An Investigation of Effectiveness and Safety of Varenicline Tartrate in Helping People Quit Smoking

NCT ID: NCT00371813

Last Updated: 2015-04-22

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

334 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-06-30

Brief Summary

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To investigate safety and efficacy of varenicline tartrate in helping people quit smoking

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 tartrate

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Current cigarette smokers between the ages of 18 and 75 years, who are motivated to stop smoking

Exclusion Criteria

* Patients currently suffering from depression, or have been diagnosed with depression in the last 12 months, or subjects with past or present history of psychosis, panic disorder, or bipolar disorder
* Any subject with known severe chronic obstructive pulmonary disease (COPD)
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

Shenyang, Liaoning, China

Site Status

Pfizer Investigational Site

Beijing, , China

Site Status

Pfizer Investigational Site

Beijing, , China

Site Status

Pfizer Investigational Site

Beijing, , China

Site Status

Pfizer Investigational Site

Beijing, , China

Site Status

Pfizer Investigational Site

Guangzhou, , China

Site Status

Pfizer Investigational Site

Shanghai, , China

Site Status

Pfizer Investigational Site

Shenyang, , China

Site Status

Pfizer Investigational Site

Tanjin, , China

Site Status

Pfizer Investigational Site

Singapore, , Singapore

Site Status

Pfizer Investigational Site

Singapore, , Singapore

Site Status

Pfizer Investigational Site

Singapore, , Singapore

Site Status

Pfizer Investigational Site

Bangkok, , Thailand

Site Status

Pfizer Investigational Site

Chiang Mai, , Thailand

Site Status

Countries

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China Singapore Thailand

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)

Wang C, Xiao D, Chan KP, Pothirat C, Garza D, Davies S. Varenicline for smoking cessation: a placebo-controlled, randomized study. Respirology. 2009 Apr;14(3):384-92. doi: 10.1111/j.1440-1843.2008.01476.x. Epub 2009 Feb 20.

Reference Type DERIVED
PMID: 19192221 (View on PubMed)

Related Links

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Other Identifiers

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A3051055

Identifier Type: -

Identifier Source: org_study_id

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