Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events (SPIRE-LDL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01968967
First received: October 21, 2013
Last updated: March 25, 2015
Last verified: March 2015
  Purpose

This study is a multicenter, randomized study in subjects with high cholesterol receiving highly effective statins to assess the efficacy, safety and tolerability of Bococizumab (PF-04950615;RN316) to lower LDL-C.


Condition Intervention Phase
Hyperlipidemia
Drug: Bococizumab (PF-04950615; RN316)
Other: 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: Treatment
Official Title: A Phase 3 Double-blind, Randomized, Placebo-controlled, Parallel-group Study To Assess The Efficacy, Long-term Safety And Tolerability Of PF-04950615 In Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percent Change from Baseline in LDL-C at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Low Density Lipoprotein Cholesterol (LDL-C)


Secondary Outcome Measures:
  • Change from Baseline in Lipid Parameters at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Percent change in Total Cholesterol (TC), Apolipoprotein B (Apo B), non-HDL-C, LDL-C by TG level (< or >+ 200 mg/dL), Lipoprotein (a) (Lp(a), High Density Lipoprotein (HDL), Triglycerides, Very Low Density Lipoprotein (VLDL), ApoA-I, and ApoA-II blood concentrations.

  • Change from Baseline in Lipid Parameters at Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Low Density Lipoprotein (LDL), Mean Total Cholesterol (TC), High Density Lipoprotein (HDL), Triglycerides, Very Low Density Lipoprotein (VLDL), ApoA-I, and ApoA-II blood concentrations.

  • Change from Baseline in Lipid Parameters at Week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Low Density Lipoprotein (LDL), Mean Total Cholesterol (TC), High Density Lipoprotein (HDL), Triglycerides, Very Low Density Lipoprotein (VLDL), ApoA-I, and ApoA-II blood concentrations.

  • Proportion of Subjects Achieving Fasting LDL-C <= 100 mg/dL and <=70 mg/dL [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Proportion of Subjects Achieving Fasting LDL-C <= 100 mg/dL and <=70 mg/dL

  • Proportion of Subjects Achieving Fasting LDL-C <= 100 mg/dL and <=70 mg/dL [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Proportion of Subjects Achieving Fasting LDL-C <= 100 mg/dL and <=70 mg/dL

  • Proportion of Subjects Achieving Fasting LDL-C <= 100 mg/dL and <=70 mg/dL [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Proportion of Subjects Achieving Fasting LDL-C <= 100 mg/dL and <=70 mg/dL

  • Plasma PF-04950615 concentration [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Plasma PF-04950615 concentration

  • Plasma PF-04950615 concentration [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Plasma PF-04950615 concentration

  • Plasma PF-04950615 concentration [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Plasma PF-04950615 concentration


Estimated Enrollment: 1932
Study Start Date: October 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bococizumab (PF-04950615; RN316) Drug: Bococizumab (PF-04950615; RN316)
150 mg every 2 weeks, subcutaneous injection, 12 months
Other Name: Bococizumab (PF-04950615; RN316)
Placebo Comparator: Placebo Other: Placebo
subcutaneous injection every 2 weeks for 12 months

  Eligibility

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

Inclusion Criteria:

  • Treated with a statin.
  • Fasting LDL-C > 70 mg/dL and triglyceride <=400 mg/dL.
  • High or very high risk of incurring a cardiovascular event.

Exclusion Criteria:

  • Pregnant or breastfeeding females.
  • Cardiovascular or cerebrovascular event of procedures during the past 30 days.
  • Congestive heart failure NYHA class IV.
  • Poorly controlled hypertension.
  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: NCT01968967

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

  Hide Study Locations
Locations
United States, Alabama
Office of Ernest L. Hendrix, MD, PC Recruiting
Athens, Alabama, United States, 35611
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Alabama Internal Medicine, P.C. Recruiting
Birmingham, Alabama, United States, 35235
Heart Center Research, Llc Not yet recruiting
Huntsville, Alabama, United States, 35801
United States, Arizona
Radiant Research Incorporated Recruiting
Chandler, Arizona, United States, 85224
Advanced Research Associates Recruiting
Glendale, Arizona, United States, 85308
Arizona Center For Internal Medicine Recruiting
Mesa, Arizona, United States, 85205
Holland Center for Family Health Recruiting
Peoria, Arizona, United States, 85381
Elite Clinical Studies, LLC Recruiting
Phoenix, Arizona, United States, 85018
Phoenix Clinical Recruiting
Phoenix, Arizona, United States, 85021
Clinical Research Advantage, Inc./Colorado Springs Health Partners, SW (Administrative Mailing Only) Recruiting
Tempe, Arizona, United States, 85282
Advanced Arizona Clinical Research Active, not recruiting
Tucson, Arizona, United States, 85712
Cornerstone Health and Family Practice Recruiting
Tucson, Arizona, United States, 85705
Desert Sun Clinical Research, LLC Recruiting
Tucson, Arizona, United States, 85710
Nelson A. Sandoval, M.D. Recruiting
Tucson, Arizona, United States, 85710-2193
United States, California
Care Clinical Research Corporation Recruiting
Banning, California, United States, 92220
Med Center Not yet recruiting
Carmichael, California, United States, 95608
Med Investigations (Administrative Only) Not yet recruiting
Fair Oaks, California, United States, 95628
Family Care Providers Medical Group Not yet recruiting
Fresno, California, United States, 93703
California Heart Specialists Recruiting
Huntington Beach, California, United States, 92648
Alia Clinical Research Inc. Recruiting
Huntington Park, California, United States, 90255
Anthony Mills, MD, Inc. Not yet recruiting
Los Angeles, California, United States, 90069
Downtown L.A. Research Center, Inc. Recruiting
Los Angeles, California, United States, 90017
Richard S. Cherlin, M.D. Recruiting
Los Gatos, California, United States, 95032
California Medical Research Associates Inc. Recruiting
Northridge, California, United States, 91324
Arch Health Partners Clinical Research Department Recruiting
Poway, California, United States, 92064
Clinical Trials Research Recruiting
Sacramento, California, United States, 95821
Northern California Research Recruiting
Sacramento, California, United States, 95821
Alta California Medical Group Recruiting
Simi Valley, California, United States, 93065
Orange County Research Center Recruiting
Tustin, California, United States, 92780
Empire Clinical Research Recruiting
Upland, California, United States, 91786
Diablo Clinical Research, Inc. Recruiting
Walnut Creek, California, United States, 94598
Infosphere Clinical Research, Inc. Recruiting
West Hills, California, United States, 91307
United States, Colorado
Clinicos, LLC Recruiting
Colorado Springs, Colorado, United States, 80904
Colorado Springs Health Partners- Southwest/Clinical Research Advantage Recruiting
Colorado Springs, Colorado, United States, 80906
United States, Connecticut
YNHH, Heart and Vascular Recruiting
Guilford, Connecticut, United States, 06437
United States, Florida
ACRC-Cardiology Recruiting
Atlantis, Florida, United States, 33462
Avail Clinical Research, LLC Recruiting
DeLand, Florida, United States, 32720
Fleming Island Center for Clinical Research Recruiting
Fleming Island, Florida, United States, 32081
Invesclinic, LLC Recruiting
Fort Lauderdale, Florida, United States, 33308
Florida Research Network, LLC Recruiting
Gainesville, Florida, United States, 32605
The Research Center, Inc. Recruiting
Hialeah, Florida, United States, 33013
AGA Clinical Trials Active, not recruiting
Hialeah, Florida, United States, 33012
Homestead Medical Research Inc. Recruiting
