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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01574703
First received: April 6, 2012
Last updated: May 20, 2015
Last verified: May 2015
  Purpose

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: Observational
Study Design: Time Perspective: Retrospective
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 ]

Estimated Enrollment: 6800
Study Start Date: May 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
placebo Drug: placebo
All dosing to have taken place per study A3051123
varenicline Drug: varenicline tartrate
All dosing to have taken place per study A3051123
Other Name: Chantix; Champix
bupropion Drug: bupropion hydrochloride
All dosing to have taken place per study A3051123
Other Name: Zyban
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01574703

  Hide Study Locations
Locations
United States, Alabama
Coastal Clinical Research, Incorporated
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
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States, 32256
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Ocala Psychiatric Associates
Ocala, Florida, United States, 34474
Renstar Medical Research
Ocala, Florida, United States, 34471
Clinical Neuroscience Solutions Inc.
Orlando, Florida, United States, 32801
Meridien Research
Tampa, Florida, United States, 33606
United States, Georgia
Northwest Behavioral Research Center
Marietta, Georgia, United States, 30060
Clinical Research Atlanta
Stockbridge, Georgia, United States, 30281
United States, Idaho
Northwest Neurobehavioral Health
Meridian, Idaho, United States, 83642
Advanced Clinical Research
Meridian, Idaho, United States, 83642
United States, Illinois
AMR-Baber Research Incorporated
Naperville, Illinois, United States, 60563
United States, Indiana
Goldpoint Clinical Research, LLC
Indianapolis, Indiana, United States, 46260
Davis Clinic, Incorporated
Indianapolis, Indiana, United States, 46250
American Health Network of IN, LLC
Indianapolis, Indiana, United States, 46254
United States, Kansas
Vince & Associates Clinical Research
Overland Park, Kansas, United States, 66212
Vince & Associates Clinical Research, Inc.
Overland Park, Kansas, United States, 66211
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, 40217
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
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
PRA Health Sciences
Philadelphia, Pennsylvania, United States, 19139
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
Knoxville, Tennessee, United States, 37920
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States, 38119
Clinical Research Associates, Incorporated
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
Argentina
Centro 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
Brazil
Hospital Sao Lucas da PUCRS
Porto Alegre, RS, Brazil, 90610-000
Instituto Jaqueline Scholz Issa e Mario Issa de cardiologia S/C Ltda
Sao Paulo, SP, Brazil, 05017-000
Hospital e Maternidade Celso Pierro - Pontifícia Universidade Católica de Campinas - Campus II
Campinas, São Paulo, Brazil, 13059-740
Bulgaria
Tsentar za Psihichno Zdrave 'Prof. Ivan Temkov'EOOD
Burgas, 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
UMBAL Sveti Georgi EAD, Klinika po psihiatriya
Plovdiv, Bulgaria, 4002
SHATPPD "Ruse Ltd."
Ruse, Bulgaria, 7002
Tsentar za psihichno zdrave - Ruse EOOD
Ruse, Bulgaria, 7004
Meditsinski Tsentar ¿Sveti Naum¿ EOOD
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
Chile
Centro Respiratorio Integral (CENRESIN Ltda.)
Quillota, Valparaiso, V region, Chile, 2260877
Hospital Regional de Talca, Unidad de Enfermedades Respiratorias
Talca, Chile, 3460001
Denmark
CCBR A/S
Ballerup, Denmark, 2750
CCBR A/S
Vejle, Denmark, DK-7100
Finland
Mehiläinen Leppävaara
Espoo, Finland, 02600
Savon Psykiatripalvelu Oy
Kuopio, Finland, 70110
Mehiläinen Nummela
Nummela, Finland, 03100
Oulu Mentalcare Oy
Oulu, Finland, 90100
Porin Lääkäritalo
Pori, Finland, 28100
PEL, Psykiatrian ErikoisLääkärit
Turku, Finland, 20100
Germany
emovis GmbH
Berlin, Germany, 10629
Klinische Forschung Berlin-Mitte GmbH
Berlin, Germany, 10117
Universitaetsklinikum Freiburg
Freiburg, Germany, 79104
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
Mexico
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
Clinical Mental Hospital #12
Moscow, Russian Federation, 125367
Federal State Institution Moscow Scientific Research Institute of Psychiatry Minzdravsotsrazvitiya
Moscow, Russian Federation, 107076
State Institution Scientific Centre for Psychic Health of RAMS
Moscow, Russian Federation, 115522
Moscow Research Institute of Psychiatry
Moscow, Russian Federation, 107076
Clinical Psychiatric Hospital #1 of Nizhni Novgorod
Nizhni Novgorod, Russian Federation, 603155
FSBI ##SPb Scientific Research Psychoneurolog.Institute n.a. V. M. Bechterev## of MoH of RF
St. Petersburg, Russian Federation, 192019
St. Petersburg State Healthcare Institution, St. Nikolay Chudotvorets Mental Hospital
St. Petersburg, Russian Federation, 190121
State Healthcare Institution "Psychoneurological Dispensary #2
St. Petersburg, Russian Federation, 197341
Slovakia
Nestatna psychiatricka ambulancia, MUDr. Livia Vavrusova, PhD
Bratislava, Slovakia, 851 01
Psychiatricka ambulancia, Mentum, s.r.o.
Bratislava, Slovakia, 82007
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
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
Flexivest Fourteen Research Center
Bellville, Western Cape, South Africa, 7530
Dr John O'Brien Incorporated
Cape Town, Western Cape, South Africa, 8001
Spain
Centro de Salud Mental Ii "La Corredoria"
Oviedo, Asturias, Spain, 33011
Hospital Clinic I Provincial
Barcelona, Spain, 08036
Hospital de La Santa Creu I Sant Pau
Barcelona, Spain, 08025
Hospital General de La Vall D'Hebron
Barcelona, Spain, 08035
Hospital San Pedro de Alcantara
Caceres, Spain, 10003
Unidad Especializada En Tabaquismo de La Comunidad de Madrid
Madrid, Spain, 28015
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01574703     History of Changes
Other Study ID Numbers: A3051148, 2011-005513-37, CATS
Study First Received: April 6, 2012
Last Updated: May 20, 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
Bupropion
Varenicline
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Cholinergic Agents
Cholinergic Agonists
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Nicotinic Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2015