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

This study has been completed.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: April 6, 2012
Last updated: October 16, 2015
Last verified: October 2015
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.

Condition Intervention Phase
Smoking Cessation
Drug: placebo
Drug: varenicline tartrate
Drug: bupropion hydrochloride
Drug: Nicotine Replacement Therapy Patch
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
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

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Time to major cardiovascular event (MACE; 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 in study A3051123) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to MACE up to date of last dose of study drug plus 30 days in study A3051123 [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • Time to MACE until the end of study (A3051148) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of each of the following events assessed up to date of last dose of study drug: [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    MACE; - MACE + (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; • CV deaths; • Non fatal MI; • Non fatal stroke.

  • Incidence of each of the following events will be assessed up to date of last dose of study drug plus 30 days • MACE; • MACE + (defined as any MACE or a new onset or worsening peripheral vascular disease (PVD) requiring intervention, [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • a need for coronary revascularization, or hospitalization for unstable angina; • CV deaths; • Non fatal MI; • Non fatal stroke. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of each of the following events will be assessed until end of study: • MACE; • MACE + (defined as any MACE or a new onset or worsening peripheral vascular disease (PVD) requiring intervention, a need for coronary [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • revascularization, or hospitalization for unstable angina; • CV deaths; • Non fatal MI; • Non fatal stroke. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 4599
Study Start Date: May 2012
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: placebo Drug: placebo
All dosing to have taken place per study A3051123
Experimental: varenicline Drug: varenicline tartrate
All dosing to have taken place per study A3051123
Other Name: Chantix; Champix
Experimental: bupropion Drug: bupropion hydrochloride
All dosing to have taken place per study A3051123
Other Name: Zyban
Experimental: Nicotine Replacement Therapy Patch Drug: Nicotine Replacement Therapy Patch
All dosing to have taken place per study A3051123
Other Name: NRT

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.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • Participation in study A3051123 ceased (ie, withdrew consent, lost to follow-up, etc) prior to final visit of study A3051123.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01574703

