12 Week Evaluation of the Safety and Efficacy of a Flexible Dose of CP-526,555 and Placebo for Smoking Cessation

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: September 6, 2005
Last updated: May 31, 2007
Last verified: May 2007
The purpose of the study was to measure the safety and efficacy of a 12-week flexible dosing strategy of CP-526,555 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 A3051019

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 Twelve-Week Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of a Flexible-Dosing Strategy for CP-526,555 ( 0.5 mg to 2.0 mg Total Daily Dose ) in Smoking Cessation

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 4-week continuous quit rate (CQR) at Weeks 4-7 and 9-12 .

Secondary Outcome Measures:
  • Continuous abstinence rate from target quit date to end of treatment (Week 12)
  • 7-day point prevalence of abstinence at Week 12
  • Number of cigarettes smoked per day
  • Urge to smoke and withdrawal symptoms assessed by Minnesota Nicotine Withdrawal Scale
  • Rewarding effects of smoking assessed by Smoking Effects Inventory
  • weight change from baseline

Estimated Enrollment: 300
Study Start Date: December 2001
Study Completion Date: September 2002

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Subjects with history of clinically significant cardiovascular disease
  • Subjects with uncontrolled hypertension.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00150228

United States, Kentucky
Pfizer Investigational Site
Lexington, Kentucky, United States
United States, Minnesota
Pfizer Investigational Site
Albert Lea, Minnesota, United States
Pfizer Investigational Site
Rochester, Minnesota, United States
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States
United States, Rhode Island
Pfizer Investigational Site
Providence, Rhode Island, United States
United States, Wisconsin
Pfizer Investigational Site
La Crosse, Wisconsin, United States
Pfizer Investigational Site
Madison, Wisconsin, United States
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00150228     History of Changes
Other Study ID Numbers: A3051016 
Study First Received: September 6, 2005
Last Updated: May 31, 2007
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on February 11, 2016