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

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ClinicalTrials.gov Identifier: NCT00143299

Recruitment Status : Completed

First Posted : September 2, 2005

Last Update Posted : June 4, 2007

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by:

Pfizer

Tracking Information

First Submitted Date ^ICMJE

August 31, 2005

First Posted Date ^ICMJE

September 2, 2005

Last Update Posted Date

June 4, 2007

Study 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

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 Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

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 ^ICMJE

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Condition ^ICMJE

Smoking Cessation

Intervention ^ICMJE

Drug: varenicline (CP-526,555)

Study Arms ^ICMJE

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. doi: 10.1185/030079907x182185.

* 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

Original Enrollment ^ICMJE

Same as current

Study Completion Date ^ICMJE

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.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years to 75 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Australia, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00143299

Other Study ID Numbers ^ICMJE

A3051037

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Current Responsible Party

Not Provided

Original Responsible Party

Same as current

Current Study Sponsor ^ICMJE

Pfizer

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

PRS Account

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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