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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.
Information provided by:
Pfizer Identifier:
First received: September 6, 2005
Last updated: October 16, 2015
Last verified: October 2015
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
Intervention Model: Parallel Assignment
Masking: Double
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:

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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00150241

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
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information: Identifier: NCT00150241     History of Changes
Other Study ID Numbers: A3051002
Study First Received: September 6, 2005
Last Updated: October 16, 2015

Additional relevant MeSH terms:
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on September 21, 2017