Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders.
CATS
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
3 other identifiers
interventional
4,595
16 countries
134
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2012
Typical duration for phase_4
134 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2012
CompletedFirst Posted
Study publicly available on registry
April 10, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedResults Posted
Study results publicly available
December 29, 2016
CompletedDecember 29, 2016
October 1, 2016
3.2 years
April 6, 2012
July 7, 2016
October 31, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.
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.
Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).
Secondary Outcomes (8)
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.
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).
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).
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).
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.
- +3 more secondary outcomes
Study Arms (4)
placebo
EXPERIMENTALvarenicline
EXPERIMENTALbupropion
EXPERIMENTALNicotine Replacement Therapy Patch
EXPERIMENTALInterventions
All dosing to have taken place per study A3051123
All dosing to have taken place per study A3051123
All dosing to have taken place per study A3051123
Eligibility Criteria
You may qualify if:
- Subjects will be eligible if they were randomized to study A3051123.
You may not qualify if:
- Participation in study A3051123 ceased (ie, withdrew consent, lost to follow-up, etc) prior to final visit of study A3051123.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (134)
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608, United States
Pharmacology Research Institute
Encino, California, 91316, United States
Synergy Clinical Research Center of Escondido
Escondido, California, 92025, United States
Sun Valley Research Center
Imperial, California, 92251, United States
Omega Clinical Trials
La Habra, California, 90631, United States
Pacific Treatment and Research Center
La Jolla, California, 92037, United States
Pharmacology Research Institute
Los Alamitos, California, 90720, United States
Pharmacology Research Institute (PRI)
Newport Beach, California, 92660, United States
North County Clinical Research
Oceanside, California, 92056, United States
NRC Research Institute
Orange, California, 92868, United States
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, 91403, United States
University of Colorado Anschutz Medical Campus Behavioral Health and Wellness Program
Aurora, Colorado, 80045, United States
Western Affiliated Research Institute
Denver, Colorado, 80209, United States
Comprehensive Psychiatric Care
Norwich, Connecticut, 06360, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, 33912, United States
Broward Research Group
Hollywood, Florida, 33024, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Clinical Neuroscience Solutions
Jacksonville, Florida, 32256, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Ocala Psychiatric Associates
Ocala, Florida, 34474, United States
Clinical Neuroscience Solutions Inc.
Orlando, Florida, 32801, United States
Meridien Research
Tampa, Florida, 33634, United States
Northwest Behavioral Research Center
Marietta, Georgia, 30060, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
Advanced Clinical Research
Meridian, Idaho, 83642, United States
Baber Research Group Incorporated
Naperville, Illinois, 60563, United States
Davis Clinic, Incorporated
Indianapolis, Indiana, 46250, United States
American Health Network of IN, LLC
Indianapolis, Indiana, 46254, United States
Goldpoint Clinical Research, LLC
Indianapolis, Indiana, 46260, United States
Vince & Associates Clinical Research, Inc.
Overland Park, Kansas, 66211, United States
Vince & Associates Clinical Research, Inc.
Overland Park, Kansas, 66212, United States
Vince and Associates Clinical Research, Inc.
Overland Park, Kansas, 66212, United States
Heartland Research Associates, LLC
Wichita, Kansas, 67207, United States
Central Kentucky Research Associates, Incorporated
Lexington, Kentucky, 40509, United States
Kentucky Research Group
Louisville, Kentucky, 40218, United States
The Center for Sexual Health
Metairie, Louisiana, 70002, United States
Maine Research Associates
Auburn, Maine, 04210, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Milford Emergency Associates, Incorporated
Milford, Massachusetts, 01757, United States
University of Minnesota - TC
Minneapolis, Minnesota, 55414, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Precise Research Centers
Flowood, Mississippi, 39232, United States
The Center for Pharmaceutical Research, PC
Kansas City, Missouri, 64114, United States
Mercy Health Research
St Louis, Missouri, 63141, United States
CRI Worldwide, LLC
Marlton, New Jersey, 08053, United States
Global Medicinal Institutes, LLC; Princeton Medical Institute
Princeton, New Jersey, 08540, United States
SPRI Clinical Trails LLC
Brooklyn, New York, 11235, United States
Regional Clinical Research, Incorporated
Endwell, New York, 13760, United States
PMG Research of Raleigh, LLC
Cary, North Carolina, 27518, United States
Wake Internal Medicine Consultants, Inc
Raleigh, North Carolina, 27612, United States
Wake Research Associates, LLC
Raleigh, North Carolina, 27612, United States
Midwest Clinical Research Center
Dayton, Ohio, 45417, United States
Oregon Health and Science University
Portland, Oregon, 97239-3098, United States
Southeastern PA Medical Institute
Broomall, Pennsylvania, 19008, United States
Belmont Center for Comprehensive Treatment
Philadelphia, Pennsylvania, 19131, United States
Lincoln Research, LLC
Lincoln, Rhode Island, 02865, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
Volunteer Research Group
Knoxville, Tennessee, 37920, United States
Clinical Neuroscience Solutions,Inc
Memphis, Tennessee, 38119, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, 37203, United States
James G. Kyser, MD
Nashville, Tennessee, 37203, United States
Future Search Clinical Trials
Austin, Texas, 78731, United States
InSite Clinical Research
DeSoto, Texas, 75115, United States
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030-1439, United States
Clinical Research Associates of Tidewater, Inc
Norfolk, Virginia, 23507, United States
Centro de Investigacion Clinica WM
Capital Federal, Buenos Aires, C1440BRR, Argentina
Centro Medico Dra. De Salvo
Buenos Aires, Buenos Aires F.D., C1426ABP, Argentina
Monash Alfred Psychiatry Research Centre
Melbourne, Victoria, 3004, Australia
Hospital Sao Lucas da PUCRS - Uniao Brasileira de Educacao e Assistencia
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Hospital e Maternidade Celso Pierro - Pontifícia Universidade Católica de Campinas - Campus II
Campinas, São Paulo, 13059-740, Brazil
Jaqueline Scholz Issa e Mario Issa de cardiologia Ltda
São Paulo, São Paulo, 05017-000, Brazil
Mental Health Center "Prof. Dr. Ivan Temkov-Bourgas" Ltd.
Burgas, Bourgas, 8000, Bulgaria
MHAT "Dr. Hristo Stambolski" Ltd.
Kazanlak, 6100, Bulgaria
NPH "Sv. Ivan Rilski"
Novi Iskar, 1282, Bulgaria
UMHAT "Dr. Georgi Stranski" Ltd.
Pleven, 5800, Bulgaria
UMHAT "Sveti Georgi" Ltd.
Plovdiv, 4002, Bulgaria
SHATPPD - Ruse Ltd.
Rousse, 7002, Bulgaria
Mental Health Center - Ruse Ltd.
Rousse, 7004, Bulgaria
MHATNP "Sveti Naum" Ltd.
Sofia, 1113, Bulgaria
MHATNP Sveti Naum SJsc.
Sofia, 1113, Bulgaria
SHATPD - Troyan Ltd.
Troyan Municipality, 5600, Bulgaria
Hamilton Medical Research Group
Hamilton, Ontario, L8M 1K7, Canada
Medical Research Associates
Mississauga, Ontario, L5M 4N4, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
Canadian Phase Onward Inc.
Toronto, Ontario, M3J 2C5, Canada
Centre for Addiction and Mental Health (CAMH)
Toronto, Ontario, M5S 2S1, Canada
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, J1H 1Z1, Canada
Hospital Regional de Talca, Unidad de Enfermedades Respiratorias
Talca, Maule Region, 3460001, Chile
Centro Respiratorio Integral (CENRESIN Ltda.)
