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Drug Use Investigation Of Varenicline (Regulatory Post Marketing Commitment Plan)

Last updated on April 10, 2018

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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.
Show details

- Patients need to be administered Varenicline(Champix) in order to be enrolled in the
surveillance.

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

- Patients not administered Varenicline(Champix).

NCT00772941
Pfizer
Completed
Drug Use Investigation Of Varenicline (Regulatory Post Marketing Commitment Plan)

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Drug Use Investigation Of Varenicline (Regulatory Post Marketing Commitment Plan)
Drug Use Investigation Of Champix (Regulatory Post Marketing Commitment Plan)
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
All the patients whom an investigator prescribes the first Varenicline(Champix) should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
The patients whom an investigator involving A3051109 prescribes the Varenicline(Champix).
Smoking Cessation
Drug: Varenicline

Champix Tablets 0.5mg or Champix Tablets 1mg, depending on the Investigator prescription.

Frequency and duration are according to Package Insert as follows.

"The usual adult dosage for oral use is 0.5 mg of varenicline once daily after eating for days 1 to 3, 0.5 mg twice daily after eating in the morning and evening for days 4 to 7, and 1 mg twice daily after eating in the morning and evening on and after day 8. The drug should be administered to patients for 12 weeks."

Other Name: Champix, Chantix
Varenicline
Patients taking Varenicline.
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
3939
December 2012
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients need to be administered Varenicline(Champix) in order to be enrolled in the surveillance.

Exclusion Criteria:

  • Patients not administered Varenicline(Champix).
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00772941
A3051109
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2014

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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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