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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)

Primary Purpose

Hyperlipidemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bococizumab (PF-04950615; RN316)
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemia focused on measuring mixed dyslipidemia, high risk of cardiovascular events, multiple cardiovascular disease risk factors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ernest L. Hendrix, MD, PC
  • North Alabama Research Center, LLC
  • The Kirklin Clinic
  • Alabama Internal Medicine, P.C.
  • Drug Shipment and Study Conducted at Address: University of Alabama at Birmingham
  • Heart Center Research, Llc
  • Radiant Research Incorporated
  • Advanced Research Associates
  • Arizona Center For Internal Medicine
  • Holland Center for Family Health
  • Elite Clinical Studies, LLC
  • Phoenix Clinical
  • Desert Sun Clinical Research, LLC
  • Advanced Arizona Clinical Research
  • Care Clinical Research Corporation
  • Med Center
  • Med Investigations
  • California Heart Specialists
  • Alia Clinical Research, Inc.
  • Downtown L.A. Research Center, Inc.
  • Richard S. Cherlin, M.D.
  • California Medical Research Associates Inc.
  • Arch Health Partners Clinical Research Department
  • Clinical Trials Research
  • Northern California Research
  • Alta California Medical Group
  • Orange County Research Center
  • Empire Clinical Research
  • Diablo Clinical Research, Inc.
  • Infosphere Clinical Research, INC
  • Clinicos, LLC
  • Clinical Research Advantage, Inc./Colorado Springs Health Partners, SW
  • YNHH, Heart and Vascular
  • ACRC-Cardiology
  • Morton Plant Mease Health Care, Inc. Cardiovascular Research
  • Avail Clinical Research, LLC
  • Fleming Island Center for Clinical Research
  • Invesclinic, LLC
  • Florida Research Network, LLC
  • AGA Clinical Trials
  • The Research Center, Inc.
  • Homestead Medical Research Inc.
  • Nature Coast Clinical Research
  • Westside Center for Clinical Research
  • East Coast Institute for Research, LLC at Baker-Gilmour Cardiovascular Institute, PA
  • East Coast Institute for Research, LLC at Jacksonville Cardiovascular Center
  • East Coast Institute for Research, LLC at Northeast Florida Cardiology Clinic
  • East Coast Institute for Research, LLC at Northeast Florida Endocrine & Diabetes Associates
  • St. Vincent's Cardiology
  • San Marcus Research Clinic, Inc.
  • Clinical Research of Miami
  • Finlay Medical Research
  • Medical Research Center
  • International Research Associates, LLC
  • Kendall South Medical Center
  • Florida Institute For Clinical Research, LLC
  • Oviedo Medical Research, LLC
  • A&R Research Group, LLC
  • DBC Research
  • St. Johns Center for Clinical Research
  • South Miami Clinical Research Center, LLC
  • Dolphin Medical Research
  • Metabolic Research Institute Incorporated
  • Clinical Research of Central Florida
  • Atlanta Diabetes Associates
  • Atlanta Center for Clinical Research / Internal Medicine
  • North Georgia Clinical Research
  • North Georgia Internal Medicine
  • East-West Medical Research Institute
  • Northwest Clinical Trials, Inc.
  • Solaris Clinical Research
  • Investigators Research Group, LLC
  • American Health Network, LLC
  • Midwest Institute for Clinical Research
  • Buynak Clinical Research, P.C.
  • West Broadway Clinic
  • The University of Iowa - College of Public Health - Preventive Intervention Center
  • University of Kansas Medical Center
  • Midwest Heart and Vascular Specialists
  • Omega Clinical Research
  • New Orleans Center for Clinical Research
  • Southern Maine Health Care
  • Columbia Medical Practice
  • MD Medical Research
  • IHA Chelsea Family & Internal Medicine
  • QUEST Research Institute
  • Westside Family Medical Center, Pc
  • Michigan Heart and Vascular Specialists
  • Oakland Medical Research Center
  • Radiant Research, Inc.
  • HealthEast Medical Research Institute
  • HealthEast St. Joseph's Hospital Pharmacy
  • KCUMB Center for Community and Clinical Research
  • Mercy Health Research
  • Om Medical
  • Clinical Research of South Nevada
  • Rutgers Biomedical and Health Sciences- Robert Wood Johnson Medical School
  • Cardio Metabolic Institute
  • Premier Research
  • Albany Medical College, Division of Community Endocrinology
  • Drug Trials Brooklyn
  • Drug Trials America
  • SJH Cardiology Associates
  • Mid Hudson Medical Research, PLLC
  • Sensenbrenner Primary Care
  • PharmQuest
  • Crossroads Clinical Research, Inc.
  • PMG Research of Salisbury, LLC
  • PMG Research of Wilmington, LLC
  • PMG Research of Winston-Salem
  • Radiant Research, Inc
  • Community Health Care, Inc.
  • Sterling Research Group, Ltd.
