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Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia At Risk Of Cardiovascular Events (SPIRE-LL)

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 Primary hyperlipidemia or 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 >=100 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 or procedure within 90 days
  • Congestive heart failure NYHA class IV
  • Poorly controlled hypertension

Sites / Locations

  • Advanced Cardiovascular, LLC Research
  • Advanced Cardiovascular, LLC, Research
  • Clinical Research Advantage, Inc./Family Practice Specialists, Ltd.
  • Clinical Research Advantage, Inc./Family Practice Specialists, LTD
  • Radiant Research, Inc.
  • Radiant Research, Inc
  • Lynn Institute of the Ozarks
  • The Office of Larry Watkins, MD
  • American Institute of Research
  • lntermed Group
  • IMD Medical Group
  • The Office of Lucita M. Cruz, M.D., Inc.
  • Superior Research, LLC
  • Superior Research ,LLC
  • Radiant Research, Inc.
  • Orange County Research Center
  • Ventura Clinical Trials
  • University of Colorado Hospital
  • Clinical Research Advantage, Inc. / Colorado Springs Family Practice
  • Creekside Endocrine Associates, PC
  • Boca Raton Clinical Research Associates
  • BRCR Medical Center, Inc.
  • Meridien Research
  • Linfritz Research Institute Inc.
  • Florida Health Center
  • Health Care Family Rehab & Research Center
  • Indago Research & Health Center, Inc.
  • NewPhase Clinical Trials, Corp.
  • Panax Clinical Research
  • Precision Research Organization
  • Sunrise Research Institute, Inc
  • Prestige Clinical Research Center, Inc.
  • Suncoast Research Group, LLD
  • Elite Clinical Research
  • Advanced Clinical Research of Miami
  • The Research Specialists of Florida, Inc.
  • Columbus Clinical Services, LLC
  • First Quality
  • American Family Medical
  • Renstar Medical Research
  • Andres Patron, D.O.P.A.
  • Pines Care Research Center, LLC
  • DBC Research USA
  • Progressive Medical Research
  • Accord Clinical Research, Llc
  • East Coast Institute for Research, LLC/ Baker-Gilmour Cardiovascular Institute
  • East Coast Institute for RSCH, St. Augustine Cardiology Associates, Research
  • Meridien Research
  • Cardiovascular Center of Sarasota
  • Meridien Research
  • Northwest Clinical Trials, Inc.
  • American Health Network of Indiana, LLC
  • Heartland Research Associates, LLC
  • Heartland Research Associates, LLC
  • Northwest Family Physicians
  • Heartland Research Associates, LLC
  • Imperial Health, LLP
  • Crescent City Clinical Research Center, LLC
  • Clinical Trials of America LA
  • Bethesda Health Research
  • Centennial Medical Group
  • McLaren Flint
  • CentraCare Heart & Vascular Center @ St. Cloud Hospital
  • CentraCare Heart & Vascular Center at St. Cloud Hospital
  • Riser Medical Research
  • Washington University, The Center for Advanced Medicine
  • Washington University School of Medicine
  • Clinical Research Advantage, Inc. (Prairie Fields Family Medicine, PC)
  • ActivMed Practices & Research, Inc.
  • Albuquerque Clinical Trials, Inc.
  • Physician's East Endocrinology
  • Physician's East P.A.
  • Physician's East, PA
  • Catawba Valley Medical Group, Inc.
  • Clinical Trials of America, Inc.
  • PMG Research of Hickory
  • Wake Internal Medicine Consultants, Inc.
  • Wake Research Associates, LLC
  • Primed Clinical Research
  • Office of Daniel G. Williams, MD
  • South Oklahoma Heart Research, LLC
  • Castlerock Clinical Research Consultants,LLC
  • Harleysville Medical Associates
  • Berks Cardiologists, Ltd.
  • Medical Research South, LLC
  • Ellipsis Research Group, LLC
  • Spartanburg Medical Research
  • Stern Cardiovascular Foundation, Inc
  • Apex Cardiology
  • Research Associates of Jackson
  • PMG Research, Inc d/b/a PMG Research of Knoxville
  • Punzi Medical Center
  • Juno Research, LLC
  • Gulf Coast Medical Research,LLC
  • Office of Michelle Zaniewski MD., PA.