Homestead, Florida, United States, 33030
Nature Coast Clinical Research Recruiting
Inverness, Florida, United States, 34452
Westside Center for Clinical Research Recruiting
Jacksonville, Florida, United States, 32205
East Coast Institue for Research, LLC Recruiting
Jacksonville, Florida, United States, 32216
East Coast Institute for Research, LLC at Baker-Gilmour Cardiovascular Institute, PA Recruiting
Jacksonville, Florida, United States, 32216
St. Vincent's Cardiology Not yet recruiting
Jacksonville, Florida, United States, 32216
Clinical Research of Miami Recruiting
Miami, Florida, United States, 33126
Finlay Medical Research Recruiting
Miami, Florida, United States, 33126
International Research Associates, LLC Recruiting
Miami, Florida, United States, 33183
Kendall South Medical Center Recruiting
Miami, Florida, United States, 33185
San Marcus Research Clinic Recruiting
Miami, Florida, United States, 33015
Medical Research Center Recruiting
Miami, Florida, United States, 33144
Invesclinic, LLC d/b/a Southeast Medical Centre Recruiting
Oakland Park, Florida, United States, 33309
Florida Institute For Clinical Research, LLC Recruiting
Orlando, Florida, United States, 32825
Compass Research East, LLC Recruiting
Oviedo, Florida, United States, 32765
A&R Research Group, LLC Recruiting
Pembroke Pines, Florida, United States, 33024
DBC Research Recruiting
Pembroke Pines, Florida, United States, 33029
The Heart & Vascular Institute of Florida Not yet recruiting
Safety Harbor, Florida, United States, 34695
South Miami Clinical Research Center, LLC Recruiting
South Miami, Florida, United States, 33143
Interventional Cardiac Consultants Not yet recruiting
Trinity, Florida, United States, 34655
Dolphin Medical Research Recruiting
Virginia Gardens, Florida, United States, 33166
Metabolic Research Institute Incorporated Recruiting
West Palm Beach, Florida, United States, 33401
Clinical Research of Central Flordia Recruiting
Winter Haven, Florida, United States, 33880
United States, Georgia
Atlanta Diabetes Associates Recruiting
Atlanta, Georgia, United States, 30318
Atlanta Center for Clinical Research / Internal Medicine Recruiting
Roswell, Georgia, United States, 30075
North Georgia Clinical Research Recruiting
Woodstock, Georgia, United States, 30189
North Georgia Internal Medicine Recruiting
Woodstock, Georgia, United States, 30189
United States, Hawaii
East-West Medical Research Institute Recruiting
Honolulu, Hawaii, United States, 96814
United States, Idaho
Northwest Clinical Trials, Inc. Recruiting
Boise, Idaho, United States, 83704
Elias Research Associates LLC Recruiting
Idaho Falls, Idaho, United States, 83402
Solaris Clinical Research Recruiting
Meridian, Idaho, United States, 83646
United States, Illinois
Consultants In Cardiovascular Medicine Not yet recruiting
Melrose Park, Illinois, United States, 60160
United States, Indiana
Investigators Research Group, LLC Recruiting
Brownsburg, Indiana, United States, 46112
American Health Network Recruiting
Indianapolis, Indiana, United States, 46254
Midwest Institute for Clinical Research Recruiting
Indianapolis, Indiana, United States, 46260
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
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Midwest Heart and Vascular Specialists Recruiting
Overland Park, Kansas, United States, 66215
United States, Kentucky
Kentucky Medical Research Not yet recruiting
Lexington, Kentucky, United States, 40504
United States, Louisiana
Omega Clinical Research Recruiting
Metairie, Louisiana, United States, 70006
New Orleans Center for Clinical Research Recruiting
New Orleans, Louisiana, United States, 70119
United States, Maine
Southern Maine Health Care Recruiting
Biddeford, Maine, United States, 04005
United States, Maryland
Columbia Medical Practice Recruiting
Columbia, Maryland, United States, 21045
MD Medical Research Recruiting
Oxon Hill, Maryland, United States, 20745
United States, Michigan
Quest Research Institute Recruiting
Bingham Farms, Michigan, United States, 48025