  • The Lindner Center for Research and Education at The Christ Hospital
  • Metabolic and Atherosclerosis Research Center
  • Sentral Clinical Research Services - Admin Only
  • Sentral Clinical Research Services
  • Sterling Research Group, Ltd.
  • LION Research
  • Clinical Research Institute of Southern Oregon, PC
  • Brandywine Clinical Research
  • Altoona Center for Clinical Research
  • Liberty Family Practice
  • Detweiler Family Medicine and Associates, PC
  • Suburban Research Associates
  • Allegheny Endocrinology Associates
  • Guthrie Medical Group, PC
  • Warminster Medical Associates, P.C.
  • Coastal Cardiology
  • Upstate Pharmaceutical Research
  • Palmetto Clinical Research
  • Cardiovascular Research of Knoxville
  • New Orleans Center for Clinical Research
  • Volunteer Research Group
  • KRK Medical Research
  • North Texas Healthcare System, Dallas VAMC
  • Research Institute of Dallas
  • University of North Texas Health Science Center at Fort Worth
  • Baylor College of Medicine
  • lnvestigational Drug Services (IDA)
  • Northwest Houston Cardiology
  • Texas Center for Drug Development, Inc.
  • Pioneer Research Solutions, Inc.
  • Hill Country Medical Associates
  • Advanced Clinical Research Associates
  • Sun Research Institute
  • Bandera Family Health Care, LLC
  • Northwest Heart Center
  • Radiant Research
  • Manassas Clinical Research Center
  • National Clinical Research-Richmond, Inc.
  • Amherst Family Practice, P.C.
  • Selma Medical Associates
  • Rainier Clinical Research Center
  • Zain Research LLC
  • Discovery Clinical Services Ltd.
  • Vizel Cardiac Research, Saul Vizel Professional Medicine Corporation
  • The Office of Dr. Allen Greenspoon
  • London Health Sciences Centre
  • Stroke Prevention & Atherosclerosis Research Centre (SPARC)
  • Newmarket Cardiology Research Group
  • London Road Diagnostic Clinic and Medical Centre
  • St. Michael's Hospital Health Centre
  • Rhodin Recherche Clinique
  • LMC Research Inc. d.b.a. Manna Research Inc.
  • Omnispec Clinical Research Inc.
  • Montreal Heart Institute
  • DIEX Research Sherbrooke Inc.
  • Rodrigo Botero S.A.S
  • Centro de Medicina del Ejercicio y Rehabilitacion Cardiaca S.A. CEMDE S.A.
  • Fundacion del Caribe para la Investigacion Biomedica-Fundacion Bios
  • BIOMELAB Ltda.
  • IPS Centro Cientifico Asistencial Jose Luis Accini S.A.S.
  • Centro de Diagnostico Cardiologico LTDA.
  • Asociacion IPS Medicos InterniStas de Caldas
  • Dexa Diab Servicios Medicos Ltda. IPS
  • Instituto de Investigacion Endocrinologia y Prevencion Metabolica ENDOCARE LTDA
  • Fundacion Cardiomet - CEQUIN
  • Fundacion Cardiovascular De Colombia
  • Fundacion Centro de Investigaciones Biomedicas RIESCARD
  • Centro de Investigaciones Clinicas S.A.S
  • Nouvelles Cliniques Nantaises
  • CHU La Miletrie
  • CHU de Toulouse - Hopital Rangueil
  • Hopital Guy Chatiliez
  • Hopital Guy Chatillez
  • Magyar Imre Korhaz, Belgyogyaszati Szakrendeles
  • Bajai Szent Rokus Korhaz
  • Lausmed Kft.
  • DRC Kft.
  • SYNEXUS Magyarorszag Kft.
  • Synexus Magyarorzag Kft.
  • Pharma 4 Trial Kft.
  • Borsod-Abauj-Zemplen Megyei Korhaz, es Egyetemi Oktatokorhaz
  • TaNaMed Kft.
  • Pecsi Tudomanyegyetem
  • Zala Megyei Korhaz
  • PI Kaunas Silainiai Outpatient Clinic
  • Private Clinic Elite Medicale
  • PI Klaipeda Seamen Hospital
  • Vilnius University Hospital Santariskiu Klinikos
  • Clinicos Asociados BOCM, S.C.
  • Hospital General de Naucalpan "Dr. Maximiliano Ruiz Castaneda" (Emergencies)
  • Instituto Jalisciense de Investigacion en Diabetes y Obesidad, S.C.
  • Instituto de Diabetes, Obesidad y Nutricion S.C.
  • Administradora de Clinicas S.A. de C.V. Hospital Inovamed Cuernavaca
  • Centro de Atención e Investigación Cardiovascular del Potosí S.C.
