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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01574703




Registration number
NCT01574703
Ethics application status
Date submitted
6/04/2012
Date registered
10/04/2012
Date last updated
29/12/2016

Titles & IDs
Public title
Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders.
Scientific title
A Phase 4, Non-treatment Follow-up For Cardiac Assessments Following Use Of Smoking Cessation Treatments In Subjects With And Without A History Of Psychiatric Disorders
Secondary ID [1] 0 0
2011-005513-37
Secondary ID [2] 0 0
A3051148
Universal Trial Number (UTN)
Trial acronym
CATS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking Cessation 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - placebo
Treatment: Drugs - varenicline tartrate
Treatment: Drugs - bupropion hydrochloride
Treatment: Drugs - Nicotine Replacement Therapy Patch

Experimental: placebo -

Experimental: varenicline -

Experimental: bupropion -

Experimental: Nicotine Replacement Therapy Patch -


Treatment: Drugs: placebo
All dosing to have taken place per study A3051123

Treatment: Drugs: varenicline tartrate
All dosing to have taken place per study A3051123

Treatment: Drugs: bupropion hydrochloride
All dosing to have taken place per study A3051123

Treatment: Drugs: Nicotine Replacement Therapy Patch
All dosing to have taken place per study A3051123
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.
Timepoint [1] 0 0
Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).
Secondary outcome [1] 0 0
Time to MACE up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.
Timepoint [1] 0 0
Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days.
Secondary outcome [2] 0 0
Time to MACE Until the End of Study NCT01574703.
Timepoint [2] 0 0
Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703).
Secondary outcome [3] 0 0
Incidence of MACE Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.
Timepoint [3] 0 0
Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).
Secondary outcome [4] 0 0
Incidence of MACE + Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.
Timepoint [4] 0 0
Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).
Secondary outcome [5] 0 0
Incidence of MACE Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.
Timepoint [5] 0 0
Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up.
Secondary outcome [6] 0 0
Incidence of MACE+ Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.
Timepoint [6] 0 0
Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up.
Secondary outcome [7] 0 0
Incidence of MACE Assessed Until End of Study NCT01574703.
Timepoint [7] 0 0
Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703).
Secondary outcome [8] 0 0
Incidence of MACE+ Assessed Until End of Study NCT01574703.
Timepoint [8] 0 0
Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703).

Eligibility
Key inclusion criteria
* Subjects will be eligible if they were randomized to study A3051123.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Participation in study A3051123 ceased (ie, withdrew consent, lost to follow-up, etc) prior to final visit of study A3051123.

Study design
Purpose of the study
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
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
1/05/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2015
Sample size
Target
Accrual to date
Final
4595
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Alfred Psychiatry Research Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
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United States of America
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Alabama
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California
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Connecticut
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Texas
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Buenos Aires
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Argentina
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Capital Federal
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Brazil
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RS
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Brazil
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Brazil
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Sao Paulo
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Bourgas
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Pleven
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Ruse
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Sofia
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Pori
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Germany
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Bayern
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Hamburg
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Leipzig
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Tuebingen
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Nuevo Leon
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Rotorua
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Russian Federation
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Moscow
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Russian Federation
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Nizhni Novgorod
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Russian Federation
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Saint Petersburg
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Russian Federation
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St. Petersburg
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Slovakia
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Bratislava
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Slovakia
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Levice
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Slovakia
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Rimavska Sobota
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Slovakia
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Roznava
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South Africa
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Cape Town
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South Africa
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Gauteng
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South Africa
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Kwa-zulu Natal, South Africa
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South Africa
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Kwazulu Natal
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South Africa
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Western Cape
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Spain
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Barcelona
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Spain
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Caceres
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Spain
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Madrid
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Spain
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Zaragoza

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

Ethics approval
Ethics application status

Summary
Brief summary
Non-treatment extension to study A3051123, aimed at collecting data on cardiovascular safety for all participants in the A3051123 trial for an additional 28 weeks, allowing for a total of 52 weeks of cardiovascular safety data collection.
Trial website
https://clinicaltrials.gov/study/NCT01574703
Trial related presentations / publications
Benowitz NL, Pipe A, West R, Hays JT, Tonstad S, McRae T, Lawrence D, St Aubin L, Anthenelli RM. Cardiovascular Safety of Varenicline, Bupropion, and Nicotine Patch in Smokers: A Randomized Clinical Trial. JAMA Intern Med. 2018 May 1;178(5):622-631. doi: 10.1001/jamainternmed.2018.0397.
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/NCT01574703