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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00371813
First received: August 31, 2006
Last updated: June 12, 2008
Last verified: June 2008
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00371813

Locations
China, Liao Ning
Pfizer Investigational Site
Shen Yang, Liao Ning, China, 110001
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, 100853
Pfizer Investigational Site
Beijing, China, 100036
Pfizer Investigational Site
Guangzhou, China, 510120
Pfizer Investigational Site
Shanghai, China, 200233
Pfizer Investigational Site
Tanjin, China, 300052
Singapore
Pfizer Investigational Site
Singapore, Singapore, 159964
Pfizer Investigational Site
Singapore, Singapore, 228310
Pfizer Investigational Site
Singapore, Singapore, 169608
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
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00371813     History of Changes
Other Study ID Numbers: A3051055
Study First Received: August 31, 2006
Last Updated: June 12, 2008
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 24, 2014