  • Centenario Hospital Miguel Hidalgo
  • Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV
  • Centro Hospitalario Mac, S.A. De C.V. (Emergencies)
  • Hospital Angeles Centro Medico del Potosi (Emergencies)
  • Spitalul Clinic Judetean de Urgenta Craiova, Cardiologie
  • Centrul Medical de Diagnostic si Tratament Ambulator Neomed, Medicina Interna
  • Spitalul Universitar de Urgenta Militar Central, Dr. Carol Davila"
  • Centrul Medical Unirea, Diabet Nutritie si Boli Metabolice
  • Elit Medical SRL
  • Federal State Budgetary Institution "Research Institute of Complex problems of Cardio-vascular
  • FSAEI of Higher Education "People's Friendship University of Russia",
  • Saint-Petersburg State Budgetary Institution of Healthcare Municipal hospital # 40 of the Kurortnyi
  • Saint-Petersburg State Budgetary Institution of Healthcare "Municipal Hospital #15"
  • Municipal Institution of Healthcare "City Clinical Hospital 12
  • LLC "Institute of medical research"
  • Centro Salud Petrer I
  • Hospital Universitario de Bellvitge
  • Hospital Clinico Universitario Santiago de Compostela
  • Hospital Universitario Quiron Madrid
  • Hospital Universitario Sant Joan de Reus
  • Hospital Universitario La Ribera
  • Hospital Universitari Vall d'Hebron
  • Hospital Universitario La Paz; Unidad Metabolico-Vascular
  • Hospital Clinico Universitario Miguel Servet; Medicina Interna
  • Cardinal Tien Hospital
  • China Medical University Hospital
  • Taichung Veterans General Hospital
  • Taipei Veterans General Hospital
  • Synexus Thames Valley Clinical Research Centre
  • Synexus Manchester Clinical Research Centre
  • Synexus Scotland Clinical Research Centre
  • Synexus Lancashire Clinical Research Centre
  • Synexus Wales Clinical Research Centre
  • Synexus Merseyside Clinical Research Centre
  • Northmed Clinical Research Ltd, Randalstown Health Centre
  • Southern Health & Social Care Trust, Craigavon Area Hospital
  • Synexus North East Clinical Research Centre-Hexham General Hospital
  • Synexus North East Clinical Research Centre
  • The Crouch Oak Family Practice
  • Synexus Midlands Clinical Research Centre
  • The Bradford on Avon & Melksham Health Partnership
  • Ninewells Hospital & Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bococizumab (PF-04950615; RN316)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

Secondary Outcome Measures

Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52
Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52
Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides (TG) Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52
Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Week 12, 24 and 52
Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24, 52: Treatment Period
Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52
Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52
Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52
Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52
Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12
Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12
Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12
Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (HDL-C) at Week 12
Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12
Absolute Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Week 12
Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12
Absolute Change From Baseline in Ratio of Fasting Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52
Change From Baseline in Ratio of Fasting Apolipoprotein B (ApoB) to Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52
Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52
Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52
Plasma Concentration of PF-04950615 at Week 12, 24 and 52
Plasma concentration of PF-04950615 at Week 12, 24 and 52 was reported.
Number of Participants With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions
Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia's, polysynovitis, fever and if severe then included glomerulonephritis. Injection site reactions included injection site bruising, discolouration, erythema, haematoma, haemorrhage, nodule, induration, inflammation, mass, pain, paraesthesia, pruritus, swelling, vesicles, warmth, scab and rash. Participants with type 1 or type 3 hypersensitivity reactions and participants with injection site reactions were reported in this outcome measure.
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Treatment Period
Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. ADA titer >=6.23 (log2) unit was considered to be ADA positive and nAb titer >=1.58 (log2) unit was considered to be nAb positive.
Number of Participants Who Changed Concomitant Medication During Extension Period
In this outcome measure, total number of participants who changed their lipid-lowering medications or added a monoclonal antibody medication during the extension period were reported.
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 Follow-up Visit, 71, 84, 97 and 110: Extension Period
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period
Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. ADA titer >=6.23 (log2) unit was considered to be ADA positive and nAb titer >=1.58 (log2) unit was considered to be nAb positive.

