Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders.
- Conditions
- Smoking Cessation
- Interventions
- Registration Number
- NCT01574703
- Lead Sponsor
- Pfizer
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4595
- Subjects will be eligible if they were randomized to study A3051123.
- Participation in study A3051123 ceased (ie, withdrew consent, lost to follow-up, etc) prior to final visit of study A3051123.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description bupropion bupropion hydrochloride - varenicline varenicline tartrate - Nicotine Replacement Therapy Patch Nicotine Replacement Therapy Patch - placebo placebo -
- Primary Outcome Measures
Name Time Method Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks). 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.
- Secondary Outcome Measures
Name Time Method Time to MACE Until the End of Study NCT01574703. 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). 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.
Incidence of MACE Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up. 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.
Time to MACE up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days. 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.
Incidence of MACE Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks). 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).
Incidence of MACE + Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks). 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.
Incidence of MACE+ Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up. 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.
Incidence of MACE Assessed Until End of Study NCT01574703. 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). 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.
Incidence of MACE+ Assessed Until End of Study NCT01574703. 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). 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.
Related Research Topics
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Trial Locations
- Locations (131)
Diex Research Sherbrooke Inc.
🇨🇦Sherbrooke, Quebec, Canada
UMHAT "Dr. Georgi Stranski" Ltd.
🇧🇬Pleven, Bulgaria
UMHAT "Sveti Georgi" Ltd.
🇧🇬Plovdiv, Bulgaria
MHATNP Sveti Naum SJsc.
🇧🇬Sofia, Bulgaria
Centro Respiratorio Integral (CENRESIN Ltda.)
🇨🇱Quillota, Valparaiso, V Region, Chile
Mental Health Center - Ruse Ltd.
🇧🇬Ruse, Bulgaria
Savon Psykiatripalvelu Oy
🇫🇮Kuopio, Finland
FSBI "Federal Medical Research Center of Psychiatry and Addiction Medicine"
🇷🇺Moscow, Russian Federation
Nestatna psychiatricka ambulancia, MUDr. Livia Vavrusova, PhD
🇸🇰Bratislava, Slovakia
Psychiatricka ambulancia, PsychoLine s.r.o.
🇸🇰Rimavska Sobota, Slovakia
Nemocnica s poliklinikou sv. Barbory Roznava a.s.
🇸🇰Roznava, Slovakia
Davis Clinic, Incorporated
🇺🇸Indianapolis, Indiana, United States
American Health Network of IN, LLC
🇺🇸Indianapolis, Indiana, United States
Clinical Research Associates, Inc.
🇺🇸Nashville, Tennessee, United States
Vince & Associates Clinical Research, Inc.
🇺🇸Overland Park, Kansas, United States
Heartland Research Associates, LLC
🇺🇸Wichita, Kansas, United States
Vince and Associates Clinical Research, Inc.
🇺🇸Overland Park, Kansas, United States
Klinische Forschung Berlin-Mitte GmbH
🇩🇪Berlin, Germany
Hospital Clinic I Provincial
🇪🇸Barcelona, Spain
Private Practice
🇿🇦Durban, Kwa-zulu Natal, South Africa, South Africa
emovis GmbH
🇩🇪Berlin, Germany
Moscow State Public Healthcare Institution Mental Clinical Hospital #1 n.a. N.A. Alexeeva
🇷🇺Moscow, Russian Federation
Mehiläinen Leppävaara
🇫🇮Espoo, Finland
PEL, Psykiatrian ErikoisLääkärit
🇫🇮Turku, Finland
Hospital Regional de Talca, Unidad de Enfermedades Respiratorias
🇨🇱Talca, Maule, Chile
Clinical Mental Hospital #12 of Moscow Healthcare Department
🇷🇺Moscow, Russian Federation
Hospital de La Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
State Healthcare Institution of St.Petersburg "Psychoneurological Dispensary #2
🇷🇺St. Petersburg, Russian Federation
Psychiatricka ambulancia, Mentum, s.r.o.
