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12 Week Evaluation of the Safety and Efficacy of 4 Dosing Strategies of CP-526,555 and Placebo for Smoking Cessation.

NCT ID: NCT00150254

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

625 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2002-10-31

Brief Summary

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The purpose of the study is to measure the safety and efficacy of four dosing strategies of CP-526,555 for 12 weeks 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 A3051018

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 on average of at least ten cigarettes per day during the past year
* Subjects must have no period of abstinence greater than three months in the past year

Exclusion Criteria

* Subjects with any history of clinically significant cardiovascular disease
* 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

Los Angeles, California, United States

Site Status

Pfizer Investigational Site

San Bernardino, California, United States

Site Status

Pfizer Investigational Site

Upland, California, United States

Site Status

Pfizer Investigational Site

West Covina, California, United States

Site Status

Pfizer Investigational Site

Farmington, Connecticut, United States

Site Status

Pfizer Investigational Site

Jackson, Florida, United States

Site Status

Pfizer Investigational Site

Lexington, Kentucky, United States

Site Status

Pfizer Investigational Site

New Orleans, Louisiana, United States

Site Status

Pfizer Investigational Site

Jackson, Mississippi, United States

Site Status

Pfizer Investigational Site

Omaha, Nebraska, United States

Site Status

Pfizer Investigational Site

Cincinnati, Ohio, United States

Site Status

Pfizer Investigational Site

Portland, Oregon, United States

Site Status

Pfizer Investigational Site

Houston, Texas, 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)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3051007&StudyName=+12+Week+Evaluation+of+the+Safety+and+Efficacy+of+4+Dosing+Strategies+of+CP%2D526%2C555+and+Placebo+for+Smoking+Cessation%2E

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Other Identifiers

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A3051007

Identifier Type: -

Identifier Source: org_study_id