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 April 2016 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01968967
First received: October 21, 2013
Last updated: April 20, 2016
Last verified: April 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


Estimated Enrollment: 1932
Study Start Date: October 2013
Estimated Study Completion Date: July 2016
Estimated 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
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
North Alabama Research Center, LLC Active, not recruiting
Athens, Alabama, United States, 35611
Drug Shipment and Study Conducted at Address: University of Alabama at Birmingham Active, not recruiting
Birmingham, Alabama, United States, 35294
Alabama Internal Medicine, P.C. Active, not recruiting
Birmingham, Alabama, United States, 35235
The Kirklin Clinic 4th floor Active, not recruiting
Birmingham, Alabama, United States, 35233
Heart Center Research, Llc Active, not recruiting
Huntsville, Alabama, United States, 35801
United States, Arizona
Radiant Research Incorporated Active, not recruiting
Chandler, Arizona, United States, 85224
Advanced Research Associates Active, not recruiting
Glendale, Arizona, United States, 85308
Arizona Center For Internal Medicine Active, not recruiting
Mesa, Arizona, United States, 85205
Holland Center for Family Health Active, not recruiting
Peoria, Arizona, United States, 85381
Elite Clinical Studies, LLC Active, not recruiting
Phoenix, Arizona, United States, 85018
Phoenix Clinical Active, not recruiting
Phoenix, Arizona, United States, 85021
Desert Sun Clinical Research, LLC Active, not recruiting
Tucson, Arizona, United States, 85710
Advanced Arizona Clinical Research Active, not recruiting
Tucson, Arizona, United States, 85712
United States, California
Care Clinical Research Corporation Active, not recruiting
Banning, California, United States, 92220
Med Center Active, not recruiting
Carmichael, California, United States, 95608
Med Investigations (Administrative Only) Active, not recruiting
Fair Oaks, California, United States, 95628
California Heart Specialists Active, not recruiting
Huntington Beach, California, United States, 92648
Alia Clinical Research Inc. Active, not recruiting
Huntington Park, California, United States, 90255
Downtown L.A. Research Center, Inc. Active, not recruiting
Los Angeles, California, United States, 90017
Richard S. Cherlin, M.D. Active, not recruiting
Los Gatos, California, United States, 95032
California Medical Research Associates Inc. Active, not recruiting
Northridge, California, United States, 91324
Arch Health Partners Clinical Research Department Active, not recruiting
Poway, California, United States, 92064
Northern California Research Active, not recruiting
Sacramento, California, United States, 95821
Clinical Trials Research Active, not recruiting
Sacramento, California, United States, 95821
Alta California Medical Group Active, not recruiting
Simi Valley, California, United States, 93065
Orange County Research Center Terminated
Tustin, California, United States, 92780
Empire Clinical Research Active, not recruiting
Upland, California, United States, 91786
Diablo Clinical Research, Inc. Active, not recruiting
Walnut Creek, California, United States, 94598
Infosphere Clinical Research, INC Active, not recruiting
West Hills, California, United States, 91307
United States, Colorado
Clinicos, LLC Active, not recruiting
Colorado Springs, Colorado, United States, 80904
Clinical Research Advantage, Inc. / Colorado Springs Family Practice Active, not recruiting
Colorado Springs, Colorado, United States, 80909
United States, Connecticut
Yale School Of Medicine, Campus Address: Ynhh Heart & Vasc. Active, not recruiting
North Haven, Connecticut, United States, 06473
United States, Florida
