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NCT00143299 Clinical Trial

A 52-Week Placebo-Controlled Study Evaluating the Safety of Varenicline

Smoking Cessation Clinical Trial

Official title:
A 52-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety of Varenicline Tartrate ( CP-526,555) for Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00143299
Other study ID # A3051037
Secondary ID
Status Completed
Phase Phase 3
First received August 31, 2005
Last updated June 1, 2007
Start date October 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 obtain safety information on cigarette smokers treated with 52 weeks of varenicline regardless of smoking status.

Recruitment information / eligibility
Status Completed
Enrollment 375
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 with clinically significant, recent cardiovascular disease.

Study Design

Allocation: Randomized, Endpoint Classification: Safety 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
Australia Pfizer Investigational Site Woodville South South Australia
United States Pfizer Investigational Site Albuquerque New Mexico
United States Pfizer Investigational Site Charlotte North Carolina
United States Pfizer Investigational Site Denver Colorado
United States Pfizer Investigational Site Harleysville Pennsylvania
United States Pfizer Investigational Site Milford Massachusetts
United States Pfizer Investigational Site Oklahoma City Oklahoma
United States Pfizer Investigational Site Richmond Virginia
United States Pfizer Investigational Site Syracuse New York

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Summarization of safety data in smokers treated with either varenicline or placebo.
Secondary Information will be collected for the 7 day point prevalence of smoking cessation.
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