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A 52-Week Placebo-Controlled Study Evaluating the Safety of Varenicline
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00143299
First received: August 31, 2005
Last updated: June 1, 2007
Last verified: June 2007
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Purpose
The primary purpose of this study is to obtain safety information on cigarette smokers treated with 52 weeks of varenicline regardless of smoking status.
| Condition | Intervention | Phase |
|---|---|---|
| Smoking Cessation | Drug: varenicline (CP-526,555) | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Summarization of safety data in smokers treated with either varenicline or placebo.
Secondary Outcome Measures:
- Information will be collected for the 7 day point prevalence of smoking cessation.
| Estimated Enrollment: | 375 |
| Study Start Date: | October 2003 |
| Estimated Study Completion Date: | March 2005 |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| 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 with clinically significant, recent cardiovascular disease.
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: NCT00143299
Please refer to this study by its ClinicalTrials.gov identifier: NCT00143299
Locations
| 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 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00143299 History of Changes |
| Other Study ID Numbers: |
A3051037 |
| Study First Received: | August 31, 2005 |
| Last Updated: | June 1, 2007 |
Additional relevant MeSH terms:
|
Varenicline Nicotinic Agonists Cholinergic Agonists Cholinergic Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on August 16, 2017