Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01968967
First received: October 21, 2013
Last updated: August 23, 2016
Last verified: August 2016
  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

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


Enrollment: 2139
Study Start Date: October 2013
Study Completion Date: July 2016
Primary Completion Date: July 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
Placebo Comparator: Placebo Other: Placebo
subcutaneous injection every 2 weeks for 12 months

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

  Hide Study Locations
Locations
United States, Alabama
Ernest L. Hendrix, MD, PC
Athens, Alabama, United States, 35611
North Alabama Research Center, LLC
Athens, Alabama, United States, 35611
The Kirklin Clinic
Birmingham, Alabama, United States, 35233
Alabama Internal Medicine, P.C.
Birmingham, Alabama, United States, 35235
Drug Shipment and Study Conducted at Address: University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Heart Center Research, Llc
Huntsville, Alabama, United States, 35801
United States, Arizona
Radiant Research Incorporated
Chandler, Arizona, United States, 85224
Advanced Research Associates
Glendale, Arizona, United States, 85308
Arizona Center For Internal Medicine
Mesa, Arizona, United States, 85205
Holland Center for Family Health
Peoria, Arizona, United States, 85381
Elite Clinical Studies, LLC
Phoenix, Arizona, United States, 85018
Phoenix Clinical
Phoenix, Arizona, United States, 85021
Desert Sun Clinical Research, LLC
Tucson, Arizona, United States, 85710
Advanced Arizona Clinical Research
Tucson, Arizona, United States, 85712
United States, California
Care Clinical Research Corporation
Banning, California, United States, 92220
Med Center
Carmichael, California, United States, 95608
Med Investigations
Fair Oaks, California, United States, 95628
California Heart Specialists
Huntington Beach, California, United States, 92648
Alia Clinical Research, Inc.
Huntington Park, California, United States, 90255
Downtown L.A. Research Center, Inc.
Los Angeles, California, United States, 90017
Richard S. Cherlin, M.D.
Los Gatos, California, United States, 95032
California Medical Research Associates Inc.
Northridge, California, United States, 91324
Arch Health Partners Clinical Research Department
Poway, California, United States, 92064
Clinical Trials Research
Sacramento, California, United States, 95821
Northern California Research
Sacramento, California, United States, 95821
Alta California Medical Group
Simi Valley, California, United States, 93065
Orange County Research Center
Tustin, California, United States, 92780
Empire Clinical Research
Upland, California, United States, 91786
Diablo Clinical Research, Inc.
Walnut Creek, California, United States, 94598
Infosphere Clinical Research, INC
West Hills, California, United States, 91307
United States, Colorado
Clinicos, LLC
Colorado Springs, Colorado, United States, 80904
Clinical Research Advantage, Inc. / Colorado Springs Family Practice
Colorado Springs, Colorado, United States, 80909
United States, Connecticut
YNHH
North Haven, Connecticut, United States, 06473
United States, Florida
ACRC-Cardiology
Atlantis, Florida, United States, 33462
Avail Clinical Research, LLC
DeLand, Florida, United States, 32720
Fleming Island Center for Clinical Research
Fleming Island, Florida, United States, 32003
Invesclinic, LLC
Fort Lauderdale, Florida, United States, 33308
Florida Research Network, LLC
Gainesville, Florida, United States, 32605
AGA Clinical Trials
Hialeah, Florida, United States, 33012
The Research Center, Inc.
Hialeah, Florida, United States, 33013
Homestead Medical Research Inc.
Homestead, Florida, United States, 33030
Nature Coast Clinical Research
Inverness, Florida, United States, 34452
Westside Center for Clinical Research
Jacksonville, Florida, United States, 32205
East Coast Institute for Research, LLC at Baker-Gilmour Cardiovascular Institute, PA
Jacksonville, Florida, United States, 32216
East Coast Institute for Research, LLC at Jacksonville Cardiovascular Center
Jacksonville, Florida, United States, 32216
East Coast Institute for Research, LLC at Northeast Florida Cardiology Clinic
Jacksonville, Florida, United States, 32216
East Coast Institute for Research, LLC at Northeast Florida Endocrine & Diabetes Associates
Jacksonville, Florida, United States, 32216
St. Vincent's Cardiology
Jacksonville, Florida, United States, 32216
San Marcus Research Clinic
Miami, Florida, United States, 33015
Clinical Research of Miami
Miami, Florida, United States, 33126
Finlay Medical Research
Miami, Florida, United States, 33126
Medical Research Center
Miami, Florida, United States, 33144
International Research Associates, LLC
Miami, Florida, United States, 33183
Kendall South Medical Center, Inc.
