Randomized Clinical Trial Of Bococizumab (PF-04950615; RN316) In Subjects With Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events (SPIRE-HR)

April 6, 2017 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

711

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Maroubra, New South Wales, Australia, 2035
        • Australian Clinical Research Network
    • Queensland
      • Milton, Queensland, Australia, 4064
        • Core Research Group Pty Ltd
    • Victoria
      • St. Kilda East, Victoria, Australia, 3183
        • The Avenue Cardiovascular Centre
  • Canada
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 7K9
        • Ecogene-21
      • Montreal, Quebec, Canada, H1T 1C8
        • Montreal Heart Institute
      • Montreal, Quebec, Canada, H4N 3C5
        • Diex Research Montreal Inc.
      • Quebec City, Quebec, Canada, G3K 2P8
        • Alpha Recherche Clinique
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre hospitalier universitaire de Sherbrooke (CHUS)
      • Victoriaville, Quebec, Canada, G6P 6P6
        • Medexa Recherche
  • Czech Republic
      • Hradec Kralove, Czech Republic, 500 05
        • Fakultni nemocnice Hradec Kralove
      • Praha 5, Czech Republic, 158 00
        • Kardiologie a interni lekarstvi
      • Zlin, Czech Republic, 760 01
        • Lekarsky dum Ormiga
  • Germany
      • Berlin, Germany, 10117
        • Klinische Forschung Berlin-Mitte GmbH
      • Hannover, Germany, 30159
        • Klinische Forschung Hannover - Mitte GmbH
      • Ludwigshafen, Germany, 67063
        • Klinikum der Stadt Ludwigshafen am Rhein gGmbH
      • Schwerin, Germany, 19055
        • Klinische forschung Schwerin GmbH
  • Hong Kong
      • Shatin, Hong Kong
        • The Chinese University of Hong Kong
      • Shatin, NT, Hong Kong
        • Department of Medicine & Therapeutics-The Chinese University of Hong Kong
  • Italy
    • MI
      • Milano, MI, Italy, 20132
        • IRCCS Ospedale San Raffaele
      • Milano, MI, Italy, 20138
        • IRCCS Centro Cardiologico Fondazione Monzino
      • Milano, MI, Italy, 20145
        • IRCCS Istituto Auxologico Italiano
    • PA
      • Palermo, PA, Italy, 90127
        • Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"
    • RM
      • Roma, RM, Italy, 00161
        • Dipartimento di Medicina Interna e Specialita Mediche Policlinico Umberto I
  • Korea, Republic of
      • Gangwon-Do, Korea, Republic of, 220-701
        • Yonsei University Wonju Severance Christian Hospital
      • Gwangju, Korea, Republic of, 501-757
        • Chonnam National University Hospital
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 120-752
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 137-701
        • The Catholic University of Korea, Seoul St. Mary's Hospital
      • Seoul, Korea, Republic of, 135-720
        • Gangnam Sevrance Hospital, Yeonsei University Health System
      • Suwon, Korea, Republic of, 443-380
        • Ajou University Hospital
      • Ulsan, Korea, Republic of, 682-714
        • Ulsan University Hospital
    • Gyeonggi-do
      • Uijeongbu-si, Gyeonggi-do, Korea, Republic of, 480-717
        • The Catholic University of Korea, Uijeongbu St. Mary's Hospital
  • Poland
      • Gdynia, Poland, 81-384
        • Synexus Polska Sp. z o.o. Oddzial w Gdyni
      • Lodz, Poland, 92-003
        • Niepubliczny Zaklad Opieki Zdrowotnej CEREO-MED Sp. z o.o.
      • Opole, Poland, 45-706
        • Medicus w Opolu sp z o.o.
      • Oswiecim, Poland, 32-600
        • Medicome Sp. Z O.O.
      • Poznan, Poland, 60-702
        • Synexus Polska Sp. z o.o Oddzial w Poznaniu
      • Skierniewice, Poland, 96-100
        • Centrum Medyczne Ogrodowa Sp. z o.o.
      • Sopot, Poland, 81-756
        • Centrum Medyczne "SOPMED" Sp. z o.o.
      • Warszawa, Poland, 01-518
        • Centrum Medyczne AMED
      • Warszawa, Poland, 01-192
        • Synexus Polska Sp. z o.o. Oddzial w Warszawie
      • Warszawa, Poland, 02-507
        • CSK MSW w Warszawie, Klinika Kardiologii Zachowawczej i Nadcisnienia Tetniczego
      • Wroclaw, Poland, 50-088
        • Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
    • Mazowieckie
      • Katowice, Mazowieckie, Poland, 40-040
        • Synexus Polska Sp. Z O.O. Oddzial W Katowicach
    • Slaskie
      • Katowice, Slaskie, Poland, 40-752
        • NZOZ Terapia Optima
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Achieve Clinical Research, LLC
      • Birmingham, Alabama, United States, 35243
        • Cardiovascular Associates of the Southeast, LLC
    • Arizona
      • Tucson, Arizona, United States, 85712
        • ARA-Arizona Research Associates
      • Tucson, Arizona, United States, 85710
        • Southwest Heart Group
    • California
      • Encinitas, California, United States, 92024
        • Diagnamics, Inc.
      • Encinitas, California, United States, 92024
        • Encompass Clinical Research North Coast
      • Fountain Valley, California, United States, 92708
        • MD Studies, Inc.
      • Laguna Hills, California, United States, 92653
        • Alliance Research Centers
