A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia
NCT ID: NCT01968980
Last Updated: 2017-06-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
370 participants
INTERVENTIONAL
2013-10-23
2016-04-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Bococizumab (PF-04950615;RN316)
Bococizumab (PF-04950615;RN316)
Bococizumab (PF-04950615;RN316)
150 mg every 2 weeks, subcutaneous injection, 12 months
Placebo
Placebo
subcutaneous injection every 2 weeks for 12 months
Interventions
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Bococizumab (PF-04950615;RN316)
150 mg every 2 weeks, subcutaneous injection, 12 months
Placebo
subcutaneous injection every 2 weeks for 12 months
Eligibility Criteria
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Inclusion Criteria
* Fasting LDL-C \> 70 mg/dL and triglyceride \<=400 mg/dL.
* High or very high risk of incurring a cardiovascular event.
* Heterozygous familial hypercholesterolemia.
Exclusion Criteria
* Cardiovascular or cerebrovascular event of procedures during the past 30 days.
* Congestive heart failure NYHA class IV.
* Poorly controlled hypertension.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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IMD Medical Group
Los Angeles, California, United States
Hartford Hospital, JB704
Hartford, Connecticut, United States
Best Quality Research, Inc.
Hialeah, Florida, United States
Medical Research Center
Miami, Florida, United States
Premier Research Associate, Inc
Miami, Florida, United States
Columbus Clinical Services, LLC
Miami, Florida, United States
NewPhase Clinical Trials, Corp.
Miami Beach, Florida, United States
Om Medical
Las Vegas, Nevada, United States
The University of North Carolina at Chapel Hill Center for Heart & Vascular Care
Chapel Hill, North Carolina, United States
The University of North Carolina Hospitals - Clinical and Translational Research Center Clinic
Chapel Hill, North Carolina, United States
Metabolic and Atherosclerosis Research Center
Cincinnati, Ohio, United States
Oklahoma Heart Hospital Physicians
Oklahoma City, Oklahoma, United States
Oklahoma Heart Hospital Research Foundation
Oklahoma City, Oklahoma, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
OnSite Clinical Solutions, LLC
Gaffney, South Carolina, United States
Galenos Research
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Pioneer Research Solutions, Inc.
Houston, Texas, United States
Pioneer Research Solutions, Inc.
Sugar Land, Texas, United States
Focus Clinical Research, LLC
Draper, Utah, United States
Burke Internal Medicine & Research
Burke, Virginia, United States
SHAT in Cardiology EAD
Pleven, , Bulgaria
UMHAT "Sveti Georgi" EAD, Clinic of Cardiology
Plovdiv, , Bulgaria
Second MHAT - Sofia EAD
Sofia, , Bulgaria
MHAT "Sveta Anna", Clinic of Internal Diseases
Sofia, , Bulgaria
St. Paul's Hospital, Healthy Heart
Vancouver, British Columbia, Canada
Discovery Clinical Services Ltd.
Victoria, British Columbia, Canada
Asper Clinical Research Institute
Winnipeg, Manitoba, Canada
Health Sciences Centre
St. John's, Newfoundland and Labrador, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Ecogene-21
Chicoutimi, Quebec, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Institut de Recherches Cliniques de Montreal
Montreal, Quebec, Canada
Clinique des maladies lipidiques de Quebec Inc
Québec, Quebec, Canada
Helsinki Central University Hospital
Helsinki, , Finland
Pohjois-Karjala Projekti Saatio/Ita-Suomen
Joensuu, , Finland
Pohjois-Karjala Projekti Saatio
Joensuu, , Finland
Laakarikeskus Aava Kerava/Aava Kerava Medical Center
Kerava, , Finland
Oulu University Hospital
Oulu, , Finland
Division of Medicine Turku University Hospital
Turku, , Finland
Policlinico "Paolo Giaccone"
Palermo, PA, Italy
Ospedale "Santa Maria della Misericordia"
Perugia, PG, Italy
Ospedale di Circolo e Fondazione Macchi
Varese, VA, Italy
Azienda Ospedaliero Universitaria "Federico II" di Napoli
Napoli, , Italy
St. Franciscus Gasthuis
Rotterdam, South Holland, Netherlands
Admiraal de Ruyter ziekenhuis
Goes, Zeeland, Netherlands
Academic Medical Center
Amsterdam, , Netherlands
Amphia Hospital
Breda, , Netherlands
Deventer Ziekenhuis
Deventer, , Netherlands
Rotterdam Research Institute
Rotterdam, , Netherlands
Albert Schweitzer Hospital
Sliedrecht, , Netherlands
Hagaziekenhuis
The Hague, , Netherlands
UMC Utrecht
Utrecht, , Netherlands
Oslo Universitetssykehus HF
Oslo, , Norway
Oslo Universitetssykehus HF, Ulleval
Oslo, , Norway
NZOZ Vitamed
Bydgoszcz, , Poland
NZOZ Centrum Zdrowia i Profilaktyki Dabie Sp zo.o.
Krakow, , Poland
NZOZ Przychodnia Specjalistyczna Andrzej Wittek Henryk Rudzki S.C
Ruda Śląska, , Poland
IATROS International
Bloemfontein, Free State, South Africa
Unitas hospital
Centurion, Gauteng, South Africa
Midrand Medical Centre
Halfway House, Gauteng, South Africa
Medipark Centre for Clinical Research
Pretoria, Gauteng, South Africa
Jongaie Research
Pretoria, Gauteng, South Africa
Synexus Watermeyer Clinical Research Centre
Pretoria, Gauteng, South Africa
Roodepoort Medicross Clinical Research Centre
Roodepoort, Gauteng, South Africa
Chelmsford Medical Centre 3
Durban, KwaZulu-Natal, South Africa
Tiervlei Trial Centre, Karl Bremer Hospital
Bellville, Cape Town, Western Cape, South Africa
TREAD Research cc.
Parow, Cape Town, Western Cape, South Africa
Synexus Helderberg Clinical Research Centre
Somerset West, Western Cape, South Africa
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Clinico Universitario, Santiago de Compostela
Santiago de Compostela, Galicia, Spain
Hospital Universitario Sant Joan de Reus
Reus, Tarragona, Spain
Hospital Clinic
Barcelona, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Fundacion Jimenez Diaz; Servicio de Medicina Interna
Madrid, , Spain
Hospital Clinico San Carlos; U. de Lipidos; Medicina Interna III
Madrid, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Clinico Universitario Miguel Servet; Medicina Interna
Zaragoza, , Spain
Clinical Trials Pharmacy, 4th Floor Inpatient Pharmacy
Manchester, Greater Manchester, United Kingdom
Pennine Acute Hospitals NHS Trust
Oldham, Greater Manchester, United Kingdom
East and North Hertfordshire NHS Trust
Stevenage, Hertfordshire, United Kingdom
Burton Hospitals NHS Foundation Trust
Burton-on-Trent, Staffordshire, United Kingdom
Heart of England NHS Foundation Trust
Birmingham, West Midlands, United Kingdom
Royal Free London NHS Foundation Trust
London, , United Kingdom
Central Manchester University Hospitals NHS Foundation Trust
Manchester, , United Kingdom
Peterborough and Stamford Hospitals NHS Foundation Trust
Peterborough, , United Kingdom
Countries
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References
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Wang EQ, Kaila N, Plowchalk D, Gibiansky L, Yunis C, Sweeney K. Population PK/PD modeling of low-density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent anti-PCSK9 monoclonal antibody. CPT Pharmacometrics Syst Pharmacol. 2023 Dec;12(12):2013-2026. doi: 10.1002/psp4.13050. Epub 2023 Nov 22.
McCush F, Wang E, Yunis C, Schwartz P, Baltrukonis D. Anti-drug Antibody Magnitude and Clinical Relevance Using Signal to Noise (S/N): Bococizumab Case Study. AAPS J. 2023 Sep 2;25(5):85. doi: 10.1208/s12248-023-00846-x.
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.
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.
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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2013-002644-87
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SPIRE-HF
Identifier Type: OTHER
Identifier Source: secondary_id
B1481021
Identifier Type: -
Identifier Source: org_study_id
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