Miami, Florida, United States, 33185
Kendall South Medical Center
Miami, Florida, United States, 33185
Florida Institute For Clinical Research, Llc
Orlando, Florida, United States, 32825
Oviedo Medical Research, LLC
Oviedo, Florida, United States, 32765
A&R Research Group, LLC
Pembroke Pines, Florida, United States, 33024
DBC Research
Pembroke Pines, Florida, United States, 33029
St. Johns Center for Clinical Research
Ponte Vedra, Florida, United States, 32081
BayCare Medical Group
Safety Harbor, Florida, United States, 34695
South Miami Clinical Research Center, LLC
South Miami, Florida, United States, 33143
Dolphin Medical Research
Virginia Gardens, Florida, United States, 33166
Metabolic Research Institute Incorporated
West Palm Beach, Florida, United States, 33401
Clinical Research of Central Florida
Winter Haven, Florida, United States, 33880
United States, Georgia
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30318
Atlanta Center for Clinical Research / Internal Medicine
Roswell, Georgia, United States, 30075
North Georgia Clinical Research
Woodstock, Georgia, United States, 30189
North Georgia Internal Medicine
Woodstock, Georgia, United States, 30189
United States, Hawaii
East-West Medical Research Institute
Honolulu, Hawaii, United States, 96814
United States, Idaho
Northwest Clinical Trials, Inc.
Boise, Idaho, United States, 83704
Solaris Clinical Research
Meridian, Idaho, United States, 83646
United States, Indiana
Investigators Research Group, LLC
Brownsburg, Indiana, United States, 46112
American Health Network, LLC
Indianapolis, Indiana, United States, 46254
Midwest Institute for Clinical Research
Indianapolis, Indiana, United States, 46260
Buynak Clinical Research, P.C.
Valparaiso, Indiana, United States, 46383
United States, Iowa
West Broadway Clinic
Council Bluffs, Iowa, United States, 51501
The University of Iowa - College of Public Health - Preventive Intervention Center
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Midwest Heart and Vascular Specialists
Overland Park, Kansas, United States, 66215
United States, Louisiana
Omega Clinical Research
Metairie, Louisiana, United States, 70006
New Orleans Center for Clinical Research
New Orleans, Louisiana, United States, 70119
United States, Maine
Southern Maine Health Care
Biddeford, Maine, United States, 04005
United States, Maryland
Columbia Medical Practice
Columbia, Maryland, United States, 21045
MD Medical Research
Oxon Hill, Maryland, United States, 20745
United States, Michigan
IHA Chelsea Family & Internal Medicine
Chelsea, Michigan, United States, 48118
QUEST Research Institute
Farmington Hills, Michigan, United States, 48334
Westside Family Medical Center, Pc
Kalamazoo, Michigan, United States, 49009
Michigan Heart and Vascular Specialists
Petoskey, Michigan, United States, 49770
Oakland Medical Research Center
Troy, Michigan, United States, 48085
United States, Minnesota
Radiant Research, Inc.
Edina, Minnesota, United States, 55435
HealthEast Medical Research Institute
St. Paul, Minnesota, United States, 55102
HealthEast St. Joseph's Hospital Pharmacy
St. Paul, Minnesota, United States, 55102
United States, Missouri
KCUMB Center for Community and Clinical Research
Kansas City, Missouri, United States, 64106
Mercy Health Research
Washington, Missouri, United States, 63090
United States, Nevada
Om Medical
Las Vegas, Nevada, United States, 89119
Clinical Research of South Nevada
Las Vegas, Nevada, United States, 89121
United States, New Jersey
Rutgers Biomedical and Health Sciences- Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
Cardio Metabolic Institute
Somerset, New Jersey, United States, 08873
Premier Research
Trenton, New Jersey, United States, 08611
United States, New York
Albany Medical College, Division of Community Endocrinology
Albany, New York, United States, 12206
Drug Trials Brooklyn
Brooklyn, New York, United States, 11230
Drug Trials America
Hartsdale, New York, United States, 10530
SJH Cardiology Associates
Liverpool, New York, United States, 13088
Mid Hudson Medical Research, PLLC
New Windsor, New York, United States, 12553
United States, North Carolina
Sensenbrenner Primary Care
Charlotte, North Carolina, United States, 28277
PharmQuest
Greensboro, North Carolina, United States, 27408
Crossroads Clinical Research, Inc.
Mooresville, North Carolina, United States, 28117
PMG Research of Salisbury, LLC
Salisbury, North Carolina, United States, 28144
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States, 28401
PMG Research of Winston-Salem
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Radiant Research, Inc
Akron, Ohio, United States, 44311
Community Health Care, Inc.
Canal Fulton, Ohio, United States, 44614
Sterling Research Group, Ltd.
Cincinnati, Ohio, United States, 45219
The Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, United States, 45219
Metabolic and Atherosclerosis Research Center
Cincinnati, Ohio, United States, 45227
Sentral Clinical Research Services
Cincinnati, Ohio, United States, 45236
Sterling Research Group, Ltd.
Cincinnati, Ohio, United States, 45246
United States, Oklahoma
LION Research
Norman, Oklahoma, United States, 73069
LION Research
Norman, Oklahoma, United States, 73072
United States, Oregon
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, United States, 97504
United States, Pennsylvania
Brandywine Clinical Research
Downingtown, Pennsylvania, United States, 19335
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Liberty Family Practice
Erie, Pennsylvania, United States, 16508
Detweiler Family Medicine and Associates, PC
Lansdale, Pennsylvania, United States, 19446
Suburban Research Associates
Media, Pennsylvania, United States, 19063
Allegheny Endocrinology Associates
Pittsburgh, Pennsylvania, United States, 15212
Guthrie Medical Group, PC
Sayre, Pennsylvania, United States, 18840
Warminster Medical Associates, P.C.
Warminster, Pennsylvania, United States, 18974
United States, South Carolina
Coastal Cardiology
Charleston, South Carolina, United States, 29407
Upstate Pharmaceutical Research
Greenville, South Carolina, United States, 29615
Palmetto Clinical Research
Summerville, South Carolina, United States, 29485
United States, Tennessee
Cardiovascular Research of Knoxville
Knoxville, Tennessee, United States, 37917
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States, 37920
Volunteer Research Group
Knoxville, Tennessee, United States, 37920
United States, Texas
KRK Medical Research
Arlington, Texas, United States, 76012
North Texas Healthcare System, Dallas VAMC
Dallas, Texas, United States, 75216
Research Institute of Dallas
Dallas, Texas, United States, 75231
University of North Texas Health Science Center at Fort Worth
Fort Worth, Texas, United States, 76107
Baylor College of Medicine
Houston, Texas, United States, 77030
lnvestigational Drug Services (IDA)
Houston, Texas, United States, 77030
Northwest Houston Cardiology
Houston, Texas, United States, 77070
Texas Center for Drug Development, Inc.
Houston, Texas, United States, 77081
Pioneer Research Solutions, Inc.
Houston, Texas, United States, 77099
Hill Country Medical Associates
New Braunfels, Texas, United States, 78130
Advanced Clinical Research Associates
Plano, Texas, United States, 75093
Sun Research Institute
San Antonio, Texas, United States, 78215
Bandera Family Health Care, LLC
San Antonio, Texas, United States, 78249
Northwest Heart Center
Tomball, Texas, United States, 77375
United States, Utah
Radiant Research
Murray, Utah, United States, 84123
United States, Virginia
Manassas Clinical Research Center
Manassas, Virginia, United States, 20110
National Clinical Research-Richmond, Inc.
Richmond, Virginia, United States, 23294
Amherst Family Practice, P.C.
Winchester, Virginia, United States, 22601
Selma Medical Associates
Winchester, Virginia, United States, 22601
United States, Washington
Rainier Clinical Research Center
Renton, Washington, United States, 98057
Zain Research LLC
Richland, Washington, United States, 99352
Canada, British Columbia
Discovery Clinical Services Ltd.
Victoria, British Columbia, Canada, V8T 5G4
Canada, Ontario
Vizel Cardiac Research, Saul Vizel Professional Medicine Corporation
Cambridge, Ontario, Canada, N1R 7R1
The Office of Dr. Allen Greenspoon
Hamilton, Ontario, Canada, L8L 5G8
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Stroke Prevention & Atherosclerosis Research Centre (SPARC)
London, Ontario, Canada, N6G 2V2
Newmarket Cardiology Research Group
Newmarket, Ontario, Canada, L3Y 8C3
London Road Diagnostic Clinic and Medical Centre
Sarnia, Ontario, Canada, N7T 4X3
St. Michael's Hospital Health Centre
Toronto, Ontario, Canada, M5C 2T2
Canada, Quebec
Rhodin Recherche Clinique
Drummondville, Quebec, Canada, J2B 7T1
LMC Research Inc. d.b.a. Manna Research Inc.