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United States, Alabama
Coastal Clinical Research, Inc.
Mobile, Alabama, United States, 36608
United States, California
Pharmacology Research Institute
Encino, California, United States, 91316
Synergy Clinical Research Center of Escondido
Escondido, California, United States, 92025
Sun Valley Research Center
Imperial, California, United States, 92251
Omega Clinical Trials, LLC
La Habra, California, United States, 90631
Pacific Treatment and Research Center
La Jolla, California, United States, 92037
Pharmacology Research Institute
Los Alamitos, California, United States, 90720
Pharmacology Research Institute (PRI)
Newport Beach, California, United States, 92660
North County Clinical Research
Oceanside, California, United States, 92056
NRC Research Institute
Orange, California, United States, 92868
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, United States, 91403
United States, Colorado
University of Colorado Anschutz Medical Campus Behavioral Health and Wellness Program
Aurora, Colorado, United States, 80045
Western Affiliated Research Institute
Denver, Colorado, United States, 80209
United States, Connecticut
Comprehensive Psychiatric Care
Norwich, Connecticut, United States, 06360
United States, Florida
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States, 33912
Broward Research Group
Hollywood, Florida, United States, 33024
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States, 32256
Renstar Medical Research
Ocala, Florida, United States, 34471
Ocala Psychiatric Associates
Ocala, Florida, United States, 34474
Clinical Neuroscience Solutions Inc.
Orlando, Florida, United States, 32801
Meridien Research
Tampa, Florida, United States, 33634
United States, Georgia
Northwest Behavioral Research Center
Marietta, Georgia, United States, 30060
Clinical Research Atlanta
Stockbridge, Georgia, United States, 30281
United States, Idaho
Advanced Clinical Research
Meridian, Idaho, United States, 83642
United States, Illinois
AMR-Baber Research Incorporated
Naperville, Illinois, United States, 60563
United States, Indiana
Davis Clinic, Incorporated
Indianapolis, Indiana, United States, 46250
American Health Network of IN, LLC
Indianapolis, Indiana, United States, 46254
Goldpoint Clinical Research, LLC
Indianapolis, Indiana, United States, 46260
United States, Kansas
Vince & Associates Clinical Research, Inc.
Overland Park, Kansas, United States, 66211
Vince & Associates Clinical Research
Overland Park, Kansas, United States, 66212
Vince and Associates Clinical Research, LLC
Overland Park, Kansas, United States, 66212
Heartland Research Associates, LLC
Wichita, Kansas, United States, 67207
United States, Kentucky
Central Kentucky Research Association, Incorporated
Lexington, Kentucky, United States, 40509
Kentucky Research Group
Louisville, Kentucky, United States, 40218
United States, Louisiana
The Center for Sexual Health
Metairie, Louisiana, United States, 70002
United States, Maine
Maine Research Associates
Auburn, Maine, United States, 04210
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Milford Emergency Associates, Incorporated
Milford, Massachusetts, United States, 01757
United States, Minnesota
University of Minnesota - TC
Minneapolis, Minnesota, United States, 55414
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Mississippi
Precise Research Centers
Flowood, Mississippi, United States, 39232
United States, Missouri
The Center for Pharmaceutical Research, PC
Kansas City, Missouri, United States, 64114
Mercy Health Research
St. Louis, Missouri, United States, 63141
United States, New Jersey
CRI Worldwide, LLC
Marlton, New Jersey, United States, 08053
Global Medicinal Institutes, LLC; Princeton Medical Institute
Princeton, New Jersey, United States, 08540
United States, New York
Social Psychiatry Research Institute
Brooklyn, New York, United States, 11235
Regional Clinical Research, Incorporated
Endwell, New York, United States, 13760
United States, North Carolina
PMG Research of Raleigh, LLC
Cary, North Carolina, United States, 27518
Wake Internal Medicine Consultants, Inc
Raleigh, North Carolina, United States, 27612
Wake Research Associates, LLC
Raleigh, North Carolina, United States, 27612
United States, Ohio
Midwest Clinical Research Center
Dayton, Ohio, United States, 45417
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239-3098
United States, Pennsylvania
Southeastern PA Medical Institute
Broomall, Pennsylvania, United States, 19008
Belmont Center for Comprehensive Treatment
Philadelphia, Pennsylvania, United States, 19131
United States, Rhode Island
Lincoln Research, LLC
Lincoln, Rhode Island, United States, 02865
United States, South Carolina
Coastal Carolina Research Center
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States, 37920
Volunteer Research Group
Koxville, Tennessee, United States, 37920
Clinical Neuroscience Solutions,Inc
Memphis, Tennessee, United States, 38119
Clinical Research Associates, Inc.
Nashville, Tennessee, United States, 37203
James G. Kyser, MD
Nashville, Tennessee, United States, 37203
United States, Texas
Future Search Clinical Trials
Austin, Texas, United States, 78731
InSite Clinical Research
DeSoto, Texas, United States, 75115
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030-1439
United States, Virginia
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States, 23507
Centro de Investigacion Clinica WM
Capital Federal, Buenos Aires, Argentina, C1440BRR
Centro Medico Dra. De Salvo
