This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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: March 7, 2017
Last verified: March 2017
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 ]
    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.


Secondary Outcome Measures:
  • Number of Responders With Continuous Abstinence (CA) Through Week 52 [ Time Frame: Week 9 through Week 52 ]
    Responders: participants who remained abstinent based on 'since the last contact' question in Nicotine Use Inventory 1) "Has participant smoked any cigarettes (even a puff) since last contact?" = No AND 2) "Has participant used any other tobacco products… since last contact?" = No. Participant a non-responder if expired CO > 10 ppm.

  • Number of Long-Term Quit Responders [ Time Frame: Week 9 through Week 52 ]
    Responders: participants were considered Long Term Quit responders if 1) they were responders for the primary endpoint (the 4-week CQR for Weeks 9-12) and 2) had no more than 6 days of smoking from Week 12 through the given visit.

  • Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 12 [ Time Frame: Week 12 ]
    Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) "Has the participant smoked any cigarettes in the last 7 days?" = No AND 2) "Has the participant used any other tobacco products in the last 7 days?" = No. Participant a non-responder if expired CO > 10 ppm.

  • Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 24 [ Time Frame: Week 24 ]
    Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) "Has the participant smoked any cigarettes in the last 7 days?" = No AND 2) "Has the participant used any other tobacco products in the last 7 days?" = No. Participant a non-responder if expired CO > 10 ppm.

  • Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 52 [ Time Frame: Week 52 ]
    Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) "Has the participant smoked any cigarettes in the last 7 days?" = No AND 2) "Has the participant used any other tobacco products in the last 7 days?" = No. Participant a non-responder if expired CO > 10 ppm.

  • 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]) ]
    Responders: participants with abstinence during the last 4 weeks of non-treatment based on answering 'no' to both of the two 'last 4 week' questions in the Nicotine Use Inventory (NUI). NUI collected information of cigarette or other nicotine use during the study.

  • Number of Responders With Continuous Abstinence (CA) Through Week 24 [ Time Frame: Week 9 through Week 24 ]
    Responders: participants who remained abstinent based on 'since the last contact' question in Nicotine Use Inventory 1) "Has participant smoked any cigarettes (even a puff) since the last contact?" = No AND 2) "Has participant used any other tobacco products… since the last contact?" = No. Non- responder if the expired CO > 10 ppm at any given timepoint.

  • Cigarettes Smoked Per Day [ Time Frame: Day 21 ]
    Cigarettes smoked each day during the first 3 weeks of the treatment phase.

  • Number of Long-Term Quit Responders From Week 9 Through Week 24 [ Time Frame: Week 9 through Week 24 ]
    Responders: participants were considered Long Term Quit Responders if 1) they were responders for the primary endpoint (the 4-week CQR for Weeks 9-12) and 2) had no more than 6 days of smoking from Week 12 through the given visit.


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   (Adult, Senior)
Sexes Eligible for Study:   All
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

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

Additional Information:
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: March 7, 2017

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

ClinicalTrials.gov processed this record on August 18, 2017