IHA Chelsea Family & Internal Medicine Recruiting
Chelsea, Michigan, United States, 48118
Westside Family Medical Center, Pc Recruiting
Kalamazoo, Michigan, United States, 49009
Michigan Heart and Vascular Specialists Recruiting
Petoskey, Michigan, United States, 49770
Oakland Medical Research Center Recruiting
Troy, Michigan, United States, 48085
United States, Minnesota
Radiant Research, Inc. Recruiting
Edina, Minnesota, United States, 55435
HealthEast Medical Research Institute Not yet recruiting
St. Paul, Minnesota, United States, 55102
HealthEast St. Joseph's Hospital Pharmacy Not yet recruiting
St. Paul, Minnesota, United States, 55102
United States, Missouri
KCUMB Center for Community and Clinical Research Active, not recruiting
Kansas City, Missouri, United States, 64106
St. Louis Heart and Vascular, P.C. Not yet recruiting
St. Louis, Missouri, United States, 63136
Mercy Health Research Recruiting
Washington, Missouri, United States, 63090
United States, Nevada
Clinical Research of South Nevada Recruiting
Las Vegas, Nevada, United States, 89121
Om Medical Recruiting
Las Vegas, Nevada, United States, 89119
United States, New Jersey
Central Jersey Medical Research Center Not yet recruiting
Elizabeth, New Jersey, United States, 07202
"The Cardiovascular Institute" Rutgers University- Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08901
Cardio Metabolic Institute Not yet recruiting
Somerset, New Jersey, United States, 08873
Premier Research Recruiting
Trenton, New Jersey, United States, 08611
United States, New York
The Endocrine Group, Llp Recruiting
Albany, New York, United States, 12206
Drug Trials Brooklyn Recruiting
Brooklyn, New York, United States, 12230
Drug Trials America Recruiting
Hartsdale, New York, United States, 10530
SJH Cardiology Associates Recruiting
Liverpool, New York, United States, 13088
Mid Hudson Medical Research Recruiting
New Windsor, New York, United States, 12553
Syracuse Preventive Cardiology Recruiting
Syracuse, New York, United States, 13202
United States, North Carolina
Sensenbrenner Primary Care Recruiting
Charlotte, North Carolina, United States, 28277
PharmQuest Recruiting
Greensboro, North Carolina, United States, 27408
Crossroads Clinical Research, Inc. Recruiting
Mooresville, North Carolina, United States, 28117
PMG Research of Salisbury, LLC Recruiting
Salisbury, North Carolina, United States, 28144
PMG Research of Wilmington, LLC Recruiting
Wilmington, North Carolina, United States, 28401
PMG Research of Winston-Salem Recruiting
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Radiant Research, Inc Recruiting
Akron, Ohio, United States, 44311
Community Health Care, Inc. Recruiting
Canal Fulton, Ohio, United States, 44614
Sentral Clinical Research Services Recruiting
Cincinnati, Ohio, United States, 45236
Metabolic and Atherosclerosis Research Center Recruiting
Cincinnati, Ohio, United States, 45227
Sentral Clinical Research Services - Admin Only Recruiting
Cincinnati, Ohio, United States, 45236
Sterling Research Group, Ltd. Recruiting
Cincinnati, Ohio, United States, 45246
Sterling Research Group, Ltd. Recruiting
Cincinnati, Ohio, United States, 45219
The Lindner Center for Research and Education at The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Medpace Clinical Pharmacology Unit Recruiting
Cincinnati, Ohio, United States, 45212
United States, Oklahoma
LION Research Recruiting
Norman, Oklahoma, United States, 73069
United States, Oregon
Clinical Research Institute of Southern Oregon, PC Recruiting
Medford, Oregon, United States, 97504
United States, Pennsylvania
Suburban Research Associates Recruiting
Darby, Pennsylvania, United States, 19023
Brandywine Clinical Research Recruiting
Downingtown, Pennsylvania, United States, 19335
Altoona Center for Clinical Research Recruiting
Duncansville, Pennsylvania, United States, 16635
Liberty Family Practice Recruiting
Erie, Pennsylvania, United States, 16508
Detweiler Family Medicine and Associates, PC Recruiting
