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A Study of the Efficacy and Safety of Varenicline in Japanese Smokers Motivated to Quit Smoking

NCT ID: NCT00635401

Last Updated: 2008-04-10

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2004-08-31

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of varenicline in Japanese smokers. Efficacy is evaluated by continuous quit rate and withdrawal symptoms of smokers. Safety is evaluated by adverse events, laboratory tests, and other safety tests.

Detailed Description

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Conditions

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Smoking

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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0.5 mg BID

Group Type EXPERIMENTAL

Varenicline

Intervention Type DRUG

0.5 mg BID for 7 weeks

Interventions

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Varenicline

0.5 mg BID for 7 weeks

Intervention Type DRUG

Other Intervention Names

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Chantix, Champix, CP-526,555

Eligibility Criteria

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Inclusion Criteria

* Japanese smokers motivated to quit smoking
* No period without smoking of more than 3 months
* Smoked an average of at least 10 cigarettes/day in the past year

Exclusion Criteria

* Subjects who have used nicotine replacement therapy within 1 month of the study screening visit
* Subjects intending to use nicotine replacement therapy or other smoking cessation treatments 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

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Chuo-ku Fukuoka, Fukuoka, Japan

Site Status

Pfizer Investigational Site

Nishi-ku Yokohama, Kanagawa, Japan

Site Status

Pfizer Investigational Site

Beppu, Oita Prefecture, Japan

Site Status

Pfizer Investigational Site

Ōita, Oita Prefecture, 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

Toshima-ku, Tokyo, Japan

Site Status

Countries

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Japan

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3051043&StudyName=A%20study%20of%20the%20efficacy%20and%20safety%20of%20varenicline%20in%20Japanese%20smokers%20motivated%20to%20quit%20smoking

To obtain contact information for a study center near you, click here.

Other Identifiers

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A3051043

Identifier Type: -

Identifier Source: org_study_id