12 Week Evaluation of the Safety and Efficacy of 4 Dosing Strategies of CP-526,555 and Placebo for Smoking Cessation.

June 1, 2007 updated by: Pfizer

A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of Four Dosing Strategies for CP-526,555 ( 0.5 mg BID Titrated, 0.5 mg BID, 1 mg BID, and Titrated 1 mg BID ) in Smoking Cessation

The purpose of the study is to measure the safety and efficacy of four dosing strategies of CP-526,555 for 12 weeks compared with placebo for smoking cessation. Post-treatment follow-up of smoking status to one year from randomization was performed in a non-treatment extension Protocol A3051018

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
      • San Bernardino, California, United States
        • Pfizer Investigational Site
      • Upland, California, United States
        • Pfizer Investigational Site
      • West Covina, California, United States
        • Pfizer Investigational Site
    • Connecticut
      • Farmington, Connecticut, United States
        • Pfizer Investigational Site
    • Florida
      • Jackson, Florida, United States
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States
        • Pfizer Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States
        • Pfizer Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, United States
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, 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 clinically significant cardiovascular disease
  • Uncontrolled 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 Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
4 week continuous quit rate (CQR) at Weeks 9-12 and Weeks 4-7

Secondary Outcome Measures

Outcome Measure
Number of cigarettes smoked per day
Continuous abstinence rate from target quit date to end of treatment (Week 12)
Urge to smoke and withdrawal symptoms assessed by Minnesota Nicotine Withdrawal Scale
Rewarding effects of smoking assessed by Smoking Effects Inventory
Carbon monoxide(CO)-confirmed 7-day point prevalence of abstinence at Week 12
Weight change from baselin

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

September 1, 2001

Study Completion (Actual)

October 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)

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

  • A3051007

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.

Clinical Trials on Smoking Cessation

Clinical Trials on CP-526,555 (varenicline)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe