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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 November 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01968967
First received: October 21, 2013
Last updated: November 5, 2014
Last verified: November 2014
  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
Alabama Internal Medicine, P.C. Not yet recruiting
Birmingham, Alabama, United States, 35235
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
United States, Arizona
Radiant Research, Inc. Not yet recruiting
Chandler, Arizona, United States, 85224
Advanced Research Associates Not yet recruiting
Glendale, Arizona, United States, 85308
Arizona Center For Internal Medicine Not yet recruiting
Mesa, Arizona, United States, 85205
Holland Center for Family Health Not yet recruiting
Peoria, Arizona, United States, 85381
Phoenix Clinical Not yet recruiting
Phoenix, Arizona, United States, 85021
Elite Clinical Studies, LLC Recruiting
Phoenix, Arizona, United States, 85018
Clinical Research Advantage, Inc./Colorado Springs Health Partners, SW (Administrative Mailing Only) Recruiting
Tempe, Arizona, United States, 85282
Advanced Arizona Clinical Research Not yet recruiting
Tucson, Arizona, United States, 85712
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
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
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
Northern California Research Recruiting
Sacramento, California, United States, 95821
Clinical Trials Research Recruiting
Sacramento, California, United States, 95821
Sharp Rees-Stealy Medical Group, Inc. Not yet recruiting
San Diego, California, United States, 92101
Alta California Medical Group Not yet recruiting
Simi Valley, California, United States, 93065
Orange County Research Center Recruiting
Tustin, California, United States, 92780
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, 32003
Invesclinic, LLC Recruiting
Fort Lauderdale, Florida, United States, 33308
Florida Research Network, LLC Recruiting
Gainesville, Florida, United States, 32605
AGA Clinical Trials Recruiting
Hialeah, Florida, United States, 33012
The Research Center, Inc Recruiting
Hialeah, Florida, United States, 33016
Homestead Medical Research Inc. Not yet recruiting
Homestead, Florida, United States, 33030
Nature Coast Clinical Research Recruiting
Inverness, Florida, United States, 34452
East Coast Institute for Research, LLC at Baker-Gilmour Cardiovascular Institute, PA Recruiting
Jacksonville, Florida, United States, 32216
Westside Center for Clinical Research Recruiting
Jacksonville, Florida, United States, 32205
San Marcus Research Clinic Recruiting
Miami, Florida, United States, 33015
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
Clinical Research of Miami Recruiting
Miami, Florida, United States, 33126
Medical Research Center Recruiting
Miami, Florida, United States, 33144
A&R Research Group, LLC Recruiting
Pembroke Pines, Florida, United States, 33024
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 Not yet 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
Midwest Institute for Clinical Research Recruiting
Indianapolis, Indiana, United States, 46260
American Health Network Recruiting
Indianapolis, Indiana, United States, 46254
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 Not yet recruiting
Kansas City, Kansas, United States, 66160
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 Not yet recruiting
Kalamazoo, Michigan, United States, 49009
Oakland Medical Research Center Recruiting
Troy, Michigan, United States, 48085
United States, Minnesota
Radiant Research, Inc. Recruiting
Edina, Minnesota, United States, 55435
United States, Missouri
KCUMB Center for Community and Clinical Research Active, not recruiting
Kansas City, Missouri, United States, 64106
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 Not yet recruiting
New Brunswick, New Jersey, United States, 08901
Premier Research Recruiting
Trenton, New Jersey, United States, 08611
United States, New York
The Endocrine Group, Llp Recruiting
Albany, New York, United States, 12206
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
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, 27013
United States, Ohio
Radiant Research, Inc Recruiting
Akron, Ohio, United States, 44311
Community Health Care, Inc. Recruiting
Canal Fulton, Ohio, United States, 44614
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
Metabolic and Atherosclerosis Research Center Recruiting
Cincinnati, Ohio, United States, 45227
Sentral Clinical Research Services 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
Sentral Clinical Research Services - Admin Only Recruiting
Cincinnati, Ohio, United States, 45236
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 Not yet recruiting
