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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: August 31, 2006
Last updated: April 21, 2015
Last verified: April 2015
To investigate safety and efficacy of varenicline tartrate in helping people quit smoking

Condition Intervention Phase
Smoking Cessation
Drug: Varenicline tartrate
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 334
Study Start Date: September 2006
Study Completion Date: June 2007

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

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)
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Please refer to this study by its identifier: NCT00371813

China, Liaoning
Pfizer Investigational Site
Shenyang, Liaoning, China, 110016
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
Pfizer Investigational Site
Singapore, Singapore, 159964
Pfizer Investigational Site
Singapore, Singapore, 169608
Pfizer Investigational Site
Singapore, Singapore, 228310
Pfizer Investigational Site
Bangkok, Thailand, 10330
Pfizer Investigational Site
Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00371813     History of Changes
Other Study ID Numbers: A3051055
Study First Received: August 31, 2006
Last Updated: April 21, 2015

Additional relevant MeSH terms:
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on April 28, 2017