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.

First Received: September 6, 2005 Last Updated: May 31, 2007 History of Changes

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00150228

Purpose

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 II

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 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:

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Varenicline

U.S. FDA Resources

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

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 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150228

Locations

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
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

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional 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

No publications provided by Pfizer

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Niaura R, Hays JT, Jorenby DE, Leone FT, Pappas JE, Reeves KR, Williams KE, Jr CB. The efficacy and safety of varenicline for smoking cessation using a flexible dosing strategy in adult smokers: a randomized controlled trial. Curr Med Res Opin. 2008 May 29; [Epub ahead of print]

Study ID Numbers:	A3051016
Study First Received:	September 6, 2005
Last Updated:	May 31, 2007
ClinicalTrials.gov Identifier:	NCT00150228 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Smoking
Varenicline

Additional relevant MeSH terms:

Habits
Smoking

ClinicalTrials.gov processed this record on August 30, 2009