A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia
- Conditions
- Heterozygous Familial Hypercholesterolemia
- Interventions
- Other: Placebo
- Registration Number
- NCT01968980
- Lead Sponsor
- Pfizer
- Brief Summary
This is a multicenter, randomized study in subjects with heterozygous familial hypercholesterolemia receiving highly effective statins to assess the safety, efficacy and tolerability of Bococizumab (PF-04950615; RN316) to lower LDL-C.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 370
- 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.
- Heterozygous familial hypercholesterolemia.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bococizumab (PF-04950615;RN316) Bococizumab (PF-04950615;RN316) Bococizumab (PF-04950615;RN316) Placebo Placebo -
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 Baseline, Week 12
- Secondary Outcome Measures
Name Time Method Percent Change From Baseline in Total Cholesterol (TC) at Week 12 Baseline, Week 12 Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 Baseline, Week 12 Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 70 Milligram Per Deciliter (1.81 Millimoles Per Liter) at Week 12, 24 and 52 Week 12, 24, 52 Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52 Baseline, Week 12, 24, 52 Absolute Change From Baseline in Lipoprotein (a) at Week 12 Baseline, Week 12 Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 100 Milligram Per Deciliter (2.59 Millimoles Per Liter) at Week 12, 24 and 52 Week 12, 24, 52 Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 Baseline, Week 12 Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and 52 Baseline, Week 24, 52 Absolute Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 Baseline, Week 12 Absolute Change From Baseline in Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52 Baseline, Week 12, 24, 52 Percentage of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb) 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 in this outcome measure. ADA titer greater than or equal to (\>=) 6.23 were considered as ADA positive and nAb titer level \>=1.58 were considered as nAb positive.
Percent Change From Baseline in Lipoprotein (a) at Week 12 Baseline, Week 12 Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 Baseline, Week 12 Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 Baseline, Week 24, 52 Percent Change From Baseline in Total Cholesterol (TC) at Week 24 and 52 Baseline, Week 24, 52 Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 24 and 52 Baseline, Week 24, 52 Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24 and 52 Baseline, Week 24, 52 Percent Change From Baseline in Lipoprotein (a) at Week 24 and 52 Baseline, Week 24, 52 Percent Change From Baseline in Triglycerides (TG) at Week 12, 24 and 52 Baseline, Week 12, 24, 52 Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52 Baseline, Week 12, 24, 52 Absolute Change From Baseline in Ratio of Apolipoprotein B to Apolipoprotein A-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52 Baseline, Week 12, 24, 52 Plasma PF-04950615 Concentrations at Week 12, 24 and 52 Week 12, 24, 52 Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52 Baseline, Week 12, 24, 52 Absolute Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12 Baseline, Week 12 Absolute Change From Baseline in Total Cholesterol (TC) at Week 12 Baseline, Week 12 Absolute Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 Baseline, Week 12 Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12 Baseline, Week 12 Number of Participants With Adverse Events Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions 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, polysynovitis, fever and if severe then included glomerulonephritis as well. Injection site reaction is a reaction at the site of the subcutaneous injection and characterized by the symptoms of erythema, swelling, tenderness and warmth. Participants with any of the above type 1 or type 3 hypersensitivity reactions and participants with any of the above injection site reactions were reported in this outcome measure.
Trial Locations
- Locations (87)
IMD Medical Group
🇺🇸Los Angeles, California, United States
Galenos Research
🇺🇸Dallas, Texas, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Pioneer Research Solutions, Inc.
🇺🇸Sugar Land, Texas, United States
Discovery Clinical Services Ltd.
🇨🇦Victoria, British Columbia, Canada
Deventer Ziekenhuis
🇳🇱Deventer, Netherlands
NewPhase Clinical Trials, Corp.
🇺🇸Miami Beach, Florida, United States
Focus Clinical Research, LLC
🇺🇸Draper, Utah, United States
Columbus Clinical Services, LLC
🇺🇸Miami, Florida, United States
Ecogene-21
🇨🇦Chicoutimi, Quebec, Canada
The University of North Carolina Hospitals - Clinical and Translational Research Center Clinic
🇺🇸Chapel Hill, North Carolina, United States
Clinique des maladies lipidiques de Quebec Inc
🇨🇦Quebec, Canada
NZOZ Vitamed
🇵🇱Bydgoszcz, Poland
UMC Utrecht
🇳🇱Utrecht, Netherlands
Oslo Universitetssykehus HF, Ulleval
🇳🇴Oslo, Norway
Hospital Clinico Universitario Miguel Servet; Medicina Interna
🇪🇸Zaragoza, Spain
Hartford Hospital, JB704
🇺🇸Hartford, Connecticut, United States
Premier Research Associate, Inc
🇺🇸Miami, Florida, United States
Medical Research Center
🇺🇸Miami, Florida, United States
Best Quality Research, Inc.
