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Smoking CessationPhase 4CATSNCT01574703

Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders.

A Phase 4 study testing varenicline tartrate, bupropion hydrochloride and Nicotine Replacement Therapy Patch in people with Smoking Cessation, run by Pfizer at 134 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Smoking Cessation
What is being tested?
varenicline tartrate, bupropion hydrochloride and Nicotine Replacement Therapy Patch
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
4,595 participants
Where
134 sitesin 16 countries
Study dates
May 2012to Jul 2015
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subjects will be eligible if they were randomized to study A3051123.

Who cannot join

  • Participation in study A3051123 ceased (ie, withdrew consent, lost to follow-up, etc) prior to final visit of study A3051123.

Trial locations and contacts

134 sites in 16 countries.

134 sites in 16 countries

United States65 sites

  • Maine Research Associates

    Auburn, Maine, 04210

  • University of Colorado Anschutz Medical Campus Behavioral Health and Wellness Program

    Aurora, Colorado, 80045

  • Future Search Clinical Trials

    Austin, Texas, 78731

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • SPRI Clinical Trails LLC

    Brooklyn, New York, 11235

  • Southeastern PA Medical Institute

    Broomall, Pennsylvania, 19008

  • PMG Research of Raleigh, LLC

    Cary, North Carolina, 27518

  • Midwest Clinical Research Center

    Dayton, Ohio, 45417

  • Western Affiliated Research Institute

    Denver, Colorado, 80209

  • InSite Clinical Research

    DeSoto, Texas, 75115

  • Pharmacology Research Institute

    Encino, California, 91316

  • Regional Clinical Research, Incorporated

    Endwell, New York, 13760

  • Synergy Clinical Research Center of Escondido

    Escondido, California, 92025

  • Precise Research Centers

    Flowood, Mississippi, 39232

  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers, Florida, 33912

  • Broward Research Group

    Hollywood, Florida, 33024

  • The University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77030-1439

  • Sun Valley Research Center

    Imperial, California, 92251

  • Davis Clinic, Incorporated

    Indianapolis, Indiana, 46250

  • American Health Network of IN, LLC

    Indianapolis, Indiana, 46254

  • Goldpoint Clinical Research, LLC

    Indianapolis, Indiana, 46260

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Clinical Neuroscience Solutions

    Jacksonville, Florida, 32256

  • The Center for Pharmaceutical Research, PC

    Kansas City, Missouri, 64114

  • Volunteer Research Group

    Knoxville, Tennessee, 37920

  • Omega Clinical Trials

    La Habra, California, 90631

  • Pacific Treatment and Research Center

    La Jolla, California, 92037

  • Central Kentucky Research Associates, Incorporated

    Lexington, Kentucky, 40509

  • Lincoln Research, LLC

    Lincoln, Rhode Island, 02865

  • Pharmacology Research Institute

    Los Alamitos, California, 90720

  • Kentucky Research Group

    Louisville, Kentucky, 40218

  • Northwest Behavioral Research Center

    Marietta, Georgia, 30060

  • CRI Worldwide, LLC

    Marlton, New Jersey, 08053

  • Clinical Neuroscience Solutions,Inc

    Memphis, Tennessee, 38119

  • Advanced Clinical Research

    Meridian, Idaho, 83642

  • The Center for Sexual Health

    Metairie, Louisiana, 70002

  • Milford Emergency Associates, Incorporated

    Milford, Massachusetts, 01757

  • University of Minnesota - TC

    Minneapolis, Minnesota, 55414

  • Coastal Clinical Research, Inc.

    Mobile, Alabama, 36608

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • Baber Research Group Incorporated

    Naperville, Illinois, 60563

  • Clinical Research Associates, Inc.

