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

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NCT00794365

Last updated on April 10, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Smoking Cessation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Smoking adults aged ≥ 18 years intending to quit tobacco use who are prescribed
Varenicline (Champix™) by their Physicians and those who are prescribed with
Varenicline (Champix™) for the first time.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Subjects in whom varenicline (Champix?) may be taken in a manner that is not according
to the approved local product document.

- Pregnant or lactating women, or women of childbearing potential not using an
acceptable method of contraception

- Subjects with known hypersensitivity to varenicline.

NCT00794365
Pfizer
Completed
Post Marketing Surveillance Study of Champix in Smoking Cessation for Filipino Patients

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Pfizer Clinical Trials Contact Center

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[email protected]

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Post Marketing Surveillance Study of Champix in Smoking Cessation for Filipino Patients
Post-Marketing Surveillance Study To Observe The Safety And Effectiveness Of Varenicline (Champix) Tablets In Smoking Cessation Among Filipino Subjects

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
The study will enroll smoking patients.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
This post-marketing surveillance study will be conducted nationwide and will enroll approximately 3,000 study patients. Subject enrollment of less than 3,000 will be acceptable in case of less than expected use of Varenicline (Champix?) by physicians.
Smoking Cessation
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.

Other Name: Chantix, Champix
Open-label
Intervention: Drug: Varenicline
Park PW, Casiano EM, Escoto L, Claveria AM. Observational study of safety and efficacy of varenicline for smoking cessation among Filipino smokers. Curr Med Res Opin. 2011 Oct;27(10):1869-75. doi: 10.1185/03007995.2011.607436. Epub 2011 Aug 12.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
330
November 2009
November 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Smoking adults aged ? 18 years intending to quit tobacco use who are prescribed Varenicline (Champix?) by their Physicians and those who are prescribed with Varenicline (Champix?) for the first time.

Exclusion Criteria:

  • Subjects in whom varenicline (Champix?) may be taken in a manner that is not according to the approved local product document.
  • Pregnant or lactating women, or women of childbearing potential not using an acceptable method of contraception
  • Subjects with known hypersensitivity to varenicline.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00794365
A3051079
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2010

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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