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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:
ClinicalTrials.gov Identifier:
NCT00150241
First Posted: September 8, 2005
Last Update Posted: October 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  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
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
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00150241     History of Changes
Other Study ID Numbers: A3051002
First Submitted: September 6, 2005
First Posted: September 8, 2005
Last Update Posted: October 19, 2015
Last Verified: October 2015

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