Ciudad Autonoma de Buenos Aires, Capital Federal, Argentina, C1426ABP
Australia, Victoria
Monash Alfred Psychiatry Research Centre
Melbourne, Victoria, Australia, 3004
Hospital Sao Lucas da PUCRS - Uniao Brasileira de Educacao e Assistencia
Porto Alegre, RS, Brazil, 90610-000
Hospital e Maternidade Celso Pierro - Pontifícia Universidade Católica de Campinas - Campus II
Campinas, São Paulo, Brazil, 13059-740
Instituto Jaqueline Scholz Issa e Mario Issa de cardiologia S/C Ltda
San Paulo, Brazil, 05017-000
Mental Health Center "Prof. Dr. Ivan Temkov-Bourgas" Ltd.
Bourgas, Bulgaria, 8000
MHAT "Dr. Hristo Stambolski" Ltd.
Kazanlak, Bulgaria, 6100
NPH "Sv. Ivan Rilski"
Novi Iskar, Bulgaria, 1282
UMHAT "Dr. Georgi Stranski" Ltd.
Pleven, Bulgaria, 5800
UMHAT "Sveti Georgi" Ltd.
Plovdiv, Bulgaria, 4002
SHATPPD "Ruse Ltd."
Ruse, Bulgaria, 7002
Mental Health Center - Ruse Ltd.
Ruse, Bulgaria, 7004
MHATNP "Sveti Naum" Ltd.
Sofia, Bulgaria, 1113
MHATNP Sveti Naum SJsc., Second Psychiatric clinic
Sofia, Bulgaria, 1113
SHATPD - Troyan Ltd.
Troyan, Bulgaria, 5600
Canada, Ontario
Hamilton Medical Research Group
Hamilton, Ontario, Canada, L8M 1K7
Medical Research Associates
Mississauga, Ontario, Canada, L5M 4N4
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Canadian Phase Onward Inc.
Toronto, Ontario, Canada, M3J 2C5
Centre for Addiction and Mental Health (CAMH)
Toronto, Ontario, Canada, M5S 2S1
Canada, Quebec
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, Canada, J1H 1Z1
Centro Respiratorio Integral (CENRESIN Ltda.)
Quillota, Valparaiso, V region, Chile, 2260877
Hospital Regional de Talca, Unidad de Enfermedades Respiratorias
Talca, Chile, 3460001
Ballerup, Denmark, 2750
Vejle, Denmark, DK-7100
Mehiläinen Leppävaara
Espoo, Finland, 02600
Savon Psykiatripalvelu Oy
Kuopio, Finland, 70110
Mehiläinen Nummela
Nummela, Finland, 03100
Oulu Mentalcare Oy
Oulu, Finland, 90100
Porin Lääkäritalo Oy
Pori, Finland, 28100
PEL, Psykiatrian ErikoisLääkärit
Turku, Finland, 20100
Universitaetsklinikum Freiburg
Freiburg, Baden-Wuerttemberg, Germany, 79104
Klinische Forschung Berlin-Mitte GmbH
Berlin, Germany, 10117
emovis GmbH
Berlin, Germany, 10629
Klinische Forschung Hamburg GmbH
Hamburg, Germany, 20253
ZSL - Zentrum fuer Medizinische Studien Leipzig GmbH
Leipzig, Germany, 04157
Ludwig Maximilians-Universitaet Muenchen
Muenchen, Germany, 80336
Universitaetsklinik Tuebingen, Klinik fuer Psychiatrie und Psychotherapie
Tuebingen, Germany, 72076
Instituto Mexicano de la Investigacion Clinica S.A. de C.V.
Mexico, DF, Mexico, 06700
Centro de Estudios Clinicos y Especialidades Medicas S.C.
Monterrey, Nuevo Leon, Mexico, 64620
New Zealand
Lakeland Clinical Trials
Rotorua, New Zealand, 3010
Russian Federation
Federal State Institution Moscow Scientific Research Institute of Psychiatry Minzdravsotsrazvitiya
Moscow, Russian Federation, 107076
Moscow Research Institute of Psychiatry
Moscow, Russian Federation, 107076
Moscow State Public Healthcare Institution Mental Clinical Hospital #1 n.a. N.A. Alexeeva
Moscow, Russian Federation, 117152
Clinical Mental Hospital #12 of Moscow Healthcare Department
Moscow, Russian Federation, 125367
Clinical Psychiatric Hospital #1 of Nizhni Novgorod
Nizhni Novgorod, Russian Federation, 603155
FSBI "Saint-Petersburg Scientific Research Psychoneurological Institute n.a. V.M. Bekhterev" of MoH
Saint Petersburg, Russian Federation, 192019
St. Petersburg State Healthcare Institution, St. Nikolay Chudotvorets Mental Hospital
St. Petersburg, Russian Federation, 190121
State Healthcare Institution of St.Petersburg "Psychoneurological Dispensary #2
St. Petersburg, Russian Federation, 197341
Psychiatricka ambulancia, Mentum, s.r.o.
Bratislava, Slovakia, 82007
Nestatna psychiatricka ambulancia, MUDr. Livia Vavrusova, PhD
Bratislava, Slovakia, 851 01
Psychiatricka ambulancia MUDr. Nada Kuriackova, s.r.o.
Levice, Slovakia, 93401
Psychiatricka ambulancia, PsychoLine s.r.o.
Rimavska Sobota, Slovakia, 979 01
Nemocnica s poliklinikou sv. Barbory Roznava a.s.
Roznava, Slovakia, 04801
South Africa
Flexivest Fourteen Research Center
Bellville, Cape Town, South Africa, 7530
Worthwhile Clinical Trials
Benoni, Gauteng, South Africa, 1500
Vista Clinic
Centurion, Gauteng, South Africa, 0157
Soweto Clinical Trials Centre
Johannesburg, Gauteng, South Africa, 1818
Midrand Medical Centre
Midrand, Gauteng, South Africa, 1685
I Engelbrecht Research Pty(Ltd)
Pretoria, Gauteng, South Africa, 0157
Private Practice
Durban, Kwa-Zulu Natal, South Africa, 4091
Randles Road Medical Centre
Durban, Kwazulu Natal, South Africa, 4091
Dr John O'Brien Incorporated
Cape Town, Western Cape, South Africa, 8001
Hospital de La Santa Creu I Sant Pau
Barcelona, Spain, 08025
Hospital General Universitari Vall D'Hebron
Barcelona, Spain, 08035
Hospital Clinic I Provincial
Barcelona, Spain, 08036
Hospital San Pedro de Alcantara
Caceres, Spain, 10003
Unidad Especializada En Tabaquismo de La Comunidad de Madrid
Madrid, Spain, 28015
Centro de Salud Torrero-La Paz.
Zaragoza, Spain, 50007
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer Identifier: NCT01574703     History of Changes
Other Study ID Numbers: A3051148  2011-005513-37  CATS 
Study First Received: April 6, 2012
Last Updated: October 16, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
smoking cessation
psychiatric disease
cardiovascular events

Additional relevant MeSH terms:
Mental Disorders
Problem Behavior
Behavioral Symptoms
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors processed this record on December 09, 2016