The Evaluation Of PF-04950615 (RN316) In Reducing The Occurrence Of Major Cardiovascular Events In High Risk Subjects (SPIRE-2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01975389
First received: October 21, 2013
Last updated: October 10, 2014
Last verified: October 2014
  Purpose

This study evaluates the PCSK9 inhibitor, PF-04950615 (RN316), compared to placebo, in reducing the occurrrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization in high risk subjects who are receiving background lipid lowering therapy and have cholesterol laboratory values of LDL-C >/= 100 mg/dL (2.6 mmol/L) or non-HDL-C >/=130 mg/dL (3.4 mmol/L).


Condition Intervention Phase
Cardiovascular Disease
Drug: PF-04950615
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase 3 Multi Center, Double Blind, Randomized, Placebo Controlled, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Pf 04950615, In Reducing The Occurrence Of Major Cardiovascular Events In High Risk Subjects

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Cardiovascular event [ Time Frame: The time from Randomization to the first adjudicated and confirmed occurrence of a primary endpoint major cardiovascular event, up to Month 60 ] [ Designated as safety issue: No ]
    Confirmed occurrence of a major cardiovascular event, a composite endpoint which includes CV death, non fatal MI, non fatal stroke, and hospitalization for unstable angina needing urgent revascularization


Secondary Outcome Measures:
  • Hospitalization for unstable angina needing urgent revascularization [ Time Frame: The time from randomization to the first adjudicated and confirmed hospitalization for unstable angina needing urgent revascularization, assessed up to Month 60 ] [ Designated as safety issue: No ]
  • A composite endpoint of CV death, non fatal MI, and non fatal stroke [ Time Frame: The time from randomization to the first adjudicated and confirmed occurrence of a composite endpoint of CV death, non-fatal MI, and non-fatal stroke, assessed up to Month 60 ] [ Designated as safety issue: No ]
  • A composite endpoint of all-cause death, non fatal MI, and non fatal stroke, and hospitalization for unstable angina needing urgent revascularization. [ Time Frame: The time from randomization to the first adjudicated and confirmed occurrence of a composite endpoint of all-cause death, non-fatal MI, and non-fatal stroke, and hospitalization for unstable angina needing urgent revascularization, assessed up to M60 ] [ Designated as safety issue: No ]

Estimated Enrollment: 6300
Study Start Date: October 2013
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-04950615 Drug: PF-04950615
150 mg, every 2 weeks, subcutaneous. The duration of the treatment period will depend upon reaching the targeted number of adjudicated and confirmed CV outcome events, approximately 3 to 4 years after the entry of first subject into the study.
Other Name: RN316
Placebo Comparator: Placebo Drug: Placebo
Placebo comparator, every 2 weeks, subcutaneous. The duration of the treatment period will depend upon reaching the targeted number of adjudicated and confirmed CV outcome events, approximately 3 to 4 years after the entry of first subject into the study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be on background lipid lowering treatment.
  • Must be at high risk of a CV event.
  • Must have an LDL C >/=100 mg/dL (2.6 mmol/L) OR non HDL C >/=130 mg/dL (3.4 mmol/L).

Exclusion Criteria:

  • An LDL C <100 mg/dL (2.6 mmol/L) or non HDL C <130 mg/dL (3.4 mmol/L).
  • Planned coronary (PCI or CABG) or other arterial revascularization.
  • New York Heart Association Class IV congestive heart failure or left ventricular ejection fraction < 25% by cardiac imaging.
  • Chronic renal insufficiency with creatinine clearance of <30 ml/min/1.73m^2 by MDRD formula or with end state renal disease on dialysis.
  • History of hemorrhagic stroke.
  • Prior exposure to PF 04950615 (RN316) or other investigational PCSK9 inhibitor.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01975389

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

  Hide Study Locations
Locations
United States, Alabama
North Alabama Research Center, LLC Recruiting
Athens, Alabama, United States, 35611
Office of Ernest L. Hendrix, MD, PC Recruiting
Athens, Alabama, United States, 35611
Birmingham Heart Clinic, P.C. Not yet recruiting
Birmingham, Alabama, United States, 35235
University of Alabama at Birmingham (Drug Shipment) Recruiting
Birmingham, Alabama, United States, 35294
The Kirklin Clinic Recruiting
Birmingham, Alabama, United States, 35233
United States, Arizona
Arrowhead Internal Medicine Recruiting
Glendale, Arizona, United States, 85308
Clinical Research Advantage, Inc. (Administrative Mailing Only) Recruiting
Tempe, Arizona, United States, 85282
Southwest Heart Group Recruiting
Tucson, Arizona, United States, 85710
United States, California
Triwest Research Associates, LLC Recruiting
El Cajon, California, United States, 92020
Encompass Clinical Research North Coast Not yet recruiting
Encinitas, California, United States, 92024
Clinical Trials Research Recruiting
Lincoln, California, United States, 95648
Richard S. Cherlin, MD Recruiting
Los Gatos, California, United States, 95032
Facey Medical Foundation Recruiting
Mission Hills, California, United States, 91345
Arch Health Partners/Clinical Research Department Not yet recruiting
Poway, California, United States, 92064
Coastal Biomedical Research, Inc. Recruiting
Santa Monica, California, United States, 90404
St. Joseph's Medical Associates Recruiting
Stockton, California, United States, 95204
Westlake Medical Research Recruiting
Thousand Oaks, California, United States, 91360
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center Recruiting
Torrance, California, United States, 90502
United States, Colorado
Lynn Institute of the Rockies Recruiting
Colorado Springs, Colorado, United States, 80907
Lynn Institute of Denver Recruiting
Denver, Colorado, United States, 80246
United States, Connecticut
Stamford Therapeutics Consortium Recruiting
Stamford, Connecticut, United States, 6905
United States, Florida
ACRC - Cardiology Recruiting
Atlantis, Florida, United States, 33462
GulfCoast Endocrine and Diabetes Center Recruiting
Clearwater, Florida, United States, 33756
Invesclinic, LLC Recruiting
Fort Lauderdale, Florida, United States, 33308
The Office of Maxine E. Hamilton, MD, PA Recruiting
Fort Lauderdale, Florida, United States, 33316
Broward Health Medical Center Not yet recruiting
Fort Lauderdale, Florida, United States, 33316
The Office of Dr. Alan Graff, MD, PA Recruiting
Ft. Lauderale, Florida, United States, 33308
River City Clinical Research Not yet recruiting
Jacksonville, Florida, United States, 32207
Jacksonville Center for Clinical Research Recruiting
Jacksonville, Florida, United States, 32216
South Florida Research Group, LLC Recruiting
Miami, Florida, United States, 33176
International Research Associates, LLC Recruiting
Miami, Florida, United States, 33183
Research Institute of South Florida, Inc. Recruiting
Miami, Florida, United States, 33173
Pharmax Research Clinic, Inc. Recruiting
Miami, Florida, United States, 33126
Ocean Blue Medical Research Center, Inc. Recruiting
Miami Springs, Florida, United States, 33166
Invesclinic, LLC d/b/a SouthEast Medical Centre Recruiting
Oakland Park, Florida, United States, 33309
Omega Research Consultants, LLC Recruiting
Orlando, Florida, United States, 32860
A&R Research Group, LLC Not yet recruiting
Pembroke Pines, Florida, United States, 33024
Concept Clinical Trials, LLC Recruiting
Tamarac, Florida, United States, 33319
Metabolic Research Institute, Inc. Recruiting
West Palm Beach, Florida, United States, 33401
United States, Georgia
Atlanta Diabetes Associates Recruiting
Atlanta, Georgia, United States, 30318
Neurostudies.net, LLC Recruiting
Decatur, Georgia, United States, 30033
In-Quest Medical Research, LLC Recruiting
Norcross, Georgia, United States, 30092
United States, Idaho
Elite Clinical Trials LLLP Not yet recruiting
Blackfoot, Idaho, United States, 83221
United States, Illinois
Evanston Premier Healthcare Research, LLC Recruiting
Evanston, Illinois, United States, 60201
United States, Indiana
Investigators Research Group, LLC Recruiting
Brownsburg, Indiana, United States, 46112
Deaconess Clinic Mt. Pleasant Recruiting
Evansville, Indiana, United States, 47725
Deaconess Clinic Downtown Recruiting
Evansville, Indiana, United States, 47713
Clinical Research Advantage, Inc. Recruiting
Evansville, Indiana, United States, 47714
American Health Network of Indiana, LLC Recruiting
Muncie, Indiana, United States, 47304
Buynak Clinical Research, P.C. Recruiting
Valparaiso, Indiana, United States, 46383
United States, Iowa
West Broadway Clinic Recruiting
Council Bluffs, Iowa, United States, 51501
University of Iowa College of Public Health - Preventive Intervention Center Recruiting
Iowa City, Iowa, United States, 52242
University of Iowa, University of Hospitals and Clinics - Division Recruiting
Iowa City, Iowa, United States, 52242
United States, Kansas
Midwest Heart & Vascular Specialists, LLC Recruiting
Overland Park, Kansas, United States, 66209
Women's & Family Care D.B.A. GTC Research Recruiting
Shawnee, Kansas, United States, 66218
United States, Kentucky
The Research Group of Lexington, LLC Recruiting
Lexington, Kentucky, United States, 40503
L-MARC Recruiting
Louisville, Kentucky, United States, 40213