Lansdale, Pennsylvania, United States, 19446
Allegheny Endocrinology Associates Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Guthrie Medical Group, PC Recruiting
Sayre, Pennsylvania, United States, 18840
Warminster Medical Associates, P.C. Recruiting
Warminster, Pennsylvania, United States, 18974
United States, South Carolina
Coastal Cardiology Recruiting
Charleston, South Carolina, United States, 29407
Upstate Pharmaceutical Research Recruiting
Greenville, South Carolina, United States, 29615
Palmetto Primary Care Physicians Recruiting
North Charleston, South Carolina, United States, 29406
Palmetto Clinical Research Recruiting
Summerville, South Carolina, United States, 29485
Palmetto Primary Care Physicians Recruiting
Summerville, South Carolina, United States, 29485
United States, Tennessee
Cardiovascular Research of Knoxville Recruiting
Knoxville, Tennessee, United States, 37917
Volunteer Research Group Recruiting
Knoxville, Tennessee, United States, 37920
New Orleans Center for Clinical Research Recruiting
Knoxville, Tennessee, United States, 37920
United States, Texas
KRK medical Research Recruiting
Dallas, Texas, United States, 75230
North Texas Healthcare System, Dallas VAMC Not yet recruiting
Dallas, Texas, United States, 75216
Research Institute of Dallas Recruiting
Dallas, Texas, United States, 75231
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
ICTR/Baylor Shipment Address for Regulatory TO: ICTR/Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Investigational Product Shipment Address TO: Investigational Drug Services (IDS) Recruiting
Houston, Texas, United States, 77030
Northwest Houston Cardiology Recruiting
Houston, Texas, United States, 77070
Pioneer Research Solutions, Inc. Recruiting
Houston, Texas, United States, 77099
Texas Center for Drug Development, Inc. Recruiting
Houston, Texas, United States, 77081
R/D Clinical Research, Inc. Recruiting
Lake Jackson, Texas, United States, 77566
Hill Country Medical Associates Recruiting
New Braunfels, Texas, United States, 78130
Advanced Clinical Research Associates Not yet recruiting
Plano, Texas, United States, 75093
Bandera Family Health Care, LLC Recruiting
San Antonio, Texas, United States, 78249
Sun Research Institute Recruiting
San Antonio, Texas, United States, 78215
Pioneer Research Solutions, Inc. Recruiting
Sugar Land, Texas, United States, 77479
Northwest Houston Center Recruiting
Tomball, Texas, United States, 77375
United States, Utah
Radiant Research Recruiting
Murray, Utah, United States, 84123
United States, Virginia
Manassas Clinical Research Center Recruiting
Manassas, Virginia, United States, 20110
National Clinical Research - Richmond, Inc. Recruiting
Richmond, Virginia, United States, 23294
Amherst Family Practice, P.C. Recruiting
Winchester, Virginia, United States, 22601
Selma Medical Associates Not yet recruiting
Winchester, Virginia, United States, 22601
United States, Washington
Rainier Clinical Research Center Recruiting
Renton, Washington, United States, 98057
Zain Research LLC Active, not recruiting
Richland, Washington, United States, 99352
Canada, British Columbia
Discovery Clinical Services Ltd. Recruiting
Victoria, British Columbia, Canada, V8T 5G4
Canada, Ontario
Vizel Cardiac Research, Saul Vizel Professional Medicine Corporation Recruiting
Cambridge, Ontario, Canada, N1R 7R1
The Office of Dr. Allen Greenspoon Recruiting
Hamilton, Ontario, Canada, L8L 5G8
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5A5
Stroke Prevention & Atherosclerosis Research Centre (SPARC) Recruiting
London, Ontario, Canada, N6G 2V2
Newmarket Cardiology Research Group Recruiting
Newmarket, Ontario, Canada, L3Y 8C3
London Road Diagnostic Clinic and Medical Centre Recruiting
Sarnia, Ontario, Canada, N7T 4X3
St. Michael's Hospital Health Centre Not yet recruiting
Toronto, Ontario, Canada, M5C 2T2
Canada, Quebec
Rhodin Recherche Clinique Recruiting
Drummondville, Quebec, Canada, J2B 7T1
Omnispec Clinical Research, Inc. Not yet recruiting
Mirabel, Quebec, Canada, J7J 2K8
