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

Last updated on October 11, 2019

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Study Location
Contact
1-800-718-1021
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.
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- 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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Descriptive Information
Brief TitleVarenicline (Champix®) Special Investigation (Regulatory Post Marketing Commitment Plan)
Official TitleChampix Tablets Special Investigation -Retrospective Survey For Subjects Who Have Been Retreated With Champix.-(Regulatory Post Marketing Commitment Plan).
Brief SummaryThe 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).
Detailed DescriptionThe subjects have been retreated with varenicline within 52 weeks, and subjects have been enrolled to varenicline Drug Use Investigation protocol A3051109.
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationThe subjects who have been retreated with varenicline in A3051109 (NCT# NCT00772941) within 52 weeks of initial treatment.
ConditionSmoking Cessation
InterventionDrug: 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
Study Groups/Cohortsvarenicline (Champix®)
Subjects who have been retreated with varenicline within 52 weeks and have been enrolled to varenicline protocol A3051109.
Intervention: Drug: varenicline
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: June 10, 2014)
20
Original Estimated Enrollment
 (submitted: February 2, 2010)
100
Actual Study Completion DateFebruary 2014
Actual Primary Completion DateFebruary 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.

Sex/Gender
Sexes Eligible for Study:All
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01061710
Other Study ID NumbersA3051117
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJanuary 2015

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

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