ACRC-Cardiology Active, not recruiting
Atlantis, Florida, United States, 33462
Avail Clinical Research, LLC Active, not recruiting
DeLand, Florida, United States, 32720
Fleming Island Center for Clinical Research Active, not recruiting
Fleming Island, Florida, United States, 32003
Invesclinic, LLC Active, not recruiting
Fort Lauderdale, Florida, United States, 33308
Florida Research Network, LLC Active, not recruiting
Gainesville, Florida, United States, 32605
AGA Clinical Trials Active, not recruiting
Hialeah, Florida, United States, 33012
The Research Center, Inc. Active, not recruiting
Hialeah, Florida, United States, 33013
Clinical Research of Homestead Active, not recruiting
Homestead, Florida, United States, 33030
Nature Coast Clinical Research Active, not recruiting
Inverness, Florida, United States, 34452
Westside Center for Clinical Research Active, not recruiting
Jacksonville, Florida, United States, 32205
East Coast Institue for Research, LLC Active, not recruiting
Jacksonville, Florida, United States, 32216
St. Vincent's Cardiology Terminated
Jacksonville, Florida, United States, 32216
East Coast Institute for Research, LLC at Jacksonville Cardiovascular Center Active, not recruiting
Jacksonville, Florida, United States, 32216
East Coast Institute for Research, LLC at Northeast Florida Endocrine & Diabetes Associates Active, not recruiting
Jacksonville, Florida, United States, 32216
East Coast Institute for Research, LLC at Baker-Gilmour Cardiovascular Institute, PA Active, not recruiting
Jacksonville, Florida, United States, 32216
San Marcus Research Clinic Active, not recruiting
Miami, Florida, United States, 33015
Clinical Research of Miami Active, not recruiting
Miami, Florida, United States, 33126
Finlay Medical Research Active, not recruiting
Miami, Florida, United States, 33126
Medical Research Center Active, not recruiting
Miami, Florida, United States, 33144
International Research Associates, LLC Active, not recruiting
Miami, Florida, United States, 33183
Kendall South Medical Center Active, not recruiting
Miami, Florida, United States, 33185
Invesclinic, LLC d/b/a Southeast Medical Centre Active, not recruiting
Oakland Park, Florida, United States, 33309
Florida Institute For Clinical Research, LLC Active, not recruiting
Orlando, Florida, United States, 32825
Compass Research East, LLC Active, not recruiting
Oviedo, Florida, United States, 32765
A&R Research Group, LLC Active, not recruiting
Pembroke Pines, Florida, United States, 33024
DBC Research Active, not recruiting
Pembroke Pines, Florida, United States, 33029
St. Johns Center for Clinical Research Active, not recruiting
Ponte Vedra, Florida, United States, 32081
The Heart & Vascular Institute Research Active, not recruiting
Safety Harbor, Florida, United States, 34695
South Miami Clinical Research Center, LLC Active, not recruiting
South Miami, Florida, United States, 33143
Dolphin Medical Research Active, not recruiting
Virginia Gardens, Florida, United States, 33166
Metabolic Research Institute Incorporated Active, not recruiting
West Palm Beach, Florida, United States, 33401
Clinical Research of Central Flordia Active, not recruiting
Winter Haven, Florida, United States, 33880
United States, Georgia
Atlanta Diabetes Associates Active, not recruiting
Atlanta, Georgia, United States, 30318
Atlanta Center for Clinical Research / Internal Medicine Active, not recruiting
Roswell, Georgia, United States, 30075
North Georgia Clinical Research Active, not recruiting
Woodstock, Georgia, United States, 30189
North Georgia Internal Medicine Active, not recruiting
Woodstock, Georgia, United States, 30189
United States, Hawaii
East-West Medical Research Institute Active, not recruiting
Honolulu, Hawaii, United States, 96814
United States, Idaho
