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Varenicline (Champix®) Special Investigation (Regulatory Post Marketing Commitment Plan)

NCT01061710 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2015-02-11

Study results available
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Summary

The purpose of this study is to collect the efficacy and safety information in subjects who have been retreated with varenicline (Champix®) within 52 weeks of initial treatment for their appropriate use in daily practice and are participants for varenicline Drug Use Investigation protocol A3051109 ((NCT# NCT00772941).

Conditions

  • Smoking Cessation

Interventions

DRUG

varenicline

Dosage form: tablet 0.5mg, tablet 1mg. The usual adult dosage for oral use is 0.5 mg once daily after eating on Days 1 to 3; 0.5 mg twice daily after eating in the morning and evening on Days 4 to 7, and 1 mg twice daily after eating in the morning and evening on Day 8 and thereafter. The drug should be administered to subjects for 12 weeks.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2014-02-28
Completion
2014-02-28

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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 NCT01061710 on ClinicalTrials.gov