Text Size

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

This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01574703
First received: April 6, 2012
Last updated: May 1, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention Phase
Smoking Cessation
 Drug: placebo
Drug: varenicline tartrate
Drug: bupropion hydrochloride
Drug: Nicotine Replacement Therapy Patch
 Phase 4

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: A Phase 4, Non-Treatment Follow-Up For Cardiac Assessments Following Use Of Different Treatments For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to MACE up to date of last dose of study drug plus 30 days in study A3051123 [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • Time to MACE until the end of study (A3051148) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • 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, [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • or hospitalization for unstable angina; • CV deaths; • Non fatal MI; • Non fatal stroke. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • 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, [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • a need for coronary revascularization, or hospitalization for unstable angina; • CV deaths; • Non fatal MI; • Non fatal stroke. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • revascularization, or hospitalization for unstable angina; • CV deaths; • Non fatal MI; • Non fatal stroke. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 8000
Study Start Date: May 2012
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
placebo Drug: placebo
All dosing to have taken place per study A3051123
varenicline Drug: varenicline tartrate
All dosing to have taken place per study A3051123
Other Name: Chantix; Champix
bupropion Drug: bupropion hydrochloride
All dosing to have taken place per study A3051123
Other Name: Zyban
Nicotine Replacement Therapy Patch Drug: Nicotine Replacement Therapy Patch
All dosing to have taken place per study A3051123
Other Name: NRT