Northwest Clinical Trials, Inc. Active, not recruiting
Boise, Idaho, United States, 83704
Elias Research Associates LLC Active, not recruiting
Idaho Falls, Idaho, United States, 83402
Solaris Clinical Research Active, not recruiting
Meridian, Idaho, United States, 83646
United States, Indiana
Investigators Research Group, LLC Active, not recruiting
Brownsburg, Indiana, United States, 46112
American Health Network, LLC Active, not recruiting
Indianapolis, Indiana, United States, 46254
Midwest Institute for Clinical Research Active, not recruiting
Indianapolis, Indiana, United States, 46260
Buynak Clinical Research, P.C. Active, not recruiting
Valparaiso, Indiana, United States, 46383
United States, Iowa
West Broadway Clinic Active, not recruiting
Council Bluffs, Iowa, United States, 51501
The University of Iowa - College of Public Health - Preventive Intervention Center Active, not recruiting
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Medical Center Active, not recruiting
Kansas City, Kansas, United States, 66160
Midwest Heart and Vascular Specialists Active, not recruiting
Overland Park, Kansas, United States, 66215
United States, Louisiana
Omega Clinical Research Active, not recruiting
Metairie, Louisiana, United States, 70006
New Orleans Center for Clinical Research Active, not recruiting
New Orleans, Louisiana, United States, 70119
United States, Maine
Southern Maine Health Care Active, not recruiting
Biddeford, Maine, United States, 04005
United States, Maryland
Columbia Medical Practice Active, not recruiting
Columbia, Maryland, United States, 21045
MD Medical Research Active, not recruiting
Oxon Hill, Maryland, United States, 20745
United States, Michigan
Quest Research Institute Active, not recruiting
Bingham Farms, Michigan, United States, 48025
IHA Chelsea Family & Internal Medicine Active, not recruiting
Chelsea, Michigan, United States, 48118
Westside Family Medical Center, Pc Active, not recruiting
Kalamazoo, Michigan, United States, 49009
Michigan Heart and Vascular Specialist Active, not recruiting
Petoskey, Michigan, United States, 49770
Oakland Medical Research Center Active, not recruiting
Troy, Michigan, United States, 48085
United States, Minnesota
Radiant Research, Inc. Active, not recruiting
Edina, Minnesota, United States, 55435
HealthEast St. Joseph's Hospital Pharmacy Active, not recruiting
St. Paul, Minnesota, United States, 55102
HealthEast Medical Research Institute Active, not 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
Mercy Health Research Active, not recruiting
Washington, Missouri, United States, 63090
United States, Nevada
Om Medical Active, not recruiting
Las Vegas, Nevada, United States, 89119
Clinical Research of South Nevada Active, not recruiting
Las Vegas, Nevada, United States, 89121
United States, New Jersey
Rutgers Biomedical and Health Sciences- Robert Wood Johnson Medical School Terminated
New Brunswick, New Jersey, United States, 08901
Cardio Metabolic Institute Active, not recruiting
Somerset, New Jersey, United States, 08873
Premier Research Active, not recruiting
Trenton, New Jersey, United States, 08611
United States, New York
The Endocrine Group, Llp Active, not recruiting
Albany, New York, United States, 12206
Drug Trials Brooklyn Active, not recruiting
Brooklyn, New York, United States, 11230
Drug Trials America Active, not recruiting
Hartsdale, New York, United States, 10530
SJH Cardiology Associates Active, not recruiting
Liverpool, New York, United States, 13088
Mid Hudson Medical Research, PLLC Active, not recruiting
New Windsor, New York, United States, 12553
United States, North Carolina
Sensenbrenner Primary Care Active, not recruiting
Charlotte, North Carolina, United States, 28277
PharmQuest Active, not recruiting
Greensboro, North Carolina, United States, 27408
