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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-HR)

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

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

  • Achieve Clinical Research, LLC
  • Cardiovascular Associates of the Southeast, LLC
  • Southwest Heart Group
  • ARA-Arizona Research Associates
  • Diagnamics, Inc.
  • Encompass Clinical Research North Coast
  • MD Studies, Inc.
  • Alliance Research Centers
  • Prime Care Clinical Research
  • Providence Clinical Research
  • San Diego Family Care
  • St. Joseph's Medical Associates
  • Orange County Research Center
  • Clinical Research Advantage, Inc./Cassidy Medical Group - Vista
  • Elite Clinical Trials
  • Expresscare Clinical Research
  • Soundview Medical Associates
  • Eastern Research, Inc.
  • East Coast Institute for Research, LLC at Northeast Florida Endocrine & Diabetes Associates
  • Care Partners Clinical Research, LLC
  • Prestige Clinical Research Center Inc
  • Edgewater Medical Research
  • Gulfcoast Medical Research Center, LLC
  • Fellows Research Alliance, Inc.
  • SouthCoast Medical Group
  • Evanston Premier Healthcare Research LLC
  • Comunity Clinical Research Center
  • American Health Network of Indiana, LLC
  • Midwest Institute for Clinical Research
  • Horizon Research Group of Opelousas, LLC
  • Internal Medicine Associates
  • Beacon Clinical Research, LLC
  • Allina Health System, dba Abbott Northwestern Hospital
  • Minneapolis Heart Institute Foundation
  • University of MN, Lillehei Clinical Trials Unit
  • Montana Medical Research Inc.
  • PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
  • Clinical Trials of America, Inc.
  • Radiant Research, Inc
  • Rapid Medical Research, Inc.
  • The Office of Daniel G. Williams, MD
  • Great Lakes Medical Research, LLC
  • South Oklahoma Heart Research LLC
  • Integrated Medical Research, PC
  • Columbia Research Group, Inc.
  • Harleysville Medical Associates
  • Perelman Center for Advanced Medicine Heart & Vascular Center
  • Berks Cardiologists, Ltd.
  • Medical Research South,LLC
  • Berkeley Family Practice
  • Internal Medicine and Pediatric Associates of Bristol, PC
  • 3 rd Coast Research Associates
  • Texas Center For Drug Development, Inc.
  • Pioneer Research Solutions, Inc.
  • Protenium Clinical Research
  • Utah Cardiology, P.C.
  • National Clinical Research - Norfolk, Inc.
  • Premier Clinical Research
  • Australian Clinical Research Network
  • Core Research Group Pty Ltd
  • The Avenue Cardiovascular Centre
  • Ecogene-21
  • Montreal Heart Institute
  • Diex Research Montreal Inc.
  • ALPHA Recherche Clinique
  • Centre Hospitalier Universitaire de Sherbrooke (CHUS)
  • Medexa Recherche
  • Fakultni nemocnice Hradec Kralove
  • Kardiologie a interni lekarstvi
  • Lekarsky dum Ormiga
  • Klinische Forschung Berlin-Mitte GmbH
  • Klinische Forschung Hannover - Mitte GmbH
  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH
  • Klinische Forschung Schwerin GmbH
  • Department of Medicine & Therapeutics-The Chinese University of Hong Kong
  • The Chinese University of Hong Kong
  • IRCCS Ospedale San Raffaele
  • IRCCS Centro Cardiologico Fondazione Monzino
  • IRCCS Istituto Auxologico Italiano
  • Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"
  • Dipartimento di Medicina Interna e Specialita Mediche Policlinico Umberto I
  • The Catholic University of Korea, Uijeongbu St. Mary's Hospital
  • Yonsei University Wonju Severance Christian Hospital
  • Chonnam National University Hospital
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Gangnam Sevrance Hospital, Yeonsei University Health System
  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Ajou University Hospital
  • Ulsan University Hospital
  • SYNEXUS Polska Sp. z o.o. Oddzial w Katowicach
  • NZOZ Terapia Optima
  • Synexus Polska Sp. z o.o. Oddzial w Gdyni
  • Niepubliczny Zaklad Opieki Zdrowotnej CEREO-MED Sp. z o.o.
  • Medicus w Opolu Sp z o.o.
  • Medicome Sp. z o.o.
  • Synexus Polska Sp. z o.o Oddzial w Poznaniu
  • Centrum Medyczne Ogrodowa Sp. z o.o.
  • Centrum Medyczne "SOPMED" Sp. z o.o.
  • Synexus Polska Sp. z o.o. Oddzial w Warszawie
  • Centrum Medyczne AMED
  • CSK MSW w Warszawie, Klinika Kardiologii Zachowawczej i Nadcisnienia Tetniczego
  • Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

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 Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12