United States, Michigan
St. Joseph Mercy Health System (Drug shipment Only) Recruiting
Ann Arbor, Michigan, United States, 48106
Quest Research Institute Recruiting
Bingham Farms, Michigan, United States, 48025
Medical Research Associates, Inc. Not yet recruiting
Traverse City, Michigan, United States, 49684
Oakland Medical Research Center Not yet recruiting
Troy, Michigan, United States, 48085
Troy Internal Medicine, PC Recruiting
Troy, Michigan, United States, 48098
Michigan Heart Recruiting
Ypsilanti, Michigan, United States, 48197
United States, Mississippi
Cardiology Associates Research, LLC Recruiting
Tupelo, Mississippi, United States, 38801
United States, Missouri
Saint Luke's Lipid and Diabetes Research Center Not yet recruiting
Kansas City, Missouri, United States, 64111
United States, Montana
Montana Medical Research Inc. Recruiting
Missoula, Montana, United States, 59808
United States, New Jersey
NJ Heart Recruiting
Linden, New Jersey, United States, 07036
Arysmed LLC Not yet recruiting
Lodi, New Jersey, United States, 07644
Rutgers Biomedical and Health Sciences - Robert Wood Johnson Medical School Not yet recruiting
New Brunswick, New Jersey, United States, 08901
Westwood Cardiology Associates, P.A. Recruiting
Westwood, New Jersey, United States, 07675
United States, New York
The Endocrine Group Recruiting
Albany, New York, United States, 12206
Long Island Heart Associates Not yet recruiting
Mineola, New York, United States, 11501
Mid Hudson Medical Research, PLLC Recruiting
New Windsor, New York, United States, 12553
Clinical Research Development Associates, LLC Recruiting
Rosedale, New York, United States, 11422
Syracuse Preventive Cardiology Not yet recruiting
Syracuse, New York, United States, 13202
United States, North Carolina
Sensenbrenner Primary Care Recruiting
Charlotte, North Carolina, United States, 28277
Research Institute of the Carolinas of Piedmont Healthcare, PA Recruiting
Mooresville, North Carolina, United States, 28117
Wake Forest University School of Medicine Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
Lillestol Research LLC Recruiting
Fargo, North Dakota, United States, 58103
United States, Ohio
The Lindner Center for Research and Education at The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Metabolic and Atherosclerosis Research Center Recruiting
Cincinnati, Ohio, United States, 45227
Medpace Clinical Pharmacology Unit Recruiting
Cincinnati, Ohio, United States, 45212
Sterling Research Group, Ltd. Recruiting
Cincinnati, Ohio, United States, 45246
SV Research LLC Recruiting
Marion, Ohio, United States, 43302
Office of Daniel G. Williams, MD Recruiting
Perrysburg, Ohio, United States, 43551
North Ohio Heart Center, Inc. Recruiting
Sandusky, Ohio, United States, 44870
United States, Oklahoma
LION Research Recruiting
Norman, Oklahoma, United States, 73069
United States, Oregon
Hillsboro Cardiology, P.C. Recruiting
Hillsboro, Oregon, United States, 97123
United States, Pennsylvania
Pennsylvania Research Institute Not yet recruiting
Bensalem, Pennsylvania, United States, 19020
Jefferson Cardiology Association Recruiting
Clairton, Pennsylvania, United States, 15025
Brandywine Clinical Research Recruiting
Downingtown, Pennsylvania, United States, 19335-2620
Doylestown Cardiology Associates - VIAA Recruiting
Doylestown, Pennsylvania, United States, 18901
Green and Seidner Family Practice Associates Recruiting
Lansdale, Pennsylvania, United States, 19446
Family Medical Associates Recruiting
Levittown, Pennsylvania, United States, 19056
Allegheny Endocrinology Associates Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Preferred Primary Care Physicians Recruiting
Pittsburgh, Pennsylvania, United States, 15236
Guthrie Medical Group, PC Recruiting
Sayre, Pennsylvania, United States, 18840
TriValley Primary Care - Pennridge Not yet recruiting
Sellersville, Pennsylvania, United States, 18960
Grand View Hospital Clinical Research Department Not yet recruiting
Sellersville, Pennsylvania, United States, 18960
Grand View Hospital Not yet recruiting
Sellersville, Pennsylvania, United States, 18960
United States, South Carolina
Coastal Cardiology Recruiting
Charleston, South Carolina, United States, 29407
Upstate Pharmaceutical Research Recruiting
Greenville, South Carolina, United States, 29615
The Diabetes Center Recruiting
Murrells Inlet, South Carolina, United States, 29576
United States, Tennessee
New Orleans Center for Clinical Research Recruiting
Knoxville, Tennessee, United States, 37920
Volunteer Research Group Recruiting
Knoxville, Tennessee, United States, 37920
United States, Texas
Arlington Family Research Center, Inc. Recruiting
Arlington, Texas, United States, 76012