Crossroads Clinical Research, Inc. Active, not recruiting
Mooresville, North Carolina, United States, 28117
PMG Research of Salisbury, LLC Active, not recruiting
Salisbury, North Carolina, United States, 28144
PMG Research of Wilmington, LLC Active, not recruiting
Wilmington, North Carolina, United States, 28401
PMG Research of Winston-Salem Active, not recruiting
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Radiant Research, Inc Active, not recruiting
Akron, Ohio, United States, 44311
Community Health Care, Inc. Active, not recruiting
Canal Fulton, Ohio, United States, 44614
Sterling Research Group, Ltd. Active, not recruiting
Cincinnati, Ohio, United States, 45246
Sterling Research Group, Ltd. Active, not recruiting
Cincinnati, Ohio, United States, 45219
Metabolic and Atherosclerosis Research Center Active, not recruiting
Cincinnati, Ohio, United States, 45227
Sentral Clinical Research Services - Admin Only Active, not recruiting
Cincinnati, Ohio, United States, 45236
Sentral Clinical Research Services Active, not recruiting
Cincinnati, Ohio, United States, 45236
The Lindner Center for Research and Education at The Christ Hospital Active, not recruiting
Cincinnati, Ohio, United States, 45219
United States, Oklahoma
LION Research Active, not recruiting
Norman, Oklahoma, United States, 73069
United States, Oregon
Clinical Research Institute of Southern Oregon, PC Active, not recruiting
Medford, Oregon, United States, 97504
United States, Pennsylvania
Brandywine Clinical Research Active, not recruiting
Downingtown, Pennsylvania, United States, 19335
Altoona Center for Clinical Research Active, not recruiting
Duncansville, Pennsylvania, United States, 16635
Liberty Family Practice Active, not recruiting
Erie, Pennsylvania, United States, 16508
Detweiler Family Medicine and Associates, PC Active, not recruiting
Lansdale, Pennsylvania, United States, 19446
Suburban Research Associates Terminated
Media, Pennsylvania, United States, 19063
Allegheny Endocrinology Associates Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15212
Guthrie Medical Group, PC Active, not recruiting
Sayre, Pennsylvania, United States, 18840
Warminster Medical Associates, P.C. Active, not recruiting
Warminster, Pennsylvania, United States, 18974
United States, South Carolina
Coastal Cardiology Active, not recruiting
Charleston, South Carolina, United States, 29407
Upstate Pharmaceutical Research Active, not recruiting
Greenville, South Carolina, United States, 29615
Palmetto Primary Care Physicians (Trial Related Physicals Only) Active, not recruiting
North Charleston, South Carolina, United States, 29406
Palmetto Clinical Research Active, not recruiting
Summerville, South Carolina, United States, 29485
Palmetto Primary Care Physicians (Trial Related Physicals Only) Active, not recruiting
Summerville, South Carolina, United States, 29485
United States, Tennessee
Volunteer Research Group Active, not recruiting
Knoxville, Tennessee, United States, 37920
New Orleans Center for Clinical Research Active, not recruiting
Knoxville, Tennessee, United States, 37920
Cardiovascular Research of Knoxville Active, not recruiting
Knoxville, Tennessee, United States, 37917
United States, Texas
KRK Medical Research Active, not recruiting
Arlington, Texas, United States, 76012
North Texas Healthcare System, Dallas VAMC Active, not recruiting
Dallas, Texas, United States, 75216
Research Institute of Dallas Active, not recruiting
Dallas, Texas, United States, 75231
University of North Texas Health Science Center at Forth Worth Active, not recruiting
Fort Worth, Texas, United States, 76107
Pioneer Research Solutions, Inc. Active, not recruiting
Houston, Texas, United States, 77099
Investigational Product Shipment Address TO: Investigational Drug Services (IDS) Active, not recruiting
