Randomized Study Comparing the Efficacy and Safety of Varenicline Tartrate to Placebo in Smoking Cessation When Subjects Are Allowed to Set Their Own Quit Date

October 16, 2015 updated by: Pfizer

A Phase 4, Prospective, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate Smoking Cessation With Varenicline Tartrate Compared With Placebo In The Setting Of Patient Self-Selected (Flexible) Quit Date

The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

659

Phase

  • Phase 4

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

  • Argentina
      • Buenos Aires, Argentina, C1405BCH
        • Pfizer Investigational Site
  • Brazil
    • SP
      • Santo André, SP, Brazil, 09060-650
        • Pfizer Investigational Site
  • Canada
      • Quebec, Canada, G1V 4M6
        • Pfizer Investigational Site
    • Alberta
      • Calgary, Alberta, Canada, T1Y 6J4
        • Pfizer Investigational Site
  • China
      • Beijing, China, 100020
        • Pfizer Investigational Site
      • Guangzhou, China, 510120
        • Pfizer Investigational Site
    • Liaoning
      • Shenyang, Liaoning, China, 110016
        • Pfizer Investigational Site
  • Czech Republic
      • Brno, Czech Republic, 656 91
        • Pfizer Investigational Site
      • Praha 2, Czech Republic, 120 00
        • Pfizer Investigational Site
  • France
      • Caen, France, 14033
        • Pfizer Investigational Site
  • Germany
      • Berlin, Germany, 10787
        • Pfizer Investigational Site
      • Goettingen, Germany, 37075
        • Pfizer Investigational Site
  • Hungary
      • Budapest, Hungary, 1525
        • Pfizer Investigational Site
      • Debrecen, Hungary, 4012
        • Pfizer Investigational Site
  • Italy
      • Pisa, Italy, 56124
        • Pfizer Investigational Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 135-710
        • Pfizer Investigational Site
  • Mexico
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Pfizer Investigational Site
  • Taiwan
      • Gwei Shan Township, Taoyuan County, Taiwan, 333
        • Pfizer Investigational Site
      • Kaohsiung, Taiwan, 813
        • Pfizer Investigational Site
  • United Kingdom
      • London, United Kingdom, SW18 4DD
        • Pfizer Investigational Site
  • United States
    • Arizona
      • Litchfield Park, Arizona, United States, 85340
        • Pfizer Investigational Site
    • California
      • Los Angeles, California, United States, 90095
        • Pfizer Investigational Site
      • Santa Ana, California, United States, 92705
        • Pfizer Investigational Site
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Pfizer Investigational Site
    • Massachusetts
      • Milford, Massachusetts, United States, 01757
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68116-2004
        • Pfizer Investigational Site
    • New York
      • Endwell, New York, United States, 13760
        • Pfizer Investigational Site
    • Pennsylvania
      • Bridgeville, Pennsylvania, United States, 15017
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19146
        • Pfizer Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • 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

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women
  • 18 to 75 yrs old
  • Motivated to stop smoking
  • Smoke at least 10 cigarettes/day

Exclusion Criteria:

  • Active psychiatric disease
  • Severe or unstable cardiovascular or pulmonary disease
  • Current or recent treatment to stop smoking
  • Previous use of varenicline

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: placebo
placebo tablet taken orally twice daily for 12 weeks
Experimental: varenicline
Drug: varenicline
varenicline tablets, 1 mg taken orally twice daily for 12 weeks
Other Names:
  • Chantix, Champix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With 4-week Continuous Abstinence (CA)
Time Frame: Week 9 through Week 12
The percentage of participants who reported complete abstinence from cigarette smoking and other nicotine use (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) >10 parts per million (ppm) at any visits Week 9 through Week 12. A participant was considered a responder if they met the following criterion: said they had not smoked or used nicotine products 'since the last visit' and did not have CO >10 ppm.
Week 9 through Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Continuous Abstinence (CA) From Smoking Weeks 9-24
Time Frame: Week 9 through Week 24
Percentage of participants with CA from cigarette smoking and other nicotine-containing (treatment phase) or tobacco (non-treatment phase) products use, who did not have CO >10 ppm at any visits Week 9 through Week 24. A participant was considered a responder if they met the following criterion: said they had not smoked or used nicotine products 'since the last visit' and did not have CO >10 ppm.
Week 9 through Week 24
Percentage of Participants With Long Term Quit Through Week 24
Time Frame: Week 9 through Week 24
Responder for the primary endpoint of CA from Week 9 through Week 12 and who had no more than 6 days of smoking during the non-treatment phase of the study. For Weeks 13, 16, 20, and 24, long term quit was determined by CO-confirmed in-clinic visit.
Week 9 through Week 24
Percentage of Participants With 7-day Point Prevalence of Nonsmoking (Smoking Cessation)
Time Frame: Week 12 and Week 24
Percentage of participants with complete abstinence from cigarette smoking or other nicotine-containing (treatment phase) or tobacco (non-treatment phase) products use for the 7 days prior to Week 12 and Week 24, respectively, who did not have CO >10 ppm at any visits. CO-confirmed in-clinic visit.
Week 12 and Week 24
Percentage of Participants With 4-week Point Prevalence of Nonsmoking
Time Frame: Week 24
Percentage of participants with complete abstinence from cigarette smoking or use of tobacco products for the 4 weeks prior to Week 24 who did not have CO >10 ppm at any visits.
Week 24

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Fagerström Test for Nicotine Dependence (FTND) to Day of First Quit Attempt (FQA) Through Week 5 by Smoking Status at Weeks 9-12
Time Frame: Baseline through Week 5
Change in nicotine dependence from baseline to the date of the FQA within the first 5 weeks. FTND was designed to provide an ordinal measure of nicotine dependence related to cigarette smoking. It contains items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. The FTND contains 4 yes-no and 2 multiple choice questions and can be used in a self-report format. The items on FTND are scored 0 to 3 for multiple choice items, the items are summed to yield a total score of 0-10 (0=minimum nicotine dependence; 10=maximum nicotine dependence).
Baseline through Week 5

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, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

June 3, 2008

First Submitted That Met QC Criteria

June 3, 2008

First Posted (Estimate)

June 5, 2008

Study Record Updates

Last Update Posted (Estimate)

November 20, 2015

Last Update Submitted That Met QC Criteria

October 16, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3051095

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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