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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01574703
First received: April 6, 2012
Last updated: April 23, 2015
Last verified: April 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: 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 ]

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)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Hide Study Locations
Locations
United States, Alabama
Coastal Clinical Research, Incorporated Active, not recruiting
Mobile, Alabama, United States, 36608
United States, California
Pharmacology Research Institute Active, not recruiting
Encino, California, United States, 91316
Synergy Clinical Research Center of Escondido Active, not recruiting
Escondido, California, United States, 92025
Sun Valley Research Center Active, not recruiting
Imperial, California, United States, 92251
Omega Clinical Trials, LLC Recruiting
La Habra, California, United States, 90631
Pacific Treatment and Research Center Active, not recruiting
La Jolla, California, United States, 92037
Pharmacology Research Institute Active, not recruiting
Los Alamitos, California, United States, 90720
Pharmacology Research Institute (PRI) Active, not recruiting
Newport Beach, California, United States, 92660
North County Clinical Research Active, not recruiting
Oceanside, California, United States, 92056
NRC Research Institute Active, not recruiting
Orange, California, United States, 92868
California Neuroscience Research Medical Group, Inc. Active, not recruiting
Sherman Oaks, California, United States, 91403
United States, Colorado
University of Colorado Anschutz Medical Campus Behavioral Health and Wellness Program Recruiting
Aurora, Colorado, United States, 80045
Western Affiliated Research Institute Active, not recruiting
Denver, Colorado, United States, 80209
United States, Connecticut
Comprehensive Psychiatric Care Active, not recruiting
Norwich, Connecticut, United States, 06360
United States, Florida
Neuropsychiatric Research Center of Southwest Florida Terminated
Fort Myers, Florida, United States, 33912
Broward Research Group Active, not recruiting
Hollywood, Florida, United States, 33024
Clinical Neuroscience Solutions, Inc. Active, not recruiting
Jacksonville, Florida, United States, 32256
Jacksonville Center for Clinical Research Active, not recruiting
Jacksonville, Florida, United States, 32216
Ocala Psychiatric Associates Active, not recruiting
Ocala, Florida, United States, 34474
Renstar Medical Research Active, not recruiting
Ocala, Florida, United States, 34471
Clinical Neuroscience Solutions Inc. Active, not recruiting
Orlando, Florida, United States, 32801
Meridien Research Active, not recruiting
Tampa, Florida, United States, 33606
United States, Georgia
Northwest Behavioral Research Center Active, not recruiting
Marietta, Georgia, United States, 30060
Clinical Research Atlanta Active, not recruiting
Stockbridge, Georgia, United States, 30281
United States, Idaho
Advanced Clinical Research Recruiting
Meridian, Idaho, United States, 83642
Northwest Neurobehavioral Health Recruiting
Meridian, Idaho, United States, 83642
United States, Illinois
AMR-Baber Research Incorporated Active, not recruiting
Naperville, Illinois, United States, 60563
United States, Indiana
American Health Network of IN, LLC Active, not recruiting
Indianapolis, Indiana, United States, 46254
Davis Clinic, Incorporated Active, not recruiting
Indianapolis, Indiana, United States, 46250
Goldpoint Clinical Research, LLC Active, not recruiting
Indianapolis, Indiana, United States, 46260
United States, Kansas
Vince & Associates Clinical Research Active, not recruiting
Overland Park, Kansas, United States, 66121
Vince & Associates Clinical Research, Inc. Active, not recruiting
Overland Park, Kansas, United States, 66211
Vince and Associates Clinical Research, Inc. Active, not recruiting
Overland Park, Kansas, United States, 66212
Vince and Associates Clinical Research, LLC Active, not recruiting
Overland Park, Kansas, United States, 66212
Heartland Research Associates, LLC Active, not recruiting
Wichita, Kansas, United States, 67207
United States, Kentucky
Central Kentucky Research Association, Incorporated Active, not recruiting
Lexington, Kentucky, United States, 40509
Kentucky Research Group Active, not recruiting
Louisville, Kentucky, United States, 40217
United States, Louisiana
The Center for Sexual Health Active, not recruiting
Metairie, Louisiana, United States, 70002
United States, Maine
Maine Research Associates Active, not recruiting
Auburn, Maine, United States, 04210
United States, Massachusetts
Massachusetts General Hospital Active, not recruiting
Boston, Massachusetts, United States, 02114
Milford Emergency Associates, Incorporated Active, not recruiting
Milford, Massachusetts, United States, 01757
United States, Minnesota
University of Minnesota - TC Active, not recruiting
Minneapolis, Minnesota, United States, 55414
Mayo Clinic Active, not recruiting
Rochester, Minnesota, United States, 55905
United States, Mississippi
Precise Research Centers Active, not recruiting
Flowood, Mississippi, United States, 39232
United States, Missouri
The Center for Pharmaceutical Research, PC Active, not recruiting
Kansas City, Missouri, United States, 64114
Mercy Health Research Active, not recruiting
St. Louis, Missouri, United States, 63141
United States, New Jersey
Global Medicinal Institutes, LLC; Princeton Medical Institute Active, not recruiting
Princeton, New Jersey, United States, 08540
United States, New York
Social Psychiatry Research Institute Active, not recruiting
Brooklyn, New York, United States, 11235
Regional Clinical Research, Incorporated Active, not recruiting
Endwell, New York, United States, 13760
United States, North Carolina
PMG Research of Raleigh, LLC Active, not recruiting
Cary, North Carolina, United States, 27518
PMG Research of Raleigh, LLC Active, not recruiting
Cary, North Carolina, United States, 27511
Wake Research Associates, LLC Active, not recruiting
Raleigh, North Carolina, United States, 27612
United States, Ohio
Midwest Clinical Research Center Active, not recruiting
Dayton, Ohio, United States, 45417
United States, Oregon
Oregon Health and Science University Active, not recruiting
Portland, Oregon, United States, 97239-3098
United States, Pennsylvania
Southeastern PA Medical Institute Terminated
Broomall, Pennsylvania, United States, 19008
CRI Worldwide, LLC Active, not recruiting
Philadelphia, Pennsylvania, United States, 19139
Belmont Center for Comprehensive Treatment Terminated
Philadelphia, Pennsylvania, United States, 19131
United States, Rhode Island
Lincoln Research, LLC Active, not recruiting
Lincoln, Rhode Island, United States, 02865
United States, South Carolina
Coastal Carolina Research Center Active, not recruiting
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
New Orleans Center for Clinical Research Active, not recruiting
Knoxville, Tennessee, United States, 37920
Volunteer Research Group Active, not recruiting
Knoxville, Tennessee, United States, 37920
Clinical Neuroscience Solutions, Inc. Active, not recruiting
Memphis, Tennessee, United States, 38119
Clinical Research Associates, Incorporated Active, not recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Future Search Clinical Trials Active, not recruiting
