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Varenicline Observational Investigation In The Cessation of Smoking

NCT00669240 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 567

Last updated 2015-07-23

Study results available
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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.

Conditions

  • Smoking Cessation

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2009-06-30
Completion
2009-08-31

Countries

  • Belgium
  • Greece
  • Hungary
  • Slovenia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00669240 on ClinicalTrials.gov