Houston, Texas, United States, 77030
Northwest Houston Cardiology Active, not recruiting
Houston, Texas, United States, 77070
Texas Center for Drug Development, Inc. Active, not recruiting
Houston, Texas, United States, 77081
Baylor College of Medicine Active, not recruiting
Houston, Texas, United States, 77030
Hill Country Medical Associates Active, not recruiting
New Braunfels, Texas, United States, 78130
Advanced Clinical Research Associates Active, not recruiting
Plano, Texas, United States, 75093
Sun Research Institute Active, not recruiting
San Antonio, Texas, United States, 78215
Bandera Family Health Care, LLC Active, not recruiting
San Antonio, Texas, United States, 78249
Bandera Family Health Care Active, not recruiting
San Antonio, Texas, United States, 78249
Pioneer Research Solutions, Inc. Active, not recruiting
Sugar Land, Texas, United States, 77479
Northwest Heart Center Active, not recruiting
Tomball, Texas, United States, 77375
United States, Utah
Radiant Research Active, not recruiting
Murray, Utah, United States, 84123
United States, Virginia
Manassas Clinical Research Center Active, not recruiting
Manassas, Virginia, United States, 20110
National Clinical Research-Richmond, Inc. Active, not recruiting
Richmond, Virginia, United States, 23294
Amherst Family Practice, P.C. Active, not recruiting
Winchester, Virginia, United States, 22601
Selma Medical Associates Active, not recruiting
Winchester, Virginia, United States, 22601
United States, Washington
Rainier Clinical Research Center Active, not recruiting
Renton, Washington, United States, 98057
Zain Research LLC Active, not recruiting
Richland, Washington, United States, 99352
Canada, British Columbia
Discovery Clinical Services Ltd. Active, not recruiting
Victoria, British Columbia, Canada, V8T 5G4
Canada, Ontario
Vizel Cardiac Research, Saul Vizel Professional Medicine Corporation Active, not recruiting
Cambridge, Ontario, Canada, N1R 7R1
The Office of Dr. Allen Greenspoon Active, not recruiting
Hamilton, Ontario, Canada, L8L 5G8
London Health Sciences Centre Active, not recruiting
London, Ontario, Canada, N6A 5A5
Stroke Prevention & Atherosclerosis Research Centre (SPARC) Active, not recruiting
London, Ontario, Canada, N6G 2V2
Newmarket Cardiology Research Group Active, not recruiting
Newmarket, Ontario, Canada, L3Y 8C3
London Road Diagnostic Clinic and Medical Centre Active, not recruiting
Sarnia, Ontario, Canada, N7T 4X3
St. Michael's Hospital Health Centre Recruiting
Toronto, Ontario, Canada, M5C 2T2
Canada, Quebec
Rhodin Recherche Clinique Terminated
Drummondville, Quebec, Canada, J2B 7T1
MannaResearch Inc. Active, not recruiting
Levis, Quebec, Canada, G6W 5M6
Omnispec Clinical Research, Inc. Active, not recruiting
Mirabel, Quebec, Canada, J7J 2K8
Montreal Heart Institute Active, not recruiting
Montreal, Quebec, Canada, H1T 1C8
DIEX Research Sherbrooke Inc. Active, not recruiting
Sherbrooke, Quebec, Canada, J1H 1Z1
Colombia
Centro de Medicina del Ejercicio y Rehabilitacion Cardiaca S.A. CEMDE S.A. Active, not recruiting
Medellin, Antioquia, Colombia, 50031
Rodrigo Botero S.A.S. Active, not recruiting
Medellin, Antioquia, Colombia
Fundacion del Caribe para la Investigacion Biomedica-Fundacion Bios Active, not recruiting
Barranquilla, Atlantico, Colombia, 80020
IPS Centro Cientifico Asistencial Jose Luis Accini S.A.S Active, not recruiting
Barranquilla, Atlantico, Colombia
BIOMELAB Ltda. Active, not recruiting
Barranquilla, Atlantico, Colombia
Centro de Diagnostico Cardiologico LTDA. Active, not recruiting
Cartagena, Bolivar, Colombia, 130013
Asociacion IPS Medicos Internitas de Caldas Active, not recruiting
Manizales, Caldas, Colombia, 17001
Instituto de Investigacion Endocrinologia y Prevencion Metabolica ENDOCARE LTDA Active, not recruiting