      • Laguna Hills, California, United States, 92653
        • Prime Care Clinical Research
      • North Hollywood, California, United States, 91606
        • Providence Clinical Research
      • San Diego, California, United States, 92111
        • San Diego Family Care
      • Stockton, California, United States, 95204
        • St. Joseph's Medical Associates
      • Tustin, California, United States, 92780
        • Orange County Research Center
      • Vista, California, United States, 92083
        • Clinical Research Advantage, Inc./Cassidy Medical Group - Vista
      • Wildomar, California, United States, 92595
        • Elite Clinical Trials
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Expresscare Clinical Research
    • Connecticut
      • Norwalk, Connecticut, United States, 06851
        • Soundview Medical Associates
    • Florida
      • Hialeah, Florida, United States, 33013
        • Eastern Research, Inc.
      • Jacksonville, Florida, United States, 32277
        • Care Partners Clinical Research, Llc
      • Jacksonville, Florida, United States, 32204
        • East Coast Institute for Research, LLC at Northeast Florida Endocrine & Diabetes Associates
      • Miami, Florida, United States, 33133
        • Prestige Clinical Research Center Inc
      • New Smyrna Beach, Florida, United States, 32169
        • Edgewater Medical Research
      • Tampa, Florida, United States, 33607
        • Gulfcoast Medical Research Center, LLC
    • Georgia
      • Savannah, Georgia, United States, 31406
        • SouthCoast Medical Group
      • Savannah, Georgia, United States, 31406
        • Fellows Research Alliance, Inc.
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Evanston Premier Healthcare Research LLC
    • Indiana
      • Anderson, Indiana, United States, 46011
        • Comunity Clinical Research Center
      • Avon, Indiana, United States, 46123
        • American Health Network of Indiana, LLC
      • Indianapolis, Indiana, United States, 46260
        • Midwest Institute for Clinical Research
    • Louisiana
      • Eunice, Louisiana, United States, 70535
        • Horizon Research Group of Opelousas, LLC
      • Eunice, Louisiana, United States, 70535
        • Internal Medicine Associates
    • Massachusetts
      • Quincy, Massachusetts, United States, 02169
        • Beacon Clinical Research, LLC
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute Foundation
      • Minneapolis, Minnesota, United States, 55407
        • Allina Health System, dba Abbott Northwestern Hospital
      • Minneapolis, Minnesota, United States, 55455
        • University of MN, Lillehei Clinical Trials Unit
    • Montana
      • Missoula, Montana, United States, 59808
        • Montana Medical Research Inc.
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
      • Winston Salem, North Carolina, United States, 27103
        • Clinical Trials of America, Inc.
    • Ohio
      • Akron, Ohio, United States, 44311
        • Radiant Research, Inc
      • Cleveland, Ohio, United States, 44122
        • Rapid Medical Research, Inc.
      • Perrysburg, Ohio, United States, 43551
        • The Office of Daniel G. Williams, MD
      • Willoughby, Ohio, United States, 44094
        • Great Lakes Medical Research, LLC
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73135
        • South Oklahoma Heart Research LLC
    • Oregon
      • Ashland, Oregon, United States, 97520
        • Integrated Medical Research, PC
      • Portland, Oregon, United States, 97239
        • Columbia Research Group, Inc.
    • Pennsylvania
      • Harleysville, Pennsylvania, United States, 19438
        • Harleysville Medical Associates
      • Philadelphia, Pennsylvania, United States, 19104
        • Perelman Center for Advanced Medicine Heart & Vascular Center
      • Wyomissing, Pennsylvania, United States, 19610
        • Berks Cardiologists, Ltd.
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Medical Research South,LLC
      • Moncks Corner, South Carolina, United States, 29461
        • Berkeley Family Practice
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Internal Medicine and Pediatric Associates of Bristol, PC
    • Texas
      • Corpus Christi, Texas, United States, 78413
        • 3 rd Coast Research Associates
      • Houston, Texas, United States, 77081
        • Texas Center for Drug Development, Inc.
      • Houston, Texas, United States, 77099
        • Pioneer Research Solutions, Inc.
      • Hurst, Texas, United States, 76054
        • Protenium Clinical Research
    • Utah
      • Layton, Utah, United States, 84041
        • Utah Cardiology, P.C.
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • National Clinical Research - Norfolk, Inc.
    • Washington
      • Spokane, Washington, United States, 99202
        • Premier Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
subcutaneous injection, every 2 weeks for 12 months
Experimental: Bococizumab (PF-04950615;RN316)
Drug: Bococizumab (PF-04950615;RN316)
150 mg every 2 weeks, subcutaneous injection, 12 months
Other Names:
  • RN316