VA North Texas Health Care System - Dallas VAMC Not yet recruiting
Dallas, Texas, United States, 75216
Research Institute of Dallas Recruiting
Dallas, Texas, United States, 75231
Texas Center For Drug Development, Inc. Recruiting
Houston, Texas, United States, 77081
DM Clinical Research Recruiting
Houston, Texas, United States, 77070
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Centex Studies, Inc. Recruiting
Houston, Texas, United States, 77062
Hill Country Medical Associates Recruiting
New Braunfels, Texas, United States, 78130
Med-Olam Clinical Research Recruiting
Pasadena, Texas, United States, 77504
Bandera Family Health Care Recruiting
San Antonio, Texas, United States, 78249
Sun Research Institute Active, not recruiting
San Antonio, Texas, United States, 78215
BFHC Research Recruiting
San Antonio, Texas, United States, 78249
Northwest Heart Center Recruiting
Tomball, Texas, United States, 77375
United States, Utah
Physicians' Research Options Not yet recruiting
Draper, Utah, United States, 84020
Optimum Clinical Research, Inc. Recruiting
Salt Lake City, Utah, United States, 84102
United States, Virginia
Burke Internal Medicine & Research Recruiting
Burke, Virginia, United States, 22015
Hampton Roads Center for Clinical Research Recruiting
Suffolk, Virginia, United States, 23435
United States, Washington
Office of Daniel W. Gottlieb, MD, PS Recruiting
Burien, Washington, United States, 98166
Wenatchee Valley Hospital and Clinics Recruiting
Wenatchee, Washington, United States, 98801
Wenatchee Valley Medical Center Recruiting
Wenatchee, Washington, United States, 98801
United States, West Virginia
Exemplar Research Inc Not yet recruiting
Fairmont, West Virginia, United States, 26554
Australia, New South Wales
Central Coast Local Health District, Gosford Hospital Not yet recruiting
Gosford, New South Wales, Australia, 2250
Australia, Queensland
Royal Brisbane and Women's Hospital Recruiting
Herston, Queensland, Australia, 4029
Core Research Group Pty Ltd Recruiting
Milton, Queensland, Australia, 4064
Redcliffe Hospital Not yet recruiting
Redcliffe, Queensland, Australia, 4020
Australia, Victoria
Barwon Health-The Geelong Hospital Recruiting
Geelong, Victoria, Australia, 3220
Australia, Western Australia
Western Diagnostic Pathology Recruiting
Joondalup, Western Australia, Australia, 6027
Joondalup Cardiovascular Trials Foundation Inc. (JCTF) Recruiting
Joondalup, Western Australia, Australia, 6027
HPS Pharmacies Recruiting
Joondalup, Western Australia, Australia, 6027
Australia
Holy Spirit Northside Private Hospital Limited Not yet recruiting
Chermside, Australia, 4032
Belgium
AZ Sint-Jan Brugge Not yet recruiting
Brugge, Belgium, 8000
University Hospital Brussels- Diabeteskliniek Not yet recruiting
Brussels, Belgium, 1090
University Hospital Brussels - Centrum voor hart- en vaatziekten Recruiting
Brussels, Belgium, 1090
ZOL Campus Sint-Jan Recruiting
Genk, Belgium, 3600
Centre Hospitalier Regional de Huy Recruiting
Huy, Belgium, 4500
University Hospitals Leuven - Neurology department Recruiting
Leuven, Belgium, 3000
ZNA Antwerpen [Jan Palfijn / Diabetologie] Not yet recruiting
Merksem, Belgium, 2170
Dr. Luc De Wolf - Private Practice Not yet recruiting
Tienen, Belgium, 3300
Algemeen Ziekenhuis Sint-Elisabeth Not yet recruiting
Zottegem, Belgium, 9620
Canada, British Columbia
SMH Cardiology Clinical Trials Inc. Not yet recruiting
Surrey, British Columbia, Canada, V3V 1N1
Surrey Memorial Hospital (SMH), Fraser Health Not yet recruiting
Surrey, British Columbia, Canada, V3V 1Z2
Dr. Stephen S. Cheung Inc. Not yet recruiting
Surrey, British Columbia, Canada, V3V 1N1
Canada, Ontario
LMC Diabetes & Endocrinology (Brampton) Recruiting
Brampton, Ontario, Canada, L6S 0C9
Vizel Cardiac Research - Saul Vizel Professional Medicine Corporation Not yet recruiting
Cambridge, Ontario, Canada, N1R 7R1
LMC Diabetes & Endocrinology (Markham) Not yet recruiting
Markham, Ontario, Canada, L6B 0P9
Newmarket Cardiology Research Group Not yet recruiting
Newmarket, Ontario, Canada, L3Y 8C3
LMC Diabetes & Endocrinology (Oakville) Recruiting
Oakville, Ontario, Canada, L6H 3P1
Sarnia Institute of Clinical Research Not yet recruiting
Sarnia, Ontario, Canada, N7T 4X3
London Road Diagnostic Clinic and Medical Centre Not yet recruiting
Sarnia, Ontario, Canada, N7T 4X3
LMC Diabetes & Endocrinology (Thornhill) Recruiting
Thornhill, Ontario, Canada, L4J 8L7
Thunder Bay Regional Research Institute Recruiting
Thunder Bay, Ontario, Canada, P7B 7C7
LMC Diabetes & Endocrinololgy (Bayview) Recruiting
Toronto, Ontario, Canada, M4G 3E8
Canada, Quebec
QT Research Chicoutimi Recruiting
Chicoutimi, Quebec, Canada, G7H 7Y8
Rhodin Recherche Clinique Not yet recruiting
Drummondville, Quebec, Canada, J7B 7T1
