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

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00143299

First received: August 31, 2005

Last updated: June 1, 2007

Last verified: June 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

August 31, 2005

Last Updated Date

June 1, 2007

Start Date ^ICMJE

October 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Summarization of safety data in smokers treated with either varenicline or placebo.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00143299 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Information will be collected for the 7 day point prevalence of smoking cessation.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Smoking Cessation

Intervention ^ICMJE

Drug: varenicline (CP-526,555)

Study Arm (s)

Not Provided

Publications *

Williams KE, Reeves KR, Billing CB Jr, Pennington AM, Gong J. A double-blind study evaluating the long-term safety of varenicline for smoking cessation. Curr Med Res Opin. 2007 Apr;23(4):793-801.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

375

Completion Date

March 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia

Administrative Information

NCT Number ^ICMJE

NCT00143299

Other Study ID Numbers ^ICMJE

A3051037

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

June 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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