🇸🇰Bratislava, Slovakia
Soweto Clinical Trials Centre
🇿🇦Johannesburg, Gauteng, South Africa
Flexivest Fourteen Research Center
🇿🇦Bellville, Cape Town, South Africa
Unidad Especializada En Tabaquismo de La Comunidad de Madrid
🇪🇸Madrid, Spain
Hospital General Universitari Vall D'Hebron
🇪🇸Barcelona, Spain
Hospital San Pedro de Alcantara
🇪🇸Caceres, Spain
North County Clinical Research
🇺🇸Oceanside, California, United States
Pharmacology Research Institute
🇺🇸Los Alamitos, California, United States
Sun Valley Research Center
🇺🇸Imperial, California, United States
Omega Clinical Trials
🇺🇸La Habra, California, United States
Pacific Treatment and Research Center
🇺🇸La Jolla, California, United States
NRC Research Institute
🇺🇸Orange, California, United States
Coastal Clinical Research, Inc.
🇺🇸Mobile, Alabama, United States
Synergy Clinical Research Center of Escondido
🇺🇸Escondido, California, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Clinical Research Atlanta
🇺🇸Stockbridge, Georgia, United States
Ocala Psychiatric Associates
🇺🇸Ocala, Florida, United States
Goldpoint Clinical Research, LLC
🇺🇸Indianapolis, Indiana, United States
Central Kentucky Research Associates, Incorporated
🇺🇸Lexington, Kentucky, United States
The University of Texas M.D. Anderson Cancer Center
🇺🇸Houston, Texas, United States
SHATPPD - Ruse Ltd.
🇧🇬Ruse, Bulgaria
The Center for Sexual Health
🇺🇸Metairie, Louisiana, United States
Milford Emergency Associates, Incorporated
🇺🇸Milford, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Minnesota - TC
🇺🇸Minneapolis, Minnesota, United States
Maine Research Associates
🇺🇸Auburn, Maine, United States
Mental Health Center "Prof. Dr. Ivan Temkov-Bourgas" Ltd.
🇧🇬Bourgas, Bulgaria
James G. Kyser, MD
🇺🇸Nashville, Tennessee, United States
Medical Research Associates
🇨🇦Mississauga, Ontario, Canada
Belmont Center for Comprehensive Treatment
🇺🇸Philadelphia, Pennsylvania, United States
Southeastern PA Medical Institute
🇺🇸Broomall, Pennsylvania, United States
PMG Research of Raleigh, LLC
🇺🇸Cary, North Carolina, United States
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
Jaqueline Scholz Issa e Mario Issa de cardiologia Ltda
🇧🇷Sao Paulo, Brazil
Universitaetsklinik Tuebingen, Klinik fuer Psychiatrie und Psychotherapie
🇩🇪Tuebingen, Germany
Lakeland Clinical Trials
🇳🇿Rotorua, New Zealand
Clinical Neuroscience Solutions,Inc
🇺🇸Memphis, Tennessee, United States
InSite Clinical Research
🇺🇸DeSoto, Texas, United States
CCBR A/S
🇩🇰Vejle, Denmark
Worthwhile Clinical Trials
🇿🇦Benoni, Johannesburg, Gauteng, South Africa
Centre for Addiction and Mental Health (CAMH)
🇨🇦Toronto, Ontario, Canada
Future Search Clinical Trials
🇺🇸Austin, Texas, United States
Ludwig Maximilians-Universitaet Muenchen
🇩🇪Muenchen, Bayern, Germany
MHAT "Dr. Hristo Stambolski" Ltd.
🇧🇬Kazanlak, Bulgaria
Midrand Medical Centre
🇿🇦Midrand, Gauteng, South Africa
Universitaetsklinikum Freiburg
🇩🇪Freiburg, Baden-wuerttemberg, Germany
Vista Clinic
🇿🇦Pretoria, Gauteng, South Africa
Hospital Sao Lucas da PUCRS - Uniao Brasileira de Educacao e Assistencia
🇧🇷Porto Alegre, RS, Brazil
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Canadian Phase Onward Inc.
🇨🇦Toronto, Ontario, Canada
Klinische Forschung Hamburg GmbH
🇩🇪Hamburg, Germany
ZSL - Zentrum fuer Medizinische Studien Leipzig GmbH
🇩🇪Leipzig, Germany
Randles Road Medical Centre
🇿🇦Durban, Kwazulu Natal, South Africa
Centro de Salud Torrero-La Paz.
🇪🇸Zaragoza, Spain
University of Colorado Anschutz Medical Campus Behavioral Health and Wellness Program
🇺🇸Aurora, Colorado, United States
Meridien Research
🇺🇸Tampa, Florida, United States
Clinical Neuroscience Solutions Inc.
