An Investigation of Effectiveness and Safety of Varenicline Tartrate in Helping People Quit Smoking

April 21, 2015 updated by: Pfizer

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Multinational Study Of Efficacy And Safety Of Varenicline Tartrate For Smoking Cessation

To investigate safety and efficacy of varenicline tartrate in helping people quit smoking

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

334

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

  • China
      • Beijing, China, 100036
        • Pfizer Investigational Site
      • Beijing, China, 100853
        • Pfizer Investigational Site
      • Beijing, China, 100020
        • Pfizer Investigational Site
      • Beijing, China, 100029
        • Pfizer Investigational Site
      • Guangzhou, China, 510120
        • Pfizer Investigational Site
      • Shanghai, China, 200233
        • Pfizer Investigational Site
      • Shen Yang, China, 110001
        • Pfizer Investigational Site
      • Tanjin, China, 300052
        • Pfizer Investigational Site
    • Liaoning
      • Shenyang, Liaoning, China, 110016
        • Pfizer Investigational Site
  • Singapore
      • Singapore, Singapore, 169608
        • Pfizer Investigational Site
      • Singapore, Singapore, 159964
        • Pfizer Investigational Site
      • Singapore, Singapore, 228310
        • Pfizer Investigational Site
  • Thailand
      • Bangkok, Thailand, 10330
        • Pfizer Investigational Site
      • Chiang Mai, Thailand, 50200
        • 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:

  • Current cigarette smokers between the ages of 18 and 75 years, who are motivated to stop smoking

Exclusion Criteria:

  • Patients currently suffering from depression, or have been diagnosed with depression in the last 12 months, or subjects with past or present history of psychosis, panic disorder, or bipolar disorder
  • Any subject with known severe chronic obstructive pulmonary disease (COPD)

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
To compare 12 weeks of treatment with varenicline 1 mg BID to placebo for smoking cessation, and to evaluate continuous abstinence from smoking for 12 weeks after the treatment period.

Secondary Outcome Measures

Outcome Measure
To gather safety data for 12 weeks of treatment with varenicline 1 mg BID or placebo followed by 12 weeks of non-treatment follow-up.

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

September 1, 2006

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

August 31, 2006

First Submitted That Met QC Criteria

August 31, 2006

First Posted (Estimate)

September 4, 2006

Study Record Updates

Last Update Posted (Estimate)

April 22, 2015

Last Update Submitted That Met QC Criteria

April 21, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3051055

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.

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