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Completed

NCT Number: NCT01061710

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

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).

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Key information

Conditions

Smoking Cessation Behavior Health Behavior Smoking

Sex eligibility

All sexes

Study type

Observational

About this study

The subjects have been retreated with varenicline within 52 weeks, and subjects have been enrolled to varenicline Drug Use Investigation protocol A3051109.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or Female subjects intend to quit tobacco use who are prescribed varenicline (Champix®) by their Physicians
  • Subjects who are prescribed varenicline (Champix®) for the second time within 52 weeks of initial treatment.

Exclusion criteria

Non-participants of varenicline (Champix®) Drug use Investigation protocol A3051109.

Treatment and study plan

Varenicline

Drug

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.

Other names: Chantix, Champix

Primary outcomes

  1. Number of Participants With Treatment-Related Adverse Events (AEs)

    Time frame: 24 weeks

    An AE was any untoward medical occurrence attributed to veranicline in a participant who received veranicline. Treatment related adverse events were evaluated in company with the causal relationship to veranicline.

  2. Number of Responders to Varenicline Treatment

    Time frame: 24 weeks

    Number of participants who succeeded in smoking cessation from 12 weeks through 24 weeks of the observation period.

Secondary outcomes

  1. Number of Treatment-Related Adverse Events (AEs) Unlisted in Japanese Package Insert

    Time frame: 24 weeks

    An AE was any untoward medical occurrence attributed to varenicline in a participant who received varenicline. Treatment related adverse events were evaluated in company with the causal relationship to veranicline.

  2. Number of Participants With Risk Factors Likely to Affect the Frequency of Treatment-Related Adverse Events (AEs)

    Time frame: 24 weeks

  3. Number of Participants With Risk Factors Likely to Affect the Proportion of Responders

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Champix Tablets Special Investigation -Retrospective Survey For Subjects Who Have Been Retreated With Champix.-(Regulatory Post Marketing Commitment Plan).

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Feb 3, 2010
Registry last updated
Feb 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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