Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders. (CATS)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01574703 |
|
Recruitment Status
:
Completed
First Posted
: April 10, 2012
Results First Posted
: December 29, 2016
Last Update Posted
: December 29, 2016
|
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Smoking Cessation | Drug: placebo Drug: varenicline tartrate Drug: bupropion hydrochloride Drug: Nicotine Replacement Therapy Patch | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 4595 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| 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 Start Date : | May 2012 |
| Actual Primary Completion Date : | July 2015 |
| Actual Study Completion Date : | July 2015 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Bupropion
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
| Experimental: placebo |
Drug: placebo
All dosing to have taken place per study A3051123
|
| Experimental: varenicline |
Drug: varenicline tartrate
All dosing to have taken place per study A3051123
Other Name: Chantix; Champix
|
| Experimental: bupropion |
Drug: bupropion hydrochloride
All dosing to have taken place per study A3051123
Other Name: Zyban
|
| Experimental: Nicotine Replacement Therapy Patch |
Drug: Nicotine Replacement Therapy Patch
All dosing to have taken place per study A3051123
Other Name: NRT
|
Primary Outcome Measures
:
- Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. [ Time Frame: 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
:
- Time to MACE up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. [ Time Frame: 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.
- Time to MACE Until the End of Study NCT01574703. [ Time Frame: 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 During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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.
- Incidence of MACE+ Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574703
Hide Study Locations
Locations
| United States, Alabama | |
| Coastal Clinical Research, Inc. | |
| Mobile, Alabama, United States, 36608 | |
| United States, California | |
| Pharmacology Research Institute | |
| Encino, California, United States, 91316 | |
| Synergy Clinical Research Center of Escondido | |
| Escondido, California, United States, 92025 | |
| Sun Valley Research Center | |
| Imperial, California, United States, 92251 | |
| Omega Clinical Trials | |
| La Habra, California, United States, 90631 | |
| Pacific Treatment and Research Center | |
| La Jolla, California, United States, 92037 | |
| Pharmacology Research Institute | |
| Los Alamitos, California, United States, 90720 | |
| Pharmacology Research Institute (PRI) | |
| Newport Beach, California, United States, 92660 | |
| North County Clinical Research | |
| Oceanside, California, United States, 92056 | |
| NRC Research Institute | |
| Orange, California, United States, 92868 | |
| California Neuroscience Research Medical Group, Inc. | |
| Sherman Oaks, California, United States, 91403 | |
| United States, Colorado | |
| University of Colorado Anschutz Medical Campus Behavioral Health and Wellness Program | |
| Aurora, Colorado, United States, 80045 | |
| Western Affiliated Research Institute | |
| Denver, Colorado, United States, 80209 | |
| United States, Connecticut | |
| Comprehensive Psychiatric Care | |
| Norwich, Connecticut, United States, 06360 | |
| United States, Florida | |
| Neuropsychiatric Research Center of Southwest Florida | |
| Fort Myers, Florida, United States, 33912 | |
| Broward Research Group | |
| Hollywood, Florida, United States, 33024 | |
| Jacksonville Center for Clinical Research | |
| Jacksonville, Florida, United States, 32216 | |
| Clinical Neuroscience Solutions | |
| Jacksonville, Florida, United States, 32256 | |
