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

Pfizer

Status: Completed

Conditions: Smoking Cessation

Treatments: Drug: Varenicline

Study type: Observational

Funder types: Industry

Identifiers

NCT00794365

A3051079

Details and patient eligibility

About

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

Full description

The study will enroll smoking patients.

Enrollment: 330 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

330 participants in 1 patient group

Open-label

Treatment:

Drug: Varenicline