    Nashville, Tennessee, 37203

  • James G. Kyser, MD

    Nashville, Tennessee, 37203

  • Pharmacology Research Institute (PRI)

    Newport Beach, California, 92660

  • Clinical Research Associates of Tidewater, Inc

    Norfolk, Virginia, 23507

  • Comprehensive Psychiatric Care

    Norwich, Connecticut, 06360

  • Renstar Medical Research

    Ocala, Florida, 34471

  • Ocala Psychiatric Associates

    Ocala, Florida, 34474

  • North County Clinical Research

    Oceanside, California, 92056

  • NRC Research Institute

    Orange, California, 92868

  • Clinical Neuroscience Solutions Inc.

    Orlando, Florida, 32801

  • Vince & Associates Clinical Research, Inc.

    Overland Park, Kansas, 66211

  • Vince & Associates Clinical Research, Inc.

    Overland Park, Kansas, 66212

  • Vince and Associates Clinical Research, Inc.

    Overland Park, Kansas, 66212

  • Belmont Center for Comprehensive Treatment

    Philadelphia, Pennsylvania, 19131

  • Oregon Health and Science University

    Portland, Oregon, 97239-3098

  • Global Medicinal Institutes, LLC; Princeton Medical Institute

    Princeton, New Jersey, 08540

  • Wake Internal Medicine Consultants, Inc

    Raleigh, North Carolina, 27612

  • Wake Research Associates, LLC

    Raleigh, North Carolina, 27612

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • California Neuroscience Research Medical Group, Inc.

    Sherman Oaks, California, 91403

  • Mercy Health Research

    St Louis, Missouri, 63141

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281

  • Meridien Research

    Tampa, Florida, 33634

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67207

Other trials in United States

Bulgaria10 sites

  • Mental Health Center "Prof. Dr. Ivan Temkov-Bourgas" Ltd.

    Burgas, Bourgas, 8000

  • MHAT "Dr. Hristo Stambolski" Ltd.

    Kazanlak, 6100

  • NPH "Sv. Ivan Rilski"

    Novi Iskar, 1282

  • UMHAT "Dr. Georgi Stranski" Ltd.

    Pleven, 5800

  • UMHAT "Sveti Georgi" Ltd.

    Plovdiv, 4002

  • SHATPPD - Ruse Ltd.

    Rousse, 7002

  • Mental Health Center - Ruse Ltd.

    Rousse, 7004

  • MHATNP "Sveti Naum" Ltd.

    Sofia, 1113

  • MHATNP Sveti Naum SJsc.

    Sofia, 1113

  • SHATPD - Troyan Ltd.

    Troyan Municipality, 5600

Other trials in Bulgaria

South Africa9 sites

  • Flexivest Fourteen Research Center

    Bellville, Cape Town, 7530

  • Worthwhile Clinical Trials

    Benoni, Johannesburg, Gauteng, 1500

  • Dr John O'Brien Incorporated

    Cape Town, Western Cape, 8001

  • Private Practice

    Durban, Kwa-zulu Natal, South Africa, 4019

  • Randles Road Medical Centre

    Durban, KwaZulu-Natal, 4091

  • Soweto Clinical Trials Centre

    Johannesburg, Gauteng, 1818

  • Midrand Medical Centre

    Midrand, Gauteng, 1685

  • I Engelbrecht Research Pty. Ltd

    Pretoria, Gauteng, 0157

  • Vista Clinic

    Pretoria, Gauteng, 0157

Other trials in South Africa

Germany7 sites

  • Klinische Forschung Berlin-Mitte GmbH

    Berlin, 10117

  • emovis GmbH

    Berlin, 10629

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79104

  • Klinische Forschung Hamburg GmbH

    Hamburg, Free and Hanseatic City of Hamburg, 20253

  • ZSL - Zentrum fuer Medizinische Studien Leipzig GmbH

    Leipzig, 04157

  • Ludwig Maximilians-Universitaet Muenchen

    Munich, Bavaria, 80336

  • Universitaetsklinik Tuebingen, Klinik fuer Psychiatrie und Psychotherapie

    Tübingen, 72076

Other trials in Germany

Russia7 sites

  • FSBI "Federal Medical Research Center of Psychiatry and Addiction Medicine"