| Renstar Medical Research | |
| Ocala, Florida, United States, 34471 | |
| Ocala Psychiatric Associates | |
| Ocala, Florida, United States, 34474 | |
| Clinical Neuroscience Solutions Inc. | |
| Orlando, Florida, United States, 32801 | |
| Meridien Research | |
| Tampa, Florida, United States, 33634 | |
| United States, Georgia | |
| Northwest Behavioral Research Center | |
| Marietta, Georgia, United States, 30060 | |
| Clinical Research Atlanta | |
| Stockbridge, Georgia, United States, 30281 | |
| United States, Idaho | |
| Advanced Clinical Research | |
| Meridian, Idaho, United States, 83642 | |
| United States, Illinois | |
| Baber Research Group Incorporated | |
| Naperville, Illinois, United States, 60563 | |
| United States, Indiana | |
| Davis Clinic, Incorporated | |
| Indianapolis, Indiana, United States, 46250 | |
| American Health Network of IN, LLC | |
| Indianapolis, Indiana, United States, 46254 | |
| Goldpoint Clinical Research, LLC | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Kansas | |
| Vince & Associates Clinical Research, Inc. | |
| Overland Park, Kansas, United States, 66211 | |
| Vince & Associates Clinical Research, Inc. | |
| Overland Park, Kansas, United States, 66212 | |
| Vince and Associates Clinical Research, Inc. | |
| Overland Park, Kansas, United States, 66212 | |
| Heartland Research Associates, LLC | |
| Wichita, Kansas, United States, 67207 | |
| United States, Kentucky | |
| Central Kentucky Research Associates, Incorporated | |
| Lexington, Kentucky, United States, 40509 | |
| Kentucky Research Group | |
| Louisville, Kentucky, United States, 40218 | |
| United States, Louisiana | |
| The Center for Sexual Health | |
| Metairie, Louisiana, United States, 70002 | |
| United States, Maine | |
| Maine Research Associates | |
| Auburn, Maine, United States, 04210 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Milford Emergency Associates, Incorporated | |
| Milford, Massachusetts, United States, 01757 | |
| United States, Minnesota | |
| University of Minnesota - TC | |
| Minneapolis, Minnesota, United States, 55414 | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Mississippi | |
| Precise Research Centers | |
| Flowood, Mississippi, United States, 39232 | |
| United States, Missouri | |
| The Center for Pharmaceutical Research, PC | |
| Kansas City, Missouri, United States, 64114 | |
| Mercy Health Research | |
| St. Louis, Missouri, United States, 63141 | |
| United States, New Jersey | |
| CRI Worldwide, LLC | |
| Marlton, New Jersey, United States, 08053 | |
| Global Medicinal Institutes, LLC; Princeton Medical Institute | |
| Princeton, New Jersey, United States, 08540 | |
| United States, New York | |
| SPRI Clinical Trails LLC | |
| Brooklyn, New York, United States, 11235 | |
| Regional Clinical Research, Incorporated | |
| Endwell, New York, United States, 13760 | |
| United States, North Carolina | |
| PMG Research of Raleigh, LLC | |
| Cary, North Carolina, United States, 27518 | |
| Wake Internal Medicine Consultants, Inc | |
| Raleigh, North Carolina, United States, 27612 | |
| Wake Research Associates, LLC | |
| Raleigh, North Carolina, United States, 27612 | |
| United States, Ohio | |
| Midwest Clinical Research Center | |
| Dayton, Ohio, United States, 45417 | |
| United States, Oregon | |
| Oregon Health and Science University | |
| Portland, Oregon, United States, 97239-3098 | |
| United States, Pennsylvania | |
| Southeastern PA Medical Institute | |
| Broomall, Pennsylvania, United States, 19008 | |
| Belmont Center for Comprehensive Treatment | |
| Philadelphia, Pennsylvania, United States, 19131 | |
| United States, Rhode Island | |
| Lincoln Research, LLC | |
| Lincoln, Rhode Island, United States, 02865 | |
| United States, South Carolina | |
| Coastal Carolina Research Center | |
