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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
History of Changes
  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:

U.S. FDA Resources

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

  Show 39 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

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
Smoking
Habits
Varenicline
Nicotinic Agonists
Cholinergic Agonists
 Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013