Austin, Texas, United States, 78731
InSite Clinical Research Active, not recruiting
DeSoto, Texas, United States, 75115
The University of Texas M.D. Anderson Cancer Center Active, not recruiting
Houston, Texas, United States, 77030-1439
United States, Virginia
Clinical Research Associates of Tidewater Recruiting
Norfolk, Virginia, United States, 23507
Argentina
Centro Investigacion Clinica WM Active, not recruiting
Capital Federal, Buenos Aires, Argentina, C1440BRR
Centro Medico Dra. De Salvo Recruiting
Ciudad Autonoma de Buenos Aires, Capital Federal, Argentina, C1426ABP
Australia, Victoria
Monash Alfred Psychiatry Research Centre Active, not recruiting
Melbourne, Victoria, Australia, 3004
Brazil
Hospital Sao Lucas da PUCRS Active, not recruiting
Porto Alegre, RS, Brazil, 90610-000
Instituto Jaqueline Scholz Issa e Mario Issa de cardiologia S/C Ltda Active, not recruiting
Sao Paulo, SP, Brazil, 05017-000
Hospital e Maternidade Celso Pierro - Pontifícia Universidade Católica de Campinas - Campus II Active, not recruiting
Campinas, São Paulo, Brazil, 13059-740
Bulgaria
Tsentar za Psihichno Zdrave 'Prof. Ivan Temkov'EOOD Active, not recruiting
Burgas, Bulgaria, 8000
MBAL Dr. Hristo Stambolski EOOD Active, not recruiting
Kazanlak, Bulgaria, 6100
NPH "Sv. Ivan Rilski" Active, not recruiting
Novi Iskar, Bulgaria, 1282
UMBAL Dr. Georgi Stranski EAD, Active, not recruiting
Pleven, Bulgaria, 5800
UMBAL Sveti Georgi EAD, Klinika po psihiatriya Active, not recruiting
Plovdiv, Bulgaria, 4002
SBALPFZ - Ruse EOOD, Active, not recruiting
Ruse, Bulgaria, 7002
Tsentar za psihichno zdrave - Ruse EOOD Active, not recruiting
Ruse, Bulgaria, 7004
Meditsinski Tsentar ¿Sveti Naum¿ EOOD Active, not recruiting
Sofia, Bulgaria, 1113
MHATNP ¿Sveti Naum¿ SJsc., Second Psychiatric clinic Active, not recruiting
Sofia, Bulgaria, 1113
Specializirana Bolnitsa za Aktivno Lechenie na Belodrobni Bolesti-Troyan EOOD, Active, not recruiting
Troyan, Bulgaria, 5600
Canada, Ontario
Hamilton Medical Research Group Active, not recruiting
Hamilton, Ontario, Canada, L8M 1K7
Medical Research Associates Active, not recruiting
Mississauga, Ontario, Canada, L5M 4N4
University of Ottawa Heart Institute Active, not recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Canadian Phase Onward Inc. Active, not recruiting
Toronto, Ontario, Canada, M3J 2C5
Centre for Addiction and Mental Health (CAMH) Active, not recruiting
Toronto, Ontario, Canada, M5S 2S1
Canada, Quebec
Diex Research Sherbrooke Inc. Active, not recruiting
Sherbrooke, Quebec, Canada, J1H 1Z1
Chile
Hospital San Martin de Quillota Active, not recruiting
Quillota, V Region, Chile, 2260494
Hospital Regional de Talca, Unidad de Enfermedades Respiratorias Active, not recruiting
Talca, Chile, 3460001
Denmark
CCBR A/S Active, not recruiting
Ballerup, Denmark, 2750
CCBR A/S Active, not recruiting
Vejle, Denmark, DK-7100
Finland
Mehiläinen Leppävaara Active, not recruiting
Espoo, Finland, 02600
Savon Psykiatripalvelu Oy Active, not recruiting
Kuopio, Finland, 70110
Mehiläinen Nummela Active, not recruiting
Nummela, Finland, 03100
Oulu Mentalcare Oy Active, not recruiting
Oulu, Finland, 90100
Porin Lääkäritalo Active, not recruiting
Pori, Finland, 28100
PEL, Psykiatrian ErikoisLääkärit Active, not recruiting
Turku, Finland, 20100
Germany
Klinische Forschung Berlin-Mitte GmbH Active, not recruiting
Berlin, Germany, 10117
emovis GmbH Active, not recruiting
Berlin, Germany, 10629
Universitaetsklinikum Freiburg Active, not recruiting
Freiburg, Germany, 79104
Klinische Forschung Hamburg GmbH Active, not recruiting
