A Seven-Week Dose-Ranging Study of CP-526,555 Compared With Placebo and Zyban for Smoking Cessation

October 16, 2015 updated by: Pfizer

A Seven-Week Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of Three Doses of CP-526,555 ( 0.3 mg QD, 1 mg QD, and 1 mg BID ) in Comparison With Zyban in Smoking Cessation

The purpose of the study is to measure the safety and efficacy of three doses of varenicline for smoking cessation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

625

Phase

  • Phase 2

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

  • United States
    • California
      • Los Angeles, California, United States
        • Pfizer Investigational Site
    • Connecticut
      • Farmington, Connecticut, United States
        • Pfizer Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States
        • Pfizer Investigational Site
    • New York
      • New York, New York, United States
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, United States
        • Pfizer Investigational Site
    • West Virginia
      • Morgantown, West Virginia, 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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects must have smoked on average of at least ten cigarettes per day during the past year
  • Subjects must have no period of abstinence greater than three months in the past year

Exclusion Criteria:

  • Subjects with any history of cardiovascular disease
  • Myocardial infarction
  • Significant arrhythmias
  • Poorly controlled hypertension

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
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary efficacy outcome is smoking abstinence for any continuous 4-week period (4-week CQR) during the study treatment phase.

Secondary Outcome Measures

Outcome Measure
Minnesota Nicotine Withdrawal Scale
Smoking Effects Inventory
Fixed window 4-week CQR, Weeks 3-6, 4-7
Continuous abstinence from Target Quit Date to Weeks 12, 24, and 52
7-day Point Prevalence of abstinence Week 52
Number of cigarettes smoked per day
Brief Questionnaire of Smoking Urge

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.

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

February 1, 2000

Study Completion (Actual)

January 1, 2002

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Estimate)

October 19, 2015

Last Update Submitted That Met QC Criteria

October 16, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3051002

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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