Clinical trial NCT00143286: A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline for the Maintenance of Smoking Cessation
Official title: A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline ( CP-526,555) for the Maintenance of Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking Cessation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-02
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52.


Eligibility 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 cardiovascular disease in the past 6 months.

Primary outcomes:
measure: Continuous abstinence Weeks 13 -24.
Secondary outcomes:
measure: Continuous abstinence Weeks 13-52
measure: Long term quit rate at Week 52
measure: 7-day Point Prevalence of abstinence at Weeks 24, 52
measure: 4-week Point Prevalence of abstinence at Week 52
measure: Time to first cigarette post randomization
Other outcomes:
Locations:
city: Santa Ana
country: United States
facility: Pfizer Investigational Site
state: California
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Mogadore
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Halifax
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Ottawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Cornwall
country: Canada
facility: Pfizer Investigational Site
state: Prince Edward Island
city: Sherbrooke
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Prague 2
country: Czech Republic
facility: Pfizer Investigational Site
city: Hellerup
country: Denmark
facility: Pfizer Investigational Site
state: Copenhagen
city: Aarhus C
country: Denmark
facility: Pfizer Investigational Site
city: Frederikssund
country: Denmark
facility: Pfizer Investigational Site
city: Bergen
country: Norway
facility: Pfizer Investigational Site
city: Honefoss
country: Norway
facility: Pfizer Investigational Site
city: Oslo
country: Norway
facility: Pfizer Investigational Site
city: Göteborg
country: Sweden
facility: Pfizer Investigational Site
city: Helsingborg
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
state: Surrey
city: London
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Hajek P, Tonnesen P, Arteaga C, Russ C, Tonstad S. Varenicline in prevention of relapse to smoking: effect of quit pattern on response to extended treatment. Addiction. 2009 Sep;104(9):1597-602. doi: 10.1111/j.1360-0443.2009.02646.x.
citation: Tonstad S, Tonnesen P, Hajek P, Williams KE, Billing CB, Reeves KR; Varenicline Phase 3 Study Group. Effect of maintenance therapy with varenicline on smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):64-71. doi: 10.1001/jama.296.1.64.