Levis, Quebec, Canada, G6W 0M5
Omnispec Clinical Research Inc.
Mirabel, Quebec, Canada, J7J 2K8
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
DIEX Research Sherbrooke Inc.
Sherbrooke, Quebec, Canada, J1H 1Z1
Colombia
Rodrigo Botero S.A.S.
Medellin, Antioquia, Colombia, 050012
Centro de Medicina del Ejercicio y Rehabilitacion Cardiaca S.A. CEMDE S.A.
Medellin, Antioquia, Colombia, 50031
Unidad de Cardiologia - Clinica Medellin (sede centro)
Medellin, Antioquia, Colombia
Fundacion del Caribe para la Investigacion Biomedica-Fundacion Bios
Barranquilla, Atlantico, Colombia, 80020
BIOMELAB Ltda.
Barranquilla, Atlantico, Colombia
IPS Centro Cientifico Asistencial Jose Luis Accini S.A.S.
Barranquilla, Atlantico, Colombia
Centro de Diagnostico Cardiologico LTDA.
Cartagena, Bolivar, Colombia, 130013
Asociacion IPS Medicos InterniStas de Caldas
Manizales, Caldas, Colombia, 17001
Dexa Diab Servicios Medicos Ltda. IPS
Bogota, Cundinamarca, Colombia, 110221
Instituto de Investigacion Endocrinologia y Prevencion Metabolica ENDOCARE LTDA
Bogota, Cundinamarca, Colombia
Fundacion Cardiomet - CEQUIN
Armenia, Quindio, Colombia
Fundacion Cardiovascular De Colombia - Instituto del Corazón Floridablanca
Floridablanca, Santander, Colombia
Fundacion Centro de Investigaciones Biomedicas RIESCARD
Espinal, Tolima, Colombia
Centro de Investigaciones Clinicas S.A.S"
Cali, Valle Del Cauca, Colombia, 760032
France
Nouvelles Cliniques Nantaises
Nantes, France, 44200
CHU La Miletrie
Poitiers, France, 86021
CHU de Toulouse - Hopital Rangueil
Toulouse cedex 9, France, 31059
Hopital Guy Chatiliez
Tourcoing, France, 59200
Hopital Guy Chatillez
Tourcoing, France, 59200
Hungary
Magyar Imre Korhaz, Belgyogyaszati Szakrendeles
Ajka, Hungary, 8400
Bajai Szent Rokus Korhaz
Baja, Hungary, 6500
Lausmed Kft.
Baja, Hungary, 6500
Drug Research Centre Ltd
Balatonfured, Hungary, 8230
SYNEXUS Magyarorszag Kft.
Budapest, Hungary, 1036
Pharma 4 Trial Kft.
Gyongyos, Hungary, 3200
Borsod-Abauj-Zemplen Megyei Korhaz, es Egyetemi Oktatokorhaz
Miskolc, Hungary, 3526
TaNaMed Kft.
Mosonmagyarovar, Hungary, 9200
Pecsi Tudomanyegyetem
Pecs, Hungary, 7623
Zala Megyei Korhaz
Zalaegerszeg, Hungary, 8900
Lithuania
PI Kaunas Silainiai Outpatient Clinic
Kaunas, Lithuania, LT-48259
Private Clinic Elite Medicale
Kaunas, Lithuania, LT-50177
PI Klaipeda seamen hospital
Klaipeda, Lithuania, LT-92288
Vilnius University Hospital Santariskiu Klinikos
Vilnius, Lithuania, LT-08661
Mexico
Clinicos Asociados BOCM, S.C.
Mexico, Distrito Federal, Mexico, 03300
Hospital General de Naucalpan "Dr. Maximiliano Ruiz Castaneda" (Emergencies)
Naucalpan, Estado de Mexico, Mexico, 35510
Instituto Jalisciense de Investigacion en Diabetes y Obesidad, S.C.
Guadalajara, Jalisco, Mexico, 44600
Instituto de Diabetes, Obesidad y Nutricion S.C.