  • Juno Research, LLC
  • Gulf Coast Medical Research, LLC
  • Clinical Research Advantage, Inc./ Plano Internal Medicine Associates
  • Clinical Trials of Texas, Inc.
  • Gulf Coast Medical Research, LLC
  • Aspen Clinical Research
  • Millennium Clinical Trials, LLC
  • National Clinical Research-Norfolk, Inc.
  • Sound Health Care Center
  • Sound Medical Research
  • Walla Walla Clinic
  • Clinical Investigation Specialists, Inc.
  • HFM Heart and Vascular Center/Holy Family Memorial, Inc
  • LMC Clinical Research Inc. (Calgary)
  • Office of Dr. Ronald Collette MD
  • Medical Arts Health Research Group
  • The Medical Arts Health Research Group
  • Glover Medical Clinic
  • Fraser Clinical Trials
  • The Medical Arts Health Research Group
  • The Office of James K. Lai, MD Inc.
  • Cook Street Medical Clinic
  • LMC Clinical Research Inc. (Barrie)
  • LMC Clinical Research Inc. (Brampton)
  • Aggarwal And Associates Ltd
  • Corunna Medical Research Centre
  • LMC Clinical Research Inc. (Etobicoke)
  • LMC Clinical Research Inc. (Markham)
  • SKDS Research Inc.
  • LMC Clinical Research Inc. (Oakville)
  • The Office of Dr. James Cha
  • Kawartha Cardiology Clinical Trials
  • Scarborough Cardiology Research
  • LMC Clinical Research Inc. (Thornhill)
  • Rouge Valley Health System - Centenary
  • LMC Clinical Research Inc. (Bayview)
  • Manna Research Inc.
  • Ecogene-21
  • ViaCar Recherche Clinique Inc.
  • Centre de Depistage et de Recherche Cardiovasculaire Rive-Sud
  • Montreal Heart Institute
  • Centre De Sante Et De Services Sociaux De Beauce (CSSSB)
  • C.I.C. Maurice Inc.
  • C.I.C. Mauricie Inc.
  • Clinique des maladies lipidiques de Quebec
  • Alpha Recherche Clinique
  • Kardiologicka ambulance
  • Fakultni Nemocnice Kralovske Vinohrady, II. interni klinika
  • Fakultni nemocnice u sv. Anny Brno. Oddeleni klinicke biochemie
  • Fakultni nemocnice u sv. Anny. Nemoenicni lekarna (pharmacy)
  • Cardiocentrum Kladno s.r.o., Kardiologicka ambulance
  • Lekarna - P-P Klinika Kladno
  • Lunacor s.r.o.
  • Fakultni Nemocnice Olomouc, III. interni klinika ¿ nefrologicka, revmatologicka a endokrinologicka
  • Lekarna Fakultni nemocnice Olomouc (pharmacy)
  • Lekarna Domovina
  • PreventaMed, s.r.o.
  • IKEM, Oddeleni preventivni kardiologie
  • IKEM, Ustavni lekarna
  • BENU lekarna
  • Kardiologicka ambulance, III. Poliklinika
  • Lekarna 203-02
  • Nemocnice Slany, Interni oddeleni
  • AeskuLab k.s., Lipidova poradna
  • Lekarna Centrum (pharmacy)
  • Dr.Max lekarna
  • Etela-Karjalan Keskussairaala
  • Turku University Hospital
  • Sacred Heart Hospital-Hallym University
  • Hanyang University Guri Hospital
  • Dong-A University Hospital
  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Medisch Spectrum Twente
  • St Lucas Andreas Hospital
  • Gelre Hospitals
  • Andromed Eindhoven
  • Medisch Spectrum Twente
  • Beatrix Hospital
  • Martini Ziekenhuis
  • Zuyderland Medisch Centrum
  • Andro Medical Research B.V.