Centre de Recherche Clinique de Laval Not yet recruiting
Laval, Quebec, Canada, H7T 2P5
Centre Medical Acadie Not yet recruiting
Montreal, Quebec, Canada, H4N 2W2
Montreal Heart Institute Recruiting
Montreal, Quebec, Canada, H1T 1C8
C.I.C. Mauricie Inc. Not yet recruiting
Trois-Rivieres, Quebec, Canada, G8T 7A1
Canada
Clinique des maladies lipidiques de Quebec Inc Not yet recruiting
Quebec, Canada, G1V 4M6
Colombia
Centro Cientifico Asistencial Jose Luis Accini S.A.S Recruiting
Barranquilla, Atlantico, Colombia
Centro de Investigacion y Proyectos en Neurociencias CIPNA LTDA IPS. Recruiting
Barranquilla, Atlantico, Colombia
Centro de Diagnostico Cardiologico LTDA. Recruiting
Cartagena, Bolivar, Colombia
Centro Cardiovascular Aristides Sotomayor Santa Lucia Sociedad por Acciones Simplificadas IPS Recruiting
Cartagena, Bolivar, Colombia, 130010
Dexadiab Servicios Medicos LTDA. Recruiting
Bogota D.C., Cundinamarca, Colombia, 00000
Hospital Universitario San Ignacio Not yet recruiting
Bogota, Colombia
Czech Republic
Fakultni nemocnice Hradec Kralove Not yet recruiting
Hradec Kralove, Czech Republic, 500 05
Kardiologicka Ambulance - Plzen Not yet recruiting
Plzen, Czech Republic, 326 00
Kardiologie Plzen s.r.o. Not yet recruiting
Plzen, Czech Republic, 326 00
Nemocnice Na Frantisku Not yet recruiting
Praha 1, Czech Republic, 110 00
Fakultni Nemocnice Kralovske Vinohrady Not yet recruiting
Praha 10, Czech Republic, 100 34
Kardiologie a interni lekarstvi Recruiting
Praha 5, Czech Republic, 158 00
Lekarsky dum Ormiga Not yet recruiting
Zlin, Czech Republic, 760 01
Denmark
Gentofte Hospital Not yet recruiting
Hellerup, Denmark, 2900
Aarhus University Hospital Not yet recruiting
Skejby, Denmark, 8200
Finland
Helsinki University Central Hospital Recruiting
Helsinki, Finland, 00029
Sedes Oy - The Office of Jaakko Tuomilehto Recruiting
Helsinki, Finland, 00920
Helsinki University Central Hospital (HUCH) Recruiting
Helsinki, Finland, 00029
Studycor Oy Recruiting
Jyvaskyla, Finland, 40620
Laakarikeskus Aava Kerava/Aava Kerava Medical Center Recruiting
Kerava, Finland, 04200
Ite Lasaretti Recruiting
Kuopio, Finland, 70100
Oy Foodfiles Ltd Not yet recruiting
Kuopio, Finland, 70210
Oulu University Hospital Recruiting
Oulu, Finland, 90029
Terveystalo Oulu, Diapolis Recruiting
Oulu, Finland, 90100
FinnMedi Oy Recruiting
Tampere, Finland, 33520
Valkeakoski Hospital Not yet recruiting
Valkeakoski, Finland, 37600
Vantaa Research Center Recruiting
Vantaa, Finland, 01600
France
Hopital Guy Chatilliez Recruiting
Tourcoing, Nord Pas-De-Calais, France, 59200
Centre Hospitalier de Cannes Not yet recruiting
Cannes Cedex, France, 06414
Centre Hospitalier Sud-Francilien - Not yet recruiting
Corbeil-Essonnes, France, 91106
Polyclinique du Bois Not yet recruiting
Lille, France, 59000
Dr. Alain Boye MD, Office of Not yet recruiting
Nantesqq, France, 44200
Centre Hospitalier de PAU - Service de cardiologie Recruiting
Pau, France, 64046
CHU de Poitiers Not yet recruiting
Poitiers Cedex, France, 86021
Cabinet du Dr Taminau Denis Not yet recruiting
Rosiers d'Egletons, France, 19300
Centre Hospitalier (CH) de Valenciennes Recruiting
Valenciennes, France, 59300
Germany
Klinische Forschung Berlin-Buch GmbH Recruiting
Berlin, Germany, 13125
Institut fuer Klinische Forschung und Entwicklung(IKFE) Berlin GmbH Recruiting
Berlin, Germany, 10115
Synexus Clinical Research GmbH Recruiting
Berlin, Germany, 12627
Städtische Kliniken Bielefeld gem. GmbH Recruiting
Bielefeld, Germany, 33604
Kliniken Bielefeld - Abteilung für Klinische Forschung Recruiting
Bielefeld, Germany, 33604
Synexus Clinical Research GmbH, Bochum Research Centre Recruiting
Bochum, Germany, 44787
Cardiac Research GmbH Recruiting
Dortmund, Germany, 44227
Gesellschaft fur Wissens- und Technologietransfer der TU Dresden Not yet recruiting
Dresden, Germany, 01307
Synexus Clinical Research GmbH Recruiting
Frankfurt, Germany, 60596
Universitätsklinikum der Ernst-Moritz-Arndt-Universität Greifswald Not yet recruiting
Greifswald, Germany, 17475
Klinik und Poliklinik fur Innere Medizin B - Kardiologie, Angiologie, Pulmologie, Not yet recruiting
Greifswald, Germany, 17475
Klinische Forschung Hannover - Mitte GmbH Recruiting
Hannover, Germany, 30159
Universitatsklinikum Jena Recruiting
Jena, Germany, 07747
Synexus Clinical Research GmbH Not yet recruiting
Leipzig, Germany, 04103
Staedtisches Klinikum Muenchen GmbH Recruiting
Munich, Germany, 81737
Klinische Forschung Schwerin GmbH Recruiting
Schwerin, Germany, 19055
Hungary
DRC Kft. Recruiting
Balatonfured, Hungary, 8230
Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet Recruiting
Budapest, Hungary, 1097
Synexus Magyarorszag Ltd Not yet recruiting
Budapest, Hungary, 1036
Semmelweis Egyetem, II. Belgyogyaszati Klinika Not yet recruiting
Budapest, Hungary, 1088
Debreceni Egyetem, I. Sz. Belgyogyaszati Klinika Not yet recruiting
Debrecen, Hungary, 4032
Medifarma-98 Kft. Recruiting
Nyiregyhaza, Hungary, 4400
Zala Megyei Korhaz, Diabetologiai Szakrendeles Recruiting
Zalaegerszeg, Hungary, 8900
Zala Megyei Korhaz Recruiting
Zalaegerszeg, Hungary, 8900
Israel
Gefen - Cardiac Health Center Recruiting
Givatayim, Israel, 53583
Rambam Medical Center Recruiting
Haifa, Israel, 31096
Edith Wolfson Medical Center Not yet recruiting
Holon, Israel, 58100
Meier Medical Center Not yet recruiting
Kfar-Saba, Israel, 52111
Department of Neurology & Sagol Neuroscience Center Recruiting
Ramat Gan, Israel, 52621
The Bert W. Strassburger Lipid Center Recruiting
Tel Hashomer, Israel, 5262000
Italy
Centro Cardiologico Monzino Recruiting
Milano, MI, Italy, 20138
Dip. Medicina Interna e Specialita Mediche Policlinico Umberto I Recruiting
Roma, RM, Italy, 00161
Dipartimento di Medicina Clinica e delle Patologie Emergenti-University Hospital of Palermo Not yet recruiting
Palermo, Italy, 90127
Korea, Republic of
Seoul National University Bundang Hospital Not yet recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Daegu Catholic University Medical Center Not yet recruiting
Daegu, Korea, Republic of, 705-718
Konyang University Hospital Not yet recruiting
Daejeon, Korea, Republic of, 302-718
The Catholic University of Korea, Bucheon St. Mary's Hospital Not yet recruiting
Gyeonggi-do, Korea, Republic of, 420-717
Gangnam Severance Hospital, Yonsei University Health System Not yet recruiting
Seoul, Korea, Republic of, 135-720
Hallym University Kangdong Sacred Heart Hospital Not yet recruiting
Seoul, Korea, Republic of, 134-701
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Seoul Metropolitan Government - Seoul National University Boramae Medical Center Recruiting
Seoul, Korea, Republic of, 156-707
Mexico
Instituto de Diabetes Obesidad y Nutricion, S.C. Not yet recruiting
Cuernavaca, Morelos, Mexico, 62250
Hospital Inovamed Cuernavaca (Emergencies) Not yet recruiting
Cuernavaca, Morelos, Mexico, 62270
Hospital D' Maria (Emergencies) Not yet recruiting
Veracruz, Mexico, 91910
Centro Especializado En Diabetes Y Metabolismo Not yet recruiting
Veracruz, Mexico, 91910
Netherlands
Andromed Breda Recruiting
Breda, Netherlands, 4811 SW
Van Weel Bethesda Hospital Recruiting
Dirksland, Netherlands, 3247 BW
Albert Schweitzer Hospital Recruiting
Dordrecht, Netherlands, 3318 AT
Andromed Medical Research Center Recruiting
Rotterdam, Netherlands, 3021
Rotterdam Research Institute Recruiting
Rotterdam, Netherlands, 3039 BD
VieCuri Medisch Centrum Recruiting
Venlo, Netherlands, 5912 BL
Poland
CenterMed Lublin Sp. z.o.o. Not yet recruiting
Lublin, Iubelskie, Poland, 20-044
Niepubliczny Zaklad Opieki Zdrowotnej CEREO-MED Sp. z o.o. Not yet recruiting
Lodz, Lodzkie, Poland, 92-003
UJ CM - Szpital Uniwersytecki w Krakowie Not yet recruiting
Krakow, Malopolskie, Poland, 31-501
Szpital Specjalistyczny im. J. Dietla Not yet recruiting
Krakow, Malopolskie, Poland, 31-121
II Klinika Kardiologii iNstytutu Kardiologii Not yet recruiting
Warszawa, Mazowieckie, Poland, 00-415
Centrum Medyczne "SOPMED" Sp. z o.o. Not yet recruiting
Sopot, Pomorskie, Poland, 81-756
Indywidualna Specjalistyczna Praktyka Lekarska Malgorzata Biedrzycka Recruiting
Starogard Gdanski, Pomorskie, Poland, 83-200
Medica Pro Familia Sp. z o.o. S.K.A - Oddzial Katowice Not yet recruiting
Katowice, Slaskie, Poland, 40-954
Prywatny Gabinet Lekarski Marianna Janion Recruiting
Kielce, Swietokrzyskie, Poland, 25-315
Pomorskie Centra Kardiologiczne, Spolka z ograniczona odpowiedzialnoscia S.K.A. Not yet recruiting
Gdansk, Poland, 80-126
Marek Piepiorka Gabinet Kardiologiczno - lnternistyczny Not yet recruiting
Gdynia, Poland, 81-472
Synexus Polska Sp z o.o. Not yet recruiting
Gdynia, Poland, 81-384
Medica Pro Familia Sp. z o.o. Spolka Komandytowo Akcyjna, Oddzial w Gdyni Recruiting
Gdynia, Poland, 81-338
Synexus Polska sp z o.o Not yet recruiting
Katowice, Poland, 40-040
NZOZ Terapia Optima Recruiting
Katowice, Poland, 40-752
University Hospital Pharmacy Not yet recruiting
Krakow, Poland, 31-501
"LANDA"Specjalistyczne Gabinety Lekarskie Recruiting
Krakow, Poland, 30-015
Medicus w Opolu Sp z o. o. Recruiting
Opole, Poland, 45-706
Specjalistyczny Osrodek Leczniczo-Badawczy Zbigniew Zegota Not yet recruiting
Ostroda, Poland, 14-100
Prywatny Gabinet Lekarski Dr n. med. Michal Ogorek Not yet recruiting
Piotrkow Trybunalski, Poland, 97-300
Niepubliczny Zaklad Opieki Zdrowotnej SOLUMED Not yet recruiting
Poznan, Poland, 60-539
Synexus Polska sp z o.o Not yet recruiting
Poznan, Poland, 60-702
NZOZ Przychodnia Specjalistyczna Andrzej wittek Henryk Rudzki S.C. Not yet recruiting
