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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
1/02/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2008
Sample size
Target
Accrual to date
Final
714
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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00282984