  • Ikazia Hospital
  • D&A Research and Genetics
  • St. Elisabeth Hospital
  • University Medical Center Utrecht
  • Ossum Gronert Legetjeneste AS
  • Oslo Universitetssykehus HF
  • Oslo Universitetssykehus HF, Ulleval
  • KO-MED Centra Kliniczne Lublin
  • KO-MED Centra Kliniczne Zamosc
  • KO-MED. Centra Kliniczne Staszow
  • Synexus Polska Sp. z o.o. Oddzial w Gdyni
  • MCBK Sc lwona Czajkowska Monika Barney
  • Synexus Polska Sp. z o. o. Oddizial w Katowicach.
  • Clinport Tura Lipinska Dabrowski S.C.
  • Krakowski Szpital Specjalistyczny im. Jana Pawla II
  • Jan Zbigniew Peruga NZOZ SALUS
  • Zespol Opieki Zdrowotnej W Olawie, Oddzial Chorob Wewnetrznych
  • Synexus Polska Sp. z o.o Oddzial w Poznaniu
  • KO-MED Centra Kliniczne Sp. z o.o.
  • Synexus Polska Sp. z o.o. Oddzial w Warszawie
  • Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
  • .WroMedica Irena Bielicka, Janusz Szczepanik Spolka Cywlina
  • Ponce School Of Medicine
  • Cardiometabolic Research Center, Inc
  • Caparra Internal Medicine
  • National University Hospital
  • National Heart Centre Singapore
  • Clinical Trial Center (CTC)/Centrum foer klinisk proevning
  • Vardcentralen Lessebo
  • Clinical Trials Consultants AB
  • ProbarE i Lund AB
  • Capio Citykliniken Hjartmottagning
  • Dalecarlia Clinical Research Center
  • Citydiabetes
  • Karolinska Universitetssjukhuset Huddinge
  • Synexus Thames Valley Clinical Research Centre
  • Salford Royal NHS Foundation Trust
  • Synexus Scotland Clinical Research Centre
  • Synexus Lancashire Clinical Research Centre
  • Synexus North East Clinical Research Centre - Hexham General Hospital
  • Worcestershire Acute Hospitals NHS Trust - Worcestershire Royal Hospital
  • University Hospital Ayr - Nhs Ayrshire And Arran
  • Synexus Midlands Clinical Research Centre
  • Hull and East Yorkshire Hospitals NHS Trust
  • Synexus Merseyside Clinical Research Centre
  • Synexus Manchester Clinical Research Centre
  • Abertawe Bro Morgannwg University Local Health Board Joint Clinical Research Facility,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bococizumab (PF-04950615; RN316)

placebo

Arm Description

Bococizumab (PF-04950615; RN316)

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 (Non HDL-C) at Week 12, 24 and 52
Percent 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, 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 (Non 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
Absolute 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 Versus Time Summary of PF-04950615
Percentage of Participants With Adverse Events (AEs) Related to Type 1 and 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 (log 2) unit was considered to be ADA positive and nAb titer >=1.58 (log 2) 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), 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
March 27, 2014
Last Updated
July 2, 2018
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT02100514
Brief Title
Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia At Risk Of Cardiovascular Events
Acronym
SPIRE-LL
Official Title
A 52 Week Phase 3 Double-blind, Randomized, Placebo-controlled, Parallel-group Study To Assess The Efficacy, 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 28, 2014 (Actual)
Primary Completion Date
July 15, 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, double-blind, randomized study to access the efficacy, safety and tolerability of Bococizumab (PF-04950615; RN316) in subjects with hyperlipidemia receiving background statin therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia
Keywords
Primary hyperlipidemia or 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 ProviderInvestigator
Allocation
Randomized
Enrollment
746 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bococizumab (PF-04950615; RN316)
Arm Type
Experimental
Arm Description
Bococizumab (PF-04950615; RN316)
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 for 52 weeks.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous injection every 2 weeks for 52 weeks.