Secondary Outcome Measures

Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52
Percent Change From Baseline in Non- High Density Lipoprotein-Cholesterol (Non HDL-C) at Week 12, 24 and 52
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52
Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52
Percent Change From Baseline in 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 12 in Participants With Primary Hyperlipidemia
Participants with primary hyperlipidemia are defined as participants with triglycerides (TG) level less than (<) 200 milligram per decilitre (mg/dL) (2.26 millimoles per litre [mmol/L]) at pre-randomization.
Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Mixed Dyslipidemia
Participants with mixed dyslipidemia are defined as TG level greater than or equal to (>=) 200 mg/dL (2.26 mmol/L) at pre-randomization.
Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 24 and 52
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off
Percent change from baseline in fasting LDL-C among participants with TG cut-off of <200 mg/dL and >=200 mg/dL (2.26 mmol/L) were reported in this outcome measure.
Percent Change From Baseline in Fasting Triglyceride (TG) at Week 12, 24 and 52
Percent Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52
Percent Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52
Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Week 12, 24 and 52
Absolute Change From Baseline in Fasting Low Density Lipoprotein-C (LDL-C) at Week 12 by Trigylceride Cut-Off
Absolute change from baseline among participants with TG cut-off of <200 mg/dL and >=200 mg/dL (2.26 mmol/L) were reported in this outcome measure.
Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52
Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52
Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52
Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52
Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52
Absolute Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52
Absolute Change From Baseline in Ratio of Fasting Total Cholesterol to High Density Lipoprotein-Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52
Absolute Change From Baseline in Ratio of Apolipoprotein B to ApolipoproteinA-I (ApoB/ApoA-I Ratio) 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 (2.59 Millimoles Per Litre) 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 (1.81 Millimoles Per Litre) at Week 12, 24 and 52
Plasma PF-04950615 Concentrations at Week 12, 24 and 52
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 as well. Injection site reactions included injection site bruising, discolouration, erythema, haematoma, haemorrhage, nodule, induration, pain, pruritus 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)
Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. Participants with their ADA titer >=6.23 were considered to be ADA positive and participants with their nAb titer >=1.58 were considered to be nAb positive.

Full Information

First Posted
October 21, 2013
Last Updated
April 6, 2017
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01968954
Brief Title
Randomized Clinical Trial Of Bococizumab (PF-04950615; RN316) In Subjects With Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events
Acronym
SPIRE-HR
Official Title
A 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
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
711 (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)
Other Intervention Name(s)
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 Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52
Time Frame
Baseline, Week 12, 24, 52
Title
Percent Change From Baseline in 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 Apolipoprotein B (ApoB) at Week 12, 24 and 52
Time Frame
Baseline, Week 12, 24, 52
Title
Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52
Time Frame
Baseline, Week 12, 24, 52
Title
Percent Change From Baseline in 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 12 in Participants With Primary Hyperlipidemia
Description
Participants with primary hyperlipidemia are defined as participants with triglycerides (TG) level less than (<) 200 milligram per decilitre (mg/dL) (2.26 millimoles per litre [mmol/L]) at pre-randomization.
Time Frame
Baseline, Week 12
Title
Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Mixed Dyslipidemia
Description
Participants with mixed dyslipidemia are defined as TG level greater than or equal to (>=) 200 mg/dL (2.26 mmol/L) at pre-randomization.
Time Frame
Baseline, Week 12
Title
Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 24 and 52
Time Frame
Baseline, Week 24, 52
Title
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off
Description
Percent change from baseline in fasting LDL-C among participants with TG cut-off of <200 mg/dL and >=200 mg/dL (2.26 mmol/L) were reported in this outcome measure.
Time Frame
Baseline, Week 24, 52
Title
Percent Change From Baseline in Fasting Triglyceride (TG) at Week 12, 24 and 52
Time Frame
Baseline, Week 12, 24, 52
Title
Percent Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52
Time Frame
Baseline, Week 12, 24, 52
Title
Percent Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52
Time Frame
Baseline, Week 12, 24, 52
Title
Percent Change From Baseline in 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-C (LDL-C) at Week 12 by Trigylceride Cut-Off
Description
Absolute change from baseline among participants with TG cut-off of <200 mg/dL and >=200 mg/dL (2.26 mmol/L) were reported in this outcome measure.
Time Frame
Baseline, Week 12
Title
Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52
Time Frame
Baseline, Week 12, 24, 52
Title
Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52
Time Frame
Baseline, Week 12, 24, 52
Title
Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52
Time Frame
Baseline, Week 12, 24, 52
Title
Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52
Time Frame
Baseline, Week 12, 24, 52
Title
Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52
Time Frame
Baseline, Week 12, 24, 52
Title
Absolute Change From Baseline in 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 Total Cholesterol to High Density Lipoprotein-Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52
Time Frame
Baseline, Week 12, 24, 52
Title
Absolute Change From Baseline in Ratio of Apolipoprotein B to ApolipoproteinA-I (ApoB/ApoA-I Ratio) 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 (2.59 Millimoles Per Litre) at Week 12, 24 and 52
Time Frame
Week 12, 24 and 52
Title
Percentage of Participants Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (1.81 Millimoles Per Litre) at Week 12, 24 and 52
Time Frame
Week 12, 24 and 52
Title
Plasma PF-04950615 Concentrations at Week 12, 24 and 52
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 as well. Injection site reactions included injection site bruising, discolouration, erythema, haematoma, haemorrhage, nodule, induration, pain, pruritus 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 the end of study (up to 58 weeks)
Title
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)
Description
Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. Participants with their ADA titer >=6.23 were considered to be ADA positive and participants with their nAb titer >=1.58 were considered to be nAb positive.
Time Frame
Baseline up to the end of study (up to 58 weeks)
Other Pre-specified Outcome Measures:
Title
Absolute Change From Baseline in Triglyceride (TG) at Week 12, 24 and 52
Time Frame
Baseline, Week 12, 24, 52
Title
Absolute Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52
Time Frame
Baseline, Week 12, 24, 52
Title
Absolute Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52
Time Frame
Baseline, Week 12, 24, 52

