Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00282984
Registration number
NCT00282984
Ethics application status
Date submitted
26/01/2006
Date registered
27/01/2006
Date last updated
5/04/2017
Titles & IDs
Public title
Efficacy and Safety of Varenicline in Smokers With Cardiovascular Disease Who Wish to Quit Smoking
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
A3051049
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Smoking Cessation
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - placebo
Treatment: Drugs - Varenicline
Placebo Comparator: placebo -
Experimental: varenicline -
Treatment: Drugs: placebo
1 mg placebo twice daily by mouth for 12 weeks
Treatment: Drugs: Varenicline
1 mg twice daily by mouth for 12 weeks
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
weeks 9 through 12
Query!
Secondary outcome [1]
0
0
Number of Responders With Continuous Abstinence (CA) Through Week 52
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Week 9 through Week 52
Query!
Secondary outcome [2]
0
0
Number of Long-Term Quit Responders
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Week 9 through Week 52
Query!
Secondary outcome [3]
0
0
Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 12
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Week 12
Query!
Secondary outcome [4]
0
0
Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 24
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Week 24
Query!
Secondary outcome [5]
0
0
Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 52
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Week 52
Query!
Secondary outcome [6]
0
0
Number of Participants With a 4 Week Point Prevalence of Smoking Cessation
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
Week 48 through Week 52 (final 4 weeks of non-treatment period [pd])
Query!
Secondary outcome [7]
0
0
Number of Responders With Continuous Abstinence (CA) Through Week 24
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
Week 9 through Week 24
Query!
Secondary outcome [8]
0
0
Cigarettes Smoked Per Day
Query!
Assessment method [8]
0
0
Cigarettes smoked each day during the first 3 weeks of the treatment phase.
Query!
Timepoint [8]
0
0
Day 21
Query!
Secondary outcome [9]
0
0
Number of Long-Term Quit Responders From Week 9 Through Week 24
Query!
Assessment method [9]
0
0
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.
Query!
Timepoint [9]
0
0
Week 9 through Week 24
Query!
Eligibility
Key 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.
Query!
Minimum age
35
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Participants with unstable cardiovascular disease
- Cardiovascular events in the past 2 months
- Moderate or severe chronic obstructive pulmonary disease (COPD)
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/02/2006
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/08/2008
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
714
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Query!
Recruitment hospital [1]
0
0
Pfizer Investigational Site - Concord
Query!
Recruitment hospital [2]
0
0
Pfizer Investigational Site - Herston
Query!
Recruitment postcode(s) [1]
0
0
2139 - Concord
Query!
Recruitment postcode(s) [2]
0
0
4029 - Herston
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Connecticut
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Massachusetts
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Wisconsin
Query!
Country [4]
0
0
Argentina
Query!
State/province [4]
0
0
Buenos Aires
Query!
Country [5]
0
0
Brazil
Query!
State/province [5]
0
0
RS
Query!
Country [6]
0
0
Brazil
Query!
State/province [6]
0
0
SP
Query!
Country [7]
0
0
Canada
Query!
State/province [7]
0
0
Ontario
Query!
Country [8]
0
0
Canada
Query!
State/province [8]
0
0
Quebec
Query!
Country [9]
0
0
Czech Republic
Query!
State/province [9]
0
0
Brno
Query!
Country [10]
0
0
Czech Republic
Query!
State/province [10]
0
0
Praha 2
Query!
Country [11]
0
0
Denmark
Query!
State/province [11]
0
0
Aarhus C
Query!
Country [12]
0
0
Denmark
Query!
State/province [12]
0
0
Hellerup
Query!
Country [13]
0
0
France
Query!
State/province [13]
0
0
Caen
Query!
Country [14]
0
0
France
Query!
State/province [14]
0
0
Marseille
Query!
Country [15]
0
0
France
Query!
State/province [15]
0
0
Toulouse Cedex
Query!
Country [16]
0
0
Germany
Query!
State/province [16]
0
0
Berlin
Query!
Country [17]
0
0
Germany
Query!
State/province [17]
0
0
Goettingen
Query!
Country [18]
0
0
Germany
Query!
State/province [18]
0
0
Tuebingen
Query!
Country [19]
0
0
Greece
Query!
State/province [19]
0
0
Athens
Query!
Country [20]
0
0
Greece
Query!
State/province [20]
0
0
Pireaus
Query!
Country [21]
0
0
Korea, Republic of
Query!
State/province [21]
0
0
Korea
Query!
Country [22]
0
0
Korea, Republic of
Query!
State/province [22]
0
0
Seoul
Query!
Country [23]
0
0
Mexico
Query!
State/province [23]
0
0
Mexico D.F.
Query!
Country [24]
0
0
Mexico
Query!
State/province [24]
0
0
Nuevo León
Query!
Country [25]
0
0
Netherlands
Query!
State/province [25]
0
0
Amsterdam
Query!
Country [26]
0
0
Netherlands
Query!
State/province [26]
0
0
Zuthpen
Query!
Country [27]
0
0
Taiwan
Query!
State/province [27]
0
0
Taipei
Query!
Country [28]
0
0
Taiwan
Query!
State/province [28]
0
0
Tau-Yuan Hsien
Query!
Country [29]
0
0
United Kingdom
Query!
State/province [29]
0
0
Surrey
Query!
Country [30]
0
0
United Kingdom
Query!
State/province [30]
0
0
West Yorkshire
Query!
Country [31]
0
0
United Kingdom
Query!
State/province [31]
0
0
Leicester
Query!
Country [32]
0
0
United Kingdom
Query!
State/province [32]
0
0
Paisley
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Pfizer
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00282984
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
Query!
Address
0
0
Pfizer
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00282984
Download to PDF