A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline for the Maintenance of Smoking Cessation

June 1, 2007 updated by: Pfizer

A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline ( CP-526,555) for the Maintenance of Smoking Cessation

The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

2000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Pfizer Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Pfizer Investigational Site
    • Ontario
      • Ottawa, Ontario, Canada
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada
        • Pfizer Investigational Site
    • Prince Edward Island
      • Cornwall, Prince Edward Island, Canada
        • Pfizer Investigational Site
    • Quebec
      • Sherbrooke, Quebec, Canada
        • Pfizer Investigational Site
  • Czech Republic
      • Prague 2, Czech Republic
        • Pfizer Investigational Site
  • Denmark
      • Aarhus C, Denmark
        • Pfizer Investigational Site
      • Frederikssund, Denmark
        • Pfizer Investigational Site
    • Copenhagen
      • Hellerup, Copenhagen, Denmark
        • Pfizer Investigational Site
  • Norway
      • Bergen, Norway
        • Pfizer Investigational Site
      • Honefoss, Norway
        • Pfizer Investigational Site
      • Oslo, Norway
        • Pfizer Investigational Site
  • Sweden
      • Göteborg, Sweden
        • Pfizer Investigational Site
      • Helsingborg, Sweden
        • Pfizer Investigational Site
      • Stockholm, Sweden
        • Pfizer Investigational Site
  • United Kingdom
      • London, United Kingdom
        • Pfizer Investigational Site
    • Surrey
      • London, Surrey, United Kingdom
        • Pfizer Investigational Site
  • United States
    • California
      • Santa Ana, California, United States
        • Pfizer Investigational Site
    • Florida
      • West Palm Beach, Florida, United States
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States
        • Pfizer Investigational Site
    • Ohio
      • Mogadore, Ohio, United States
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, United States
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 cardiovascular disease in the past 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Continuous abstinence Weeks 13 -24.

Secondary Outcome Measures

Outcome Measure
4-week Point Prevalence of abstinence at Week 52
Continuous abstinence Weeks 13-52
Long term quit rate at Week 52
7-day Point Prevalence of abstinence at Weeks 24, 52
Time to first cigarette post randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Study Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

August 31, 2005

First Submitted That Met QC Criteria

August 31, 2005

First Posted (Estimate)

September 2, 2005

Study Record Updates

Last Update Posted (Estimate)

June 4, 2007

Last Update Submitted That Met QC Criteria

June 1, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3051035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe