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12 Week Evaluation of the Safety and Efficacy of a Flexible Dose of CP-526,555 and Placebo for Smoking Cessation

NCT ID: NCT00150228

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

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Study Completion Date

2002-09-30

Brief Summary

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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

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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CP-526,555 (varenicline)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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

Lexington, Kentucky, United States

Site Status

Pfizer Investigational Site

Albert Lea, Minnesota, United States

Site Status

Pfizer Investigational Site

Rochester, Minnesota, United States

Site Status

Pfizer Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Providence, Rhode Island, United States

Site Status

Pfizer Investigational Site

La Crosse, Wisconsin, United States

Site Status

Pfizer Investigational Site

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

Reference Type DERIVED
PMID: 37142273 (View on PubMed)

Niaura R, Hays JT, Jorenby DE, Leone FT, Pappas JE, Reeves KR, Williams KE, Billing CB Jr. 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 Jul;24(7):1931-41. doi: 10.1185/03007990802177523. Epub 2008 May 29.

Reference Type DERIVED
PMID: 18513462 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3051016&StudyName=+12+Week+Evaluation+of+the+Safety+and+Efficacy+of+a+Flexible+Dose+of+CP%2D526%2C555+and+Placebo+for+Smoking+Cessation

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Other Identifiers

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A3051016

Identifier Type: -

Identifier Source: org_study_id