Full Information

First Posted
October 21, 2013
Last Updated
July 2, 2018
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01968967
Brief Title
Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events
Acronym
SPIRE-LDL
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 29, 2013 (Actual)
Primary Completion Date
July 5, 2016 (Actual)
Study Completion Date
July 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia
Keywords
mixed dyslipidemia, high risk of cardiovascular events, multiple cardiovascular disease risk factors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bococizumab (PF-04950615; RN316)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Bococizumab (PF-04950615; RN316)
Intervention Description
150 mg every 2 weeks, subcutaneous injection, 12 months
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
subcutaneous injection every 2 weeks for 12 months
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52
Time Frame
Baseline, Week 12, 24, 52
Title
Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52
Time Frame
Baseline, Week 12, 24, 52
Title
Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52
Time Frame
Baseline, Week 12, 24, 52
Title
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides (TG) Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52
Time Frame
Baseline, Week 12, 24, 52
Title
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52
Time Frame
Baseline, Week 12, 24, 52
Title
Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Week 12, 24 and 52
Time Frame
Baseline, Week 12, 24, 52
Title
Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52
Time Frame
Baseline, Week 12, 24, 52
Title
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24, 52: Treatment Period
Time Frame
Baseline, Week 24, 52
Title
Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52
Time Frame
Baseline, Week 12, 24, 52
Title
Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52
Time Frame
Baseline, Week 12, 24, 52
Title
Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52
Time Frame
Baseline, Week 12, 24, 52
Title
Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52
Time Frame
Baseline, Week 12, 24, 52
Title
Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12
Time Frame
Baseline, Week 12
Title
Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12
Time Frame
Baseline, Week 12
Title
Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Time Frame
Baseline, Week 12
Title
Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12
Time Frame
Baseline, Week 12
Title
Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (HDL-C) at Week 12
Time Frame
Baseline, Week 12
Title
Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12
Time Frame
Baseline, Week 12
Title
Absolute Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Week 12
Time Frame
Baseline, Week 12
Title
Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12
Time Frame
Baseline, Week 12
Title
Absolute Change From Baseline in Ratio of Fasting Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52
Time Frame
Baseline, Week 12, 24, 52
Title
Change From Baseline in Ratio of Fasting Apolipoprotein B (ApoB) to Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52
Time Frame
Baseline, Week 12, 24, 52
Title
Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52
Time Frame
Week 12, 24, 52
Title
Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52
Time Frame
Week 12, 24, 52
Title
Plasma Concentration of PF-04950615 at Week 12, 24 and 52
Description
Plasma concentration of PF-04950615 at Week 12, 24 and 52 was reported.
Time Frame
Week 12, 24, 52
Title
Number of Participants With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions
Description
Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia's, polysynovitis, fever and if severe then included glomerulonephritis. Injection site reactions included injection site bruising, discolouration, erythema, haematoma, haemorrhage, nodule, induration, inflammation, mass, pain, paraesthesia, pruritus, swelling, vesicles, warmth, scab and rash. Participants with type 1 or type 3 hypersensitivity reactions and participants with injection site reactions were reported in this outcome measure.
Time Frame
Baseline up to Week 58
Title
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Treatment Period
Description
Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. ADA titer >=6.23 (log2) unit was considered to be ADA positive and nAb titer >=1.58 (log2) unit was considered to be nAb positive.
Time Frame
Baseline up to Week 58
Title
Number of Participants Who Changed Concomitant Medication During Extension Period
Description
In this outcome measure, total number of participants who changed their lipid-lowering medications or added a monoclonal antibody medication during the extension period were reported.
Time Frame
Week 58 follow-up visit to Week 110
Title
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 Follow-up Visit, 71, 84, 97 and 110: Extension Period
Time Frame
Baseline, Week 58 follow-up visit, 71, 84, 97, 110
Title
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period
Description
Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. ADA titer >=6.23 (log2) unit was considered to be ADA positive and nAb titer >=1.58 (log2) unit was considered to be nAb positive.
Time Frame
Week 58 follow-up visit, Week 71, Week 84, Week 97, Week 110

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Ernest L. Hendrix, MD, PC
City
Athens
State/Province
Alabama
ZIP/Postal Code
35611
Country
United States
Facility Name
North Alabama Research Center, LLC
City
Athens
State/Province
Alabama
ZIP/Postal Code
35611
Country
United States
Facility Name
The Kirklin Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Alabama Internal Medicine, P.C.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Drug Shipment and Study Conducted at Address: University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Heart Center Research, Llc
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Radiant Research Incorporated
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Advanced Research Associates
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
Facility Name
Arizona Center For Internal Medicine
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85205
Country
United States
Facility Name
Holland Center for Family Health
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Elite Clinical Studies, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Phoenix Clinical
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85021
Country
United States
Facility Name
Desert Sun Clinical Research, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Advanced Arizona Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Care Clinical Research Corporation
City
Banning
State/Province
California
ZIP/Postal Code
92220
Country
United States
Facility Name
Med Center
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
Med Investigations
City
Fair Oaks
State/Province
California
ZIP/Postal Code
95628
Country
United States
Facility Name
California Heart Specialists
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Facility Name
Alia Clinical Research, Inc.
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
Downtown L.A. Research Center, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Richard S. Cherlin, M.D.
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
California Medical Research Associates Inc.
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Arch Health Partners Clinical Research Department
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Clinical Trials Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Northern California Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Alta California Medical Group
City
Simi Valley
State/Province
California
ZIP/Postal Code
93065
Country
United States
Facility Name
Orange County Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Empire Clinical Research
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Diablo Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Infosphere Clinical Research, INC
City
West Hills
State/Province
California
ZIP/Postal Code
91307
Country
United States
Facility Name
Clinicos, LLC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80904
Country
United States
Facility Name
Clinical Research Advantage, Inc./Colorado Springs Health Partners, SW
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80906
Country
United States
Facility Name
YNHH, Heart and Vascular
City
North Haven
State/Province
Connecticut
ZIP/Postal Code
06473
Country
United States
Facility Name
ACRC-Cardiology
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Morton Plant Mease Health Care, Inc. Cardiovascular Research
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Avail Clinical Research, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Fleming Island Center for Clinical Research
City
Fleming Island
State/Province
Florida
ZIP/Postal Code
32003
Country
United States
Facility Name
Invesclinic, LLC
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Florida Research Network, LLC
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
AGA Clinical Trials
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
The Research Center, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
Homestead Medical Research Inc.
