Assessment of Safety and Efficacy of Varenicline in Patients That Wish to Stop Smoking
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00594204
First received: January 3, 2008
Last updated: July 14, 2010
Last verified: July 2010
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Purpose
The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period will also be evaluated.
Condition | Intervention | Phase |
---|---|---|
Smoking Cessation |
Drug: varenicline tartrate (CP-526, 555-18) Drug: Placebo |
Phase 4 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
Official Title: | A 12-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study With Follow-Up Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555-18) 1 Mg Bid For Smoking Cessation (Protocol A3051080) |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Number of Participants With 4-week Continuous Abstinence [ Time Frame: Weeks 9 through 12 ] [ Designated as safety issue: No ]The number of participants who, at each visit from Week 9 through 12 (inclusive), reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) > 10 parts per milion (ppm) at any of these visits
Secondary Outcome Measures:
- Number of Participants With Continuous Abstinence [ Time Frame: Weeks 9 through 24 ] [ Designated as safety issue: No ]The number of participants who, at each contact from Week 9 through the given timepoint, reported no smoking and no use of other nicotine-containing products (Treatment Phase) or tobacco products (Nontreatment Phase) since the last study contact(on the Nicotine Use Inventory) and who did not have CO > 10 ppm
- Number of Participants With Seven-day Point Prevalence of Abstinence [ Time Frame: Week 12 and 24 ] [ Designated as safety issue: No ]Number of participants who, at the given visit or telephone contact, reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) in the last 7 days and who did not have CO >10 ppm on that day
Enrollment: | 593 |
Study Start Date: | April 2008 |
Study Completion Date: | August 2009 |
Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Active Comparator: varenicline |
Drug: varenicline tartrate (CP-526, 555-18)
1 mg twice a day for 12 weeks, starting with a 1-week titration period.
Other Name: Chantix, Champix
|
Placebo Comparator: placebo |
Drug: Placebo
matching placebo 1 tablet twice a day for 12 weeks
|
Eligibility
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Current male or female cigarette smokers who are motivated to stop smoking.
- Smoked an average of 10 cigarettes per day during past year and the month prior to first visit.
Exclusion Criteria:
- Patients who have used a nicotine replacement product, bupropion, clonidine or notriptyline within the past 6 months.
- Patients currently with depression or diagnosed with depression in past 12 months.
- Past or present history of psychosis, panic disorder, or bipolar disorder.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00594204
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Show 41 Study Locations
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):
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 17, 2012
Additional Information:
No publications provided by Pfizer
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer Inc |
ClinicalTrials.gov Identifier: | NCT00594204 History of Changes |
Other Study ID Numbers: | A3051080 |
Study First Received: | January 3, 2008 |
Results First Received: | May 27, 2010 |
Last Updated: | July 14, 2010 |
Health Authority: | Brazil: National Committee of Ethics in Research Brazil: National Health Surveillance Agency |
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 October 17, 2012