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NCT00141206 Clinical Trial

A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo and Zyban for Smoking Cessation

Smoking Cessation Clinical Trial

Official title:
A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study With Follow-up Evaluating the Safety and Efficacy of Varenicline Tartrate ( CP-526,555) in Comparison to Zyban for Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00141206
Other study ID # A3051028
Secondary ID
Status Completed
Phase Phase 3
First received August 30, 2005
Last updated June 1, 2007
Start date May 2003
Est. completion date April 2005

Study information
Verified date June 2007
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The primary purpose of this study is to evaluate the safety and efficacy of varenicline given for a twelve week treatment period in comparison with placebo and Zyban for smoking cessation.

Recruitment information / eligibility
Status Completed
Enrollment 1005
Est. completion date April 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.

Exclusion Criteria:

- Subjects who have used bupropion (Zyban, or Wellbutrin) previously.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• varenicline (CP-526,555)

Locations
Country Name City State
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Brooklyn New York
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Farmington Connecticut
United States Pfizer Investigational Site Great Neck New York
United States Pfizer Investigational Site Lexington Kentucky
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Morgantown West Virginia
United States Pfizer Investigational Site New Orleans Louisiana
United States Pfizer Investigational Site Newport Beach California
United States Pfizer Investigational Site Omaha Nebraska
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Portland Oregon
United States Pfizer Investigational Site Riverside California
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site San Francisco California
United States Pfizer Investigational Site Tucson Arizona
United States Pfizer Investigational Site Upland California
United States Pfizer Investigational Site Worcester Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
Secondary Continuous abstinence Weeks 9-52
Secondary Long-term Quit Rate Week 52
Secondary Continuous abstinence Weeks 9 -24
Secondary 7-day Point Prevalence Abstinence Weeks 12, 24, and 52
Secondary 4-week Point Prevalence Abstinence at Week 52
Secondary Minnesota Nicotine Withdrawal Scale
Secondary Brief Questionnaire of Smoking Urges
Secondary Smoking Effects Inventory
Secondary Change from baseline in bodyweight
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