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030
Country
United States
Facility Name
Nature Coast Clinical Research
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
Westside Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32205
Country
United States
Facility Name
East Coast Institute for Research, LLC at Baker-Gilmour Cardiovascular Institute, PA
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
East Coast Institute for Research, LLC at Jacksonville Cardiovascular Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
East Coast Institute for Research, LLC at Northeast Florida Cardiology Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
East Coast Institute for Research, LLC at Northeast Florida Endocrine & Diabetes Associates
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
St. Vincent's Cardiology
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
San Marcus Research Clinic, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
Clinical Research of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Finlay Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Medical Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
International Research Associates, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33183
Country
United States
Facility Name
Kendall South Medical Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33185
Country
United States
Facility Name
Florida Institute For Clinical Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32825
Country
United States
Facility Name
Oviedo Medical Research, LLC
City
Oviedo
State/Province
Florida
ZIP/Postal Code
32765
Country
United States
Facility Name
A&R Research Group, LLC
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
DBC Research
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33029
Country
United States
Facility Name
St. Johns Center for Clinical Research
City
Ponte Vedra
State/Province
Florida
ZIP/Postal Code
32081
Country
United States
Facility Name
South Miami Clinical Research Center, LLC
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Dolphin Medical Research
City
Virginia Gardens
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Metabolic Research Institute Incorporated
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Clinical Research of Central Florida
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Atlanta Diabetes Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Atlanta Center for Clinical Research / Internal Medicine
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30075
Country
United States
Facility Name
North Georgia Clinical Research
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
North Georgia Internal Medicine
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
East-West Medical Research Institute
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Northwest Clinical Trials, Inc.
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Solaris Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646
Country
United States
Facility Name
Investigators Research Group, LLC
City
Brownsburg
State/Province
Indiana
ZIP/Postal Code
46112
Country
United States
Facility Name
American Health Network, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46254
Country
United States
Facility Name
Midwest Institute for Clinical Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Buynak Clinical Research, P.C.
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
Facility Name
West Broadway Clinic
City
Council Bluffs
State/Province
Iowa
ZIP/Postal Code
51501
Country
United States
Facility Name
The University of Iowa - College of Public Health - Preventive Intervention Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Midwest Heart and Vascular Specialists
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Omega Clinical Research
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
New Orleans Center for Clinical Research
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
Facility Name
Southern Maine Health Care
City
Biddeford
State/Province
Maine
ZIP/Postal Code
04005
Country
United States
Facility Name
Columbia Medical Practice
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
Facility Name
MD Medical Research
City
Oxon Hill
State/Province
Maryland
ZIP/Postal Code
20745
Country
United States
Facility Name
IHA Chelsea Family & Internal Medicine
City
Chelsea
State/Province
Michigan
ZIP/Postal Code
48118
Country
United States
Facility Name
QUEST Research Institute
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Westside Family Medical Center, Pc
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Michigan Heart and Vascular Specialists
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
Oakland Medical Research Center
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Radiant Research, Inc.
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
HealthEast Medical Research Institute
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
HealthEast St. Joseph's Hospital Pharmacy
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
KCUMB Center for Community and Clinical Research
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64106
Country
United States
Facility Name
Mercy Health Research
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
Om Medical
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Clinical Research of South Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89121
Country
United States
Facility Name
Rutgers Biomedical and Health Sciences- Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Cardio Metabolic Institute
City
Somerset
State/Province
New Jersey
ZIP/Postal Code
08873
Country
United States
Facility Name
Premier Research
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08611
Country
United States
Facility Name
Albany Medical College, Division of Community Endocrinology
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Drug Trials Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11230
Country
United States
Facility Name
Drug Trials America
City
Hartsdale
State/Province
New York
ZIP/Postal Code
10530
Country
United States
Facility Name
SJH Cardiology Associates
City
Liverpool
State/Province
New York
ZIP/Postal Code
13088
Country
United States
Facility Name
Mid Hudson Medical Research, PLLC
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Facility Name
Sensenbrenner Primary Care
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
PharmQuest
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Crossroads Clinical Research, Inc.
City
Mooresville
State/Province
North Carolina
ZIP/Postal Code
28117
Country
United States
Facility Name
PMG Research of Salisbury, LLC
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
PMG Research of Wilmington, LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
PMG Research of Winston-Salem
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Radiant Research, Inc
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
Community Health Care, Inc.
