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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
A3051049
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking Cessation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

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)
Timepoint [1] 0 0
weeks 9 through 12
Secondary outcome [1] 0 0
Number of Responders With Continuous Abstinence (CA) Through Week 52
Timepoint [1] 0 0
Week 9 through Week 52
Secondary outcome [2] 0 0
Number of Long-Term Quit Responders
Timepoint [2] 0 0
Week 9 through Week 52
Secondary outcome [3] 0 0
Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 12
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 24
Timepoint [4] 0 0
Week 24
Secondary outcome [5] 0 0
Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 52
Timepoint [5] 0 0
Week 52
Secondary outcome [6] 0 0
Number of Participants With a 4 Week Point Prevalence of Smoking Cessation
Timepoint [6] 0 0
Week 48 through Week 52 (final 4 weeks of non-treatment period [pd])
Secondary outcome [7] 0 0
Number of Responders With Continuous Abstinence (CA) Through Week 24
Timepoint [7] 0 0
Week 9 through Week 24
Secondary outcome [8] 0 0
Cigarettes Smoked Per Day
Timepoint [8] 0 0
Day 21
Secondary outcome [9] 0 0
Number of Long-Term Quit Responders From Week 9 Through Week 24
Timepoint [9] 0 0
Week 9 through Week 24

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.
Minimum age
35 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants with unstable cardiovascular disease
* Cardiovascular events in the past 2 months
* Moderate or severe chronic obstructive pulmonary disease (COPD)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Concord
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Herston
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Wisconsin
Country [4] 0 0
Argentina
State/province [4] 0 0
Buenos Aires
Country [5] 0 0
Brazil
State/province [5] 0 0
RS
Country [6] 0 0
Brazil
State/province [6] 0 0
SP
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec
Country [9] 0 0
Czech Republic
State/province [9] 0 0
Brno
Country [10] 0 0
Czech Republic
State/province [10] 0 0
Praha 2
Country [11] 0 0
Denmark
State/province [11] 0 0
Aarhus C
Country [12] 0 0
Denmark
State/province [12] 0 0
Hellerup
Country [13] 0 0
France
State/province [13] 0 0
Caen
Country [14] 0 0
France
State/province [14] 0 0
Marseille
Country [15] 0 0
France
State/province [15] 0 0
Toulouse Cedex
Country [16] 0 0
Germany
State/province [16] 0 0
Berlin
Country [17] 0 0
Germany
State/province [17] 0 0
Goettingen
Country [18] 0 0
Germany
State/province [18] 0 0
Tuebingen
Country [19] 0 0
Greece
State/province [19] 0 0
Athens
Country [20] 0 0
Greece
State/province [20] 0 0
Pireaus
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Korea
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Seoul
Country [23] 0 0
Mexico
State/province [23] 0 0
Mexico D.F.
Country [24] 0 0
Mexico
State/province [24] 0 0
Nuevo León
Country [25] 0 0
Netherlands
State/province [25] 0 0
Amsterdam
Country [26] 0 0
Netherlands
State/province [26] 0 0
Zuthpen
Country [27] 0 0
Taiwan
State/province [27] 0 0
Taipei
Country [28] 0 0
Taiwan
State/province [28] 0 0
Tau-Yuan Hsien
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Surrey
Country [30] 0 0
United Kingdom
State/province [30] 0 0
West Yorkshire
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Leicester
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Paisley

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00282984
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00282984