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OpenTrials
Completed

NCT Number: NCT00483002

Post Marketing Surveillance Study To Observe Safety And Efficacy Of Champix® Tablets

To monitor use in real practice including safety and efficacy of Champix tablets 0.5mg, 1mg medication for 12 weeks in smokers

Completed

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

No sampling method will be applied to this study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects selected for this study are those who would have been prescribed Champix tablets by the physician according to the subject's condition in usual clinical practice.

Exclusion criteria

  • None

Treatment and study plan

Varenicline

Drug

As prescribed by physician in usual clinical practice.

Other names: Champix, Chantix, CP-526,555

Primary outcomes

  1. Percentage of Participants With 7-day Point Prevalence From Week 3 to Less Than Week 7

    Time frame: Week 3 through Week 7

    Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No).

  2. Percentage of Participants With 7-day Point Prevalence From Week 7 to Less Than Week 11

    Time frame: Week 7 through Week 11

    Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No).

  3. Percentage of Participants With 7-day Point Prevalence for at Least Week 11

    Time frame: At least Week 11

    Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No).

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Jun 6, 2007
Registry last updated
May 11, 2012

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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