Efficacy and Safety of Varenicline in Smokers With Cardiovascular Disease Who Wish to Quit Smoking

Smoking Cessation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00282984
• Other study ID #: A3051049
• Status: Completed
• Phase: Phase 3
• First received: January 26, 2006
• Last updated: August 27, 2009
• Start date: February 2006
• Est. completion date: August 2008

Study information

• Verified date: August 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 714
• Est. completion date: August 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Smoking Cessation

Intervention

Drug:
• placebo
1 mg placebo twice daily by mouth for 12 weeks
• Varenicline
1 mg twice daily by mouth for 12 weeks

Locations

Country	Name	City	State
Argentina	Pfizer Investigational Site	Capital Federal	Buenos Aires
Argentina	Pfizer Investigational Site	Ciudad de Buenos Aires	Buenos Aires
Australia	Pfizer Investigational Site	Concord	New South Wales
Australia	Pfizer Investigational Site	Herston	Queensland
Brazil	Pfizer Investigational Site	Porto Alegre	RS
Brazil	Pfizer Investigational Site	São Paulo	SP
Canada	Pfizer Investigational Site	Drummondville	Quebec
Canada	Pfizer Investigational Site	London	Ontario
Canada	Pfizer Investigational Site	Ottawa	Ontario
Canada	Pfizer Investigational Site	Quebec
Czech Republic	Pfizer Investigational Site	Brno
Czech Republic	Pfizer Investigational Site	Praha 2
Denmark	Pfizer Investigational Site	Aarhus C
Denmark	Pfizer Investigational Site	Hellerup
France	Pfizer Investigational Site	Caen
France	Pfizer Investigational Site	Marseille
France	Pfizer Investigational Site	Toulouse Cedex
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Goettingen
Germany	Pfizer Investigational Site	Tuebingen
Greece	Pfizer Investigational Site	Athens
Greece	Pfizer Investigational Site	Pireaus
Korea, Republic of	Pfizer Investigational Site	Seoul	Korea
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Mexico	Pfizer Investigational Site	Monterrey	Nuevo León
Mexico	Pfizer Investigational Site	Tlalpan	Mexico D.F.
Netherlands	Pfizer Investigational Site	Amsterdam
Netherlands	Pfizer Investigational Site	Zuthpen
Taiwan	Pfizer Investigational Site	Taipei
Taiwan	Pfizer Investigational Site	Tau-Yuan Hsien
United Kingdom	Pfizer Investigational Site	Bradford	West Yorkshire
United Kingdom	Pfizer Investigational Site	Carshalton	Surrey
United Kingdom	Pfizer Investigational Site	Leicester
United Kingdom	Pfizer Investigational Site	Paisley
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Hartford	Connecticut
United States	Pfizer Investigational Site	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  Czech Republic,  Denmark,  France,  Germany,  Greece,  Korea, Republic of,  Mexico,  Netherlands,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt)		weeks 9 through 12	No
Secondary	Number of Responders With Continuous Abstinence (CA) Through Week 52		Week 9 through Week 52	No
Secondary	Number of Long-Term Quit Responders		Week 9 through Week 52	No
Secondary	Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 12		Week 12	No
Secondary	Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 24		Week 24	No
Secondary	Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 52		Week 52	No
Secondary	Number of Participants With a 4 Week Point Prevalence of Smoking Cessation		Week 48 through Week 52 (final 4 weeks of non-treatment period [pd])	No
Secondary	Number of Responders With Continuous Abstinence (CA) Through Week 24		Week 9 through Week 24	No
Secondary	Cigarettes Smoked Per Day		Day 21	No
Secondary	Number of Long-Term Quit Responders From Week 9 Through Week 24		Week 9 through Week 24	No

External Links

•   To obtain contact information for a study center near you, click here.