Erie, Pennsylvania, United States, 16508
Westminster Family Medicine Not yet recruiting
Erie, Pennsylvania, United States, 16506
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 Not yet 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
New Orleans Center for Clinical Research Not yet recruiting
Knoxville, Tennessee, United States, 37920
Volunteer Research Group Not yet 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
Northwest Houston Cardiology Recruiting
Houston, Texas, United States, 77070
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
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
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. Not yet 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. Not yet recruiting
Richmond, Virginia, United States, 23294
United States, Washington
Rainier Clinical Research Center Recruiting
Renton, Washington, United States, 98057
Zain Research LLC Recruiting
Richland, Washington, United States, 99352
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) Not yet 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
Canada, Quebec
Rhodin Recherche Clinique Not yet recruiting
Drummondville, Quebec, Canada, J2B 7T1
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. Not yet recruiting
Medellin, Antioquia, Colombia
Rodrigo Botero S.A.S Recruiting
Medellin, Antioquia, Colombia
Biomelab Limitada Recruiting
Barranquila, Atlantico, Colombia
Cardiolab Ltda Not yet recruiting
Barranquilla, Atlantico, Colombia
IPS Centro Cientifico Asistencial Jose Luis Accini S.A.S. Recruiting
Barranquilla, Atlantico, Colombia
Laboratorio Clínico Continental Not yet 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
Centro de Investigacion Clinica de la Universidad del Rosario Not yet recruiting
Bogota, Cundinamarca, Colombia
Fundacion Cardiomet- CEQUIN Recruiting
Armenia, Quindio, Colombia
Fundacion Centro de Investigaciones Biomedicas RIESCARD Recruiting
Espinal, Tolima, Colombia
Centro de Investigaciones Clinicas Not yet recruiting
Cali, Valle, Colombia
Instituto de Investigacion Endocrinologia y Prevencion Metabolica ¿ ENDOCARE LTDA Recruiting
Bogota D.C., Colombia
France
Nouvelles Cliniques Nantaises Recruiting
Nantes, France, 44200
CHU de Toulouse - Hopital Rangueil Not yet recruiting
Toulouse cedex 09, France, 31059
Hopital Guy Chatiliez 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. Recruiting
Budapest, Hungary, H-1036
Debreceni Egyetem Not yet recruiting
Debrecen, Hungary, 4032
Pharma 4 Trial Kft. Recruiting
Gyongyos, Hungary, 3200
BAZ Megyei 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
Private Clinic Elite Medicale Recruiting
Kaunas, Lithuania, LT-50184
PI Kaunas Silainiai Outpatient Clinic Recruiting
Kaunas, Lithuania, LT-48259
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. Not yet recruiting
Mexico, Distrito Federal, Mexico, 03300
Hospital General de Naucalpan "Dr. Maximiliano Ruiz Castaneda" (Emergencies) Not yet recruiting
Naucalpan, Estado de Mexico, Mexico, 35510
Hospital Mexico Americano, S.C. (Emergencies) Not yet recruiting
Guadalajara, Jalisco, Mexico, 44620
Instituto Jalisciense de Investigacion en Diabetes y Obesidad, S.C. Not yet recruiting
Guadalajara, Jalisco, Mexico, 44600
Private Office Not yet recruiting
Guadalajara, Jalisco, Mexico, 44657
Hospital Bernardette, S.A. DE C.V. (Emergencies) Not yet recruiting
Guadalajara, Jalisco, Mexico, 44200
Instituto de Diabetes, Obesidad y Nutricion S.C. Not yet recruiting
Cuernavaca, Morelos, Mexico, 62250
Administradora de Clinicas S.A. de C.V. Hospital Inovamed Cuernavaca (Emergencies) Not yet recruiting
Cuernavaca, Morelos, Mexico, 62270
Centro de Atención e Investigación Cardiovascular del Potosí S.C. Not yet recruiting
San Luis Potosí, San Luis Potosi, Mexico, 78200
Centenario Hospital Miguel Hidalgo Not yet 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) Not yet 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, Diabet Zaharat Nutritie si Boli Metabolice Recruiting
Ploiesti, Romania, 100018
Spain
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 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 Ltd Recruiting
Chorley, Lancashire, United Kingdom, PR7 7NA
Synexus Merseyside Clinical Research Centre Recruiting
Liverpool, Merseyside, United Kingdom, L22 0LG
Northmed Clinical Research Ltd Recruiting
Antrim, Northern Ireland, United Kingdom, BT41 3AE
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
Synexus Wales Clinical Research Centre Not yet recruiting
Cardiff, United Kingdom, CF14 5GJ
Ninewells Hospital & Medical School Recruiting
Dundee, United Kingdom, DD1 9SY
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: November 5, 2014
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 November 27, 2014