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

Smoking Cessation Clinical Trial

— CATS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01574703
• Other study ID #: A3051148
• Secondary ID: 2011-005513-37CA
• Status: Completed
• Phase: Phase 4
• First received: April 6, 2012
• Last updated: October 16, 2015
• Start date: May 2012
• Est. completion date: July 2015

Study information

• Verified date: October 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 4599
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment

Related Conditions & MeSH terms

• Mental Disorders
• Smoking Cessation

Intervention

Drug:
• placebo
All dosing to have taken place per study A3051123
• varenicline tartrate
All dosing to have taken place per study A3051123
• bupropion hydrochloride
All dosing to have taken place per study A3051123
• Nicotine Replacement Therapy Patch
All dosing to have taken place per study A3051123

Locations

Country	Name	City	State
Argentina	Centro de Investigacion Clinica WM	Capital Federal	Buenos Aires
Argentina	Centro Medico Dra. De Salvo	Ciudad Autonoma de Buenos Aires	Capital Federal
Australia	Monash Alfred Psychiatry Research Centre	Melbourne	Victoria
Brazil	Hospital e Maternidade Celso Pierro - Pontifícia Universidade Católica de Campinas - Campus II	Campinas	São Paulo
Brazil	Hospital Sao Lucas da PUCRS - Uniao Brasileira de Educacao e Assistencia	Porto Alegre	RS
Brazil	Instituto Jaqueline Scholz Issa e Mario Issa de cardiologia S/C Ltda	San Paulo
Bulgaria	Mental Health Center "Prof. Dr. Ivan Temkov-Bourgas" Ltd.	Bourgas
Bulgaria	MHAT "Dr. Hristo Stambolski" Ltd.	Kazanlak
Bulgaria	NPH "Sv. Ivan Rilski"	Novi Iskar
Bulgaria	UMHAT "Dr. Georgi Stranski" Ltd.	Pleven
Bulgaria	UMHAT "Sveti Georgi" Ltd.	Plovdiv
Bulgaria	Mental Health Center - Ruse Ltd.	Ruse
Bulgaria	SHATPPD "Ruse Ltd."	Ruse
Bulgaria	MHATNP "Sveti Naum" Ltd.	Sofia
Bulgaria	MHATNP Sveti Naum SJsc., Second Psychiatric clinic	Sofia
Bulgaria	SHATPD - Troyan Ltd.	Troyan
Canada	Hamilton Medical Research Group	Hamilton	Ontario
Canada	Medical Research Associates	Mississauga	Ontario
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
Canada	Diex Research Sherbrooke Inc.	Sherbrooke	Quebec
Canada	Canadian Phase Onward Inc.	Toronto	Ontario
Canada	Centre for Addiction and Mental Health (CAMH)	Toronto	Ontario
Chile	Centro Respiratorio Integral (CENRESIN Ltda.)	Quillota	Valparaiso, V region
Chile	Hospital Regional de Talca, Unidad de Enfermedades Respiratorias	Talca
Denmark	CCBR A/S	Ballerup
Denmark	CCBR A/S	Vejle
Finland	Mehiläinen Leppävaara	Espoo
Finland	Savon Psykiatripalvelu Oy	Kuopio
Finland	Mehiläinen Nummela	Nummela
Finland	Oulu Mentalcare Oy	Oulu
Finland	Porin Lääkäritalo Oy	Pori
Finland	PEL, Psykiatrian ErikoisLääkärit	Turku
Germany	emovis GmbH	Berlin
Germany	Klinische Forschung Berlin-Mitte GmbH	Berlin
Germany	Universitaetsklinikum Freiburg	Freiburg	Baden-Wuerttemberg
Germany	Klinische Forschung Hamburg GmbH	Hamburg
Germany	ZSL - Zentrum fuer Medizinische Studien Leipzig GmbH	Leipzig
Germany	Ludwig Maximilians-Universitaet Muenchen	Muenchen
Germany	Universitaetsklinik Tuebingen, Klinik fuer Psychiatrie und Psychotherapie	Tuebingen
Mexico	Instituto Mexicano de la Investigacion Clinica S.A. de C.V.	Mexico	DF
Mexico	Centro de Estudios Clinicos y Especialidades Medicas S.C.	Monterrey	Nuevo Leon
New Zealand	Lakeland Clinical Trials	Rotorua
Russian Federation	Clinical Mental Hospital #12 of Moscow Healthcare Department	Moscow
Russian Federation	Federal State Institution Moscow Scientific Research Institute of Psychiatry Minzdravsotsrazvitiya	Moscow
Russian Federation	Moscow Research Institute of Psychiatry	Moscow
Russian Federation	Moscow State Public Healthcare Institution Mental Clinical Hospital #1 n.a. N.A. Alexeeva	Moscow
Russian Federation	Clinical Psychiatric Hospital #1 of Nizhni Novgorod	Nizhni Novgorod
Russian Federation	FSBI "Saint-Petersburg Scientific Research Psychoneurological Institute n.a. V.M. Bekhterev" of MoH	Saint Petersburg
Russian Federation	St. Petersburg State Healthcare Institution, St. Nikolay Chudotvorets Mental Hospital	St. Petersburg
Russian Federation	State Healthcare Institution of St.Petersburg "Psychoneurological Dispensary #2	St. Petersburg
Slovakia	Nestatna psychiatricka ambulancia, MUDr. Livia Vavrusova, PhD	Bratislava
Slovakia	Psychiatricka ambulancia, Mentum, s.r.o.	Bratislava
Slovakia	Psychiatricka ambulancia MUDr. Nada Kuriackova, s.r.o.	Levice
Slovakia	Psychiatricka ambulancia, PsychoLine s.r.o.	Rimavska Sobota
Slovakia	Nemocnica s poliklinikou sv. Barbory Roznava a.s.	Roznava
South Africa	Flexivest Fourteen Research Center	Bellville	Cape Town
South Africa	Worthwhile Clinical Trials	Benoni	Gauteng
South Africa	Dr John O'Brien Incorporated	Cape Town	Western Cape
South Africa	Vista Clinic	Centurion	Gauteng
South Africa	Private Practice	Durban	Kwa-Zulu Natal
South Africa	Randles Road Medical Centre	Durban	Kwazulu Natal
South Africa	Soweto Clinical Trials Centre	Johannesburg	Gauteng
South Africa	Midrand Medical Centre	Midrand	Gauteng
South Africa	I Engelbrecht Research Pty(Ltd)	Pretoria	Gauteng
Spain	Hospital Clinic I Provincial	Barcelona
Spain	Hospital de La Santa Creu I Sant Pau	Barcelona
Spain	Hospital General Universitari Vall D'Hebron	Barcelona
Spain	Hospital San Pedro de Alcantara	Caceres
Spain	Unidad Especializada En Tabaquismo de La Comunidad de Madrid	Madrid
Spain	Centro de Salud Torrero-La Paz.	Zaragoza
United States	Maine Research Associates	Auburn	Maine
United States	University of Colorado Anschutz Medical Campus Behavioral Health and Wellness Program	Aurora	Colorado
United States	Future Search Clinical Trials	Austin	Texas
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Social Psychiatry Research Institute	Brooklyn	New York
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	Western Affiliated Research Institute	Denver	Colorado
United States	InSite Clinical Research	DeSoto	Texas
United States	Pharmacology Research Institute	Encino	California
United States	Regional Clinical Research, Incorporated	Endwell	New York
United States	Synergy Clinical Research Center of Escondido	Escondido	California
United States	Precise Research Centers	Flowood	Mississippi
United States	Neuropsychiatric Research Center of Southwest Florida	Fort Myers	Florida
United States	Broward Research Group	Hollywood	Florida
United States	The University of Texas M.D. Anderson Cancer Center	Houston	Texas
United States	Sun Valley Research Center	Imperial	California
United States	American Health Network of IN, LLC	Indianapolis	Indiana
United States	Davis Clinic, Incorporated	Indianapolis	Indiana
United States	Goldpoint Clinical Research, LLC	Indianapolis	Indiana
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	The Center for Pharmaceutical Research, PC	Kansas City	Missouri
United States	New Orleans Center for Clinical Research	Knoxville	Tennessee
United States	Volunteer Research Group	Koxville	Tennessee
United States	Omega Clinical Trials, LLC	La Habra	California
United States	Pacific Treatment and Research Center	La Jolla	California
United States	Central Kentucky Research Association, Incorporated	Lexington	Kentucky
United States	Lincoln Research, LLC	Lincoln	Rhode Island
United States	Pharmacology Research Institute	Los Alamitos	California
United States	Kentucky Research Group	Louisville	Kentucky
United States	Northwest Behavioral Research Center	Marietta	Georgia
United States	CRI Worldwide, LLC	Marlton	New Jersey
United States	Clinical Neuroscience Solutions,Inc	Memphis	Tennessee
United States	Advanced Clinical Research	Meridian	Idaho
United States	The Center for Sexual Health	Metairie	Louisiana
United States	Milford Emergency Associates, Incorporated	Milford	Massachusetts
United States	University of Minnesota - TC	Minneapolis	Minnesota
United States	Coastal Clinical Research, Inc.	Mobile	Alabama
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	AMR-Baber Research Incorporated	Naperville	Illinois
United States	Clinical Research Associates, Inc.	Nashville	Tennessee
United States	James G. Kyser, MD	Nashville	Tennessee
United States	Pharmacology Research Institute (PRI)	Newport Beach	California
United States	Clinical Research Associates of Tidewater	Norfolk	Virginia
United States	Comprehensive Psychiatric Care	Norwich	Connecticut
United States	Ocala Psychiatric Associates	Ocala	Florida
United States	Renstar Medical Research	Ocala	Florida
United States	North County Clinical Research	Oceanside	California
United States	NRC Research Institute	Orange	California
United States	Clinical Neuroscience Solutions Inc.	Orlando	Florida
United States	Vince & Associates Clinical Research	Overland Park	Kansas
United States	Vince & Associates Clinical Research, Inc.	Overland Park	Kansas
United States	Vince and Associates Clinical Research, LLC	Overland Park	Kansas
United States	Belmont Center for Comprehensive Treatment	Philadelphia	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	Global Medicinal Institutes, LLC; Princeton Medical Institute	Princeton	New Jersey
United States	Wake Internal Medicine Consultants, Inc	Raleigh	North Carolina
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	Mayo Clinic	Rochester	Minnesota
United States	California Neuroscience Research Medical Group, Inc.	Sherman Oaks	California
United States	Mercy Health Research	St. Louis	Missouri
United States	Clinical Research Atlanta	Stockbridge	Georgia
United States	Meridien Research	Tampa	Florida
United States	Heartland Research Associates, LLC	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Bulgaria,  Canada,  Chile,  Denmark,  Finland,  Germany,  Mexico,  New Zealand,  Russian Federation,  Slovakia,  South Africa,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		12 weeks	Yes
Secondary	Time to MACE up to date of last dose of study drug plus 30 days in study A3051123		16 weeks	Yes
Secondary	Time to MACE until the end of study (A3051148)		52 weeks	Yes
Secondary	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, or hospitalization for unstable angina; • CV deaths; • Non fatal MI; • Non fatal stroke.	12 weeks	Yes
Secondary	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,		16 weeks	Yes
Secondary	a need for coronary revascularization, or hospitalization for unstable angina; • CV deaths; • Non fatal MI; • Non fatal stroke.		16 weeks	Yes
Secondary	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		52 weeks	Yes
Secondary	revascularization, or hospitalization for unstable angina; • CV deaths; • Non fatal MI; • Non fatal stroke.		52 weeks	Yes

External Links

•   To obtain contact information for a study center near you, click here.