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 July 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01574703
First received: April 6, 2012
Last updated: July 24, 2014
Last verified: July 2014
  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 Different Treatments For Smoking Cessation 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: - MACE; - MACE + (defined as any MACE or a new onset or worsening peripheral vascular disease (PVD) requiring intervention, a need for coronary revascularization, [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • or hospitalization for unstable angina; • CV deaths; • Non fatal MI; • Non fatal stroke. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • 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: 8000
Study Start Date: May 2012
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (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:   No
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

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

  Hide Study Locations
Locations
United States, Alabama
Coastal Clinical Research, Incorporated Recruiting
Mobile, Alabama, United States, 36608
United States, Arizona
NoesisPharma Research Recruiting
Phoenix, Arizona, United States, 85032
United States, California
Pharmacology Research Institute Recruiting
Encino, California, United States, 91316
Synergy Clinical Research Center of Escondido Recruiting
Escondido, California, United States, 92025
Sun Valley Research Center Recruiting
Imperial, California, United States, 92251
Omega Clinical Trials, LLC Recruiting
La Habra, California, United States, 90631
Pacific Treatment and Research Center UC San Diego Health System Recruiting
La Jolla, California, United States, 92037
Pharmacology Research Institute (PRI) Recruiting
Los Alamitos, California, United States, 90720
University of California Los Angeles David Geffen School of Medicine Recruiting
Los Angeles, California, United States, 90095
Pharmacology Research Institute (PRI) Recruiting
Newport Beach, California, United States, 92660
North County Clinical Research Recruiting
Oceanside, California, United States, 92056
Neuropsychiatric Research Center of Orange County Recruiting
Orange, California, United States, 92868
Clinical Neuroscience Research Medical Group 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 Recruiting
Denver, Colorado, United States, 80209
United States, Connecticut
Comprehensive Psychiatric Care Recruiting
Norwich, Connecticut, United States, 06360
United States, Florida
Neuropsychiatric Research Center of Southwest Florida Terminated
Fort Myers, Florida, United States, 33912
Jacksonville Center for Clinical Research Recruiting
Jacksonville, Florida, United States, 32216
Clinical Neuroscience Solutions, Inc. Recruiting
Jacksonville, Florida, United States, 32256
Ocala Psychiatric Associates Recruiting
Ocala, Florida, United States, 34474
Renstar Medical Research Recruiting
Ocala, Florida, United States, 34471
Clinical Neuroscience Solutions Inc. Recruiting
Orlando Florida, Florida, United States, 32806
Broward Research Group Recruiting
Pembroke Pines, Florida, United States, 33026
United States, Georgia
Northwest Behavioral Research Center Recruiting
Marietta, Georgia, United States, 30060
Clinical Research Atlanta Recruiting
Stockbridge, Georgia, United States, 30281
United States, Idaho
Northwest Neurobehavioral Health Recruiting
Meridian, Idaho, United States, 83642
Advanced Clinical Research Recruiting
Meridian, Idaho, United States, 83642
United States, Illinois
AMR-Baber Research Incorporated Recruiting
Naperville, Illinois, United States, 60563
United States, Indiana
American Health Network of IN, LLC Recruiting
Indianapolis, Indiana, United States, 46254
Davis Clinic, Incorporated Recruiting
Indianapolis, Indiana, United States, 46250
Goldpoint Clinical Research, LLC Recruiting
Indianapolis, Indiana, United States, 46260
United States, Kansas
Vince & Associates Clinical Research, Inc. Recruiting
Overland Park, Kansas, United States, 66212
Vince and Associates Clinical Research, Inc. Recruiting
Overland Park, Kansas, United States, 66212
Vince & Associates Clinical Research, Inc. Recruiting
Overland Park, Kansas, United States, 66211
Heartland Research Associates, LLC Recruiting
Wichita, Kansas, United States, 67207
United States, Kentucky
Central Kentucky Research Association, Incorporated Recruiting
Lexington, Kentucky, United States, 40509
Kentucky Research Group Recruiting
Louisville, Kentucky, United States, 40217