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12
Time Frame: Baseline, Week 12
Baseline, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52
Time Frame: Baseline, Week 12, 24, 52
Baseline, Week 12, 24, 52
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
Baseline, Week 12, 24, 52
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52
Time Frame: Baseline, Week 12, 24, 52
Baseline, Week 12, 24, 52
Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52
Time Frame: Baseline, Week 12, 24, 52
Baseline, Week 12, 24, 52
Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52
Time Frame: Baseline, Week 12, 24, 52
Baseline, Week 12, 24, 52
Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Primary Hyperlipidemia
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Mixed Dyslipidemia
Time Frame: Baseline, Week 12
Participants with mixed dyslipidemia are defined as TG level greater than or equal to (>=) 200 mg/dL (2.26 mmol/L) at pre-randomization.
Baseline, Week 12
Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 24 and 52
Time Frame: Baseline, Week 24, 52
Baseline, Week 24, 52
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off
Time Frame: Baseline, Week 24, 52
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.
Baseline, Week 24, 52
Percent Change From Baseline in Fasting Triglyceride (TG) at Week 12, 24 and 52
Time Frame: Baseline, Week 12, 24, 52
Baseline, Week 12, 24, 52
Percent Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52
Time Frame: Baseline, Week 12, 24, 52
Baseline, Week 12, 24, 52
Percent Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52
Time Frame: Baseline, Week 12, 24, 52
Baseline, Week 12, 24, 52
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
Baseline, Week 12, 24, 52
Absolute Change From Baseline in Fasting Low Density Lipoprotein-C (LDL-C) at Week 12 by Trigylceride Cut-Off
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
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
Baseline, Week 12, 24, 52
Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52
Time Frame: Baseline, Week 12, 24, 52
Baseline, Week 12, 24, 52
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
Baseline, Week 12, 24, 52
Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52
Time Frame: Baseline, Week 12, 24, 52
Baseline, Week 12, 24, 52
Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52
Time Frame: Baseline, Week 12, 24, 52
Baseline, Week 12, 24, 52
Absolute Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52
Time Frame: Baseline, Week 12, 24, 52
Baseline, Week 12, 24, 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
Time Frame: Baseline, Week 12, 24, 52
Baseline, Week 12, 24, 52
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
Baseline, Week 12, 24, 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
Time Frame: Week 12, 24 and 52
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
Time Frame: Week 12, 24 and 52
Week 12, 24 and 52
Plasma PF-04950615 Concentrations at Week 12, 24 and 52
Time Frame: Week 12, 24, 52
Week 12, 24, 52
Number of Participants With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions
Time Frame: Baseline up to the end of study (up to 58 weeks)
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.
Baseline up to the end of study (up to 58 weeks)
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)
Time Frame: Baseline up to the end of study (up to 58 weeks)
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.
Baseline up to the end of study (up to 58 weeks)

Other Outcome Measures

Outcome Measure
Time Frame
Absolute Change From Baseline in Triglyceride (TG) at Week 12, 24 and 52
Time Frame: Baseline, Week 12, 24, 52
Baseline, Week 12, 24, 52
Absolute Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52
Time Frame: Baseline, Week 12, 24, 52
Baseline, Week 12, 24, 52
Absolute Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52
Time Frame: Baseline, Week 12, 24, 52
Baseline, Week 12, 24, 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

October 21, 2013

First Submitted That Met QC Criteria

October 21, 2013

First Posted (Estimate)

October 24, 2013

Study Record Updates

Last Update Posted (Actual)

May 17, 2017

Last Update Submitted That Met QC Criteria

April 6, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1481019
  • 2013-002642-37 (EudraCT Number)
  • SPIRE-HR (Other Identifier: Alias Study Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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