Bogota, Cundinamarca, Colombia
Dexa Diab Servicios Medicos Ltda. IPS Active, not recruiting
Bogota, Cundinamarca, Colombia, 110221
Fundacion Cardiomet - CEQUIN Active, not recruiting
Armenia, Quindio, Colombia
Fundacion Cardiovascular de Colombia Recruiting
Floridablanca, Santander, Colombia
Fundacion Centro de Investigaciones Biomedicas RIESCARD Active, not recruiting
Espinal, Tolima, Colombia
Centro de Investigaciones Clinicas S.A.S" Active, not recruiting
Cali, Valle del Cauca, Colombia, 760032
France
Private Clinic Elite Medicale Active, not recruiting
Kaunas, France, LT-50177
Nouvelles Cliniques Nantaises Active, not recruiting
Nantes, France, 44200
CHU La Miletrie Terminated
Poitiers, France, 86021
CHU de Toulouse - Hopital Rangueil Active, not recruiting
Toulouse cedex 9, France, 31059
Hopital Guy Chatiliez - Service de cardiologie Active, not recruiting
Tourcoing, France, 59200
Hopital Guy Chatiliez Active, not recruiting
Tourcoing, France, 59200
Hungary
Magyar Imre Korhaz, Belgyogyaszati Szakrendeles Active, not recruiting
Ajka, Hungary, 8400
Bajai Szent Rokus Korhaz Active, not recruiting
Baja, Hungary, 6500
Lausmed Kft. Active, not recruiting
Baja, Hungary, 6500
Drug Research Centre Ltd Active, not recruiting
Balatonfured, Hungary, 8230
SYNEXUS Magyarorszag Kft. Active, not recruiting
Budapest, Hungary, 1036
Pharma 4 Trial Kft. Active, not recruiting
Gyongyos, Hungary, 3200
Borsod-Abauj-Zemplen M-i Korhaz, es Egyetemi Oktatokorhaz Active, not recruiting
Miskolc, Hungary, 3526
TaNaMed Kft. Active, not recruiting
Mosonmagyarovar, Hungary, 9200
Pecsi Tudomanyegyetem Active, not recruiting
Pecs, Hungary, 7623
PTE. II. Dept of Internal Med. and Nephrology Center Active, not recruiting
Pecs, Hungary, 7623
Zala Megyei Korhaz Active, not recruiting
Zalaegerszeg, Hungary, 8900
Lithuania
PI Kaunas Silainiai Outpatient Clinic Active, not recruiting
Kaunas, Lithuania, LT-48259
Private Clinic Elite Medicale Active, not recruiting
Kaunas, Lithuania, LT-50177
PI Klaipeda seamen hospital Active, not recruiting
Klaipeda, Lithuania, LT-92288
Vilnius University Hospital Santariskiu Klinikos Active, not recruiting
Vilnius, Lithuania, LT-08661
Mexico
Clinicos Asociados BOCM, S.C. Active, not recruiting
Mexico, Distrito Federal, Mexico, 03300
Hospital General de Naucalpan "Dr. Maximiliano Ruiz Castaneda" (Emergencies) Active, not recruiting
Naucalpan, Estado de Mexico, Mexico, 35510
Instituto Jalisciense de Investigacion en Diabetes y Obesidad, S.C. Active, not recruiting
Guadalajara, Jalisco, Mexico, 44600
Hospital Bernardette, S.A. DE C.V. (Emergencies) Active, not recruiting
Guadalajara, Jalisco, Mexico, 44200
Instituto de Diabetes, Obesidad y Nutricion S.C. Active, not recruiting
Cuernavaca, Morelos, Mexico, 62250
Administradora de Clinicas S.A. de C.V. Hospital Inovamed Cuernavaca (Emergencies) Active, not recruiting
Cuernavaca, Morelos, Mexico, 62270
Centro de Atención e Investigación Cardiovascular del Potosí S.C. Active, not recruiting
San Luis Potosí, San Luis Potosi, Mexico, 78200
Centenario Hospital Miguel Hidalgo Active, not recruiting
Aguascalientes, Mexico, 20230
Centro de Investigacion Cardiometabolica de Aguascalientes S.A. de C.V. Active, not recruiting
Aguascalientes, Mexico, 20230
Centro Hospitalario Mac, S.A. De C.V. (Emergencies) Active, not recruiting
Aguascalientes, Mexico, 20230
Hospital Angeles Centro Medico del Potosi (Emergencies) Active, not recruiting
San Luis Potosi, Mexico, 78200
Romania
Spitalul Clinic Judetean de Urgenta Craiova, Cardiologie Active, not recruiting
Craiova, Dolj, Romania, 200642
Centrul Medical de Diagnostic si Tratament Ambulator Neomed, Medicina Interna Active, not recruiting
Brasov, Romania, 500283
Sectia Endocrinologie Compartiment Diabet Zaharat, Nutritie si Boli Metabolice Active, not recruiting
