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

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NCT01061710

Last updated on April 11, 2018
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Study Location
Contact
1-800-718-1021
[email protected]
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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
0+
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

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

NCT01061710
Pfizer
Completed
Varenicline (Champix®) Special Investigation (Regulatory Post Marketing Commitment Plan)

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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).
The subjects have been retreated with varenicline within 52 weeks, and subjects have been enrolled to varenicline Drug Use Investigation protocol A3051109.
Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample
The subjects who have been retreated with varenicline in A3051109 (NCT# NCT00772941) within 52 weeks of initial treatment.
Smoking Cessation
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.
Other Name: Chantix, Champix
varenicline (Champix®)
Subjects who have been retreated with varenicline within 52 weeks and have been enrolled to varenicline protocol A3051109.
Intervention: Drug: varenicline
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
February 2014
February 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01061710
A3051117
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2015

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.

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1-800-718-1021

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[email protected]



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