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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00282984
First received: January 26, 2006
Last updated: August 27, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Smoking Cessation
Drug: placebo
Drug: Varenicline
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) [ Time Frame: weeks 9 through 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Responders With Continuous Abstinence (CA) Through Week 52 [ Time Frame: Week 9 through Week 52 ] [ Designated as safety issue: No ]
  • Number of Long-Term Quit Responders [ Time Frame: Week 9 through Week 52 ] [ Designated as safety issue: No ]
  • Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Number of Participants With a 4 Week Point Prevalence of Smoking Cessation [ Time Frame: Week 48 through Week 52 (final 4 weeks of non-treatment period [pd]) ] [ Designated as safety issue: No ]
  • Number of Responders With Continuous Abstinence (CA) Through Week 24 [ Time Frame: Week 9 through Week 24 ] [ Designated as safety issue: No ]
  • Cigarettes Smoked Per Day [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
  • Number of Long-Term Quit Responders From Week 9 Through Week 24 [ Time Frame: Week 9 through Week 24 ] [ Designated as safety issue: No ]

Enrollment: 714
Study Start Date: February 2006
Study Completion Date: August 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo Drug: placebo
1 mg placebo twice daily by mouth for 12 weeks
Experimental: varenicline Drug: Varenicline
1 mg twice daily by mouth for 12 weeks
Other Name: Chantix, Champix

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00282984

  Hide Study Locations
Locations
United States, Connecticut
Pfizer Investigational Site
Hartford, Connecticut, United States, 06102-5037
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
United States, Wisconsin
Pfizer Investigational Site
Madison, Wisconsin, United States, 53711
Argentina
Pfizer Investigational Site
Capital Federal, Buenos Aires, Argentina, 1181
Pfizer Investigational Site
Ciudad de Buenos Aires, Buenos Aires, Argentina, 1221
Australia, New South Wales
Pfizer Investigational Site
Concord, New South Wales, Australia, 2139
Australia, Queensland
Pfizer Investigational Site
Herston, Queensland, Australia, 4029
Brazil
Pfizer Investigational Site
Porto Alegre, RS, Brazil, 90610-000
Pfizer Investigational Site
São Paulo, SP, Brazil, 05403-904
Canada, Ontario
Pfizer Investigational Site
London, Ontario, Canada, N6C 5J1
Pfizer Investigational Site
Ottawa, Ontario, Canada, K1Y 4W7
Canada, Quebec
Pfizer Investigational Site
Drummondville, Quebec, Canada, J2B 7T1
Canada
Pfizer Investigational Site
Quebec, Canada, G1V 4M6
Czech Republic
Pfizer Investigational Site
Brno, Czech Republic, 625 00
Pfizer Investigational Site
Praha 2, Czech Republic, 120 00
Denmark
Pfizer Investigational Site
Aarhus C, Denmark, DK-8000
Pfizer Investigational Site
Hellerup, Denmark, DK-2900
France
Pfizer Investigational Site
Caen, France, 14033
Pfizer Investigational Site
Marseille, France, 13015
Pfizer Investigational Site
Toulouse Cedex, France, 31059
Germany
Pfizer Investigational Site
Berlin, Germany, 10787
Pfizer Investigational Site
Goettingen, Germany, 37075
Pfizer Investigational Site
Tuebingen, Germany, 72076
Greece
Pfizer Investigational Site
Athens, Greece, 11528
Pfizer Investigational Site
Pireaus, Greece, 18526
Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Korea, Republic of, 152-703
Pfizer Investigational Site
Seoul, Korea, Republic of, 135-720
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-799
Pfizer Investigational Site
Seoul, Korea, Republic of, 138-736
Mexico
Pfizer Investigational Site
Tlalpan, Mexico D.F., Mexico, 14080
Pfizer Investigational Site
Monterrey, Nuevo León, Mexico
Netherlands
Pfizer Investigational Site
Amsterdam, Netherlands, 1066 EC
Pfizer Investigational Site
Zuthpen, Netherlands, 7207 BA
Taiwan
Pfizer Investigational Site
Taipei, Taiwan, 11217
Pfizer Investigational Site
Tau-Yuan Hsien, Taiwan, 333
United Kingdom
Pfizer Investigational Site
Carshalton, Surrey, United Kingdom, SM5 1AA
Pfizer Investigational Site
Bradford, West Yorkshire, United Kingdom, BD9 6RJ
Pfizer Investigational Site
Leicester, United Kingdom, LE1 5WW
Pfizer Investigational Site
Paisley, United Kingdom, PA2 9PN
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov Identifier: NCT00282984     History of Changes
Other Study ID Numbers: A3051049
Study First Received: January 26, 2006
Results First Received: February 13, 2009
Last Updated: August 27, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cardiovascular Diseases
Varenicline
Cholinergic Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014