Ruda Slaska, Poland, 41-709
CLINMEDICA OMC spolka z ograniczona odpowiedzialnoscia spolka komandytowa Not yet recruiting
Skierniewice, Poland, 96-100
Synexus Polska Sp. z o.o. Oddzial w Warszawie Not yet recruiting
Warsaw, Poland, 01-192
Centrum Medyczne AMED Not yet recruiting
Warszawa, Poland, 01-518
Instytut Kardiologii im. Prymasa Tysiaclecia Stefana Kardynala Not yet recruiting
Warszawa, Poland, 04-628
Medica Pro Familia Sp. z o.o. S.K.A. Not yet recruiting
Warszawa, Poland, 01-868
Synexus Polska Sp. z o. o. Oddzial we Wroclawiu Not yet recruiting
Wroclaw, Poland, 50-088
Wojewodzki Szpital Specjalistyczny we Wroclawiu, Osrodek Badawczo-Rozwojowy, Not yet recruiting
Wroclaw, Poland, 51-124
Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II w Zamosciu Not yet recruiting
Zamosc, Poland, 22-400
Puerto Rico
Centro de Diabetes para Puerto Rico Recruiting
San Juan, Puerto Rico, 00935
Miguel Sosa-Padilla, MD-Private Practice Not yet recruiting
San Juan, Puerto Rico, 00926-2832
Romania
Spitalul Clinic Judetean de Urgenta Cluj-Napoca, Diabet Zaharat, Nutritie si Boli Metabolice Not yet recruiting
Cluj-Napoca, jud. Cluj, Romania, 400006
Centrul Medical Dr. Negrisanu SRL, Diabet Zaharat Nutritie si Boli Metabolice Recruiting
Timisoara, judet Timis, Romania, 300456
Mediab SRL, Diabet Zaharat Nutritie si Boli Metabolice Not yet recruiting
Targu Mures, Romania, 540142
Mediab SRL, Diabet Zaharat Nutritie si Boli Metabolice Not yet recruiting
Tg. Mures, Romania, 540142
Centrul Medical Sf. Stefan SRL, Diabet Nutritie si Boli Metabolice Not yet recruiting
Timisoara, Romania, 300125
Russian Federation
Medius and K LLC Not yet recruiting
Vsevolzhsk, Leningradskaya Region, Russian Federation, 188640
State Budget Scientific Institution of Tyumen Not yet recruiting
Tyumen, Tyumenskaya Obl., Russian Federation, 625023
Northern Medical Clinical Centre named after N.A.Semashko Not yet recruiting
Arkhangelsk, Russian Federation, 163000
Solombala Polyclinic - Outpatient department of Northern medical Not yet recruiting
Arkhangelsk, Russian Federation, 163000
State budget Health Care Institution Novosibirsk region Not yet recruiting
Novosibirsk, Russian Federation, 630008
Limited Liability Company "Institute of Medical research" Not yet recruiting
Saint Petersburg, Russian Federation, 196084
GBUZ "City Hospital #26" Not yet recruiting
Saint-Petersburg, Russian Federation, 196247
Clinical Hospital of St. George the martyr Not yet recruiting
St Petersburg, Russian Federation, 194354
Slovakia
Alian s.r.o., kardiologicka ambulancia Recruiting
Bardejov, Slovakia, 08501
Kardiovaskularne Centrum S.R.O. Recruiting
Bratislava, Slovakia, 83101
Metabolicke Centrum MUDr. Katariny Raslovej, S.R.O. Recruiting
Bratislava, Slovakia, 83101
JM-Interna s.r.o., interna ambulancia Recruiting
Dolny Kubin, Slovakia, 02601
CARDIO D&R spol. s r.o., Kardiologicka ambulancia Not yet recruiting
Kosice, Slovakia, 04022
Kardiocentrum Nitra, s.r.o. Not yet recruiting
Nitra, Slovakia, 949 01
Fakultna nemocnica s poliklinikou Nove Zamky, I. interna klinika Recruiting
Nove Zamky, Slovakia, 940 34
Internal Clinic, Faculty Hospital Nove Zamky Recruiting
Nove Zamky, Slovakia, 940 34
Medivasa S.R.O., Diabetologicka Ambulancia Recruiting
Zilina, Slovakia, 01001
South Africa
Medipark Centre for Clinical Research Not yet recruiting
Rooihuiskraal, Gauteng, South Africa, 0158
Helderberg Clinical Trials Centre Not yet recruiting
Somerset West, Western Cape, South Africa, 7130
Global Clinical Trials (Pty) Ltd. Not yet recruiting
Arcadia, Pretoria, South Africa, 0001
IATROS International Recruiting
Bloemfontein, South Africa, 9301
Unitas Hospital Not yet recruiting
Centurion, South Africa, 0157
Centre for Diabetes and Endocrinology Not yet recruiting
Houghton, South Africa, 2198
Nash Ranjith Research Centre Not yet recruiting
Merebank, Durban, South Africa, 4052
Synexus SA Watermeyer Clinical Research Centre Not yet recruiting
Meyerspark, South Africa, 0184
Midrand Medical Centre Not yet recruiting
Midrand, South Africa, 1685
Paarl Research Centre Recruiting
Paarl, South Africa, 7646
TREAD Research cc Recruiting
Parow, South Africa, 7500
I Engelbrecht Research Not yet recruiting
Pretoria, South Africa, 0157
Helderberg Research Institute Not yet recruiting
Somerset West, South Africa, 7130
Roodepoort Medicross Clinical Research Centre Not yet recruiting
Synexus, South Africa
Drs Joynt Venter & Associates Not yet recruiting
Witbank (eMalahleni), South Africa, 1035
Clinical Projects Research SA (Pty) Ltd Recruiting
Worcester, South Africa, 6850
Spain
Hospital Regional Universitario de Malaga Not yet recruiting
Malaga, Andalucia, Spain, 29010
Hospital Universitario San Juan de Alicante Not yet recruiting
