A 52-Week Placebo-Controlled Study Evaluating the Safety of Varenicline

A 52-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety of Varenicline Tartrate ( CP-526,555) for Smoking Cessation

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00143299

Enrollment

375

Registered

2005-09-02

Start date

2003-10-31

Completion date

2005-03-31

Last updated

2007-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Brief summary

The primary purpose of this study is to obtain safety information on cigarette smokers treated with 52 weeks of varenicline regardless of smoking status.

Interventions

DRUGvarenicline (CP-526,555)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.

Exclusion criteria

* Subjects with clinically significant, recent cardiovascular disease.

Design outcomes

Primary

Measure	Time frame
Summarization of safety data in smokers treated with either varenicline or placebo.	—

Secondary

Measure	Time frame
Information will be collected for the 7 day point prevalence of smoking cessation.	—

Countries

Australia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026