🇺🇸Orlando, Florida, United States
Kentucky Research Group
🇺🇸Louisville, Kentucky, United States
Northwest Behavioral Research Center
🇺🇸Marietta, Georgia, United States
Pharmacology Research Institute (PRI)
🇺🇸Newport Beach, California, United States
California Neuroscience Research Medical Group, Inc.
🇺🇸Sherman Oaks, California, United States
Western Affiliated Research Institute
🇺🇸Denver, Colorado, United States
Clinical Neuroscience Solutions
🇺🇸Jacksonville, Florida, United States
Neuropsychiatric Research Center of Southwest Florida
🇺🇸Fort Myers, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Baber Research Group Incorporated
🇺🇸Naperville, Illinois, United States
Regional Clinical Research, Incorporated
🇺🇸Endwell, New York, United States
CRI Worldwide, LLC
🇺🇸Marlton, New Jersey, United States
Mercy Health Research
🇺🇸St. Louis, Missouri, United States
Wake Internal Medicine Consultants, Inc
🇺🇸Raleigh, North Carolina, United States
Wake Research Associates, LLC
🇺🇸Raleigh, North Carolina, United States
Lincoln Research, LLC
🇺🇸Lincoln, Rhode Island, United States
Psychiatricka ambulancia MUDr. Nada Kuriackova, s.r.o.
🇸🇰Levice, Slovakia
Broward Research Group
🇺🇸Hollywood, Florida, United States
I Engelbrecht Research Pty. Ltd
🇿🇦Pretoria, Gauteng, South Africa
SPRI Clinical Trails LLC
🇺🇸Brooklyn, New York, United States
The Center for Pharmaceutical Research, PC
🇺🇸Kansas City, Missouri, United States
NPH "Sv. Ivan Rilski"
🇧🇬Novi Iskar, Bulgaria
Precise Research Centers
🇺🇸Flowood, Mississippi, United States
MHATNP "Sveti Naum" Ltd.
🇧🇬Sofia, Bulgaria
SHATPD - Troyan Ltd.
🇧🇬Troyan, Bulgaria
Global Medicinal Institutes, LLC; Princeton Medical Institute
🇺🇸Princeton, New Jersey, United States
Advanced Clinical Research
🇺🇸Meridian, Idaho, United States
Coastal Carolina Research Center
🇺🇸Mount Pleasant, South Carolina, United States
Centro Medico Dra. De Salvo
🇦🇷Buenos Aires, Capital Federal, Argentina
Hospital e Maternidade Celso Pierro - PontifÃcia Universidade Católica de Campinas - Campus II
🇧🇷Campinas, São Paulo, Brazil
Volunteer Research Group
🇺🇸Knoxville, Tennessee, United States
Centro de Investigacion Clinica WM
🇦🇷Capital Federal, Buenos Aires, Argentina
Mehiläinen Nummela
🇫🇮Nummela, Finland
Oulu Mentalcare Oy
🇫🇮Oulu, Finland
Porin Lääkäritalo Oy
🇫🇮Pori, Finland
Consultorios de Medicina Especializada del Sector Privado
🇲🇽Mexico, Mexico Df, Mexico
Centro de Estudios Clinicos y Especialidades Medicas S.C.
🇲🇽Monterrey, Nuevo Leon, Mexico
Clinical Psychiatric Hospital #1 of Nizhni Novgorod
🇷🇺Nizhni Novgorod, Russian Federation
FSBI "Saint-Petersburg Scientific Research Psychoneurological Institute n.a. V.M. Bekhterev"
🇷🇺Saint Petersburg, Russian Federation
St. Petersburg State Healthcare Institution, St. Nikolay Chudotvorets Mental Hospital
🇷🇺St. Petersburg, Russian Federation
Dr John O'Brien Incorporated
🇿🇦Cape Town, Western Cape, South Africa
Clinical Research Associates of Tidewater, Inc
🇺🇸Norfolk, Virginia, United States
Monash Alfred Psychiatry Research Centre
🇦🇺Melbourne, Victoria, Australia
University of Ottawa Heart Institute
🇨🇦Ottawa, Ontario, Canada
Hamilton Medical Research Group
🇨🇦Hamilton, Ontario, Canada
Comprehensive Psychiatric Care
🇺🇸Norwich, Connecticut, United States