NCT00282984

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
714

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2006

Geographic Reach
15 countries

39 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2006

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
9 months until next milestone

Results Posted

Study results publicly available

April 29, 2009

Completed
Last Updated

April 5, 2017

Status Verified

March 1, 2017

Enrollment Period

1.7 years

First QC Date

January 26, 2006

Results QC Date

February 13, 2009

Last Update Submit

March 7, 2017

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

  • Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt)

    Participants considered Responders (4-week CQR \<=10 parts per million \<ppm\>) through reports of cigarette or other nicotine use since last study visit, confirmed by measurement of end-expiratory exhaled carbon monoxide (CO). If any CO measurement at a particular timepoint was \>10 ppm, subject was considered to be Non-Responder at that timepoint.

    weeks 9 through 12

Secondary Outcomes (9)

  • Number of Responders With Continuous Abstinence (CA) Through Week 52

    Week 9 through Week 52

  • Number of Long-Term Quit Responders

    Week 9 through Week 52

  • Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 12

    Week 12

  • Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 24

    Week 24

  • Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 52

    Week 52

  • +4 more secondary outcomes

Study Arms (2)

placebo

PLACEBO COMPARATOR
Drug: placebo

varenicline

EXPERIMENTAL
Drug: Varenicline

Interventions

placeboDRUG

1 mg placebo twice daily by mouth for 12 weeks

placebo
VareniclineDRUG

1 mg twice daily by mouth for 12 weeks

Also known as: Chantix, Champix
varenicline

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (39)

Pfizer Investigational Site

Hartford, Connecticut, 06102-5037, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02114, United States

Location

Pfizer Investigational Site

Madison, Wisconsin, 53711, United States

Location

Pfizer Investigational Site

Capital Federal, Buenos Aires, 1181, Argentina

Location

Pfizer Investigational Site

Ciudad de Buenos Aires, Buenos Aires, 1221, Argentina

Location

Pfizer Investigational Site

Concord, New South Wales, 2139, Australia

Location

Pfizer Investigational Site

Herston, Queensland, 4029, Australia

Location

Pfizer Investigational Site

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 05403-904, Brazil

Location

Pfizer Investigational Site

London, Ontario, N6C 5J1, Canada

Location

Pfizer Investigational Site

Ottawa, Ontario, K1Y 4W7, Canada

Location

Pfizer Investigational Site

Drummondville, Quebec, J2B 7T1, Canada

Location

Pfizer Investigational Site

Québec, Quebec, G1V 4M6, Canada

Location

Pfizer Investigational Site

Brno, 625 00, Czechia

Location

Pfizer Investigational Site

Prague, 120 00, Czechia

Location

Pfizer Investigational Site

Aarhus C, DK-8000, Denmark

Location

Pfizer Investigational Site

Hellerup, DK-2900, Denmark

Location

Pfizer Investigational Site

Caen, 14033, France

Location

Pfizer Investigational Site

Marseille, 13015, France

Location

Pfizer Investigational Site

Toulouse, 31059, France

Location

Pfizer Investigational Site

Berlin, 10787, Germany

Location

Pfizer Investigational Site

Göttingen, 37075, Germany

Location

Pfizer Investigational Site

Tübingen, 72076, Germany

Location

Pfizer Investigational Site

Athens, 11528, Greece

Location

Pfizer Investigational Site

Pireaus, 18526, Greece

Location

Pfizer Investigational Site

Tlalpan, Mexico City, 14080, Mexico

Location

Pfizer Investigational Site

Monterrey, Nuevo León, Mexico

Location

Pfizer Investigational Site

Amsterdam, 1066 EC, Netherlands

Location

Pfizer Investigational Site

Zuthpen, 7207 BA, Netherlands

Location

Pfizer Investigational Site

Seoul, Korea, 152-703, South Korea

Location

Pfizer Investigational Site

Seoul, 110-799, South Korea

Location

Pfizer Investigational Site

Seoul, 135-720, South Korea

Location

Pfizer Investigational Site

Seoul, 138-736, South Korea

Location

Pfizer Investigational Site

Taipei, Taiwan, 11217, Taiwan

Location

Pfizer Investigational Site

Tau-Yuan Hsien, 333, Taiwan

Location

Pfizer Investigational Site

Carshalton, Surrey, SM5 1AA, United Kingdom

Location

Pfizer Investigational Site

Bradford, West Yorkshire, BD9 6RJ, United Kingdom

Location

Pfizer Investigational Site

Leicester, LE1 5WW, United Kingdom

Location

Pfizer Investigational Site

Paisley, PA2 9PN, United Kingdom

Location

Related Publications (2)

  • Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

    PMID: 37142273DERIVED

  • 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.

    PMID: 20048210DERIVED

Related Links

MeSH Terms

Conditions

Smoking Cessation

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalines

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.govCallCenter@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 26, 2006

First Posted

January 27, 2006

Study Start

February 1, 2006

Primary Completion

November 1, 2007

Study Completion

August 1, 2008

Last Updated

April 5, 2017

Results First Posted

April 29, 2009

Record last verified: 2017-03

Locations

AU(2)BR(2)KR(4)CA(4)US(3)DE(3)TW(2)AR(2)GR(2)DK(2)NL(2)ME(2)CZ(2)FR(3)GB(4)