12 Week Evaluation of the Safety and Efficacy of 4 Dosing Strategies of CP-526,555 and Placebo for Smoking Cessation. - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00150254

Purpose

The purpose of the study is to measure the safety and efficacy of four dosing strategies of CP-526,555 for 12 weeks 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 A3051018

Condition	Intervention	Phase
Smoking Cessation	Drug: CP-526,555 (varenicline)	Phase II

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Varenicline

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of Four Dosing Strategies for CP-526,555 ( 0.5 mg BID Titrated, 0.5 mg BID, 1 mg BID, and Titrated 1 mg BID ) in Smoking Cessation

Further study details as provided by Pfizer:

Primary Outcome Measures:

4 week continuous quit rate (CQR) at Weeks 9-12 and Weeks 4-7

Secondary Outcome Measures:

Continuous abstinence rate from target quit date to end of treatment (Week 12)
Carbon monoxide(CO)-confirmed 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 baselin

Estimated Enrollment:	625
Study Start Date:	September 2001
Study Completion Date:	October 2002

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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 clinically significant cardiovascular disease
Uncontrolled hypertension

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150254

Locations

United States, California
Pfizer Investigational Site
San Bernardino, California, United States
Pfizer Investigational Site
Upland, California, United States
Pfizer Investigational Site
West Covina, California, United States
Pfizer Investigational Site
LOS ANGELES, California, United States
United States, Connecticut
Pfizer Investigational Site
FARMINGTON, Connecticut, United States
United States, Florida
Pfizer Investigational Site
Jackson, Florida, United States
United States, Kentucky
Pfizer Investigational Site
LEXINGTON, Kentucky, United States
United States, Louisiana
Pfizer Investigational Site
New Orleans, Louisiana, United States
Pfizer Investigational Site
NEW ORLEANS, Louisiana, United States
United States, Mississippi
Pfizer Investigational Site
JACKSON, Mississippi, United States
United States, Nebraska
Pfizer Investigational Site
OMAHA, Nebraska, United States
United States, Ohio
Pfizer Investigational Site
CINCINNATI, Ohio, United States
United States, Oregon
Pfizer Investigational Site
PORTLAND, Oregon, United States
United States, Texas
Pfizer Investigational Site
HOUSTON, Texas, United States

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

Study ID Numbers:	A3051007
Study First Received:	September 6, 2005
Last Updated:	June 1, 2007
ClinicalTrials.gov Identifier:	NCT00150254
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Smoking

Additional relevant MeSH terms:

Habits

ClinicalTrials.gov processed this record on January 16, 2009