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01574703

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Hide Study Locations
Locations
United States, Alabama
Coastal Clinical Research, Incorporated Recruiting
Mobile, Alabama, United States, 36608
United States, California
Synergy Clinical Research Center of Escondido Recruiting
Escondido, California, United States, 92025
Sun Valley Research Center Recruiting
Imperial, California, United States, 92251
Omega Clinical Trials, LLC Not yet recruiting
La Habra, California, United States, 90631
North County Clinical Research Recruiting
Oceanside, California, United States, 92056
Neuropsychiatric Research Center of Orange County Recruiting
Santa Ana, California, United States, 92701
United States, Colorado
University of Colorado Anschutz Medical Campus Behavioral Health and Wellness Program Recruiting
Aurora, Colorado, United States, 80045
Western Affiliated Research Institute Recruiting
Denver, Colorado, United States, 80209
United States, Florida
Neuropsychiatric Research Center of Southwest Florida Recruiting
Fort Myers, Florida, United States, 33912
Jacksonville Center for Clinical Research Recruiting
Jacksonville, Florida, United States, 32216
Renstar Medical Research Recruiting
Ocala, Florida, United States, 34471
Ocala Psychiatric Associates Recruiting
Ocala, Florida, United States, 34474
Broward Research Group Recruiting
Pembroke Pines, Florida, United States, 33026
United States, Georgia
Clinical Research Atlanta Recruiting
Stockbridge, Georgia, United States, 30281
United States, Idaho
Advanced Clinical Research Recruiting
Meridian, Idaho, United States, 83642
Northwest Neurobehavioral Health Recruiting
Meridian, Idaho, United States, 83642
United States, Illinois
AMR-Baber Research Incorporated Recruiting
Naperville, Illinois, United States, 60563
United States, Indiana
Davis Clinic, Incorporated Recruiting
Indianapolis, Indiana, United States, 46250
American Health Network of IN, LLC Recruiting
Indianapolis, Indiana, United States, 46254
United States, Kansas
Vince and Associates Clinical Research, LLC Recruiting
Overland Park, Kansas, United States, 66212
Vince & Associates Clinical Research Recruiting
Overland Park, Kansas, United States, 66121
Heartland Research Associates, LLC Recruiting
Wichita, Kansas, United States, 67207
United States, Kentucky
Central Kentucky Research Association, Incorporated Recruiting
Lexington, Kentucky, United States, 40509
Kentucky Research Group Recruiting
Louisville, Kentucky, United States, 40217
United States, Louisiana
The Center for Sexual Health Recruiting
Metairie, Louisiana, United States, 70002
United States, Maine
Maine Research Associates Recruiting
Auburn, Maine, United States, 04210
United States, Massachusetts
Milford Emergency Associates, Incorporated Recruiting
Milford, Massachusetts, United States, 01757
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
United States, Mississippi
Precise Research Centers Recruiting
Flowood, Mississippi, United States, 39232
United States, Missouri
The Center for Pharmaceutical Research, PC Recruiting
Kansas City, Missouri, United States, 64114
Mercy Health Research Recruiting
St. Louis, Missouri, United States, 63141
United States, New Jersey
Global Medicinal Institutes, LLC; Princeton Medical Institute Recruiting
Princeton, New Jersey, United States, 08540
United States, New York
Social Psychiatry Research Institute Recruiting
Brooklyn, New York, United States, 11235
Regional Clinical Research, Incorporated Recruiting
Endwell, New York, United States, 13760
United States, North Carolina
PMG Research of Raleigh, LLC Recruiting
Cary, North Carolina, United States, 27518
Wake Research Associates, LLC Recruiting
Raleigh, North Carolina, United States, 27612
United States, Ohio
Midwest Clinical Research Center Recruiting
Dayton, Ohio, United States, 45417
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239-3098
United States, Pennsylvania
Southeastern PA Medical Institute Recruiting
Broomall, Pennsylvania, United States, 19008
Belmont Center for Comprehensive Treatment Not yet recruiting
Philadelphia, Pennsylvania, United States, 19131
CRI Worldwide, LLC Recruiting
Philadelphia, Pennsylvania, United States, 19139
United States, Rhode Island
Lincoln Research Recruiting
Lincoln, Rhode Island, United States, 02865
United States, South Carolina
Coastal Carolina Research Center Recruiting
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
New Orleans Center for Clinical Research Recruiting
Knoxville, Tennessee, United States, 37920
Volunteer Research Group Recruiting
Knoxville, Tennessee, United States, 37920
Clinical Research Associates, Incorporated Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
