An Investigation of Effectiveness and Safety of Varenicline Tartrate in Helping People Quit Smoking
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Multinational Study Of Efficacy And Safety Of Varenicline Tartrate For Smoking Cessation
1 other identifier
interventional
334
3 countries
14
Brief Summary
To investigate safety and efficacy of varenicline tartrate in helping people quit smoking
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2006
Shorter than P25 for phase_3
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2006
CompletedStudy Start
First participant enrolled
September 1, 2006
CompletedFirst Posted
Study publicly available on registry
September 4, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedApril 22, 2015
April 1, 2015
August 31, 2006
April 21, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
To compare 12 weeks of treatment with varenicline 1 mg BID to placebo for smoking cessation, and to evaluate continuous abstinence from smoking for 12 weeks after the treatment period.
Secondary Outcomes (1)
To gather safety data for 12 weeks of treatment with varenicline 1 mg BID or placebo followed by 12 weeks of non-treatment follow-up.
Interventions
Eligibility Criteria
You may qualify if:
- Current cigarette smokers between the ages of 18 and 75 years, who are motivated to stop smoking
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (14)
Pfizer Investigational Site
Shenyang, Liaoning, 110016, China
Pfizer Investigational Site
Beijing, 100020, China
Pfizer Investigational Site
Beijing, 100029, China
Pfizer Investigational Site
Beijing, 100036, China
Pfizer Investigational Site
Beijing, 100853, China
Pfizer Investigational Site
Guangzhou, 510120, China
Pfizer Investigational Site
Shanghai, 200233, China
Pfizer Investigational Site
Shenyang, 110001, China
Pfizer Investigational Site
Tanjin, 300052, China
Pfizer Investigational Site
Singapore, 159964, Singapore
Pfizer Investigational Site
Singapore, 169608, Singapore
Pfizer Investigational Site
Singapore, 228310, Singapore
Pfizer Investigational Site
Bangkok, 10330, Thailand
Pfizer Investigational Site
Chiang Mai, 50200, Thailand
Related Publications (2)
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.
PMID: 37142273DERIVEDWang 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.
PMID: 19192221DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 31, 2006
First Posted
September 4, 2006
Study Start
September 1, 2006
Study Completion
June 1, 2007
Last Updated
April 22, 2015
Record last verified: 2015-04