Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders. (CATS)

Pfizer

Status and phase: Completed; Phase 4

Conditions: Smoking Cessation

Treatments: Drug: Nicotine Replacement Therapy Patch; Drug: bupropion hydrochloride; Drug: placebo; Drug: varenicline tartrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01574703

2011-005513-37 (EudraCT Number)

CATS (Other Identifier)

A3051148

Details and patient eligibility

About

Non-treatment extension to study A3051123, aimed at collecting data on cardiovascular safety for all participants in the A3051123 trial for an additional 28 weeks, allowing for a total of 52 weeks of cardiovascular safety data collection.

Full description

This study is an extension protocol for study A3051123. No treatment is provided during this study. This study is to monitor for cardiovascular events 28 weeks after completion of A3051123. This study is an extension protocol for study A3051123. No treatment is provided during this study. This study is to monitor for cardiovascular events 28 weeks after completion of A3051123.

Enrollment: 4,595 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects will be eligible if they were randomized to study A3051123.

Exclusion criteria

• Participation in study A3051123 ceased (ie, withdrew consent, lost to follow-up, etc) prior to final visit of study A3051123.

Trial design

4,595 participants in 4 patient groups

placebo

Experimental group

Treatment:

Drug: placebo

varenicline

Experimental group

Treatment:

Drug: varenicline tartrate

bupropion

Experimental group

Treatment:

Drug: bupropion hydrochloride

Nicotine Replacement Therapy Patch

Experimental group

Treatment:

Drug: Nicotine Replacement Therapy Patch