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 (Non 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 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 (Non 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
Absolute 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 Versus Time Summary of PF-04950615
Time Frame
Week 12, 24, 52
Title
Percentage of Participants With Adverse Events (AEs) Related to Type 1 and 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 end of study (up to 110 weeks)
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 (log 2) unit was considered to be ADA positive and nAb titer >=1.58 (log 2) 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 to Week 110
Title
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 (Follow up), 71, 84, 97 and 110: Extension Period
Time Frame
Baseline, Week 58 (follow up), 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), 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 >=100 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 or procedure within 90 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
Advanced Cardiovascular, LLC Research
City
Alexander City
State/Province
Alabama
ZIP/Postal Code
35010
Country
United States
Facility Name
Advanced Cardiovascular, LLC, Research
City
Auburn
State/Province
Alabama
ZIP/Postal Code
36830
Country
United States
Facility Name
Clinical Research Advantage, Inc./Family Practice Specialists, Ltd.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Clinical Research Advantage, Inc./Family Practice Specialists, LTD
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Radiant Research, Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Radiant Research, Inc
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Lynn Institute of the Ozarks
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
The Office of Larry Watkins, MD
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
American Institute of Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
lntermed Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
IMD Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90020
Country
United States
Facility Name
The Office of Lucita M. Cruz, M.D., Inc.
City
Norwalk
State/Province
California
ZIP/Postal Code
90650
Country
United States
Facility Name
Superior Research, LLC
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Superior Research ,LLC
City
Sacramento
State/Province
California
ZIP/Postal Code
95831
Country
United States
Facility Name
Radiant Research, Inc.
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95405
Country
United States
Facility Name
Orange County Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Ventura Clinical Trials
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Clinical Research Advantage, Inc. / Colorado Springs Family Practice
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Creekside Endocrine Associates, PC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Boca Raton Clinical Research Associates
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33432
Country
United States
Facility Name
BRCR Medical Center, Inc.
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33432
Country
United States
Facility Name
Meridien Research
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34601
Country
United States
Facility Name
Linfritz Research Institute Inc.
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Florida Health Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33312
Country
United States
Facility Name
Health Care Family Rehab & Research Center
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Indago Research & Health Center, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
NewPhase Clinical Trials, Corp.
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Panax Clinical Research
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Precision Research Organization
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Sunrise Research Institute, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33130
Country
United States
Facility Name
Prestige Clinical Research Center, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Suncoast Research Group, LLD
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Elite Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Advanced Clinical Research of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
The Research Specialists of Florida, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Columbus Clinical Services, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
First Quality
City
Miramar
State/Province
Florida
ZIP/Postal Code
33025
Country
United States
Facility Name
American Family Medical
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Andres Patron, D.O.P.A.
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
Facility Name
Pines Care Research Center, LLC
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
Facility Name
DBC Research USA
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33029
Country
United States
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Accord Clinical Research, Llc
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32129
Country
United States
Facility Name
East Coast Institute for Research, LLC/ Baker-Gilmour Cardiovascular Institute
City
Saint Augustine
State/Province
Florida
ZIP/Postal Code
32086
Country
United States
Facility Name
East Coast Institute for RSCH, St. Augustine Cardiology Associates, Research
City
Saint Augustine
State/Province
Florida
ZIP/Postal Code
32086
Country
United States
Facility Name
Meridien Research
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Cardiovascular Center of Sarasota
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Meridien Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Facility Name
Northwest Clinical Trials, Inc.
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
American Health Network of Indiana, LLC
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Augusta
State/Province
Kansas
ZIP/Postal Code
67010
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Northwest Family Physicians
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Imperial Health, LLP
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Crescent City Clinical Research Center, LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Clinical Trials of America LA
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Bethesda Health Research
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
208174
Country
United States
Facility Name
Centennial Medical Group
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
Facility Name
McLaren Flint
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
CentraCare Heart & Vascular Center @ St. Cloud Hospital
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
CentraCare Heart & Vascular Center at St. Cloud Hospital
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
Riser Medical Research
City
Picayune
State/Province
Mississippi
ZIP/Postal Code
39466
Country
United States
Facility Name
Washington University, The Center for Advanced Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Clinical Research Advantage, Inc. (Prairie Fields Family Medicine, PC)
City
Fremont
State/Province
Nebraska
ZIP/Postal Code
68025
Country
United States
Facility Name
ActivMed Practices & Research, Inc.