InSite Clinical Research Recruiting
DeSoto, Texas, United States, 75115
United States, Virginia
Clinical Research Associates of Tidewater Recruiting
Norfolk, Virginia, United States, 23507
United States, Wisconsin
University of Wisconsin School of Medicine and Public Health, Recruiting
Madison, Wisconsin, United States, 53711-2027
Argentina
Centro Investigacion Clinica WM Recruiting
Capital Federal, Buenos Aires, Argentina, C1440BRR
Centro Medico Dra. De Salvo Recruiting
Buenos Aires, Capital Federal, Argentina, C1426ABP
Bulgaria
MBAL Dr. Hristo Stambolski EOOD Recruiting
Kazanlak, Bulgaria, 6100
DPB Sv. Ivan Rilski, Parvo otdelenie za maje s ostri psihichni zabolyavaniya Recruiting
Novi Iskar, Bulgaria, 1282
UMBAL Dr. Georgi Stranski EAD, Recruiting
Pleven, Bulgaria, 5800
UMBAL Sveti Georgi EAD, Klinika po psihiatriya Recruiting
Plovdiv, Bulgaria, 4002
Tsentar za psihichno zdrave - Ruse EOOD Recruiting
Ruse, Bulgaria, 7004
SBALPFZ - Ruse EOOD, Recruiting
Ruse, Bulgaria, 7002
Meditsinski Tsentar �Sveti Naum� EOOD Recruiting
Sofia, Bulgaria, 1113
MHATNP �Sveti Naum� SJsc., Second Psychiatric clinic Recruiting
Sofia, Bulgaria, 1113
Specializirana Bolnitsa za Aktivno Lechenie na Belodrobni Bolesti-Troyan EOOD, Recruiting
Troyan, Bulgaria, 5600
Canada, Ontario
Hamilton Medical Research Group Recruiting
Hamilton, Ontario, Canada, L8M 1K7
Medical Research Associates Not yet recruiting
Mississauga, Ontario, Canada, L5M 4N4
Canadian Phase Onward Inc. Recruiting
Toronto, Ontario, Canada, M3H 5S4
Canada, Quebec
Diex Research Sherbrooke Inc. Recruiting
Sherbrooke, Quebec, Canada, J1H 1Z1
Finland
Mehil�en Lepp�ara Recruiting
Espoo, Finland, 02600
Savon Psykiatripalvelu Oy Recruiting
Kuopio, Finland, 70110
Mehil�en Nummela Recruiting
Nummela, Finland, 03100
ODL Terveys Recruiting
Oulu, Finland, 90101
Porin L��talo Recruiting
Pori, Finland, 28100
PEL, Psykiatrian ErikoisL��t Recruiting
Turku, Finland, 20100
Germany
Klinische Forschung Berlin-Mitte GmbH Recruiting
Berlin, Germany, 10117
emovis GmbH Recruiting
Berlin, Germany, 10629
Universitaetsklinikum Freiburg Recruiting
Freiburg, Germany, 79104
Klinische Forschung Hamburg GmbH Recruiting
Hamburg, Germany, 20253
ZSL - Zentrum fuer Medizinische Studien Leipzig GmbH Recruiting
Leipzig, Germany, 04157
Ludwig Maximilians-Universitaet Muenchen Recruiting
Muenchen, Germany, 80336
Universitaetsklinik Tuebingen, Klinik fuer Psychiatrie und Psychotherapie Recruiting
Tuebingen, Germany, 72076
New Zealand
Lakeland Clinical Trials Recruiting
Rotorua, New Zealand
Russian Federation
Moscow Research Institute of Psychiatry Recruiting
Moscow, Russian Federation, 107076
Slovakia
Nestatna psychiatricka ambulancia, MUDr. Livia Vavrusova, PhD Recruiting
Bratislava, Slovakia, 851 01
Psychiatricka ambulancia, Mentum, s.r.o. Recruiting
Bratislava, Slovakia, 82007
Psychiatricka ambulancia MUDr. Nada Kuriackova, s.r.o. Recruiting
Levice, Slovakia, 93401
Psychiatricka ambulancia, PsychoLine s.r.o. Recruiting
Rimavska Sobota, Slovakia, 979 01
Nemocnica s poliklinikou sv. Barbory Roznava a.s. Recruiting
Roznava, Slovakia, 04801
South Africa
Worthwhile Clinical Trials Recruiting
Benoni, Gauteng, South Africa, 1500
Vista Clinic Recruiting
Centurion, Gauteng, South Africa, 0157
Soweto Clinical Trials Centre Recruiting
Johannesburg, Gauteng, South Africa, 1818
Midrand Medical Centre Recruiting
Midrand, Gauteng, South Africa, 1685
I Engelbrecht Research Pty(Ltd) Recruiting
Pretoria, Gauteng, South Africa, 0157
Private Practice Recruiting
Durban, Kwa-Zulu Natal, South Africa, 4091
Randles Road Medical Centre Recruiting
Durban, Kwazulu Natal, South Africa, 4091
Flexivest Fourteen Research Center Recruiting
Bellville, Western Cape, South Africa, 7530
Quit Support Recruiting
Cape Town, Western Cape, South Africa, 8001
Spain
Hospital Cl�c de Barcelona Departamento de Psiquiatria Recruiting
Barcelona, Spain, 08036
Hospital de La Santa Creu I Sant Pau Recruiting
Barcelona, Spain, 08025
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 08028
Hospital General de La Vall D'Hebron Recruiting
Barcelona, Spain, 08035
Hospital San Pedro de Alcantara Recruiting
Caceres, Spain, 10003
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01574703     History of Changes
Other Study ID Numbers: A3051148
Study First Received: April 6, 2012
Last Updated: May 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
smoking cessation
psychiatric disease
cardiovascular events

Additional relevant MeSH terms:
Mental Disorders
Smoking
Habits
Nicotine
Nicotine polacrilex
Varenicline
Bupropion
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
 Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013