An Open Label Study That Compares Varenicline to Transdermal Nicotine Patch for Smoking Cessation
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| ClinicalTrials.gov Identifier: NCT00143325 |
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Recruitment Status :
Completed
First Posted : September 2, 2005
Last Update Posted : June 4, 2007
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Sponsor:
Pfizer
Information provided by:
Pfizer
- Study Details
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Brief Summary:
Open-label comparison of standard 12-week regimen of varenicline with standard 10-week regimen of transdermal nicotine patch for smoking cessation.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Smoking Cessation | Drug: varenicline (CP-526,555) | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 730 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Treatment |
| Official Title: | An Open-Label, Multicenter Study With Follow-Up Evaluating the Safety and Efficacy of Varenicline Tartrate in Comparison to Transdermal Nicotine Patch for Smoking Cessation |
| Study Start Date : | January 2005 |
| Actual Study Completion Date : | June 2006 |
Resource links provided by the National Library of Medicine
Primary Outcome Measures :
- Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
Secondary Outcome Measures :
- Continuous abstinence last 4 weeks of treatment through Weeks 24 and 52
- 7-day point prevalence of abstinence: end of treatment, Weeks 24 and 52
- 4-week Point Prevalence of abstinence at Week 52
- Long-Term Quit Rate at Weeks 24 and 52
- Minnesota Nicotine Withdrawal Scale
- Smoking Effects Inventory
Information from the National Library of Medicine
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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 15 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 cardiovascular disease in the past 6 months.
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): NCT00143325
Locations
| United States, California | |
| Pfizer Investigational Site | |
| Palo Alto, California, United States | |
| Pfizer Investigational Site | |
| Santa Ana, California, United States | |
| United States, Connecticut | |
| Pfizer Investigational Site | |
| Farmington, Connecticut, United States | |
| United States, Kentucky | |
| Pfizer Investigational Site | |
| Lexington, Kentucky, United States | |
| United States, Massachusetts | |
| Pfizer Investigational Site | |
| Worcester, Massachusetts, United States | |
| United States, Oregon | |
| Pfizer Investigational Site | |
| Portland, Oregon, United States | |
| Belgium | |
| Pfizer Investigational Site | |
| Bruxelles, Belgium | |
| Pfizer Investigational Site | |
| Edegem, Belgium | |
| Pfizer Investigational Site | |
| Gent, Belgium | |
| France | |
| Pfizer Investigational Site | |
| Caen, France | |
| Pfizer Investigational Site | |
| Clermont-Ferrand, France | |
| Pfizer Investigational Site | |
| Limeil Brevannes, France | |
| Pfizer Investigational Site | |
| Limeil-Brevannes, France | |
| Pfizer Investigational Site | |
| Metz CEDEX 01, France | |
| Pfizer Investigational Site | |
| Metz Cedex 1, France | |
| Pfizer Investigational Site | |
| Paris, France | |
| Pfizer Investigational Site | |
| Vandoeuvre les Nancy, France | |
| Netherlands | |
| Pfizer Investigational Site | |
| Amsterdam, Netherlands | |
| Pfizer Investigational Site | |
| Enschede, Netherlands | |
| Pfizer Investigational Site | |
| Maastricht, Netherlands | |
| Pfizer Investigational Site | |
| Zutphen, Netherlands | |
| United Kingdom | |
| Pfizer Investigational Site | |
| London, Surrey, United Kingdom | |
| Pfizer Investigational Site | |
| London, United Kingdom | |
| Pfizer Investigational Site | |
| Nottingham, United Kingdom | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00143325 |
| Other Study ID Numbers: |
A3051044 |
| First Posted: | September 2, 2005 Key Record Dates |
| Last Update Posted: | June 4, 2007 |
| Last Verified: | June 2007 |
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 |