Randomized Study Comparing the Efficacy and Safety of Varenicline Tartrate to Placebo in Smoking Cessation When Subjects Are Allowed to Set Their Own Quit Date - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00691483

Purpose

The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.

Condition	Intervention	Phase
Smoking Cessation	Drug: placebo Drug: varenicline	Phase IV

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 Phase 4, Prospective, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate Smoking Cessation With Varenicline Tartrate Compared With Placebo In The Setting Of Patient Self-Selected (Flexible) Quit Date

Resource links provided by NLM:

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Varenicline Varenicline tartrate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Percentage of Participants With 4-week Continuous Abstinence (CA) [ Time Frame: Week 9 through Week 12 ] [ Designated as safety issue: No ]
The percentage of participants who reported complete abstinence from cigarette smoking and other nicotine use (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) >10 parts per million (ppm) at any visits Week 9 through Week 12. A participant was considered a responder if they met the following criterion: said they had not smoked or used nicotine products 'since the last visit' and did not have CO >10 ppm.

Secondary Outcome Measures:

Percentage of Participants With Continuous Abstinence (CA) From Smoking Weeks 9-24 [ Time Frame: Week 9 through Week 24 ] [ Designated as safety issue: No ]
Percentage of participants with CA from cigarette smoking and other nicotine-containing (treatment phase) or tobacco (non-treatment phase) products use, who did not have CO >10 ppm at any visits Week 9 through Week 24. A participant was considered a responder if they met the following criterion: said they had not smoked or used nicotine products 'since the last visit' and did not have CO >10 ppm.
Percentage of Participants With Long Term Quit Through Week 24 [ Time Frame: Week 9 through Week 24 ] [ Designated as safety issue: No ]
Responder for the primary endpoint of CA from Week 9 through Week 12 and who had no more than 6 days of smoking during the non-treatment phase of the study. For Weeks 13, 16, 20, and 24, long term quit was determined by CO-confirmed in-clinic visit.
Percentage of Participants With 7-day Point Prevalence of Nonsmoking (Smoking Cessation) [ Time Frame: Week 12 and Week 24 ] [ Designated as safety issue: No ]
Percentage of participants with complete abstinence from cigarette smoking or other nicotine-containing (treatment phase) or tobacco (non-treatment phase) products use for the 7 days prior to Week 12 and Week 24, respectively, who did not have CO >10 ppm at any visits. CO-confirmed in-clinic visit.
Percentage of Participants With 4-week Point Prevalence of Nonsmoking [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Percentage of participants with complete abstinence from cigarette smoking or use of tobacco products for the 4 weeks prior to Week 24 who did not have CO >10 ppm at any visits.

Enrollment:	659
Study Start Date:	September 2008
Study Completion Date:	December 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: placebo	Drug: placebo placebo tablet taken orally twice daily for 12 weeks
Experimental: varenicline	Drug: varenicline varenicline tablets, 1 mg taken orally twice daily for 12 weeks Other Name: Chantix, Champix

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men and women
18 to 75 yrs old
Motivated to stop smoking
Smoke at least 10 cigarettes/day

Exclusion Criteria:

Active psychiatric disease
Severe or unstable cardiovascular or pulmonary disease
Current or recent treatment to stop smoking
Previous use of varenicline

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00691483

Show 33 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00691483 History of Changes
Other Study ID Numbers:	A3051095
Study First Received:	June 3, 2008
Results First Received:	September 9, 2010
Last Updated:	November 19, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

smoking cessation
smoking treatment
patient self-selected quit date

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 February 09, 2012