Alicante, Comunidad Valenciana, Spain, 03550
Hospital Clinico Universitario San Cecilio de Granada Recruiting
Granada, Granada (Andalucía), Spain, 18012
Clinica Juaneda Not yet recruiting
Palma de Mallorca, Islas Baleares, Spain, 07014
Hospital Universitario Virgen De La Victoria Not yet recruiting
Málaga, Malaga, Spain, 29010
Hospital General De Requena Recruiting
Requena, Valencia, Spain, 46340
Gerencia de Gestion integrada de A Coruna Recruiting
A Coruna, Spain, 15006
Hospital General Universitario de Albacete Not yet recruiting
Albacete, Spain, 02006
Hospital Virgen del Mar Not yet recruiting
Almeria, Spain
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Park de Salut Mar - Hospital del Mar Recruiting
Barcelona, Spain, 08003
Parc de Salut Mar-Hospital del Mar Recruiting
Barcelona, Spain, 08003
EAP Sardenya Recruiting
Barcelona, Spain, 08025
Hospital Universitario Reina Sofia Recruiting
Cordoba, Spain, 14004
Hospital Universitario San Cecilio Recruiting
Granada, Spain, 18012
Hospital Universitario Virgen De Las Nieves Not yet recruiting
Granada, Spain, 18014
Hospital Gral. Univ. Gregorio Maranon Not yet recruiting
Madrid, Spain, 28007
Hospital Universitario Ramon y Cajal Recruiting
Madrid, Spain, 28034
Hospital Universitario Ramon y Cajal Not yet recruiting
Madrid, Spain, 28034
Hospital Universitario Puerta de Hierro Not yet recruiting
Madrid, Spain, 28035
Hospital Universitario Virgen del Rocio Recruiting
Sevilla, Spain, 41013
Hospital Universitario Virgen Macarena Recruiting
Sevilla, Spain, 41009
Consorcio Hospital General Universitario De Valencia Not yet recruiting
Valencia, Spain, 46014
Taiwan
E-DA Hospital Not yet recruiting
Kaohsiung City, Taiwan, 82445
Cardinal Tien Hospital Not yet recruiting
New Taipei City, Taiwan, 23148
Department of Pharmacy, China Medical University Hospital Not yet recruiting
Taichung, Taiwan, 40447
China Medical University Hospital Not yet recruiting
Taichung, Taiwan, 406
Clinical Trials Center, China Medical University Hospital Not yet recruiting
Taichung, Taiwan, 40447
Clinical Trial Pharmacy, China Medical University Hospital Not yet recruiting
Taichung, Taiwan, 40447
National Cheng-Kung University Hospital Recruiting
Tainan, Taiwan, 704
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 112
MacKay Memorial Hospital Recruiting
Taipei, Taiwan, 10449
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
United Kingdom
Synexus Thames Valley Clinical Research Centre Not yet recruiting
Reading, Berkshire, United Kingdom, RG2 0TG
Peterborough and Stamford Hospitals NHS Foundation Trust Recruiting
Peterborough, Cambridgeshire, United Kingdom, PE3 9GZ
Queens Hospital Recruiting
Romford, Essex, United Kingdom, RM7 0AG
Royal Oldham Hospital Recruiting
Oldham, Greater Manchester, United Kingdom, OL1 2JH
Lister Hospital Not yet recruiting
Stevenage, Hertfordshire, United Kingdom, SG1 4AB
Queen Elizabeth II Hospital, Howlands Recruiting
Welwyn Garden City, Hertfordshire, United Kingdom, AL7 4HQ
Layton Medical Centre Recruiting
Blackpool, Lancashire, United Kingdom, FY3 7EN
Synexus Lancashire Not yet recruiting
Chorley, Lancashire, United Kingdom, PR7 7NA
Synexus Merseyside Recruiting
Waterloo, Liverpool, United Kingdom, L22 0LG
University of Birmingham - City Hospital - Centre for Cardiovascular Sciences Not yet recruiting
Birmingham, West Midlands, United Kingdom, B18 7QH
Little Common Surgery Recruiting
East Sussex, United Kingdom, TN39 4SP
Synexus Midlands Clinical Research Centre Not yet recruiting
Edgbaston - Birmingham, United Kingdom, B15 2SQ
Glasgow Clinical Research Facility Recruiting
Glasgow, United Kingdom, G11 6NT
Western Infirmary (Pharmacy) Recruiting
Glasgow, United Kingdom, G11 6NT
BHF Glasgow Cardiovascular Research Centre Recruiting
Glasgow, United Kingdom, G12 8TA
Medway Maritime Hospital - Medway NHS Foundation Trust Not yet recruiting
Kent, United Kingdom, ME7 5NY
St Bartholomew's Hospital - Barts Health NHS Trust Recruiting
London, United Kingdom, EC1A 7BE
Barts Health NHS Trust Recruiting
London, United Kingdom, EC1M 6BQ
Manchester Royal Infirmary - Central Manchester University Hospitals NHS Foundation Trust Not yet recruiting
Manchester, United Kingdom, M13 9WL
Synexus Manchester, Clinical Research Centre Not yet recruiting
Manchester Science Park, United Kingdom, M15 6SX
The Avenue Surgery Recruiting
Wiltshire, United Kingdom, BA12 9AA
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01975389     History of Changes
Other Study ID Numbers: B1481038, CV OUTCOMES 2, 2013-002795-41
Study First Received: October 21, 2013
Last Updated: October 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
myocardial infarction
stroke
hyperlipidemia

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014