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

Pfizer

Status: Completed

Conditions: Smoking Cessation

Treatments: Drug: Varenicline

Study type: Observational

Funder types: Industry

Identifiers

NCT00772941

A3051109

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 3,939 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Patients not administered Varenicline(Champix).

Trial design

3,939 participants in 1 patient group

Varenicline

Description:

Patients taking Varenicline.

Treatment:

Drug: Varenicline