🇺🇸Hialeah, Florida, United States
The University of North Carolina at Chapel Hill Center for Heart & Vascular Care
🇺🇸Chapel Hill, North Carolina, United States
Oklahoma Heart Hospital Physicians
🇺🇸Oklahoma City, Oklahoma, United States
Oklahoma Heart Hospital
🇺🇸Oklahoma City, Oklahoma, United States
Om Medical
🇺🇸Las Vegas, Nevada, United States
Metabolic and Atherosclerosis Research Center
🇺🇸Cincinnati, Ohio, United States
Oklahoma Heart Hospital Research Foundation
🇺🇸Oklahoma City, Oklahoma, United States
SHAT in Cardiology EAD
🇧🇬Pleven, Bulgaria
OnSite Clinical Solutions, LLC
🇺🇸Gaffney, South Carolina, United States
UMHAT "Sveti Georgi" EAD, Clinic of Cardiology
🇧🇬Plovdiv, Bulgaria
Burke Internal Medicine & Research
🇺🇸Burke, Virginia, United States
MHAT "Sveta Anna", Clinic of Internal Diseases
🇧🇬Sofia, Bulgaria
St. Paul's Hospital, Healthy Heart
🇨🇦Vancouver, British Columbia, Canada
Second MHAT - Sofia EAD
🇧🇬Sofia, Bulgaria
Asper Clinical Research Institute
🇨🇦Winnipeg, Manitoba, Canada
University of Ottawa Heart Institute
🇨🇦Ottawa, Ontario, Canada
Health Sciences Centre
🇨🇦St. John's, Newfoundland and Labrador, Canada
Montreal Heart Institute
🇨🇦Montreal, Quebec, Canada
Institut de Recherches Cliniques de Montreal
🇨🇦Montreal, Quebec, Canada
Pohjois-Karjala Projekti Saatio
🇫🇮Joensuu, Finland
Ospedale "Santa Maria della Misericordia"
🇮🇹Perugia, PG, Italy
Policlinico "Paolo Giaccone"
🇮🇹Palermo, PA, Italy
St. Franciscus Gasthuis
🇳🇱Rotterdam, Zuid-holland, Netherlands
Amphia Hospital
🇳🇱Breda, Netherlands
Ospedale di Circolo e Fondazione Macchi
🇮🇹Varese, VA, Italy
Azienda Ospedaliero Universitaria "Federico II" di Napoli
🇮🇹Napoli, Italy
Rotterdam Research Institute
🇳🇱Rotterdam, Netherlands
Academic Medical Center
🇳🇱Amsterdam, Netherlands
Admiraal de Ruyter ziekenhuis
🇳🇱Goes, Zeeland, Netherlands
Hagaziekenhuis
🇳🇱Den Haag, Netherlands
Albert Schweitzer Hospital
🇳🇱Sliedrecht, Netherlands
NZOZ Przychodnia Specjalistyczna Andrzej Wittek Henryk Rudzki S.C
🇵🇱Ruda Slaska, Poland
IATROS International
🇿🇦Bloemfontein, Free State, South Africa
Unitas hospital
🇿🇦Centurion, Gauteng, South Africa
NZOZ Centrum Zdrowia i Profilaktyki Dabie Sp zo.o.
🇵🇱Krakow, Poland
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, Kwa-zulu Natal, 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 General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Hospital Universitario Reina Sofia
🇪🇸Cordoba, Spain
Hospital Clinico San Carlos; U. de Lipidos; Medicina Interna III
🇪🇸Madrid, Spain
Fundacion Jimenez Diaz; Servicio de Medicina Interna
🇪🇸Madrid, Spain
Pennine Acute Hospitals NHS Trust
🇬🇧Oldham, Greater Manchester, United Kingdom
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Clinical Trials Pharmacy, 4th Floor Inpatient Pharmacy
🇬🇧Manchester, 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
Central Manchester University Hospitals NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Peterborough and Stamford Hospitals NHS Foundation Trust
🇬🇧Peterborough, United Kingdom
Oulu University Hospital
🇫🇮Oulu, Finland
Helsinki Central University Hospital
🇫🇮Helsinki, Finland
Oslo Universitetssykehus HF
🇳🇴Oslo, Norway
TREAD Research cc.
🇿🇦Parow, Cape Town, Western Cape, South Africa
Pohjois-Karjala Projekti Saatio/Ita-Suomen
🇫🇮Joensuu, Finland
Division of Medicine Turku University Hospital
🇫🇮Turku, Finland
Laakarikeskus Aava Kerava/Aava Kerava Medical Center
🇫🇮Kerava, Finland
Tiervlei Trial Centre, Karl Bremer Hospital
🇿🇦Bellville, Cape Town, Western Cape, South Africa
Royal Free London NHS Foundation Trust
🇬🇧London, United Kingdom
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States