United States, Louisiana
The Center for Sexual Health Recruiting
Metairie, Louisiana, United States, 70002
United States, Maine
Maine Research Associates Recruiting
Auburn, Maine, United States, 04210
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Milford Emergency Associates, Incorporated Recruiting
Milford, Massachusetts, United States, 01757
United States, Minnesota
University of Minnesota - TC Recruiting
Minneapolis, Minnesota, United States, 55414
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
United States, Mississippi
Precise Research Centers Recruiting
Flowood, Mississippi, United States, 39232
United States, Missouri
The Center for Pharmaceutical Research, PC Recruiting
Kansas City, Missouri, United States, 64114
Mercy Health Research Recruiting
St. Louis, Missouri, United States, 63141
United States, New Jersey
Global Medicinal Institutes, LLC; Princeton Medical Institute Recruiting
Princeton, New Jersey, United States, 08540
United States, New York
Social Psychiatry Research Institute Recruiting
Brooklyn, New York, United States, 11235
Regional Clinical Research, Incorporated Recruiting
Endwell, New York, United States, 13760
United States, North Carolina
PMG Research of Raleigh, LLC Recruiting
Cary, North Carolina, United States, 27518
Wake Research Associates, LLC Recruiting
Raleigh, North Carolina, United States, 27612
United States, Ohio
Midwest Clinical Research Center Recruiting
Dayton, Ohio, United States, 45417
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239-3098
United States, Pennsylvania
Southeastern PA Medical Institute Recruiting
Broomall, Pennsylvania, United States, 19008
CRI Worldwide, LLC Recruiting
Philadelphia, Pennsylvania, United States, 19139
Belmont Center for Comprehensive Treatment Terminated
Philadelphia, Pennsylvania, United States, 19131
United States, Rhode Island
Lincoln Research, LLC Recruiting
Lincoln, Rhode Island, United States, 02865
United States, South Carolina
Coastal Carolina Research Center Recruiting
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
New Orleans Center for Clinical Research Recruiting
Knoxville, Tennessee, United States, 37920
Volunteer Research Group Recruiting
Knoxville, Tennessee, United States, 37920
Clinical Neuroscience Solutions, Inc. Recruiting
Memphis, Tennessee, United States, 38119
Clinical Research Associates, Incorporated Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
FutureSearch Clinical Trials, L.P. Recruiting
Austin, Texas, United States, 78731
InSite Clinical Research Recruiting
DeSoto, Texas, United States, 75115
The University of Texas M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77230-1439
United States, Virginia
Clinical Research Associates of Tidewater Recruiting
Norfolk, Virginia, United States, 23507
United States, Wisconsin
University of Wisconsin School of Medicine and Public Health, Recruiting
Madison, Wisconsin, United States, 53711-2027
Argentina
Centro Investigacion Clinica WM Recruiting
Capital Federal, Buenos Aires, Argentina, C1440BRR
Centro Medico Dra. De Salvo Recruiting
Buenos Aires, Capital Federal, Argentina, C1426ABP
Australia, Victoria
The Alfred Hospital, Alfred Psychiatry Research Centre Recruiting
Prahan, Victoria, Australia, 3004
Bulgaria
Tsentar za Psihichno Zdrave 'Prof. Ivan Temkov'EOOD Recruiting
Burgas, Bulgaria, 8000
MBAL Dr. Hristo Stambolski EOOD Recruiting
Kazanlak, Bulgaria, 6100
DPB Sv. Ivan Rilski, Parvo otdelenie za maje s ostri psihichni zabolyavaniya Recruiting
Novi Iskar, Bulgaria, 1282
UMBAL Dr. Georgi Stranski EAD, Recruiting
Pleven, Bulgaria, 5800
UMBAL Sveti Georgi EAD, Klinika po psihiatriya Recruiting
Plovdiv, Bulgaria, 4002
SBALPFZ - Ruse EOOD, Recruiting
Ruse, Bulgaria, 7002
Tsentar za psihichno zdrave - Ruse EOOD Recruiting
Ruse, Bulgaria, 7004
Meditsinski Tsentar "Sveti Naum" EOOD Recruiting
Sofia, Bulgaria, 1113
MHATNP "Sveti Naum" SJsc., Second Psychiatric clinic Recruiting
Sofia, Bulgaria, 1113
Specializirana Bolnitsa za Aktivno Lechenie na Belodrobni Bolesti-Troyan EOOD, Recruiting
Troyan, Bulgaria, 5600
Canada, Ontario
Hamilton Medical Research Group Recruiting
Hamilton, Ontario, Canada, L8M 1K7
Medical Research Associates Recruiting
Mississauga, Ontario, Canada, L5M 4N4
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Centre for Addiction and Mental Health (CAMH) Recruiting
Toronto, Ontario, Canada, M5S 2S1
Canadian Phase Onward Inc. Recruiting
Toronto, Ontario, Canada, M3H 5S4
Canada, Quebec
Diex Research Sherbrooke Inc. 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 Recruiting