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
Achieve Clinical Research, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Cardiovascular Associates of the Southeast, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Facility Name
Southwest Heart Group
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
ARA-Arizona Research Associates
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Diagnamics, Inc.
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Encompass Clinical Research North Coast
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
MD Studies, Inc.
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Alliance Research Centers
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Prime Care Clinical Research
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Providence Clinical Research
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
San Diego Family Care
City
San Diego
State/Province
California
ZIP/Postal Code
92111
Country
United States
Facility Name
St. Joseph's Medical Associates
City
Stockton
State/Province
California
ZIP/Postal Code
95204
Country
United States
Facility Name
Orange County Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Clinical Research Advantage, Inc./Cassidy Medical Group - Vista
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Elite Clinical Trials
City
Wildomar
State/Province
California
ZIP/Postal Code
92595
Country
United States
Facility Name
Expresscare Clinical Research
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Soundview Medical Associates
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06851
Country
United States
Facility Name
Eastern Research, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
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
32204
Country
United States
Facility Name
Care Partners Clinical Research, LLC
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32277
Country
United States
Facility Name
Prestige Clinical Research Center Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Edgewater Medical Research
City
New Smyrna Beach
State/Province
Florida
ZIP/Postal Code
32169
Country
United States
Facility Name
Gulfcoast Medical Research Center, LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Fellows Research Alliance, Inc.
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
SouthCoast Medical Group
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Evanston Premier Healthcare Research LLC
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Comunity Clinical Research Center
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46011
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
Midwest Institute for Clinical Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Horizon Research Group of Opelousas, LLC
City
Eunice
State/Province
Louisiana
ZIP/Postal Code
70535
Country
United States
Facility Name
Internal Medicine Associates
City
Eunice
State/Province
Louisiana
ZIP/Postal Code
70535
Country
United States
Facility Name
Beacon Clinical Research, LLC
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States
Facility Name
Allina Health System, dba Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Minneapolis Heart Institute Foundation
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
University of MN, Lillehei Clinical Trials Unit
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Montana Medical Research Inc.
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
Clinical Trials of America, Inc.
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
Rapid Medical Research, Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
The Office of Daniel G. Williams, MD
City
Perrysburg
State/Province
Ohio
ZIP/Postal Code
43551
Country
United States
Facility Name
Great Lakes Medical Research, LLC
City
Willoughby
State/Province
Ohio
ZIP/Postal Code
44094
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
Integrated Medical Research, PC
City
Ashland
State/Province
Oregon
ZIP/Postal Code
97520
Country
United States
Facility Name
Columbia Research Group, Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Harleysville Medical Associates
City
Harleysville
State/Province
Pennsylvania
ZIP/Postal Code
19438
Country
United States
Facility Name
Perelman Center for Advanced Medicine Heart & Vascular Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
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
Berkeley Family Practice
City
Moncks Corner
State/Province
South Carolina
ZIP/Postal Code
29461
Country
United States
Facility Name
Internal Medicine and Pediatric Associates of Bristol, PC
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
3 rd Coast Research Associates
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78413
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
Protenium Clinical Research
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
Facility Name
Utah Cardiology, P.C.
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