Cuernavaca, Morelos, Mexico, 62250
Administradora de Clinicas S.A. de C.V. Hospital Inovamed Cuernavaca
Cuernavaca, Morelos, Mexico, 62270
Centro de Atención e Investigación Cardiovascular del Potosí S.C.
San Luis Potosí, San Luis Potosi, Mexico, 78200
Centenario Hospital Miguel Hidalgo
Aguascalientes, Mexico, 20230
Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV
Aguascalientes, Mexico, 20230
Centro Hospitalario Mac, S.A. De C.V. (Emergencies)
Aguascalientes, Mexico, 20230
Hospital Angeles Centro Medico del Potosi (Emergencies)
San Luis Potosi, Mexico, 78200
Romania
Spitalul Clinic Judetean de Urgenta Craiova, Cardiologie
Craiova, Dolj, Romania, 200642
Centrul Medical de Diagnostic si Tratament Ambulator Neomed, Medicina Interna
Brasov, Romania, 500283
Spitalul Universitar de Urgenta Militar Central, Dr. Carol Davila"
Bucuresti, Romania, 010825
Centrul Medical Unirea, Diabet Nutritie si Boli Metabolice
Cluj-Napoca, Romania, 400349
Elit Medical SRL
Ploiesti, Romania, 100018
Russian Federation
Federal State Budgetary Institution "Research Institute of Complex problems of Cardio-vascular
Kemerovo, Russian Federation, 650002
FSAEI of Higher Education "People's Friendship University of Russia",
Moscow, Russian Federation, 117292
Saint-Petersburg State Budgetary Institution of Healthcare Municipal hospital # 40
Saint-Petersburg, Russian Federation, 197706
Saint-Petersburg State Budgetary Institution of Healthcare "Municipal Hospital #15"
Saint-Petersburg, Russian Federation, 198205
Municipal institution of healthcare "City clinical hospital 12"
Saratov, Russian Federation, 410039
LLC "Institute of medical research"
St. Petersburg, Russian Federation, 196084
Spain
Centro Salud Petrer I
Petrer, Alicante, Spain, 03610
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Clinico Universitario Santiago de Compostela
Santiago de Compostela, Galicia, Spain, 15706
Hospital Universitario Sant Joan de Reus
Reus, Tarragona, Spain, 43204
Hospital Universitario La Ribera
Alzira, Valencia, Spain, 46600
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Hospital Universitario La Paz; Unidad Metabolico-Vascular
Madrid, Spain, 28046
Hospital Universitario Quiron Madrid
Madrid, Spain, 28223
Hospital Clinico Universitario Miguel Servet; Medicina Interna
Zaragoza, Spain, 50009
Taiwan
Cardinal Tien Hospital
New Taipei City, Taiwan, 23148
China Medical University Hospital
Taichung, Taiwan, 40447
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
United Kingdom
Synexus Thames Valley Clinical Research Centre
Reading, Berkshire, United Kingdom, RG2 0TG
Synexus Manchester Clinical Research Centre
Manchester, Greater Manchester, United Kingdom, M15 6SX
Synexus Scotland clinical research centre
Glasgow, Lanarkshire, United Kingdom, G20 0SP
Synexus Lancashire Clinical Research Centre
Chorley, Lancashire, United Kingdom, PR7 7NA
Synexus Merseyside Clinical Research Centre
Liverpool, Merseyside, United Kingdom, L22 0LG
Northmed Clinical Research Ltd, Randalstown Health Centre
Antrim, Northern Ireland, United Kingdom, BT41 3AE
Southern Health & Social Care Trust, Craigavon Area Hospital
Portadown, Northern Ireland, United Kingdom, BT63 5QQ
Synexus North East Clinical Research Centre
Hexham, Northumberland, United Kingdom, NE46 1QJ
The Crouch Oak Family Practice
Addlestone, Surrey, United Kingdom, KT15 2BH
Synexus Midlands Clinical Research Centre
Birmingham, West Midlands, United Kingdom, B15 2SQ
The Bradford on Avon & Melksham Health Partnership
Bradford on Avon, Wiltshire, United Kingdom, BA15 1DQ
Synexus Wales Clinical Research Centre
Cardiff, United Kingdom, CF14 5GJ
Ninewells Hospital & Medical School
Dundee, United Kingdom, DD1 9SY
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
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: August 23, 2016
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:
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 27, 2016