Ballerup, Denmark, 2750
CCBR A/S Recruiting
Vejle, Denmark, DK-7100
Finland
Mehiläinen Leppävaara Recruiting
Espoo, Finland, 02600
Savon Psykiatripalvelu Oy Recruiting
Kuopio, Finland, 70110
Mehiläinen Nummela Recruiting
Nummela, Finland, 03100
ODL Terveys Recruiting
Oulu, Finland, 90101
Porin Lääkäritalo Recruiting
Pori, Finland, 28100
PEL, Psykiatrian ErikoisLääkärit Recruiting
Turku, Finland, 20100
Germany
Klinische Forschung Berlin-Mitte GmbH Recruiting
Berlin, Germany, 10117
emovis GmbH Recruiting
Berlin, Germany, 10629
Universitaetsklinikum Freiburg Recruiting
Freiburg, Germany, 79104
Klinische Forschung Hamburg GmbH Recruiting
Hamburg, Germany, 20253
ZSL - Zentrum fuer Medizinische Studien Leipzig GmbH Terminated
Leipzig, Germany, 04157
Ludwig Maximilians-Universitaet Muenchen Recruiting
Muenchen, Germany, 80336
Universitaetsklinik Tuebingen, Klinik fuer Psychiatrie und Psychotherapie Recruiting
Tuebingen, Germany, 72076
Mexico
Instituto Mexicano de la Investigacion Clinica S.A. de C.V. Recruiting
Mexico, DF, Mexico, 06700
Centro de Estudios Clinicos y Especialidades Medicas S.C. Recruiting
Monterrey, Nuevo Leon, Mexico, 64620
New Zealand
Lakeland Clinical Trials Recruiting
Rotorua, New Zealand
Russian Federation
FSBI "Moscow Scientific Research Institute of Psychiatry" of MoH of RF Recruiting
Moscow, Russian Federation, 107076
MSBHI "Scientific and Practical Psychoneurological Centre" of Moscow Healthcare Depart. Recruiting
Moscow, Russian Federation, 115419
MSPHI Mental Clinical Hospital #1 n.a. N.A. Alexeeva of Moscow Healthcare Depart. Recruiting
Moscow, Russian Federation, 117152
Moscow Research Institute of Psychiatry Recruiting
Moscow, Russian Federation, 107076
Clinical Mental Hospital #12 Recruiting
Moscow, Russian Federation, 125367
Clinical Psychiatric Hospital #1 of Nizhni Novgorod Recruiting
Nizhni Novgorod, Russian Federation, 603155
SBEI HPE "Smolensk State Medical Academy" of MoH of RF Recruiting
Smolensk, Russian Federation, 214019
SHI of St. Petersburg "Psychoneurological Dispensary #2" Recruiting
St. Petersburg, Russian Federation, 197341
St. Petersburg State Healthcare Institution, St. Nikolay Chudotvorets Mental Hospital Recruiting
St. Petersburg, Russian Federation, 190121
FSBI "SPb Scientific Research Psychoneurolog.Institute n.a. V. M. Bechterev" of MoH of RF Recruiting
St. Petersburg, Russian Federation, 192019
Slovakia
Psychiatricka ambulancia, Mentum, s.r.o. Recruiting
Bratislava, Slovakia, 82007
Nestatna psychiatricka ambulancia, MUDr. Livia Vavrusova, PhD Recruiting
Bratislava, Slovakia, 851 01
Psychiatricka ambulancia MUDr. Nada Kuriackova, s.r.o. Recruiting
Levice, Slovakia, 93401
Psychiatricka ambulancia, PsychoLine s.r.o. Recruiting
Rimavska Sobota, Slovakia, 979 01
Nemocnica s poliklinikou sv. Barbory Roznava a.s. Recruiting
Roznava, Slovakia, 04801
South Africa
Worthwhile Clinical Trials Recruiting
Benoni, Gauteng, South Africa, 1500
Vista Clinic Recruiting
Centurion, Gauteng, South Africa, 0157
Soweto Clinical Trials Centre Recruiting
Johannesburg, Gauteng, South Africa, 1818
Midrand Medical Centre Recruiting
Midrand, Gauteng, South Africa, 1685
I Engelbrecht Research Pty(Ltd) Recruiting
Pretoria, Gauteng, South Africa, 0157
Private Practice Recruiting
Durban, Kwa-Zulu Natal, South Africa, 4091
Randles Road Medical Centre Recruiting
Durban, Kwazulu Natal, South Africa, 4091
Flexivest Fourteen Research Center Recruiting
Bellville, Western Cape, South Africa, 7530
Quit Support Recruiting
Cape Town, Western Cape, South Africa, 8001
Spain
Centro de Salud Mental Ii La Corredoria Not yet recruiting
Oviedo, Asturias, Spain, 33011
Centro de Salud Mental Ii "La Corredoria" Recruiting
Oviedo, Asturias, Spain, 33011
Hospital Clínic de Barcelona Departamento de Psiquiatria Recruiting
Barcelona, Spain, 08036
Hospital de La Santa Creu I Sant Pau Recruiting
Barcelona, Spain, 08025
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 08028
Hospital General de La Vall D'Hebron Recruiting
Barcelona, Spain, 08035
Hospital San Pedro de Alcantara Recruiting
Caceres, Spain, 10003
Unidad Especializada En Tabaquismo de La Comunidad de Madrid 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
Study First Received: April 6, 2012
Last Updated: July 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
smoking cessation
psychiatric disease
cardiovascular events

Additional relevant MeSH terms:
Mental Disorders
Nicotine
Varenicline
Bupropion
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on August 20, 2014