City
Canal Fulton
State/Province
Ohio
ZIP/Postal Code
44614
Country
United States
Facility Name
Sterling Research Group, Ltd.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
The Lindner Center for Research and Education at The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Metabolic and Atherosclerosis Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Sentral Clinical Research Services - Admin Only
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Sentral Clinical Research Services
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Sterling Research Group, Ltd.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
Facility Name
LION Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73072
Country
United States
Facility Name
Clinical Research Institute of Southern Oregon, PC
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Brandywine Clinical Research
City
Downingtown
State/Province
Pennsylvania
ZIP/Postal Code
19335
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Liberty Family Practice
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16508
Country
United States
Facility Name
Detweiler Family Medicine and Associates, PC
City
Lansdale
State/Province
Pennsylvania
ZIP/Postal Code
19446
Country
United States
Facility Name
Suburban Research Associates
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Allegheny Endocrinology Associates
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Guthrie Medical Group, PC
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Warminster Medical Associates, P.C.
City
Warminster
State/Province
Pennsylvania
ZIP/Postal Code
18974
Country
United States
Facility Name
Coastal Cardiology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Upstate Pharmaceutical Research
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Palmetto Clinical Research
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Facility Name
Cardiovascular Research of Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37917
Country
United States
Facility Name
New Orleans Center for Clinical Research
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Volunteer Research Group
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
KRK Medical Research
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
North Texas Healthcare System, Dallas VAMC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Research Institute of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
University of North Texas Health Science Center at Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
lnvestigational Drug Services (IDA)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Northwest Houston Cardiology
City
Houston
State/Province
Texas
ZIP/Postal Code
77070
Country
United States
Facility Name
Texas Center for Drug Development, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Pioneer Research Solutions, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
Hill Country Medical Associates
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Advanced Clinical Research Associates
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Bandera Family Health Care, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Facility Name
Northwest Heart Center
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Radiant Research
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
Manassas Clinical Research Center
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States
Facility Name
National Clinical Research-Richmond, Inc.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Amherst Family Practice, P.C.
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Selma Medical Associates
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Rainier Clinical Research Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
Zain Research LLC
City
Richland
State/Province
Washington
ZIP/Postal Code
99352
Country
United States
Facility Name
Discovery Clinical Services Ltd.
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8T 5G4
Country
Canada
Facility Name
Vizel Cardiac Research, Saul Vizel Professional Medicine Corporation
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N1R 7R1
Country
Canada
Facility Name
The Office of Dr. Allen Greenspoon
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 5G8
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Stroke Prevention & Atherosclerosis Research Centre (SPARC)
City
London
State/Province
Ontario
ZIP/Postal Code
N6G 2V2
Country
Canada
Facility Name
Newmarket Cardiology Research Group
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 8C3
Country
Canada
Facility Name
London Road Diagnostic Clinic and Medical Centre
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
St. Michael's Hospital Health Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 2T2
Country
Canada
Facility Name
Rhodin Recherche Clinique
City
Drummondville
State/Province
Quebec
ZIP/Postal Code
J2B 7T1
Country
Canada
Facility Name
LMC Research Inc. d.b.a. Manna Research Inc.
City
Levis
State/Province
Quebec
ZIP/Postal Code
G6W 0M5
Country
Canada
Facility Name
Omnispec Clinical Research Inc.
City
Mirabel
State/Province
Quebec
ZIP/Postal Code
J7J 2K8
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
DIEX Research Sherbrooke Inc.
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 1Z1
Country
Canada
Facility Name
Rodrigo Botero S.A.S
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050012
Country
Colombia
Facility Name
Centro de Medicina del Ejercicio y Rehabilitacion Cardiaca S.A. CEMDE S.A.
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
50031
Country
Colombia
Facility Name
Fundacion del Caribe para la Investigacion Biomedica-Fundacion Bios
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
80020
Country
Colombia
Facility Name
BIOMELAB Ltda.
City
Barranquilla
State/Province
Atlantico
Country
Colombia
Facility Name
IPS Centro Cientifico Asistencial Jose Luis Accini S.A.S.
City
Barranquilla
State/Province
Atlantico
Country
Colombia
Facility Name
Centro de Diagnostico Cardiologico LTDA.
City
Cartagena
State/Province
Bolivar
ZIP/Postal Code
130013
Country
Colombia
Facility Name
Asociacion IPS Medicos InterniStas de Caldas
City
Manizales
State/Province
Caldas
ZIP/Postal Code
17001
Country
Colombia
Facility Name
Dexa Diab Servicios Medicos Ltda. IPS
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Instituto de Investigacion Endocrinologia y Prevencion Metabolica ENDOCARE LTDA
City
Bogota
State/Province
Cundinamarca
Country
Colombia
Facility Name
Fundacion Cardiomet - CEQUIN
City
Armenia
State/Province
Quindio
Country
Colombia
Facility Name
Fundacion Cardiovascular De Colombia
City
Floridablanca
State/Province
Santander
Country
Colombia
Facility Name
Fundacion Centro de Investigaciones Biomedicas RIESCARD
City
Espinal
State/Province
Tolima
Country
Colombia
Facility Name
Centro de Investigaciones Clinicas S.A.S
City
Cali
State/Province
Valle DEL Cauca
ZIP/Postal Code
760032
Country
Colombia
Facility Name
Nouvelles Cliniques Nantaises
City
Nantes
ZIP/Postal Code
44200
Country
France
Facility Name
CHU La Miletrie
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
CHU de Toulouse - Hopital Rangueil
City
Toulouse cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Hopital Guy Chatiliez
City
Tourcoing
ZIP/Postal Code
59200
Country
France
Facility Name
Hopital Guy Chatillez
City
Tourcoing
ZIP/Postal Code
59200
Country
France
Facility Name
Magyar Imre Korhaz, Belgyogyaszati Szakrendeles
City
Ajka
ZIP/Postal Code
8400
Country
Hungary
Facility Name
Bajai Szent Rokus Korhaz
City
Baja
ZIP/Postal Code
6500
Country
Hungary
Facility Name
Lausmed Kft.
City
Baja
ZIP/Postal Code
6500
Country
Hungary
Facility Name
DRC Kft.
City
Balatonfured
ZIP/Postal Code
8230
Country
Hungary
Facility Name
SYNEXUS Magyarorszag Kft.
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Synexus Magyarorzag Kft.
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Pharma 4 Trial Kft.
City
Gyongyos
ZIP/Postal Code
3200
Country
Hungary
Facility Name
Borsod-Abauj-Zemplen Megyei Korhaz, es Egyetemi Oktatokorhaz
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
TaNaMed Kft.
City
Mosonmagyarovar
ZIP/Postal Code
9200
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem
City
Pecs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Zala Megyei Korhaz
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
PI Kaunas Silainiai Outpatient Clinic
City
Kaunas
ZIP/Postal Code
LT-48259
Country
Lithuania
Facility Name
Private Clinic Elite Medicale
City
Kaunas
ZIP/Postal Code
LT-50177
Country
Lithuania
Facility Name
PI Klaipeda Seamen Hospital
City
Klaipeda
ZIP/Postal Code
LT-92288
Country
Lithuania
Facility Name
Vilnius University Hospital Santariskiu Klinikos
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Clinicos Asociados BOCM, S.C.
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
03300
Country
Mexico
Facility Name
Hospital General de Naucalpan "Dr. Maximiliano Ruiz Castaneda" (Emergencies)
City
Naucalpan
State/Province
Estado DE Mexico
ZIP/Postal Code
35510
Country
Mexico
Facility Name
Instituto Jalisciense de Investigacion en Diabetes y Obesidad, S.C.
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44600
Country
Mexico
Facility Name
Instituto de Diabetes, Obesidad y Nutricion S.C.
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62250
Country
Mexico
Facility Name
Administradora de Clinicas S.A. de C.V. Hospital Inovamed Cuernavaca
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62270
Country
Mexico
Facility Name
Centro de Atención e Investigación Cardiovascular del Potosí S.C.
City
San Luis Potosí
State/Province
SAN LUIS Potosi
ZIP/Postal Code
78200
Country
Mexico
Facility Name
Centenario Hospital Miguel Hidalgo
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Centro Hospitalario Mac, S.A. De C.V. (Emergencies)
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Hospital Angeles Centro Medico del Potosi (Emergencies)
City
San Luis Potosi
ZIP/Postal Code
78200
Country
Mexico
Facility Name
Spitalul Clinic Judetean de Urgenta Craiova, Cardiologie
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200642
Country
Romania
Facility Name
Centrul Medical de Diagnostic si Tratament Ambulator Neomed, Medicina Interna
City
Brasov
ZIP/Postal Code
500283
Country
Romania
Facility Name
Spitalul Universitar de Urgenta Militar Central, Dr. Carol Davila"
City
Bucuresti
ZIP/Postal Code
010825
Country
Romania
Facility Name
Centrul Medical Unirea, Diabet Nutritie si Boli Metabolice
City
Cluj-Napoca
ZIP/Postal Code
400349
Country
Romania
Facility Name
Elit Medical SRL
City
Ploiesti
ZIP/Postal Code
100018
Country
Romania
Facility Name
Federal State Budgetary Institution "Research Institute of Complex problems of Cardio-vascular
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
Facility Name
FSAEI of Higher Education "People's Friendship University of Russia",
City
Moscow
ZIP/Postal Code
117292
Country
Russian Federation
Facility Name
Saint-Petersburg State Budgetary Institution of Healthcare Municipal hospital # 40 of the Kurortnyi
City
Saint-Petersburg
ZIP/Postal Code
197706
Country
Russian Federation
Facility Name
Saint-Petersburg State Budgetary Institution of Healthcare "Municipal Hospital #15"
City
Saint-Petersburg
ZIP/Postal Code
198205
Country
Russian Federation
Facility Name
Municipal Institution of Healthcare "City Clinical Hospital 12
City
Saratov
ZIP/Postal Code
410039
Country
Russian Federation
Facility Name
LLC "Institute of medical research"
City
St. Petersburg
ZIP/Postal Code
196084
Country
Russian Federation
Facility Name
Centro Salud Petrer I
City
Petrer
State/Province
Alicante
ZIP/Postal Code
03610
Country
Spain
Facility Name
Hospital Universitario de Bellvitge
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Clinico Universitario Santiago de Compostela
City
Santiago de Compostela
State/Province
Galicia
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Universitario Quiron Madrid
City