    Moscow, 107076

  • Moscow State Public Healthcare Institution Mental Clinical Hospital #1 n.a. N.A. Alexeeva

    Moscow, 117152

  • Clinical Mental Hospital #12 of Moscow Healthcare Department

    Moscow, 125367

  • Clinical Psychiatric Hospital #1 of Nizhni Novgorod

    Nizhny Novgorod, 603155

  • St. Petersburg State Healthcare Institution, St. Nikolay Chudotvorets Mental Hospital

    Saint Petersburg, 190121

  • FSBI "Saint-Petersburg Scientific Research Psychoneurological Institute n.a. V.M. Bekhterev"

    Saint Petersburg, 192019

  • State Healthcare Institution of St.Petersburg "Psychoneurological Dispensary #2

    Saint Petersburg, 197341

Other trials in Russia

Canada6 sites

  • Hamilton Medical Research Group

    Hamilton, Ontario, L8M 1K7

  • Medical Research Associates

    Mississauga, Ontario, L5M 4N4

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7

  • Diex Research Sherbrooke Inc.

    Sherbrooke, Quebec, J1H 1Z1

  • Canadian Phase Onward Inc.

    Toronto, Ontario, M3J 2C5

  • Centre for Addiction and Mental Health (CAMH)

    Toronto, Ontario, M5S 2S1

Other trials in Canada

Finland6 sites

  • Mehiläinen Leppävaara

    Espoo, Finland, 02600

  • Savon Psykiatripalvelu Oy

    Kuopio, Finland, 70110

  • Mehiläinen Nummela

    Nummela, 03100

  • Oulu Mentalcare Oy

    Oulu, Finland, 90100

  • Porin Lääkäritalo Oy

    Pori, 28100

  • PEL, Psykiatrian ErikoisLääkärit

    Turku, 20100

Other trials in Finland

Spain6 sites

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, Barcelona, 08025

  • Hospital General Universitari Vall D'Hebron

    Barcelona, Barcelona, 08035

  • Hospital Clinic I Provincial

    Barcelona, Barcelona, 08036

  • Hospital San Pedro de Alcantara

    Cáceres, Caceres, 10003

  • Unidad Especializada En Tabaquismo de La Comunidad de Madrid

    Madrid, Madrid, 28015

  • Centro de Salud Torrero-La Paz.

    Zaragoza, Zaragoza, 50007

Other trials in Spain

Slovakia5 sites

  • Psychiatricka ambulancia, Mentum, s.r.o.

    Bratislava, 82007

  • Nestatna psychiatricka ambulancia, MUDr. Livia Vavrusova, PhD

    Bratislava, 851 01

  • Psychiatricka ambulancia MUDr. Nada Kuriackova, s.r.o.

    Levice, 93401

  • Psychiatricka ambulancia, PsychoLine s.r.o.

    Rimavská Sobota, 979 01

  • Nemocnica s poliklinikou sv. Barbory Roznava a.s.

    Rožňava, 04801

Other trials in Slovakia

Brazil3 sites

  • Hospital e Maternidade Celso Pierro - Pontifícia Universidade Católica de Campinas - Campus II

    Campinas, São Paulo, 13059-740

  • Hospital Sao Lucas da PUCRS - Uniao Brasileira de Educacao e Assistencia

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Jaqueline Scholz Issa e Mario Issa de cardiologia Ltda

    São Paulo, São Paulo, 05017-000

Other trials in Brazil

Argentina2 sites

  • Centro Medico Dra. De Salvo

    Buenos Aires, Buenos Aires F.D., C1426ABP

  • Centro de Investigacion Clinica WM

    Capital Federal, Buenos Aires, C1440BRR

Other trials in Argentina

Chile2 sites

  • Centro Respiratorio Integral (CENRESIN Ltda.)

    Quillota, Valparaiso, V Region, 2260877

  • Hospital Regional de Talca, Unidad de Enfermedades Respiratorias

    Talca, Maule Region, 3460001

Other trials in Chile

Denmark2 sites

  • CCBR A/S

    Ballerup Municipality, 2750

  • CCBR A/S

    Vejle, DK-7100

Other trials in Denmark

Mexico2 sites

  • Consultorios de Medicina Especializada del Sector Privado

    México, Mexico Df, 06100

  • Centro de Estudios Clinicos y Especialidades Medicas S.C.

    Monterrey, Nuevo León, 64620

Other trials in Mexico

Australia1 site

  • Monash Alfred Psychiatry Research Centre

    Melbourne, Victoria, 3004

Other trials in Australia

New Zealand1 site

  • Lakeland Clinical Trials

    Rotorua, 3010

Other trials in New Zealand

About this study

Official 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

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.

Read the detailed description

This study is an extension protocol for study A3051123. No treatment is provided during this study. This study is to monitor for cardiovascular events 28 weeks after completion of A3051123. This study is an extension protocol for study A3051123. No treatment is provided during this study. This study is to monitor for cardiovascular events 28 weeks after completion of A3051123.

Being tested
placebo, varenicline tartrate, bupropion hydrochloride, Nicotine Replacement Therapy Patch
Keywords
smoking cessation, psychiatric disease, cardiovascular events
Medical subject headings
Smoking Cessation, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • placeboDrug

    All dosing to have taken place per study A3051123

  • varenicline tartrateDrug

    Also called Chantix; Champix

    All dosing to have taken place per study A3051123

  • bupropion hydrochlorideDrug

    Also called Zyban

    All dosing to have taken place per study A3051123

  • Nicotine Replacement Therapy PatchDrug

    Also called NRT

    All dosing to have taken place per study A3051123

Study groups in NCT01574703
Study groupRoleWhat they receive
placeboExperimentalNot described
Receives: Drug: placebo
vareniclineExperimentalNot described
Receives: Drug: varenicline tartrate
bupropionExperimentalNot described
Receives: Drug: bupropion hydrochloride
Nicotine Replacement Therapy PatchExperimentalNot described
Receives: Drug: Nicotine Replacement Therapy Patch

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.

    This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug). The measure type mentioned in the outcome data table is Hazard Ratio relative to Placebo.

    Measured: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).

Secondary outcomes (8)

  1. Time to MACE up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.

    This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug) plus 30 days follow-up. The measure type mentioned in the outcome data table is Hazard Ratio.

    Measured: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days.

  2. Time to MACE Until the End of Study NCT01574703.

    This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated until end of study. The measure type mentioned in the outcome data table is Hazard Ratio.

    Measured: 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).

  3. Incidence of MACE Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.

    This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug).

    Measured: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).

  4. Incidence of MACE + Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.

    This is an adjudicated endpoint. MACE + is defined as any MACE or a new onset or worsening peripheral vascular disease (PVD) requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina.

    Measured: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).

  5. Incidence of MACE Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.

    This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug) plus 30 days follow-up.

    Measured: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up.

  6. Incidence of MACE+ Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.

    This is an adjudicated endpoint. MACE + is defined as any MACE or a new onset or worsening PVD requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina.

    Measured: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up.

  7. Incidence of MACE Assessed Until End of Study NCT01574703.

    This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated until end of study.

    Measured: 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).

  8. Incidence of MACE+ Assessed Until End of Study NCT01574703.

    This is an adjudicated endpoint. MACE+ is defined as any MACE or a new onset or worsening PVD requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina.

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionJul 2015
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
4,595 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01574703
Sponsor's protocol ID
A3051148
Other IDs
2011-005513-37, CATS
Acronym
CATS
Status last verified
Oct 2016
First submitted
6 Apr 2012
Last updated
29 Dec 2016
Data monitoring committee
Yes

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.

    PubMed 29630702

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing varenicline tartrate, bupropion hydrochloride and Nicotine Replacement Therapy Patch in people with Smoking Cessation, run by Pfizer at 134 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 134 sites in United States, Bulgaria, South Africa, Germany, Russia and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. (time frame: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01574703, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2016.

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