Quillota, Valparaiso, V Region, 2260877, Chile
CCBR A/S
Ballerup Municipality, 2750, Denmark
CCBR A/S
Vejle, DK-7100, Denmark
Mehiläinen Leppävaara
Espoo, Finland, 02600, Finland
Savon Psykiatripalvelu Oy
Kuopio, Finland, 70110, Finland
Oulu Mentalcare Oy
Oulu, Finland, 90100, Finland
Mehiläinen Nummela
Nummela, 03100, Finland
Porin Lääkäritalo Oy
Pori, 28100, Finland
PEL, Psykiatrian ErikoisLääkärit
Turku, 20100, Finland
Universitaetsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79104, Germany
Ludwig Maximilians-Universitaet Muenchen
Munich, Bavaria, 80336, Germany
Klinische Forschung Hamburg GmbH
Hamburg, Hamburg, 20253, Germany
Klinische Forschung Berlin-Mitte GmbH
Berlin, 10117, Germany
emovis GmbH
Berlin, 10629, Germany
ZSL - Zentrum fuer Medizinische Studien Leipzig GmbH
Leipzig, 04157, Germany
Universitaetsklinik Tuebingen, Klinik fuer Psychiatrie und Psychotherapie
Tübingen, 72076, Germany
Consultorios de Medicina Especializada del Sector Privado
México, Mexico Df, 06100, Mexico
Centro de Estudios Clinicos y Especialidades Medicas S.C.
Monterrey, Nuevo León, 64620, Mexico
Lakeland Clinical Trials
Rotorua, 3010, New Zealand
FSBI "Federal Medical Research Center of Psychiatry and Addiction Medicine"
Moscow, 107076, Russia
Moscow State Public Healthcare Institution Mental Clinical Hospital #1 n.a. N.A. Alexeeva
Moscow, 117152, Russia
Clinical Mental Hospital #12 of Moscow Healthcare Department
Moscow, 125367, Russia
Clinical Psychiatric Hospital #1 of Nizhni Novgorod
Nizhny Novgorod, 603155, Russia
St. Petersburg State Healthcare Institution, St. Nikolay Chudotvorets Mental Hospital
Saint Petersburg, 190121, Russia
FSBI "Saint-Petersburg Scientific Research Psychoneurological Institute n.a. V.M. Bekhterev"
Saint Petersburg, 192019, Russia
State Healthcare Institution of St.Petersburg "Psychoneurological Dispensary #2
Saint Petersburg, 197341, Russia
Psychiatricka ambulancia, Mentum, s.r.o.
Bratislava, 82007, Slovakia
Nestatna psychiatricka ambulancia, MUDr. Livia Vavrusova, PhD
Bratislava, 851 01, Slovakia
Psychiatricka ambulancia MUDr. Nada Kuriackova, s.r.o.
Levice, 93401, Slovakia
Psychiatricka ambulancia, PsychoLine s.r.o.
Rimavská Sobota, 979 01, Slovakia
Nemocnica s poliklinikou sv. Barbory Roznava a.s.
Rožňava, 04801, Slovakia
Flexivest Fourteen Research Center
Bellville, Cape Town, 7530, South Africa
Worthwhile Clinical Trials
Benoni, Johannesburg, Gauteng, 1500, South Africa
Soweto Clinical Trials Centre
Johannesburg, Gauteng, 1818, South Africa
Midrand Medical Centre
Midrand, Gauteng, 1685, South Africa
I Engelbrecht Research Pty. Ltd
Pretoria, Gauteng, 0157, South Africa
Vista Clinic
Pretoria, Gauteng, 0157, South Africa
Private Practice
Durban, Kwa-zulu Natal, South Africa, 4019, South Africa
Randles Road Medical Centre
Durban, KwaZulu-Natal, 4091, South Africa
Dr John O'Brien Incorporated
Cape Town, Western Cape, 8001, South Africa
Hospital de La Santa Creu I Sant Pau
Barcelona, Barcelona, 08025, Spain
Hospital General Universitari Vall D'Hebron
Barcelona, Barcelona, 08035, Spain
Hospital Clinic I Provincial
Barcelona, Barcelona, 08036, Spain
Hospital San Pedro de Alcantara
Cáceres, Caceres, 10003, Spain
Unidad Especializada En Tabaquismo de La Comunidad de Madrid
Madrid, Madrid, 28015, Spain
Centro de Salud Torrero-La Paz.
Zaragoza, Zaragoza, 50007, Spain
Related Publications (1)
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.
PMID: 29630702DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2012
First Posted
April 10, 2012
Study Start
May 1, 2012
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
December 29, 2016
Results First Posted
December 29, 2016
Record last verified: 2016-10