National Clinical Research - Norfolk, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Premier Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Australian Clinical Research Network
City
Maroubra
State/Province
New South Wales
ZIP/Postal Code
2035
Country
Australia
Facility Name
Core Research Group Pty Ltd
City
Milton
State/Province
Queensland
ZIP/Postal Code
4064
Country
Australia
Facility Name
The Avenue Cardiovascular Centre
City
St. Kilda East
State/Province
Victoria
ZIP/Postal Code
3183
Country
Australia
Facility Name
Ecogene-21
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 7K9
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Diex Research Montreal Inc.
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4N 3C5
Country
Canada
Facility Name
ALPHA Recherche Clinique
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G3K 2P8
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke (CHUS)
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Medexa Recherche
City
Victoriaville
State/Province
Quebec
ZIP/Postal Code
G6P 6P6
Country
Canada
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
Kardiologie a interni lekarstvi
City
Praha 5
ZIP/Postal Code
158 00
Country
Czech Republic
Facility Name
Lekarsky dum Ormiga
City
Zlin
ZIP/Postal Code
760 01
Country
Czech Republic
Facility Name
Klinische Forschung Berlin-Mitte GmbH
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Klinische Forschung Hannover - Mitte GmbH
City
Hannover
ZIP/Postal Code
30159
Country
Germany
Facility Name
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Facility Name
Klinische Forschung Schwerin GmbH
City
Schwerin
ZIP/Postal Code
19055
Country
Germany
Facility Name
Department of Medicine & Therapeutics-The Chinese University of Hong Kong
City
Shatin, NT
Country
Hong Kong
Facility Name
The Chinese University of Hong Kong
City
Shatin
Country
Hong Kong
Facility Name
IRCCS Ospedale San Raffaele
City
Milano
State/Province
MI
ZIP/Postal Code
20132
Country
Italy
Facility Name
IRCCS Centro Cardiologico Fondazione Monzino
City
Milano
State/Province
MI
ZIP/Postal Code
20138
Country
Italy
Facility Name
IRCCS Istituto Auxologico Italiano
City
Milano
State/Province
MI
ZIP/Postal Code
20145
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"
City
Palermo
State/Province
PA
ZIP/Postal Code
90127
Country
Italy
Facility Name
Dipartimento di Medicina Interna e Specialita Mediche Policlinico Umberto I
City
Roma
State/Province
RM
ZIP/Postal Code
00161
Country
Italy
Facility Name
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
City
Uijeongbu-si
State/Province
Gyeonggi-do
ZIP/Postal Code
480-717
Country
Korea, Republic of
Facility Name
Yonsei University Wonju Severance Christian Hospital
City
Gangwon-Do
ZIP/Postal Code
220-701
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Gangnam Sevrance Hospital, Yeonsei University Health System
City
Seoul
ZIP/Postal Code
135-720
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
Ajou University Hospital
City
Suwon
ZIP/Postal Code
443-380
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
ZIP/Postal Code
682-714
Country
Korea, Republic of
Facility Name
SYNEXUS Polska Sp. z o.o. Oddzial w Katowicach
City
Katowice
State/Province
Mazowieckie
ZIP/Postal Code
40-040
Country
Poland
Facility Name
NZOZ Terapia Optima
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-752
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Gdyni
City
Gdynia
ZIP/Postal Code
81-384
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej CEREO-MED Sp. z o.o.
City
Lodz
ZIP/Postal Code
92-003
Country
Poland
Facility Name
Medicus w Opolu Sp z o.o.
City
Opole
ZIP/Postal Code
45-706
Country
Poland
Facility Name
Medicome Sp. z o.o.
City
Oswiecim
ZIP/Postal Code
32-600
Country
Poland
Facility Name
Synexus Polska Sp. z o.o Oddzial w Poznaniu
City
Poznan
ZIP/Postal Code
60-702
Country
Poland
Facility Name
Centrum Medyczne Ogrodowa Sp. z o.o.
City
Skierniewice
ZIP/Postal Code
96-100
Country
Poland
Facility Name
Centrum Medyczne "SOPMED" Sp. z o.o.
City
Sopot
ZIP/Postal Code
81-756
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Warszawie
City
Warszawa
ZIP/Postal Code
01-192
Country
Poland
Facility Name
Centrum Medyczne AMED
City
Warszawa
ZIP/Postal Code
01-518
Country
Poland
Facility Name
CSK MSW w Warszawie, Klinika Kardiologii Zachowawczej i Nadcisnienia Tetniczego
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
City
Wroclaw
ZIP/Postal Code
50-088
Country
Poland

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
31529318
Citation
Wang EQ, Bukowski JF, Yunis C, Shear CL, Ridker PM, Schwartz PF, Baltrukonis D. Assessing the Potential Risk of Cross-Reactivity Between Anti-Bococizumab Antibodies and Other Anti-PCSK9 Monoclonal Antibodies. BioDrugs. 2019 Oct;33(5):571-579. doi: 10.1007/s40259-019-00375-0.
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=B1481019&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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