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Albuquerque Clinical Trials, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Physician's East Endocrinology
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Physician's East P.A.
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Physician's East, PA
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Catawba Valley Medical Group, Inc.
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Clinical Trials of America, Inc.
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
PMG Research of Hickory
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
Wake Internal Medicine Consultants, Inc.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Primed Clinical Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45419
Country
United States
Facility Name
Office of Daniel G. Williams, MD
City
Perrysburg
State/Province
Ohio
ZIP/Postal Code
43551
Country
United States
Facility Name
South Oklahoma Heart Research, LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73135
Country
United States
Facility Name
Castlerock Clinical Research Consultants,LLC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Harleysville Medical Associates
City
Harleysville
State/Province
Pennsylvania
ZIP/Postal Code
19438
Country
United States
Facility Name
Berks Cardiologists, Ltd.
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Medical Research South, LLC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Ellipsis Research Group, LLC
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Spartanburg Medical Research
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Stern Cardiovascular Foundation, Inc
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Apex Cardiology
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38301
Country
United States
Facility Name
Research Associates of Jackson
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38301
Country
United States
Facility Name
PMG Research, Inc d/b/a PMG Research of Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37912
Country
United States
Facility Name
Punzi Medical Center
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75006
Country
United States
Facility Name
Juno Research, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77036
Country
United States
Facility Name
Gulf Coast Medical Research,LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Office of Michelle Zaniewski MD., PA.
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Juno Research, LLC
City
Katy
State/Province
Texas
ZIP/Postal Code
77450
Country
United States
Facility Name
Gulf Coast Medical Research, LLC
City
Missouri City
State/Province
Texas
ZIP/Postal Code
77459
Country
United States
Facility Name
Clinical Research Advantage, Inc./ Plano Internal Medicine Associates
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
Gulf Coast Medical Research, LLC
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
Aspen Clinical Research
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
Country
United States
Facility Name
Millennium Clinical Trials, LLC
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22207
Country
United States
Facility Name
National Clinical Research-Norfolk, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Sound Health Care Center
City
Port Orchard
State/Province
Washington
ZIP/Postal Code
98366
Country
United States
Facility Name
Sound Medical Research
City
Port Orchard
State/Province
Washington
ZIP/Postal Code
98366
Country
United States
Facility Name
Walla Walla Clinic
City
Walla Walla
State/Province
Washington
ZIP/Postal Code
99362
Country
United States
Facility Name
Clinical Investigation Specialists, Inc.
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53142
Country
United States
Facility Name
HFM Heart and Vascular Center/Holy Family Memorial, Inc
City
Manitowoc
State/Province
Wisconsin
ZIP/Postal Code
54220
Country
United States
Facility Name
LMC Clinical Research Inc. (Calgary)
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2H 2G4
Country
Canada
Facility Name
Office of Dr. Ronald Collette MD
City
Burnaby
State/Province
British Columbia
ZIP/Postal Code
V5G 1T4
Country
Canada
Facility Name
Medical Arts Health Research Group
City
Kamloops
State/Province
British Columbia
ZIP/Postal Code
V2C 1K7
Country
Canada
Facility Name
The Medical Arts Health Research Group
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 1V6
Country
Canada
Facility Name
Glover Medical Clinic
City
Langley
State/Province
British Columbia
ZIP/Postal Code
V3A 4H9
Country
Canada
Facility Name
Fraser Clinical Trials
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W4
Country
Canada
Facility Name
The Medical Arts Health Research Group
City
Penticton
State/Province
British Columbia
ZIP/Postal Code
V2A 5C8
Country
Canada
Facility Name
The Office of James K. Lai, MD Inc.
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1K3
Country
Canada
Facility Name
Cook Street Medical Clinic
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 4A1
Country
Canada
Facility Name
LMC Clinical Research Inc. (Barrie)
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
LMC Clinical Research Inc. (Brampton)
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6S 0C9
Country
Canada
Facility Name
Aggarwal And Associates Ltd
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 0G1
Country
Canada
Facility Name
Corunna Medical Research Centre
City
Corunna
State/Province
Ontario
ZIP/Postal Code
N0N 1G0
Country
Canada
Facility Name
LMC Clinical Research Inc. (Etobicoke)
City
Etobicoke
State/Province
Ontario
ZIP/Postal Code
M9R 4E1
Country
Canada
Facility Name
LMC Clinical Research Inc. (Markham)
City
Markham
State/Province
Ontario
ZIP/Postal Code
L6B 0P9
Country
Canada
Facility Name
SKDS Research Inc.
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 5G8
Country
Canada
Facility Name
LMC Clinical Research Inc. (Oakville)
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6M 1M1
Country
Canada
Facility Name
The Office of Dr. James Cha
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1J 2K1
Country
Canada
Facility Name
Kawartha Cardiology Clinical Trials
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 0B2
Country
Canada
Facility Name
Scarborough Cardiology Research
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1E 5E9
Country
Canada
Facility Name
LMC Clinical Research Inc. (Thornhill)
City
Thornhill
State/Province
Ontario
ZIP/Postal Code
L4J 8L7
Country
Canada
Facility Name
Rouge Valley Health System - Centenary
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M1E 4B9
Country
Canada
Facility Name
LMC Clinical Research Inc. (Bayview)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3E8
Country
Canada
Facility Name
Manna Research Inc.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W 4L6
Country
Canada
Facility Name
Ecogene-21
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 7K9
Country
Canada
Facility Name
ViaCar Recherche Clinique Inc.
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2G8
Country
Canada
Facility Name
Centre de Depistage et de Recherche Cardiovasculaire Rive-Sud
City
Longueuil
State/Province
Quebec
ZIP/Postal Code
J4M2X1
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Centre De Sante Et De Services Sociaux De Beauce (CSSSB)
City
Saint-Georges, Beauce
State/Province
Quebec
ZIP/Postal Code
G5Y 4T8
Country
Canada
Facility Name
C.I.C. Maurice Inc.
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8T 7A1
Country
Canada
Facility Name
C.I.C. Mauricie Inc.
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8T 7A1
Country
Canada
Facility Name
Clinique des maladies lipidiques de Quebec
City
Quebec
ZIP/Postal Code
G1V 4W2
Country
Canada
Facility Name
Alpha Recherche Clinique
City
Quebec
ZIP/Postal Code
G3K 2P8
Country
Canada
Facility Name
Kardiologicka ambulance
City
Trutnov
State/Province
Kralovehradecky KRAJ
ZIP/Postal Code
54101
Country
Czechia
Facility Name
Fakultni Nemocnice Kralovske Vinohrady, II. interni klinika
City
Praha 10
State/Province
Vinohrady
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Fakultni nemocnice u sv. Anny Brno. Oddeleni klinicke biochemie
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Fakultni nemocnice u sv. Anny. Nemoenicni lekarna (pharmacy)
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Cardiocentrum Kladno s.r.o., Kardiologicka ambulance
City
Kladno
ZIP/Postal Code
27280
Country
Czechia
Facility Name
Lekarna - P-P Klinika Kladno
City
Kladno
ZIP/Postal Code
27280
Country
Czechia
Facility Name
Lunacor s.r.o.
City
Kromeriz
ZIP/Postal Code
76701
Country
Czechia
Facility Name
Fakultni Nemocnice Olomouc, III. interni klinika ¿ nefrologicka, revmatologicka a endokrinologicka
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Lekarna Fakultni nemocnice Olomouc (pharmacy)
City
Olomouc
ZIP/Postal Code
77520
Country
Czechia
Facility Name
Lekarna Domovina
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
PreventaMed, s.r.o.
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
IKEM, Oddeleni preventivni kardiologie
City
Praha 4
ZIP/Postal Code
140 21
Country
Czechia
Facility Name
IKEM, Ustavni lekarna
City
Praha 4
ZIP/Postal Code
140 21
Country
Czechia
Facility Name
BENU lekarna
City
Pribram
ZIP/Postal Code
261 01
Country
Czechia
Facility Name
Kardiologicka ambulance, III. Poliklinika
City
Pribram
ZIP/Postal Code
261 01
Country
Czechia
Facility Name
Lekarna 203-02
City
Slany
ZIP/Postal Code
274 01
Country
Czechia
Facility Name
Nemocnice Slany, Interni oddeleni
City
Slany
ZIP/Postal Code
274 01
Country
Czechia
Facility Name
AeskuLab k.s., Lipidova poradna
City
Teplice
ZIP/Postal Code
415 01
Country
Czechia
Facility Name
Lekarna Centrum (pharmacy)
City
Teplice
ZIP/Postal Code
415 01
Country
Czechia
Facility Name
Dr.Max lekarna
City
Trutnov
ZIP/Postal Code
541 01
Country
Czechia
Facility Name
Etela-Karjalan Keskussairaala
City
Lappeenranta
ZIP/Postal Code
53130
Country
Finland
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Sacred Heart Hospital-Hallym University
City
Anyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
431-796
Country
Korea, Republic of
Facility Name
Hanyang University Guri Hospital
City
Guri-si
State/Province
Gyeonggi-do
ZIP/Postal Code
11923
Country
Korea, Republic of
Facility Name
Dong-A University Hospital
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Medisch Spectrum Twente
City
Enschede
State/Province
ER
ZIP/Postal Code
7513
Country
Netherlands
Facility Name
St Lucas Andreas Hospital
City
Amsterdam
State/Province
North Holland
ZIP/Postal Code
1061 AE
Country
Netherlands
Facility Name
Gelre Hospitals
City
Apeldoorn
ZIP/Postal Code
7334 DZ
Country
Netherlands
Facility Name
Andromed Eindhoven
City
Eindhoven
ZIP/Postal Code
5611 NV
Country
Netherlands
Facility Name
Medisch Spectrum Twente
City
Enschede
ZIP/Postal Code
7513 ER
Country
Netherlands
Facility Name
Beatrix Hospital
City
Gorinchem
ZIP/Postal Code
4204 AA
Country
Netherlands
Facility Name
Martini Ziekenhuis
City
Groningen
ZIP/Postal Code
9728 NT
Country
Netherlands
Facility Name
Zuyderland Medisch Centrum
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
Facility Name
Andro Medical Research B.V.
City
Rotterdam
ZIP/Postal Code
3021 HC
Country
Netherlands
Facility Name
Ikazia Hospital
City
Rotterdam
ZIP/Postal Code
3083AN
Country
Netherlands
Facility Name
D&A Research and Genetics
City
Sneek
ZIP/Postal Code
8601 ZR
Country
Netherlands
Facility Name
St. Elisabeth Hospital
City
Tilburg
ZIP/Postal Code
5022 GC
Country
Netherlands
Facility Name
University Medical Center Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Ossum Gronert Legetjeneste AS
City
Honefoss
ZIP/Postal Code
3515
Country
Norway
Facility Name
Oslo Universitetssykehus HF
City
Oslo
ZIP/Postal Code
0373
Country
Norway
Facility Name
Oslo Universitetssykehus HF, Ulleval
City
Oslo
ZIP/Postal Code
0424
Country
Norway
Facility Name
KO-MED Centra Kliniczne Lublin
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-362
Country
Poland
Facility Name
KO-MED Centra Kliniczne Zamosc
City
Zamosc
State/Province
Lubelskie
ZIP/Postal Code
22-400
Country
Poland
Facility Name
KO-MED. Centra Kliniczne Staszow
City
Staszow
State/Province
Swietokrzyskie
ZIP/Postal Code
28-200
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Gdyni
City
Gdynia
ZIP/Postal Code
81-384
Country
Poland
Facility Name
MCBK Sc lwona Czajkowska Monika Barney
City
Grodzisk Mazowiecki
ZIP/Postal Code
05-825
Country
Poland
Facility Name
Synexus Polska Sp. z o. o. Oddizial w Katowicach.
City
Katowice
ZIP/Postal Code
40-040
Country
Poland
Facility Name
Clinport Tura Lipinska Dabrowski S.C.
