A 52-Week Placebo-Controlled Study Evaluating the Safety of Varenicline
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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: NCT00143299 |
Recruitment Status :
Completed
First Posted : September 2, 2005
Last Update Posted : June 4, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Smoking Cessation | Drug: varenicline (CP-526,555) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 375 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A 52-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety of Varenicline Tartrate ( CP-526,555) for Smoking Cessation |
Study Start Date : | October 2003 |
Study Completion Date : | March 2005 |

- Summarization of safety data in smokers treated with either varenicline or placebo.
- Information will be collected for the 7 day point prevalence of smoking cessation.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 with clinically significant, recent cardiovascular disease.

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): NCT00143299
United States, Colorado | |
Pfizer Investigational Site | |
Denver, Colorado, United States, 80212 | |
United States, Massachusetts | |
Pfizer Investigational Site | |
Milford, Massachusetts, United States, 01757 | |
United States, New Mexico | |
Pfizer Investigational Site | |
Albuquerque, New Mexico, United States, 87108 | |
United States, New York | |
Pfizer Investigational Site | |
Syracuse, New York, United States, 13210 | |
United States, North Carolina | |
Pfizer Investigational Site | |
Charlotte, North Carolina, United States, 28207 | |
United States, Oklahoma | |
Pfizer Investigational Site | |
Oklahoma City, Oklahoma, United States, 73103 | |
United States, Pennsylvania | |
Pfizer Investigational Site | |
Harleysville, Pennsylvania, United States, 19438 | |
United States, Virginia | |
Pfizer Investigational Site | |
Richmond, Virginia, United States, 23249 | |
Australia, South Australia | |
Pfizer Investigational Site | |
Woodville South, South Australia, Australia, 5011 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
ClinicalTrials.gov Identifier: | NCT00143299 |
Other Study ID Numbers: |
A3051037 |
First Posted: | September 2, 2005 Key Record Dates |
Last Update Posted: | June 4, 2007 |
Last Verified: | June 2007 |
Varenicline Nicotinic Agonists Cholinergic Agonists Cholinergic Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |