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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00371813
Recruitment Status : Completed
First Posted : September 4, 2006
Last Update Posted : April 22, 2015
Sponsor:
Information provided by:
Pfizer

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

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: Varenicline tartrate Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Multinational Study Of Efficacy And Safety Of Varenicline Tartrate For Smoking Cessation
Study Start Date : September 2006
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  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 Outcome Measures :
  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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00371813


Locations
China, Liaoning
Pfizer Investigational Site
Shenyang, Liaoning, China, 110016
China
Pfizer Investigational Site
Beijing, China, 100020
Pfizer Investigational Site
Beijing, China, 100029
Pfizer Investigational Site
Beijing, China, 100036
Pfizer Investigational Site
Beijing, China, 100853
Pfizer Investigational Site
Guangzhou, China, 510120
Pfizer Investigational Site
Shanghai, China, 200233
Pfizer Investigational Site
Shen Yang, China, 110001
Pfizer Investigational Site
Tanjin, China, 300052
Singapore
Pfizer Investigational Site
Singapore, Singapore, 159964
Pfizer Investigational Site
Singapore, Singapore, 169608
Pfizer Investigational Site
Singapore, Singapore, 228310
Thailand
Pfizer Investigational Site
Bangkok, Thailand, 10330
Pfizer Investigational Site
Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00371813     History of Changes
Other Study ID Numbers: A3051055
First Posted: September 4, 2006    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs