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

Sponsored by:	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

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Varenicline Varenicline tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Pfizer:

Primary Outcome Measures:

4-week continuous abstinence rate (CAR) for Weeks 9-12 [ Time Frame: wk 9-12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Continuous abstinence (CA) from smoking from Week 9 through Week 24 [ Time Frame: wk 9-24 ] [ Designated as safety issue: No ]
Long Term Quit Rate (LTQR) through Week 24 [ Time Frame: wk 9-24 ] [ Designated as safety issue: No ]
7-day point prevalence of nonsmoking at Weeks 12 and 24 [ Time Frame: wks 12, 24 ] [ Designated as safety issue: No ]
4-week point prevalence of nonsmoking at Week 24 [ Time Frame: wk 24 ] [ Designated as safety issue: No ]
Change in Fagerström Test for Nicotine Dependence (FTND) from baseline to day of first quit attempt [ Time Frame: baseline to first quit attempt ] [ Designated as safety issue: No ]

Estimated Enrollment:	652
Study Start Date:	September 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

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

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

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 30 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

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

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3051095
Study First Received:	June 3, 2008
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00691483
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

smoking cessation, smoking treatment, patient self-selected quit date

Study placed in the following topic categories:

Smoking

Additional relevant MeSH terms:

Habits

ClinicalTrials.gov processed this record on January 15, 2009