Bucuresti, Romania, 010825
Centrul Medical Unirea, Diabet Nutritie si Boli Metabolice Active, not recruiting
Cluj-Napoca, Romania, 400349
Elit Medical SRL Active, not recruiting
Ploiesti, Romania, 100018
Russian Federation
Saint-Petersburg State Budgetary Institution Active, not recruiting
Saint-Petersburg, Sestroretsk City, Russian Federation, 197706
Federal State Budgetary Institution "Research Institute of Complex problems of Cardio-vascular Active, not recruiting
Kemerovo, Russian Federation, 650002
FSAEI of Higher Education "People's Friendship University of Russia", Active, not recruiting
Moscow, Russian Federation, 117292
Saint-Petersburg State Budgetary Institution of Healthcare "Municipal Hospital #15" Active, not recruiting
Saint-Petersburg, Russian Federation, 198205
Municipal institution of healthcare "City clinical hospital 12" Active, not recruiting
Saratov, Russian Federation, 410039
LLC "Institute of medical research" Active, not recruiting
St. Petersburg, Russian Federation, 196084
Spain
Centro Salud Petrer I Active, not recruiting
Petrer, Alicante, Spain, 03610
Hospital Universitario de Bellvitge Active, not recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Clinico Universitario Santiago de Compostela Active, not recruiting
Santiago de Compostela, Galicia, Spain, 15706
Hospital Universitario Sant Joan de Reus Active, not recruiting
Reus, Tarragona, Spain, 43204
Hospital Universitario La Ribera Active, not recruiting
Alzira, Valencia, Spain, 46600
Hospital Universitari Vall d'Hebron Active, not recruiting
Barcelona, Spain, 08035
Hospital Universitario La Paz; Unidad Metabolico-Vascular Active, not recruiting
Madrid, Spain, 28046
Hospital Universitario Quiron Madrid Active, not recruiting
Madrid, Spain, 28223
Hospital Clinico Universitario Miguel Servet; Medicina Interna Active, not recruiting
Zaragoza, Spain, 50009
Taiwan
Cardinal Tien Hospital Active, not recruiting
New Taipei City, Taiwan, 23148
Taichung Veterans General Hospital Active, not recruiting
Taichung, Taiwan, 40705
China Medical University Hospital Active, not recruiting
Taichung, Taiwan, 40447
Taipei Veterans General Hospital Active, not recruiting
Taipei, Taiwan, 11217
United Kingdom
Synexus Thames Valley Active, not recruiting
Reading, Berkshire, United Kingdom, RG2 0TG
Synexus Manchester Clinical Research Centre Active, not recruiting
Manchester, Greater Manchester, United Kingdom, M15 6SX
Synexus Scotland clinical research centre Active, not recruiting
Glasgow, Lanarkshire, United Kingdom, G20 0SP
Synexus Lancashire Clinical Research Centre Active, not recruiting
Chorley, Lancashire, United Kingdom, PR7 7NA
Synexus Merseyside Clinical Research Centre Active, not recruiting
Liverpool, Merseyside, United Kingdom, L22 0LG
Northmed Clinical Research Ltd, Randalstown Health Centre Active, not recruiting
Antrim, Northern Ireland, United Kingdom, BT41 3AE
Southern Health & Social Care Trust, Craigavon Area Hospital Active, not recruiting
Portadown, Northern Ireland, United Kingdom, BT63 5QQ
Synexus North East Clinical Research Centre - Hexham General Hospital Active, not recruiting
Hexham, Northumberland, United Kingdom, NE46 1QJ
The Crouch Oak Family Practice Active, not recruiting
Addlestone, Surrey, United Kingdom, KT15 2BH
Synexus Midlands Clinical Research Centre Active, not recruiting
Birmingham, West Midlands, United Kingdom, B15 2SQ
The Bradford on Avon & Melksham Health Partnership Active, not recruiting
Bradford on Avon, Wiltshire, United Kingdom, BA15 1DQ
Synexus Wales Clinical Research Centre Active, not recruiting
Cardiff, United Kingdom, CF14 5GJ
NHS Tayside Active, not recruiting
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: April 20, 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 May 04, 2016