| Mount Pleasant, South Carolina, United States, 29464 | |
| United States, Tennessee | |
| Volunteer Research Group | |
| Knoxville, Tennessee, United States, 37920 | |
| Clinical Neuroscience Solutions,Inc | |
| Memphis, Tennessee, United States, 38119 | |
| Clinical Research Associates, Inc. | |
| Nashville, Tennessee, United States, 37203 | |
| James G. Kyser, MD | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Future Search Clinical Trials | |
| Austin, Texas, United States, 78731 | |
| InSite Clinical Research | |
| DeSoto, Texas, United States, 75115 | |
| The University of Texas M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030-1439 | |
| United States, Virginia | |
| Clinical Research Associates of Tidewater, Inc | |
| Norfolk, Virginia, United States, 23507 | |
| Argentina | |
| Centro de Investigacion Clinica WM | |
| Capital Federal, Buenos Aires, Argentina, C1440BRR | |
| Centro Medico Dra. De Salvo | |
| Buenos Aires, Capital Federal, Argentina, C1426ABP | |
| Australia, Victoria | |
| Monash Alfred Psychiatry Research Centre | |
| Melbourne, Victoria, Australia, 3004 | |
| Brazil | |
| Hospital Sao Lucas da PUCRS - Uniao Brasileira de Educacao e Assistencia | |
| Porto Alegre, RS, Brazil, 90610-000 | |
| Hospital e Maternidade Celso Pierro - Pontifícia Universidade Católica de Campinas - Campus II | |
| Campinas, São Paulo, Brazil, 13059-740 | |
| Jaqueline Scholz Issa e Mario Issa de cardiologia Ltda | |
| Sao Paulo, Brazil, 05017-000 | |
| Bulgaria | |
| Mental Health Center "Prof. Dr. Ivan Temkov-Bourgas" Ltd. | |
| Bourgas, Bulgaria, 8000 | |
| MHAT "Dr. Hristo Stambolski" Ltd. | |
| Kazanlak, Bulgaria, 6100 | |
| NPH "Sv. Ivan Rilski" | |
| Novi Iskar, Bulgaria, 1282 | |
| UMHAT "Dr. Georgi Stranski" Ltd. | |
| Pleven, Bulgaria, 5800 | |
| UMHAT "Sveti Georgi" Ltd. | |
| Plovdiv, Bulgaria, 4002 | |
| SHATPPD - Ruse Ltd. | |
| Ruse, Bulgaria, 7002 | |
| Mental Health Center - Ruse Ltd. | |
| Ruse, Bulgaria, 7004 | |
| MHATNP "Sveti Naum" Ltd. | |
| Sofia, Bulgaria, 1113 | |
| MHATNP Sveti Naum SJsc. | |
| Sofia, Bulgaria, 1113 | |
| SHATPD - Troyan Ltd. | |
| Troyan, Bulgaria, 5600 | |
| Canada, Ontario | |
| Hamilton Medical Research Group | |
| Hamilton, Ontario, Canada, L8M 1K7 | |
| Medical Research Associates | |
| Mississauga, Ontario, Canada, L5M 4N4 | |
| University of Ottawa Heart Institute | |
| Ottawa, Ontario, Canada, K1Y 4W7 | |
| Canadian Phase Onward Inc. | |
| Toronto, Ontario, Canada, M3J 2C5 | |
| Centre for Addiction and Mental Health (CAMH) | |
| Toronto, Ontario, Canada, M5S 2S1 | |
| Canada, Quebec | |
| Diex Research Sherbrooke Inc. | |
| Sherbrooke, Quebec, Canada, J1H 1Z1 | |
| Chile | |
| Hospital Regional de Talca, Unidad de Enfermedades Respiratorias | |
| Talca, Maule, Chile, 3460001 | |
| Centro Respiratorio Integral (CENRESIN Ltda.) | |
| Quillota, Valparaiso, V Region, Chile, 2260877 | |
| Denmark | |
| CCBR A/S | |
| Ballerup, Denmark, 2750 | |
| CCBR A/S | |
| Vejle, Denmark, DK-7100 | |
| Finland | |
| Mehiläinen Leppävaara | |
| Espoo, Finland, 02600 | |
| Savon Psykiatripalvelu Oy | |
| Kuopio, Finland, 70110 | |
| Mehiläinen Nummela | |
| Nummela, Finland, 03100 | |
| Oulu Mentalcare Oy | |
| Oulu, Finland, 90100 | |
| Porin Lääkäritalo Oy | |
| Pori, Finland, 28100 | |
| PEL, Psykiatrian ErikoisLääkärit | |
| Turku, Finland, 20100 | |
| Germany | |
| Universitaetsklinikum Freiburg | |
| Freiburg, Baden-wuerttemberg, Germany, 79104 | |
| Ludwig Maximilians-Universitaet Muenchen | |
| Muenchen, Bayern, Germany, 80336 | |
| Klinische Forschung Berlin-Mitte GmbH | |
| Berlin, Germany, 10117 | |
| emovis GmbH | |
| Berlin, Germany, 10629 | |
| Klinische Forschung Hamburg GmbH | |
| Hamburg, Germany, 20253 | |
| ZSL - Zentrum fuer Medizinische Studien Leipzig GmbH | |
| Leipzig, Germany, 04157 | |
