Clinical trial NCT01574703: Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Cessation
Keywords: smoking cessation
psychiatric disease
cardiovascular events
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-04-10
Enrollment: 4595
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

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.

Eligibility 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.

Primary outcomes:
measure: Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.
timeFrame: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).
Secondary outcomes:
measure: Time to MACE up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.
timeFrame: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days.
measure: Time to MACE Until the End of Study NCT01574703.
timeFrame: 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).
measure: Incidence of MACE Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.
timeFrame: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).
measure: Incidence of MACE + Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.
timeFrame: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).
measure: Incidence of MACE Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.
timeFrame: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up.
measure: Incidence of MACE+ Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.
timeFrame: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up.
measure: Incidence of MACE Assessed Until End of Study NCT01574703.
timeFrame: 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).
measure: Incidence of MACE+ Assessed Until End of Study NCT01574703.
timeFrame: 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).
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc.
state: Alabama
city: Encino
country: United States
facility: Pharmacology Research Institute
state: California
city: Escondido
country: United States
facility: Synergy Clinical Research Center of Escondido
state: California
city: Imperial
country: United States
facility: Sun Valley Research Center
state: California
city: La Habra
country: United States
facility: Omega Clinical Trials
state: California
city: La Jolla
country: United States
facility: Pacific Treatment and Research Center
state: California
city: Los Alamitos
country: United States
facility: Pharmacology Research Institute
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute (PRI)
state: California
city: Oceanside
country: United States
facility: North County Clinical Research
state: California
city: Orange
country: United States
facility: NRC Research Institute
state: California
city: Sherman Oaks
country: United States
facility: California Neuroscience Research Medical Group, Inc.
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus Behavioral Health and Wellness Program
state: Colorado
city: Denver
country: United States
facility: Western Affiliated Research Institute
state: Colorado
city: Norwich
country: United States
facility: Comprehensive Psychiatric Care
state: Connecticut
city: Fort Myers
country: United States
facility: Neuropsychiatric Research Center of Southwest Florida
state: Florida
city: Hollywood
country: United States
facility: Broward Research Group
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Ocala
country: United States
facility: Ocala Psychiatric Associates
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions Inc.
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: Marietta
country: United States
facility: Northwest Behavioral Research Center
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Meridian
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Naperville
country: United States
facility: Baber Research Group Incorporated
state: Illinois
city: Indianapolis
country: United States
facility: Davis Clinic, Incorporated
state: Indiana
city: Indianapolis
country: United States
facility: American Health Network of IN, LLC
state: Indiana
city: Indianapolis
country: United States
facility: Goldpoint Clinical Research, LLC
state: Indiana
city: Overland Park
country: United States
facility: Vince & Associates Clinical Research, Inc.
state: Kansas
city: Overland Park
country: United States
facility: Vince & Associates Clinical Research, Inc.
state: Kansas
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research, Inc.
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Lexington
country: United States
facility: Central Kentucky Research Associates, Incorporated
state: Kentucky
city: Louisville
country: United States
facility: Kentucky Research Group
state: Kentucky
city: Metairie
country: United States
facility: The Center for Sexual Health
state: Louisiana
city: Auburn
country: United States
facility: Maine Research Associates
state: Maine
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Milford
country: United States
facility: Milford Emergency Associates, Incorporated
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota - TC
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research, PC
state: Missouri
city: St. Louis
country: United States
facility: Mercy Health Research
state: Missouri
city: Marlton
country: United States
facility: CRI Worldwide, LLC
state: New Jersey
city: Princeton
country: United States
facility: Global Medicinal Institutes, LLC; Princeton Medical Institute
state: New Jersey
city: Brooklyn
country: United States
facility: SPRI Clinical Trails LLC
state: New York
city: Endwell
country: United States
facility: Regional Clinical Research, Incorporated
state: New York
city: Cary
country: United States
facility: PMG Research of Raleigh, LLC
state: North Carolina
city: Raleigh
country: United States
facility: Wake Internal Medicine Consultants, Inc
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Broomall
country: United States
facility: Southeastern PA Medical Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: Belmont Center for Comprehensive Treatment
state: Pennsylvania
city: Lincoln
country: United States
facility: Lincoln Research, LLC
state: Rhode Island
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Knoxville
country: United States
facility: Volunteer Research Group
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions,Inc
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates, Inc.
state: Tennessee
city: Nashville
country: United States
facility: James G. Kyser, MD
state: Tennessee
city: Austin
country: United States
facility: Future Search Clinical Trials
state: Texas
city: DeSoto
country: United States
facility: InSite Clinical Research
state: Texas
city: Houston
country: United States
facility: The University of Texas M.D. Anderson Cancer Center
state: Texas
city: Norfolk
country: United States
facility: Clinical Research Associates of Tidewater, Inc
state: Virginia
city: Capital Federal
country: Argentina
facility: Centro de Investigacion Clinica WM
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Centro Medico Dra. De Salvo
state: Capital Federal
city: Melbourne
country: Australia
facility: Monash Alfred Psychiatry Research Centre
state: Victoria
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas da PUCRS - Uniao Brasileira de Educacao e Assistencia
state: RS
city: Campinas
country: Brazil
facility: Hospital e Maternidade Celso Pierro - Pontifícia Universidade Católica de Campinas - Campus II
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Jaqueline Scholz Issa e Mario Issa de cardiologia Ltda
city: Bourgas
country: Bulgaria
facility: Mental Health Center "Prof. Dr. Ivan Temkov-Bourgas" Ltd.
city: Kazanlak
country: Bulgaria
facility: MHAT "Dr. Hristo Stambolski" Ltd.
city: Novi Iskar
country: Bulgaria
facility: NPH "Sv. Ivan Rilski"
city: Pleven
country: Bulgaria
facility: UMHAT "Dr. Georgi Stranski" Ltd.
city: Plovdiv
country: Bulgaria
facility: UMHAT "Sveti Georgi" Ltd.
city: Ruse
country: Bulgaria
facility: SHATPPD - Ruse Ltd.
city: Ruse
country: Bulgaria
facility: Mental Health Center - Ruse Ltd.
city: Sofia
country: Bulgaria
facility: MHATNP "Sveti Naum" Ltd.
city: Sofia
country: Bulgaria
facility: MHATNP Sveti Naum SJsc.
city: Troyan
country: Bulgaria
facility: SHATPD - Troyan Ltd.
city: Hamilton
country: Canada
facility: Hamilton Medical Research Group
state: Ontario
city: Mississauga
country: Canada
facility: Medical Research Associates
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: Canadian Phase Onward Inc.
state: Ontario
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health (CAMH)
state: Ontario
city: Sherbrooke
country: Canada
facility: Diex Research Sherbrooke Inc.
state: Quebec
city: Talca
country: Chile
facility: Hospital Regional de Talca, Unidad de Enfermedades Respiratorias
state: Maule
city: Quillota
country: Chile
facility: Centro Respiratorio Integral (CENRESIN Ltda.)
state: Valparaiso, V Region
city: Ballerup
country: Denmark
facility: CCBR A/S
city: Vejle
country: Denmark
facility: CCBR A/S
city: Espoo
country: Finland
facility: Mehiläinen Leppävaara
city: Kuopio
country: Finland
facility: Savon Psykiatripalvelu Oy
city: Nummela
country: Finland
facility: Mehiläinen Nummela
city: Oulu
country: Finland
facility: Oulu Mentalcare Oy
city: Pori
country: Finland
facility: Porin Lääkäritalo Oy
city: Turku
country: Finland
facility: PEL, Psykiatrian ErikoisLääkärit
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg
state: Baden-wuerttemberg
city: Muenchen
country: Germany
facility: Ludwig Maximilians-Universitaet Muenchen
state: Bayern
city: Berlin
country: Germany
facility: Klinische Forschung Berlin-Mitte GmbH
city: Berlin
country: Germany
facility: emovis GmbH
city: Hamburg
country: Germany
facility: Klinische Forschung Hamburg GmbH
city: Leipzig
country: Germany
facility: ZSL - Zentrum fuer Medizinische Studien Leipzig GmbH
city: Tuebingen
country: Germany
facility: Universitaetsklinik Tuebingen, Klinik fuer Psychiatrie und Psychotherapie
city: Mexico
country: Mexico
facility: Consultorios de Medicina Especializada del Sector Privado
state: Mexico Df
city: Monterrey
country: Mexico
facility: Centro de Estudios Clinicos y Especialidades Medicas S.C.
state: Nuevo Leon
city: Rotorua
country: New Zealand
facility: Lakeland Clinical Trials
city: Moscow
country: Russian Federation
facility: FSBI "Federal Medical Research Center of Psychiatry and Addiction Medicine"
city: Moscow
country: Russian Federation
facility: Moscow State Public Healthcare Institution Mental Clinical Hospital #1 n.a. N.A. Alexeeva
city: Moscow
country: Russian Federation
facility: Clinical Mental Hospital #12 of Moscow Healthcare Department
city: Nizhni Novgorod
country: Russian Federation
facility: Clinical Psychiatric Hospital #1 of Nizhni Novgorod
city: Saint Petersburg
country: Russian Federation
facility: FSBI "Saint-Petersburg Scientific Research Psychoneurological Institute n.a. V.M. Bekhterev"
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Healthcare Institution, St. Nikolay Chudotvorets Mental Hospital
city: St. Petersburg
country: Russian Federation
facility: State Healthcare Institution of St.Petersburg "Psychoneurological Dispensary #2
city: Bratislava
country: Slovakia
facility: Psychiatricka ambulancia, Mentum, s.r.o.
city: Bratislava
country: Slovakia
facility: Nestatna psychiatricka ambulancia, MUDr. Livia Vavrusova, PhD
city: Levice
country: Slovakia
facility: Psychiatricka ambulancia MUDr. Nada Kuriackova, s.r.o.
city: Rimavska Sobota
country: Slovakia
facility: Psychiatricka ambulancia, PsychoLine s.r.o.
city: Roznava
country: Slovakia
facility: Nemocnica s poliklinikou sv. Barbory Roznava a.s.
city: Bellville
country: South Africa
facility: Flexivest Fourteen Research Center
state: Cape Town
city: Benoni, Johannesburg
country: South Africa
facility: Worthwhile Clinical Trials
state: Gauteng
city: Johannesburg
country: South Africa
facility: Soweto Clinical Trials Centre
state: Gauteng
city: Midrand
country: South Africa
facility: Midrand Medical Centre
state: Gauteng
city: Pretoria
country: South Africa
facility: I Engelbrecht Research Pty. Ltd
state: Gauteng
city: Pretoria
country: South Africa
facility: Vista Clinic
state: Gauteng
city: Durban
country: South Africa
facility: Private Practice
state: Kwa-zulu Natal, South Africa
city: Durban
country: South Africa
facility: Randles Road Medical Centre
state: Kwazulu Natal
city: Cape Town
country: South Africa
facility: Dr John O'Brien Incorporated
state: Western Cape
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hospital General Universitari Vall D'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial
city: Caceres
country: Spain
facility: Hospital San Pedro de Alcantara
city: Madrid
country: Spain
facility: Unidad Especializada En Tabaquismo de La Comunidad de Madrid
city: Zaragoza
country: Spain
facility: Centro de Salud Torrero-La Paz.
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Benowitz NL, Pipe A, West R, Hays JT, Tonstad S, McRae T, Lawrence D, St Aubin L, Anthenelli RM. Cardiovascular Safety of Varenicline, Bupropion, and Nicotine Patch in Smokers: A Randomized Clinical Trial. JAMA Intern Med. 2018 May 1;178(5):622-631. doi: 10.1001/jamainternmed.2018.0397.