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

NCT ID: NCT00483002

Last Updated: 2012-05-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3719 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2011-05-31

Brief Summary

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

Detailed Description

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No sampling method will be applied to this study.

Conditions

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Smoking Cessation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy smokers

varenicline

Intervention Type DRUG

As prescribed by physician in usual clinical practice.

Interventions

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varenicline

As prescribed by physician in usual clinical practice.

Intervention Type DRUG

Other Intervention Names

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Champix, Chantix, CP-526,555

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

References

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Ock M, Shin JS, Ra SW. Safety and Effectiveness of Varenicline in Korean Smokers: A Nationwide Post-Marketing Surveillance Study. Patient Prefer Adherence. 2022 Feb 15;16:413-426. doi: 10.2147/PPA.S344757. eCollection 2022.

Reference Type DERIVED
PMID: 35210758 (View on PubMed)

Related Links

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Other Identifiers

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A3051083

Identifier Type: -

Identifier Source: org_study_id

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