Hamburg, Germany, 20253
ZSL - Zentrum fuer Medizinische Studien Leipzig GmbH Terminated
Leipzig, Germany, 04157
Ludwig Maximilians-Universitaet Muenchen Active, not recruiting
Muenchen, Germany, 80336
Universitaetsklinik Tuebingen, Klinik fuer Psychiatrie und Psychotherapie Active, not recruiting
Tuebingen, Germany, 72076
Mexico
Instituto Mexicano de la Investigacion Clinica S.A. de C.V. Active, not recruiting
Mexico, DF, Mexico, 06700
Centro de Estudios Clinicos y Especialidades Medicas S.C. Active, not recruiting
Monterrey, Nuevo Leon, Mexico, 64620
New Zealand
Lakeland Clinical Trials Active, not recruiting
Rotorua, New Zealand, 3010
Russian Federation
Clinical Mental Hospital #12 Active, not recruiting
Moscow, Russian Federation, 125367
Federal State Institution Moscow Scientific Research Institute of Psychiatry Minzdravsotsrazvitiya Active, not recruiting
Moscow, Russian Federation, 107076
Moscow Research Institute of Psychiatry Active, not recruiting
Moscow, Russian Federation, 107076
State Institution Scientific Centre for Psychic Health of RAMS Active, not recruiting
Moscow, Russian Federation, 115522
Clinical Psychiatric Hospital #1 of Nizhni Novgorod Active, not recruiting
Nizhni Novgorod, Russian Federation, 603155
St. Petersburg State Healthcare Institution, St. Nikolay Chudotvorets Mental Hospital Active, not recruiting
St. Petersburg, Russian Federation, 190121
FSBI ##SPb Scientific Research Psychoneurolog.Institute n.a. V. M. Bechterev## of MoH of RF Active, not recruiting
St. Petersburg, Russian Federation, 192019
State Healthcare Institution "Psychoneurological Dispensary #2 Active, not recruiting
St. Petersburg, Russian Federation, 197341
Slovakia
Nestatna psychiatricka ambulancia, MUDr. Livia Vavrusova, PhD Active, not recruiting
Bratislava, Slovakia, 851 01
Psychiatricka ambulancia, Mentum, s.r.o. Active, not recruiting
Bratislava, Slovakia, 82007
Psychiatricka ambulancia MUDr. Nada Kuriackova, s.r.o. Active, not recruiting
Levice, Slovakia, 93401
Psychiatricka ambulancia, PsychoLine s.r.o. Active, not recruiting
Rimavska Sobota, Slovakia, 979 01
Nemocnica s poliklinikou sv. Barbory Roznava a.s. Active, not recruiting
Roznava, Slovakia, 04801
South Africa
Worthwhile Clinical Trials Active, not recruiting
Benoni, Gauteng, South Africa, 1500
Vista Clinic Active, not recruiting
Centurion, Gauteng, South Africa, 0157
Soweto Clinical Trials Centre Active, not recruiting
Johannesburg, Gauteng, South Africa, 1818
Midrand Medical Centre Active, not recruiting
Midrand, Gauteng, South Africa, 1685
I Engelbrecht Research Pty(Ltd) Active, not recruiting
Pretoria, Gauteng, South Africa, 0157
Private Practice Active, not recruiting
Durban, Kwa-Zulu Natal, South Africa, 4091
Randles Road Medical Centre Active, not recruiting
Durban, Kwazulu Natal, South Africa, 4091
Flexivest Fourteen Research Center Active, not recruiting
Bellville, Western Cape, South Africa, 7530
Dr John O'Brien Incorporated Active, not recruiting
Cape Town, Western Cape, South Africa, 8001
Spain
Centro de Salud Mental Ii "La Corredoria" Active, not recruiting
Oviedo, Asturias, Spain, 33011
Hospital Clinic I Provincial Active, not recruiting
Barcelona, Spain, 08036
Hospital de La Santa Creu I Sant Pau Active, not recruiting
Barcelona, Spain, 08025
Hospital General de La Vall D'Hebron Active, not recruiting
Barcelona, Spain, 08035
Hospital San Pedro de Alcantara Active, not recruiting
Caceres, Spain, 10003
Unidad Especializada En Tabaquismo de La Comunidad de Madrid Active, not recruiting
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: April 23, 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 April 23, 2015