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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00150241
First received: September 6, 2005
Last updated: May 31, 2007
Last verified: May 2007
History of Changes
  Purpose

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


Condition Intervention Phase
Smoking Cessation
 Drug: CP-526,555 (varenicline)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

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

Secondary Outcome Measures:
  • 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
  • Minnesota Nicotine Withdrawal Scale
  • Smoking Effects Inventory
  • Brief Questionnaire of Smoking Urge

Estimated Enrollment: 625
Study Start Date: February 2000
Study Completion Date: January 2002
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00150241

Locations
United States, California
Pfizer Investigational Site
Los Angeles, California, United States
United States, Connecticut
Pfizer Investigational Site
Farmington, Connecticut, United States
United States, Minnesota
Pfizer Investigational Site
Minneapolis, Minnesota, United States
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States
United States, New York
Pfizer Investigational Site
New York, New York, United States
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States
United States, West Virginia
Pfizer Investigational Site
Morgantown, West Virginia, United States
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00150241     History of Changes
Other Study ID Numbers: A3051002
Study First Received: September 6, 2005
Last Updated: May 31, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Smoking
Habits
Varenicline
Nicotinic Agonists
Cholinergic Agonists
 Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013