Pozuelo de Alarcon
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Hospital Universitario Sant Joan de Reus
City
Reus
State/Province
Tarragona
ZIP/Postal Code
43204
Country
Spain
Facility Name
Hospital Universitario La Ribera
City
Alzira
State/Province
Valencia
ZIP/Postal Code
46600
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario La Paz; Unidad Metabolico-Vascular
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Clinico Universitario Miguel Servet; Medicina Interna
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Cardinal Tien Hospital
City
New Taipei City
ZIP/Postal Code
23148
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Synexus Thames Valley Clinical Research Centre
City
Reading
State/Province
Berkshire
ZIP/Postal Code
RG2 0TG
Country
United Kingdom
Facility Name
Synexus Manchester Clinical Research Centre
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M15 6SX
Country
United Kingdom
Facility Name
Synexus Scotland Clinical Research Centre
City
Glasgow
State/Province
Lanarkshire
ZIP/Postal Code
G20 0SP
Country
United Kingdom
Facility Name
Synexus Lancashire Clinical Research Centre
City
Chorley
State/Province
Lancashire
ZIP/Postal Code
PR7 7NA
Country
United Kingdom
Facility Name
Synexus Wales Clinical Research Centre
City
Cardiff
State/Province
Llanishen
ZIP/Postal Code
CF14 5GJ
Country
United Kingdom
Facility Name
Synexus Merseyside Clinical Research Centre
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L22 0LG
Country
United Kingdom
Facility Name
Northmed Clinical Research Ltd, Randalstown Health Centre
City
Antrim
State/Province
Northern Ireland
ZIP/Postal Code
BT41 3AE
Country
United Kingdom
Facility Name
Southern Health & Social Care Trust, Craigavon Area Hospital
City
Portadown
State/Province
Northern Ireland
ZIP/Postal Code
BT63 5QQ
Country
United Kingdom
Facility Name
Synexus North East Clinical Research Centre-Hexham General Hospital
City
Hexham
State/Province
Northumberland
ZIP/Postal Code
NE46 1QJ
Country
United Kingdom
Facility Name
Synexus North East Clinical Research Centre
City
Hexham
State/Province
Northumberland
ZIP/Postal Code
NE46 1QJ
Country
United Kingdom
Facility Name
The Crouch Oak Family Practice
City
Addlestone
State/Province
Surrey
ZIP/Postal Code
KT15 2BH
Country
United Kingdom
Facility Name
Synexus Midlands Clinical Research Centre
City
Birmingham
State/Province
WEST Midlands
ZIP/Postal Code
B15 2SQ
Country
United Kingdom
Facility Name
The Bradford on Avon & Melksham Health Partnership
City
Bradford on Avon
State/Province
Wiltshire
ZIP/Postal Code
BA15 1DQ
Country
United Kingdom
Facility Name
Ninewells Hospital & Medical School
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35277540
Citation
Chasman DI, Hyde CL, Giulianini F, Danning RD, Wang EQ, Hickling T, Ridker PM, Loomis AK. Genome-wide pharmacogenetics of anti-drug antibody response to bococizumab highlights key residues in HLA DRB1 and DQB1. Sci Rep. 2022 Mar 11;12(1):4266. doi: 10.1038/s41598-022-07997-5.
Results Reference
derived
PubMed Identifier
29685591
Citation
Ridker PM, Rose LM, Kastelein JJP, Santos RD, Wei C, Revkin J, Yunis C, Tardif JC, Shear CL; Studies of PCSK9 Inhibition and the Reduction of vascular Events (SPIRE) Investigators. Cardiovascular event reduction with PCSK9 inhibition among 1578 patients with familial hypercholesterolemia: Results from the SPIRE randomized trials of bococizumab. J Clin Lipidol. 2018 Jul-Aug;12(4):958-965. doi: 10.1016/j.jacl.2018.03.088. Epub 2018 Apr 3.
Results Reference
derived
PubMed Identifier
28304227
Citation
Ridker PM, Tardif JC, Amarenco P, Duggan W, Glynn RJ, Jukema JW, Kastelein JJP, Kim AM, Koenig W, Nissen S, Revkin J, Rose LM, Santos RD, Schwartz PF, Shear CL, Yunis C; SPIRE Investigators. Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab. N Engl J Med. 2017 Apr 20;376(16):1517-1526. doi: 10.1056/NEJMoa1614062. Epub 2017 Mar 17.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1481020&StudyName=Randomized%20Clinical%20Trial%20of%20RN316%20%28PF-04950615%29%20in%20Subjects%20with%20Hyperlipidemia%20or%20Mixed%20Dyslipidemia%20at%20Risk%20of%20Cardiovascular%20Events
Description
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Learn more about this trial

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

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