Montreal Heart Institute Recruiting
Montreal, Quebec, Canada, H1T 1C8
DIEX Research Sherbrooke Inc. Recruiting
Sherbrooke, Quebec, Canada, J1H 1Z1
Pro-Recherche Recruiting
St-Romuald, Quebec, Canada, G6W 5M6
Colombia
Centro de Medicina del Ejercicio y Rehabilitación Cardiaca S.A., CEMDE S.A. Recruiting
Medellin, Antioquia, Colombia
Rodrigo Botero S.A.S Recruiting
Medellin, Antioquia, Colombia
Biomelab Limitada Recruiting
Barranquila, Atlantico, Colombia
Fundacion del Caribe para la Investigacion Biomedica - Fundacion BIOS Recruiting
Barranquilla, Atlantico, Colombia
IPS Centro Cientifico Asistencial Jose Luis Accini S.A.S. Recruiting
Barranquilla, Atlantico, Colombia
Centro De Diagnostico Cardiologico Recruiting
Cartagena, Bolivar, Colombia
Asociacion IPS Medicos Internistas de Caldas Recruiting
Manizales, Caldas, Colombia
Dexa Diab Servicios Medicos Ltda. IPS Recruiting
Bogota, Cundinamarca, Colombia
Fundacion Cardiomet- CEQUIN Recruiting
Armenia, Quindio, Colombia
Fundacion Cardiovascular de Colombia Recruiting
Floridablanca, Santander, Colombia
Fundacion Centro de Investigaciones Biomedicas RIESCARD Recruiting
Espinal, Tolima, Colombia
Instituto de Investigacion Endocrinologia y Prevencion Metabolica ENDOCARE LTDA Recruiting
Bogota D.C., Colombia
Centro de Investigaciones Clinicas Recruiting
Cali, Colombia
France
Nouvelles Cliniques Nantaises Recruiting
Nantes, France, 44200
CHU La Miletrie Recruiting
Poitiers, France, 86021
CHU de Toulouse - Hopital Rangueil Recruiting
Toulouse cedex 09, France, 31059
Hopital Guy Chatiliez - Service de cardiologie Recruiting
Tourcoing, France, 59200
Hungary
Magyar Imre Korhaz, Belgyogyaszati Szakrendeles Recruiting
Ajka, Hungary, 8400
Bajai Szent Rokus Korhaz Recruiting
Baja, Hungary, 6500
Lausmed Kft. Recruiting
Baja, Hungary, H 6500
Drug Research Centre Ltd Recruiting
Balatonfured, Hungary, 8230
Synexus Magyarorszag Kft. - Synexus Hungary Clinical Research Centre Recruiting
Budapest, Hungary, 1036
Pharma 4 Trial Kft. Recruiting
Gyongyos, Hungary, 3200
Borsod-Abauj-Zemplen -i Korhaz es Egyetemi Oktatokorhaz Recruiting
Miskolc, Hungary, 3526
TaNaMed Kft. Recruiting
Mosonmagyarovar, Hungary, 9200
PTE. II. Dept. of Internal Med. and Nephrology Center Recruiting
Pecs, Hungary, 7624
Zala Megyei Korhaz Recruiting
Zalaegerszeg, Hungary, 8900
Lithuania
PI Kaunas Silainiai Outpatient Clinic Recruiting
Kaunas, Lithuania, LT-48259
Private Clinic Elite Medicale Recruiting
Kaunas, Lithuania, LT-50184
PI Klaipeda Seaman Hospital Recruiting
Klaipeda, Lithuania, LT-92288
Vilnus University Hospital Santariskiu Klinikos Recruiting
Vilnius, Lithuania, LT-08661
Mexico
Clinicos Asociados BOCM, S.C. Recruiting
Mexico, Distrito Federal, Mexico, 03300
Hospital General de Naucalpan "Dr. Maximiliano Ruiz Castaneda" (Emergencies) Recruiting
Naucalpan, Estado de Mexico, Mexico, 35510
Instituto Jalisciense de Investigacion en Diabetes y Obesidad, S.C. Recruiting
Guadalajara, Jalisco, Mexico, 44600
Hospital Bernardette, S.A. DE C.V. (Emergencies) Recruiting
Guadalajara, Jalisco, Mexico, 44200
Administradora de Clinicas S.A. de C.V. Hospital Inovamed Cuernavaca (Emergencies) Recruiting
Cuernavaca, Morelos, Mexico, 62270
Instituto de Diabetes, Obesidad y Nutricion S.C. Recruiting
Cuernavaca, Morelos, Mexico, 62250
Centro de Atención e Investigación Cardiovascular del Potosí S.C. Recruiting
San Luis Potosí, San Luis Potosi, Mexico, 78200
Centenario Hospital Miguel Hidalgo Recruiting
Aguascalientes, Mexico, 20230
Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV Recruiting
Aguascalientes, Mexico, 20230
Centro Hospitalario Mac, S.A. De C.V. (Emergencies) Recruiting
Aguascalientes, Mexico, 20230
Hospital Angeles Centro Medico del Potosi (Emergencies) Recruiting
San Luis Potosi, Mexico, 78200
Romania
Spitalul Clinic Judetean de Urgenta Craiova, Cardiologie Recruiting
Craiova, Dolj, Romania, 200642
Centrul Medical de Diagnostic si Tratament Ambulator Neomed, Medicina Interna Recruiting
Brasov, Romania, 500286
Spitalul Universitar de Urgenta Militar Central ,,Dr. Carol Davila" Recruiting
Bucuresti, Romania, 010825
Centrul Medical Unirea, Diabet Nutritie si Boli Metabolice Recruiting
Cluj-Napoca, Romania, 400349
Elit Medical SRL Recruiting
Ploiesti, Romania, 100018
Russian Federation
LLC "Medius and K" Not yet recruiting
Vsevologsk, Leningrad region, Russian Federation, 188640
Saint-Petersburg State Budgetary Institution Recruiting
Saint-Petersburg, Sestroretsk City, Russian Federation, 197706
Federal State Budgetary Institution "Research Institute of Complex problems of Cardio-vascular Recruiting
Kemerovo, Russian Federation, 650002
FSAEI of the Higher Education "People's Friendship University of Russia" Recruiting
Moscow, Russian Federation, 117198
SBHI of Moscow City "Municipal Clinical Hospital #64 of the Healthcare department of Moscow city" Recruiting
Moscow, Russian Federation, 117292
Municipal institution of healthcare "City clinical hospital 12" Recruiting
Saratov, Russian Federation, 410039
LLC "Institute of medical research" Not yet recruiting
St. Petersburg, Russian Federation, 196084
Saint-Petersburg State Budgetary Institution of healthcare "Municipal hospital # 15" Recruiting
St. Petersburg, Russian Federation, 198205
Spain
Centro Salud Petrer I Recruiting
Petrer, Alicante, Spain, 03610
Hospital Universitario de Bellvitge Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Clinico Universitario Santiago de Compostela Recruiting
Santiago de Compostela, Galicia, Spain, 15706
Hospital Universitario Quiron Madrid Recruiting
Pozuelo de Alarcon, Madrid, Spain, 28223
Hospital Universitario Sant Joan de Reus Recruiting
Reus, Tarragona, Spain, 43204
Hospital Universitario La Ribera Recruiting
Alzira, Valencia, Spain, 46600
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Hospital Clinico San Carlos Not yet recruiting
Madrid, Spain, 28040
Hospital Universitario La Paz; Unidad Metabolico-Vascular Recruiting
Madrid, Spain, 28046
Hospital Universitario Miguel Servet; Medicina Interna Recruiting
Zaragoza, Spain, 50009
Taiwan
Cardinal Tien Hospital Recruiting
New Taipei City, Taiwan, 23148
China Medical University Hospital Recruiting
Taichung, Taiwan, 40447
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan, 40705
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 11217
United Kingdom
Synexus Thames Valley Clinical Research Centre Recruiting
Reading, Berkshire, United Kingdom, RG2 0TG
Synexus Lancashire Clinical Research Centre Recruiting
Chorley, Lancashire, United Kingdom, PR7 7NA
Northmed Clinical Research Ltd Recruiting
Antrim, Northern Ireland, United Kingdom, BT41 3AE
Southern Health & Social Care Trust, Craigavon Area Hospital Not yet recruiting
Portadown, Northern Ireland, United Kingdom, BT63 5QQ
Synexus North East Clinical Research Centre Not yet recruiting
Hexham, Northumberland, United Kingdom, NE46 1QJ
The Crouch Oak Family Practice Recruiting
Addlestone, Surrey, United Kingdom, KT15 2BH
Synexus Midlands Clinical Research Centre Recruiting
Birmingham, West Midlands, United Kingdom, B15 2SQ
The Bradford on Avon & Melksham Health Partnership Not yet recruiting
Bradford on Avon, United Kingdom, BA15 1DQ
Synexus Wales Clinical Research Centre Recruiting
Cardiff, United Kingdom, CF14 5GJ
Ninewells Hospital & Medical School Recruiting
Dundee, United Kingdom, DD1 9SY
Synexus Scotland Clinical Research Centre Recruiting
Glasgow, United Kingdom, G20 0SP
Synexus Merseyside Clinical Research Centre Recruiting
Liverpool, United Kingdom, L22 0LG
Synexus Manchester Clinical Research Centre Recruiting
Manchester, United Kingdom, M15 6SX
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: NCT01968967     History of Changes
Other Study ID Numbers: B1481020, 2013-002643-28, SPIRE-LDL
Study First Received: October 21, 2013
Last Updated: March 25, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
mixed dyslipidemia
high risk of cardiovascular events
multiple cardiovascular disease risk factors

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on March 26, 2015