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

NCT00371813

Last updated date
Study Location
Pfizer Investigational Site
Shenyang, Liaoning, 110016, China
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Smoking Cessation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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)

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Advanced Information
Descriptive Information
Brief Title  ICMJE An Investigation of Effectiveness and Safety of Varenicline Tartrate in Helping People Quit Smoking
Official Title  ICMJE A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Multinational Study Of Efficacy And Safety Of Varenicline Tartrate For Smoking Cessation
Brief Summary To investigate safety and efficacy of varenicline tartrate in helping people quit smoking
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • Drug: Varenicline tartrate
  • Drug: Placebo
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 12, 2008)
334
Original Enrollment  ICMJE
 (submitted: August 31, 2006)
330
Actual Study Completion Date  ICMJE June 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China,   Singapore,   Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00371813
Other Study ID Numbers  ICMJE A3051055
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP