updated

July 23, 2015

Results First Posted

July 7, 2010

Record last verified: 2015-06

Locations

GR(10)BE(26)HU(10)SL(6)