| Universitaetsklinik Tuebingen, Klinik fuer Psychiatrie und Psychotherapie | |
| Tuebingen, Germany, 72076 | |
| Mexico | |
| Consultorios de Medicina Especializada del Sector Privado | |
| Mexico, Mexico Df, Mexico, 06100 | |
| Centro de Estudios Clinicos y Especialidades Medicas S.C. | |
| Monterrey, Nuevo Leon, Mexico, 64620 | |
| New Zealand | |
| Lakeland Clinical Trials | |
| Rotorua, New Zealand, 3010 | |
| Russian Federation | |
| FSBI "Federal Medical Research Center of Psychiatry and Addiction Medicine" | |
| Moscow, Russian Federation, 107076 | |
| Moscow State Public Healthcare Institution Mental Clinical Hospital #1 n.a. N.A. Alexeeva | |
| Moscow, Russian Federation, 117152 | |
| Clinical Mental Hospital #12 of Moscow Healthcare Department | |
| Moscow, Russian Federation, 125367 | |
| Clinical Psychiatric Hospital #1 of Nizhni Novgorod | |
| Nizhni Novgorod, Russian Federation, 603155 | |
| FSBI "Saint-Petersburg Scientific Research Psychoneurological Institute n.a. V.M. Bekhterev" | |
| Saint Petersburg, Russian Federation, 192019 | |
| St. Petersburg State Healthcare Institution, St. Nikolay Chudotvorets Mental Hospital | |
| St. Petersburg, Russian Federation, 190121 | |
| State Healthcare Institution of St.Petersburg "Psychoneurological Dispensary #2 | |
| St. Petersburg, Russian Federation, 197341 | |
| Slovakia | |
| Psychiatricka ambulancia, Mentum, s.r.o. | |
| Bratislava, Slovakia, 82007 | |
| Nestatna psychiatricka ambulancia, MUDr. Livia Vavrusova, PhD | |
| Bratislava, Slovakia, 851 01 | |
| Psychiatricka ambulancia MUDr. Nada Kuriackova, s.r.o. | |
| Levice, Slovakia, 93401 | |
| Psychiatricka ambulancia, PsychoLine s.r.o. | |
| Rimavska Sobota, Slovakia, 979 01 | |
| Nemocnica s poliklinikou sv. Barbory Roznava a.s. | |
| Roznava, Slovakia, 04801 | |
| South Africa | |
| Flexivest Fourteen Research Center | |
| Bellville, Cape Town, South Africa, 7530 | |
| Worthwhile Clinical Trials | |
| Benoni, Johannesburg, Gauteng, South Africa, 1500 | |
| Soweto Clinical Trials Centre | |
| Johannesburg, Gauteng, South Africa, 1818 | |
| Midrand Medical Centre | |
| Midrand, Gauteng, South Africa, 1685 | |
| I Engelbrecht Research Pty. Ltd | |
| Pretoria, Gauteng, South Africa, 0157 | |
| Vista Clinic | |
| Pretoria, Gauteng, South Africa, 0157 | |
| Private Practice | |
| Durban, Kwa-zulu Natal, South Africa, South Africa, 4019 | |
| Randles Road Medical Centre | |
| Durban, Kwazulu Natal, South Africa, 4091 | |
| Dr John O'Brien Incorporated | |
| Cape Town, Western Cape, South Africa, 8001 | |
| Spain | |
| Hospital de La Santa Creu I Sant Pau | |
| Barcelona, Spain, 08025 | |
| Hospital General Universitari Vall D'Hebron | |
| Barcelona, Spain, 08035 | |
| Hospital Clinic I Provincial | |
| Barcelona, Spain, 08036 | |
| Hospital San Pedro de Alcantara | |
| Caceres, Spain, 10003 | |
| Unidad Especializada En Tabaquismo de La Comunidad de Madrid | |
| Madrid, Spain, 28015 | |
| Centro de Salud Torrero-La Paz. | |
| Zaragoza, Spain, 50007 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01574703 History of Changes |
| Other Study ID Numbers: |
A3051148 2011-005513-37 ( EudraCT Number ) CATS ( Other Identifier: Alias Study Number ) |
| First Posted: | April 10, 2012 Key Record Dates |
| Results First Posted: | December 29, 2016 |
| Last Update Posted: | December 29, 2016 |
| Last Verified: | October 2016 |
Keywords provided by Pfizer:
|
smoking cessation psychiatric disease cardiovascular events |
Additional relevant MeSH terms:
|
Mental Disorders Problem Behavior Behavioral Symptoms Nicotine Varenicline Bupropion Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Nicotinic Agonists Cholinergic Agonists Cholinergic Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Dopamine Agents Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors |