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

NCT ID: NCT00143299

Last Updated: 2007-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

375 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2005-03-31

Brief Summary

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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

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Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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varenicline (CP-526,555)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Denver, Colorado, United States

Site Status

Pfizer Investigational Site

Milford, Massachusetts, United States

Site Status

Pfizer Investigational Site

Albuquerque, New Mexico, United States

Site Status

Pfizer Investigational Site

Syracuse, New York, United States

Site Status

Pfizer Investigational Site

Charlotte, North Carolina, United States

Site Status

Pfizer Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

Pfizer Investigational Site

Harleysville, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Richmond, Virginia, United States

Site Status

Pfizer Investigational Site

Woodville South, South Australia, Australia

Site Status

Countries

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United States Australia

References

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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.

Reference Type DERIVED
PMID: 17407636 (View on PubMed)

Other Identifiers

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A3051037

Identifier Type: -

Identifier Source: org_study_id