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NCT00143364 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 NCT00143364
Other study ID # A3051036
Secondary ID
Status Completed
Phase Phase 3
First received August 31, 2005
Last updated June 1, 2007
Start date June 2003
Est. completion date March 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 March 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 Albert Lea Minnesota
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Denver Colorado
United States Pfizer Investigational Site Indianapolis Indiana
United States Pfizer Investigational Site Madison Wisconsin
United States Pfizer Investigational Site Milwaukee Wisconsin
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Palo Alto California
United States Pfizer Investigational Site Pembroke Pines Florida
United States Pfizer Investigational Site Portland Maine
United States Pfizer Investigational Site Providence Rhode Island
United States Pfizer Investigational Site Rochester New York
United States Pfizer Investigational Site Rochester Minnesota
United States Pfizer Investigational Site San Diego California

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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