City
Katowice
ZIP/Postal Code
40-084
Country
Poland
Facility Name
Krakowski Szpital Specjalistyczny im. Jana Pawla II
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Jan Zbigniew Peruga NZOZ SALUS
City
Lodz
ZIP/Postal Code
91-302
Country
Poland
Facility Name
Zespol Opieki Zdrowotnej W Olawie, Oddzial Chorob Wewnetrznych
City
Olawa
ZIP/Postal Code
55-200
Country
Poland
Facility Name
Synexus Polska Sp. z o.o Oddzial w Poznaniu
City
Poznan
ZIP/Postal Code
60-702
Country
Poland
Facility Name
KO-MED Centra Kliniczne Sp. z o.o.
City
Pulawy
ZIP/Postal Code
24-100
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Warszawie
City
Warszawa
ZIP/Postal Code
01-192
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
City
Wroclaw
ZIP/Postal Code
50-088
Country
Poland
Facility Name
.WroMedica Irena Bielicka, Janusz Szczepanik Spolka Cywlina
City
Wroclaw
ZIP/Postal Code
51-685
Country
Poland
Facility Name
Ponce School Of Medicine
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Facility Name
Cardiometabolic Research Center, Inc
City
Ponce
ZIP/Postal Code
00717
Country
Puerto Rico
Facility Name
Caparra Internal Medicine
City
Rio Grande
ZIP/Postal Code
00745
Country
Puerto Rico
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
National Heart Centre Singapore
City
Singapore
ZIP/Postal Code
169609
Country
Singapore
Facility Name
Clinical Trial Center (CTC)/Centrum foer klinisk proevning
City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Vardcentralen Lessebo
City
Lessebo
ZIP/Postal Code
360 50
Country
Sweden
Facility Name
Clinical Trials Consultants AB
City
Linkoping
ZIP/Postal Code
58758
Country
Sweden
Facility Name
ProbarE i Lund AB
City
Lund
ZIP/Postal Code
222 22
Country
Sweden
Facility Name
Capio Citykliniken Hjartmottagning
City
Lund
ZIP/Postal Code
22221
Country
Sweden
Facility Name
Dalecarlia Clinical Research Center
City
Rattvik
ZIP/Postal Code
79530
Country
Sweden
Facility Name
Citydiabetes
City
Stockholm
ZIP/Postal Code
111 57
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset Huddinge
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Synexus Thames Valley Clinical Research Centre
City
Reading
State/Province
Berkshire
ZIP/Postal Code
RG2 0TG
Country
United Kingdom
Facility Name
Salford Royal NHS Foundation Trust
City
Salford
State/Province
Greater Manchester
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
Synexus Scotland Clinical Research Centre
City
Glasgow
State/Province
Lanarkshire Scotland
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 North East Clinical Research Centre - Hexham General Hospital
City
Hexham
State/Province
Northumberland
ZIP/Postal Code
NE46 1QJ
Country
United Kingdom
Facility Name
Worcestershire Acute Hospitals NHS Trust - Worcestershire Royal Hospital
City
Worcester
State/Province
Worcestershire
ZIP/Postal Code
WR5 1DD
Country
United Kingdom
Facility Name
University Hospital Ayr - Nhs Ayrshire And Arran
City
Ayr
ZIP/Postal Code
KA6 6DX
Country
United Kingdom
Facility Name
Synexus Midlands Clinical Research Centre
City
Birmingham
ZIP/Postal Code
B15 2SQ
Country
United Kingdom
Facility Name
Hull and East Yorkshire Hospitals NHS Trust
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Synexus Merseyside Clinical Research Centre
City
Liverpool
ZIP/Postal Code
L22 0LG
Country
United Kingdom
Facility Name
Synexus Manchester Clinical Research Centre
City
Manchester
ZIP/Postal Code
M15 6SX
Country
United Kingdom
Facility Name
Abertawe Bro Morgannwg University Local Health Board Joint Clinical Research Facility,
City
Swansea
ZIP/Postal Code
SA2 8PP
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=B1481045&StudyName=Randomized%20Clinical%20Trial%20of%20RN316%20%28PF-04950615%29%20inSubjects%20With%20Primary%20Hyperlipidemia%20or%20Mixed%20Dyslipidemia%20At%20Risk%20Of%20Cardiovascular%20
Description
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Learn more about this trial

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

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