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12 Week Evaluation of the Safety and Efficacy of 3 Doses of CP-526,555 and Placebo for Smoking Cessation

NCT ID: NCT00139750

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

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2006-02-28

Brief Summary

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The purpose of the study is to examine the safety and efficacy and dose-response relationship of three doses of CP-526,555 for 12 weeks compared with placebo for smoking cessation; including post-treatment follow-up of smoking status to one year from randomization. A small satellite protocol (A3051048) investigated safety of a second course of therapy in subjects who did not quit.

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

* Cigarette smokers who are motivated to stop smoking and have smoked an average of at least 10 cigarettes per day

Exclusion Criteria

* Subjects who have used a nicotine replacement product within 30 days of the study screening visit or intend to use it during the study.
Minimum Eligible Age

20 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

Noda, Chiba, Japan

Site Status

Pfizer Investigational Site

Fukuoka, Fukuoka, Japan

Site Status

Pfizer Investigational Site

Sapporo, Hokkaido, Japan

Site Status

Pfizer Investigational Site

Yokohama, Kanagawa, Japan

Site Status

Pfizer Investigational Site

Ohita, Ohita, Japan

Site Status

Pfizer Investigational Site

Beppu-shi, Oita Prefecture, Japan

Site Status

Pfizer Investigational Site

Toyonaka, Osaka, Japan

Site Status

Pfizer Investigational Site

Tosu, Saga-ken, Japan

Site Status

Pfizer Investigational Site

Hamamatsu, Shizuoka, Japan

Site Status

Pfizer Investigational Site

Edogawa-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Minato-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Musashino, Tokyo, Japan

Site Status

Pfizer Investigational Site

Setagaya-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Shinagawa-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Toshima-ku, Tokyo, Japan

Site Status

Countries

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Japan

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)

Nakamura M, Oshima A, Ohkura M, Arteaga C, Suwa K. Predictors of lapse and relapse to smoking in successful quitters in a varenicline post hoc analysis in Japanese smokers. Clin Ther. 2014 Jun 1;36(6):918-27. doi: 10.1016/j.clinthera.2014.03.013. Epub 2014 May 5.

Reference Type DERIVED
PMID: 24811751 (View on PubMed)

Nakamura M, Oshima A, Fujimoto Y, Maruyama N, Ishibashi T, Reeves KR. Efficacy and tolerability of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, in a 12-week, randomized, placebo-controlled, dose-response study with 40-week follow-up for smoking cessation in Japanese smokers. Clin Ther. 2007 Jun;29(6):1040-56. doi: 10.1016/j.clinthera.2007.06.012.

Reference Type DERIVED
PMID: 17692720 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3051046&StudyName=+12+Week+Evaluation+of+the+Safety+and+Efficacy+of+3+doses+of+CP%2D526%2C555+and+Placebo+for+Smoking+Cessation

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Other Identifiers

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A3051046

Identifier Type: -

Identifier Source: org_study_id