Clinical trial NCT00282984: Efficacy and Safety of Varenicline in Smokers With Cardiovascular Disease Who Wish to Quit Smoking
Official title: A 12-Week, Double-Blind, Placebo-Controlled, Multicenter Study With A 40 Week Follow Up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 Milligram (Mg) Twice Daily (BID) for Smoking Cessation in Subjects With Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking Cessation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-01-27
Enrollment: 714
Sex: ALL
Minimum age (years): 35
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 to determine whether or not varenicline will help people with cardiovascular disease quit smoking and to confirm it is safe in these patients.


Eligibility criteria: Inclusion Criteria:

* Participants must have stable, documented cardiovascular disease (including at least one of the following diagnosed \> 2 months prior to the Screening visit - angina, myocardial infarction (MI), revascularization, transient ischemic attack (TIA), and peripheral vascular disease (PVD).
* Participants that smoke \> 10 cigarettes / day.

Exclusion Criteria:

* Participants with unstable cardiovascular disease
* Cardiovascular events in the past 2 months
* Moderate or severe chronic obstructive pulmonary disease (COPD)

Primary outcomes:
measure: Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt)
timeFrame: weeks 9 through 12
Secondary outcomes:
measure: Number of Responders With Continuous Abstinence (CA) Through Week 52
timeFrame: Week 9 through Week 52
measure: Number of Long-Term Quit Responders
timeFrame: Week 9 through Week 52
measure: Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 12
timeFrame: Week 12
measure: Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 24
timeFrame: Week 24
measure: Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 52
timeFrame: Week 52
measure: Number of Participants With a 4 Week Point Prevalence of Smoking Cessation
timeFrame: Week 48 through Week 52 (final 4 weeks of non-treatment period [pd])
measure: Number of Responders With Continuous Abstinence (CA) Through Week 24
timeFrame: Week 9 through Week 24
measure: Cigarettes Smoked Per Day
timeFrame: Day 21
measure: Number of Long-Term Quit Responders From Week 9 Through Week 24
timeFrame: Week 9 through Week 24
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Madison
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Capital Federal
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Ciudad de Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Concord
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Herston
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Drummondville
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: Pfizer Investigational Site
city: Brno
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 2
country: Czech Republic
facility: Pfizer Investigational Site
city: Aarhus C
country: Denmark
facility: Pfizer Investigational Site
city: Hellerup
country: Denmark
facility: Pfizer Investigational Site
city: Caen
country: France
facility: Pfizer Investigational Site
city: Marseille
country: France
facility: Pfizer Investigational Site
city: Toulouse Cedex
country: France
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Goettingen
country: Germany
facility: Pfizer Investigational Site
city: Tuebingen
country: Germany
facility: Pfizer Investigational Site
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Pireaus
country: Greece
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Tlalpan
country: Mexico
facility: Pfizer Investigational Site
state: Mexico D.F.
city: Monterrey
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo León
city: Amsterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Zuthpen
country: Netherlands
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Tau-Yuan Hsien
country: Taiwan
facility: Pfizer Investigational Site
city: Carshalton
country: United Kingdom
facility: Pfizer Investigational Site
state: Surrey
city: Bradford
country: United Kingdom
facility: Pfizer Investigational Site
state: West Yorkshire
city: Leicester
country: United Kingdom
facility: Pfizer Investigational Site
city: Paisley
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Rigotti NA, Pipe AL, Benowitz NL, Arteaga C, Garza D, Tonstad S. Efficacy and safety of varenicline for smoking cessation in patients with cardiovascular disease: a randomized trial. Circulation. 2010 Jan 19;121(2):221-9. doi: 10.1161/CIRCULATIONAHA.109.869008. Epub 2010 Jan 4.