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Post Marketing Surveillance Study of Champix in Smoking Cessation for Filipino Patients

NCT00794365 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 330

Last updated 2010-12-20

Study results available
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Summary

The primary objective of this Post-Marketing Study is to monitor the safety of a novel smoking cessation drug Varenicline (Champix™) 0.5 mg and 1 mg tablets as used in clinical practice for 12 weeks among Filipino smokers.

The secondary objective is to further evaluate the effectiveness of Varenicline (Champix™) as an aid in smoking cessation based on the 7-day point prevalence of smoking cessation

Conditions

  • Smoking Cessation

Interventions

DRUG

Varenicline

There are two packs available for Varenicline (Champix™). The titration pack is prescribed initially to subjects with the recommended 1-week titration phase schedule as follows: Days 1-3 0.5 mg once daily Days 4-7 0.5 mg twice daily Day 8 - End of treatment 1 mg twice daily Following the titration period, Varenicline (Champix™) dosing is increased to 1mg twice daily for the remainder of the treatment period. Patient should set the target quit date to coincide with the start of 1 mg twice daily dosing. It should be taken after eating and with a full glass of water.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2009-11-30
Completion
2009-11-30

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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 NCT00794365 on ClinicalTrials.gov