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A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo for Smoking Cessation

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: NCT00141167
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : September 6, 2010
Sponsor:
Information provided by:
Pfizer

Study Description
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Brief Summary:
The primary purpose of this study is to evaluate the safety and efficacy of varenicline given for a twelve week treatment period in comparison with placebo for smoking cessation.

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: varenicline Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Twelve-Week, Double-Blind, Placebo-Controlled, Multicenter Study With Follow-up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 MG BID for Smoking Cessation
Study Start Date : February 2005
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 4 week continuous quit rate ( 4 week CQR ) for weeks 9 -12

Secondary Outcome Measures :
  1. Continuous abstinence rate weeks 9-24
  2. Long-term Quit Rate at week 24
  3. 7 day point prevalence week 12 and 24
  4. Results of Minnesota Nicotine Withdrawal Scale
  5. Brief Questionnaire of Smoking Urges
  6. Smoking Effects Inventory

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

Inclusion Criteria:

  • Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.

Exclusion Criteria:

  • Subjects who have used bupropion, Zyban, or Wellbutrin previously.
Contacts and Locations
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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): NCT00141167


Locations
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Korea, Republic of
Pfizer Investigational Site
Anyang-Si, Gyeonggi-do, Korea, Republic of, 431-070
Pfizer Investigational Site
Daegu-si, Korea, Republic of, 700-712
Pfizer Investigational Site
Seoul, Korea, Republic of, 100-032
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Pfizer Investigational Site
Seoul, Korea, Republic of, 138-736
Taiwan
Pfizer Investigational Site
Kweishan, Taoyuan County, Taiwan, 333
Pfizer Investigational Site
Hualien, Taiwan, 970
Pfizer Investigational Site
Kaohsiung, Taiwan, 813
Pfizer Investigational Site
Taichung, Taiwan, 40705
Pfizer Investigational Site
Taipei, Taiwan, 100
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00141167    
Obsolete Identifiers: NCT00155298
Other Study ID Numbers: A3051045
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: September 6, 2010
Last Verified: September 2010
Additional relevant MeSH terms:
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Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs