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

Hyperlipidemia Clinical Trial

— SPIRE-LDL  

Official title:

A Phase 3 Double-blind, Randomized, Placebo-controlled, Parallel-group Study To Assess The Efficacy, Long-term Safety And Tolerability Of Pf-04950615 In Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01968967
• Other study ID #: B1481020
• Secondary ID: 2013-002643-28SP
• Status: Completed
• Phase: Phase 3
• Start date: October 29, 2013
• Est. completion date: July 10, 2017

Study information

• Verified date: July 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2139
• Est. completion date: July 10, 2017
• Est. primary completion date: July 5, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemias
• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Drug:
• Bococizumab (PF-04950615; RN316)
150 mg every 2 weeks, subcutaneous injection, 12 months

Other:
• Placebo
subcutaneous injection every 2 weeks for 12 months

Locations

Country	Name	City	State
Canada	Vizel Cardiac Research, Saul Vizel Professional Medicine Corporation	Cambridge	Ontario
Canada	Rhodin Recherche Clinique	Drummondville	Quebec
Canada	The Office of Dr. Allen Greenspoon	Hamilton	Ontario
Canada	LMC Research Inc. d.b.a. Manna Research Inc.	Levis	Quebec
Canada	London Health Sciences Centre	London	Ontario
Canada	Stroke Prevention & Atherosclerosis Research Centre (SPARC)	London	Ontario
Canada	Omnispec Clinical Research Inc.	Mirabel	Quebec
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Newmarket Cardiology Research Group	Newmarket	Ontario
Canada	London Road Diagnostic Clinic and Medical Centre	Sarnia	Ontario
Canada	DIEX Research Sherbrooke Inc.	Sherbrooke	Quebec
Canada	St. Michael's Hospital Health Centre	Toronto	Ontario
Canada	Discovery Clinical Services Ltd.	Victoria	British Columbia
Colombia	Fundacion Cardiomet - CEQUIN	Armenia	Quindio
Colombia	BIOMELAB Ltda.	Barranquilla	Atlantico
Colombia	Fundacion del Caribe para la Investigacion Biomedica-Fundacion Bios	Barranquilla	Atlantico
Colombia	IPS Centro Cientifico Asistencial Jose Luis Accini S.A.S.	Barranquilla	Atlantico
Colombia	Dexa Diab Servicios Medicos Ltda. IPS	Bogota	Cundinamarca
Colombia	Instituto de Investigacion Endocrinologia y Prevencion Metabolica ENDOCARE LTDA	Bogota	Cundinamarca
Colombia	Centro de Investigaciones Clinicas S.A.S	Cali	Valle DEL Cauca
Colombia	Centro de Diagnostico Cardiologico LTDA.	Cartagena	Bolivar
Colombia	Fundacion Centro de Investigaciones Biomedicas RIESCARD	Espinal	Tolima
Colombia	Fundacion Cardiovascular De Colombia	Floridablanca	Santander
Colombia	Asociacion IPS Medicos InterniStas de Caldas	Manizales	Caldas
Colombia	Centro de Medicina del Ejercicio y Rehabilitacion Cardiaca S.A. CEMDE S.A.	Medellin	Antioquia
Colombia	Rodrigo Botero S.A.S	Medellin	Antioquia
France	Nouvelles Cliniques Nantaises	Nantes
France	CHU La Miletrie	Poitiers
France	CHU de Toulouse - Hopital Rangueil	Toulouse cedex 9
France	Hopital Guy Chatiliez	Tourcoing
France	Hopital Guy Chatillez	Tourcoing
Hungary	Magyar Imre Korhaz, Belgyogyaszati Szakrendeles	Ajka
Hungary	Bajai Szent Rokus Korhaz	Baja
Hungary	Lausmed Kft.	Baja
Hungary	DRC Kft.	Balatonfured
Hungary	SYNEXUS Magyarorszag Kft.	Budapest
Hungary	Synexus Magyarorzag Kft.	Budapest
Hungary	Pharma 4 Trial Kft.	Gyongyos
Hungary	Borsod-Abauj-Zemplen Megyei Korhaz, es Egyetemi Oktatokorhaz	Miskolc
Hungary	TaNaMed Kft.	Mosonmagyarovar
Hungary	Pecsi Tudomanyegyetem	Pecs
Hungary	Zala Megyei Korhaz	Zalaegerszeg
Lithuania	PI Kaunas Silainiai Outpatient Clinic	Kaunas
Lithuania	Private Clinic Elite Medicale	Kaunas
Lithuania	PI Klaipeda Seamen Hospital	Klaipeda
Lithuania	Vilnius University Hospital Santariskiu Klinikos	Vilnius
Mexico	Centenario Hospital Miguel Hidalgo	Aguascalientes
Mexico	Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV	Aguascalientes
Mexico	Centro Hospitalario Mac, S.A. De C.V. (Emergencies)	Aguascalientes
Mexico	Administradora de Clinicas S.A. de C.V. Hospital Inovamed Cuernavaca	Cuernavaca	Morelos
Mexico	Instituto de Diabetes, Obesidad y Nutricion S.C.	Cuernavaca	Morelos
Mexico	Instituto Jalisciense de Investigacion en Diabetes y Obesidad, S.C.	Guadalajara	Jalisco
Mexico	Clinicos Asociados BOCM, S.C.	Mexico	Distrito Federal
Mexico	Hospital General de Naucalpan "Dr. Maximiliano Ruiz Castaneda" (Emergencies)	Naucalpan	Estado DE Mexico
Mexico	Hospital Angeles Centro Medico del Potosi (Emergencies)	San Luis Potosi
Mexico	Centro de Atención e Investigación Cardiovascular del Potosí S.C.	San Luis Potosí	SAN LUIS Potosi
Romania	Centrul Medical de Diagnostic si Tratament Ambulator Neomed, Medicina Interna	Brasov
Romania	Spitalul Universitar de Urgenta Militar Central, Dr. Carol Davila"	Bucuresti
Romania	Centrul Medical Unirea, Diabet Nutritie si Boli Metabolice	Cluj-Napoca
Romania	Spitalul Clinic Judetean de Urgenta Craiova, Cardiologie	Craiova	Dolj
Romania	Elit Medical SRL	Ploiesti
Russian Federation	Federal State Budgetary Institution "Research Institute of Complex problems of Cardio-vascular	Kemerovo
Russian Federation	FSAEI of Higher Education "People's Friendship University of Russia",	Moscow
Russian Federation	Saint-Petersburg State Budgetary Institution of Healthcare "Municipal Hospital #15"	Saint-Petersburg
Russian Federation	Saint-Petersburg State Budgetary Institution of Healthcare Municipal hospital # 40 of the Kurortnyi	Saint-Petersburg
Russian Federation	Municipal Institution of Healthcare "City Clinical Hospital 12	Saratov
Russian Federation	LLC "Institute of medical research"	St. Petersburg
Spain	Hospital Universitario La Ribera	Alzira	Valencia
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitario de Bellvitge	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Universitario La Paz; Unidad Metabolico-Vascular	Madrid
Spain	Centro Salud Petrer I	Petrer	Alicante
Spain	Hospital Universitario Quiron Madrid	Pozuelo de Alarcon	Madrid
Spain	Hospital Universitario Sant Joan de Reus	Reus	Tarragona
Spain	Hospital Clinico Universitario Santiago de Compostela	Santiago de Compostela	Galicia
Spain	Hospital Clinico Universitario Miguel Servet; Medicina Interna	Zaragoza
Taiwan	Cardinal Tien Hospital	New Taipei City
Taiwan	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Taipei Veterans General Hospital	Taipei
United Kingdom	The Crouch Oak Family Practice	Addlestone	Surrey
United Kingdom	Northmed Clinical Research Ltd, Randalstown Health Centre	Antrim	Northern Ireland
United Kingdom	Synexus Midlands Clinical Research Centre	Birmingham	WEST Midlands
United Kingdom	The Bradford on Avon & Melksham Health Partnership	Bradford on Avon	Wiltshire
United Kingdom	Synexus Wales Clinical Research Centre	Cardiff	Llanishen
United Kingdom	Synexus Lancashire Clinical Research Centre	Chorley	Lancashire
United Kingdom	Ninewells Hospital & Medical School	Dundee
United Kingdom	Synexus Scotland Clinical Research Centre	Glasgow	Lanarkshire
United Kingdom	Synexus North East Clinical Research Centre	Hexham	Northumberland
United Kingdom	Synexus North East Clinical Research Centre-Hexham General Hospital	Hexham	Northumberland
United Kingdom	Synexus Merseyside Clinical Research Centre	Liverpool	Merseyside
United Kingdom	Synexus Manchester Clinical Research Centre	Manchester	Greater Manchester
United Kingdom	Southern Health & Social Care Trust, Craigavon Area Hospital	Portadown	Northern Ireland
United Kingdom	Synexus Thames Valley Clinical Research Centre	Reading	Berkshire
United States	Radiant Research, Inc	Akron	Ohio
United States	Albany Medical College, Division of Community Endocrinology	Albany	New York
United States	KRK Medical Research	Arlington	Texas
United States	Ernest L. Hendrix, MD, PC	Athens	Alabama
United States	North Alabama Research Center, LLC	Athens	Alabama
United States	Atlanta Diabetes Associates	Atlanta	Georgia
United States	ACRC-Cardiology	Atlantis	Florida
United States	Care Clinical Research Corporation	Banning	California
United States	Southern Maine Health Care	Biddeford	Maine
United States	Alabama Internal Medicine, P.C.	Birmingham	Alabama
United States	Drug Shipment and Study Conducted at Address: University of Alabama at Birmingham	Birmingham	Alabama
United States	The Kirklin Clinic	Birmingham	Alabama
United States	Northwest Clinical Trials, Inc.	Boise	Idaho
United States	Drug Trials Brooklyn	Brooklyn	New York
United States	Investigators Research Group, LLC	Brownsburg	Indiana
United States	Community Health Care, Inc.	Canal Fulton	Ohio
United States	Med Center	Carmichael	California
United States	Radiant Research Incorporated	Chandler	Arizona
United States	Coastal Cardiology	Charleston	South Carolina
United States	Sensenbrenner Primary Care	Charlotte	North Carolina
United States	IHA Chelsea Family & Internal Medicine	Chelsea	Michigan
United States	Metabolic and Atherosclerosis Research Center	Cincinnati	Ohio
United States	Sentral Clinical Research Services	Cincinnati	Ohio
United States	Sentral Clinical Research Services - Admin Only	Cincinnati	Ohio
United States	Sterling Research Group, Ltd.	Cincinnati	Ohio
United States	Sterling Research Group, Ltd.	Cincinnati	Ohio
United States	The Lindner Center for Research and Education at The Christ Hospital	Cincinnati	Ohio
United States	Morton Plant Mease Health Care, Inc. Cardiovascular Research	Clearwater	Florida
United States	Clinical Research Advantage, Inc./Colorado Springs Health Partners, SW	Colorado Springs	Colorado
United States	Clinicos, LLC	Colorado Springs	Colorado
United States	Columbia Medical Practice	Columbia	Maryland
United States	West Broadway Clinic	Council Bluffs	Iowa
United States	North Texas Healthcare System, Dallas VAMC	Dallas	Texas
United States	Research Institute of Dallas	Dallas	Texas
United States	Avail Clinical Research, LLC	DeLand	Florida
United States	Brandywine Clinical Research	Downingtown	Pennsylvania
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Radiant Research, Inc.	Edina	Minnesota
United States	Liberty Family Practice	Erie	Pennsylvania
United States	Med Investigations	Fair Oaks	California
United States	QUEST Research Institute	Farmington Hills	Michigan
United States	Fleming Island Center for Clinical Research	Fleming Island	Florida
United States	Invesclinic, LLC	Fort Lauderdale	Florida
United States	University of North Texas Health Science Center at Fort Worth	Fort Worth	Texas
United States	Florida Research Network, LLC	Gainesville	Florida
United States	Advanced Research Associates	Glendale	Arizona
United States	PharmQuest	Greensboro	North Carolina
United States	Upstate Pharmaceutical Research	Greenville	South Carolina
United States	Drug Trials America	Hartsdale	New York
United States	AGA Clinical Trials	Hialeah	Florida
United States	The Research Center, Inc.	Hialeah	Florida
United States	Homestead Medical Research Inc.	Homestead	Florida
United States	East-West Medical Research Institute	Honolulu	Hawaii
United States	Baylor College of Medicine	Houston	Texas
United States	lnvestigational Drug Services (IDA)	Houston	Texas
United States	Northwest Houston Cardiology	Houston	Texas
United States	Pioneer Research Solutions, Inc.	Houston	Texas
United States	Texas Center for Drug Development, Inc.	Houston	Texas
United States	California Heart Specialists	Huntington Beach	California
United States	Alia Clinical Research, Inc.	Huntington Park	California
United States	Heart Center Research, Llc	Huntsville	Alabama
United States	American Health Network, LLC	Indianapolis	Indiana
United States	Midwest Institute for Clinical Research	Indianapolis	Indiana
United States	Nature Coast Clinical Research	Inverness	Florida
United States	The University of Iowa - College of Public Health - Preventive Intervention Center	Iowa City	Iowa
United States	East Coast Institute for Research, LLC at Baker-Gilmour Cardiovascular Institute, PA	Jacksonville	Florida
United States	East Coast Institute for Research, LLC at Jacksonville Cardiovascular Center	Jacksonville	Florida
United States	East Coast Institute for Research, LLC at Northeast Florida Cardiology Clinic	Jacksonville	Florida
United States	East Coast Institute for Research, LLC at Northeast Florida Endocrine & Diabetes Associates	Jacksonville	Florida
United States	St. Vincent's Cardiology	Jacksonville	Florida
United States	Westside Center for Clinical Research	Jacksonville	Florida
United States	Westside Family Medical Center, Pc	Kalamazoo	Michigan
United States	KCUMB Center for Community and Clinical Research	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Cardiovascular Research of Knoxville	Knoxville	Tennessee
United States	New Orleans Center for Clinical Research	Knoxville	Tennessee
United States	Volunteer Research Group	Knoxville	Tennessee
United States	Detweiler Family Medicine and Associates, PC	Lansdale	Pennsylvania
United States	Clinical Research of South Nevada	Las Vegas	Nevada
United States	Om Medical	Las Vegas	Nevada
United States	SJH Cardiology Associates	Liverpool	New York
United States	Downtown L.A. Research Center, Inc.	Los Angeles	California
United States	Richard S. Cherlin, M.D.	Los Gatos	California
United States	Manassas Clinical Research Center	Manassas	Virginia
United States	Clinical Research Institute of Southern Oregon, PC	Medford	Oregon
United States	Suburban Research Associates	Media	Pennsylvania
United States	Solaris Clinical Research	Meridian	Idaho
United States	Arizona Center For Internal Medicine	Mesa	Arizona
United States	Omega Clinical Research	Metairie	Louisiana
United States	Clinical Research of Miami	Miami	Florida
United States	Finlay Medical Research	Miami	Florida
United States	International Research Associates, LLC	Miami	Florida
United States	Kendall South Medical Center	Miami	Florida
United States	Medical Research Center	Miami	Florida
United States	San Marcus Research Clinic, Inc.	Miami	Florida
United States	Crossroads Clinical Research, Inc.	Mooresville	North Carolina
United States	Radiant Research	Murray	Utah
United States	Hill Country Medical Associates	New Braunfels	Texas
United States	Rutgers Biomedical and Health Sciences- Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	New Orleans Center for Clinical Research	New Orleans	Louisiana
United States	Mid Hudson Medical Research, PLLC	New Windsor	New York
United States	LION Research	Norman	Oklahoma
United States	YNHH, Heart and Vascular	North Haven	Connecticut
United States	California Medical Research Associates Inc.	Northridge	California
United States	Florida Institute For Clinical Research, LLC	Orlando	Florida
United States	Midwest Heart and Vascular Specialists	Overland Park	Kansas
United States	Oviedo Medical Research, LLC	Oviedo	Florida
United States	MD Medical Research	Oxon Hill	Maryland
United States	A&R Research Group, LLC	Pembroke Pines	Florida
United States	DBC Research	Pembroke Pines	Florida
United States	Holland Center for Family Health	Peoria	Arizona
United States	Michigan Heart and Vascular Specialists	Petoskey	Michigan
United States	Elite Clinical Studies, LLC	Phoenix	Arizona
United States	Phoenix Clinical	Phoenix	Arizona
United States	Allegheny Endocrinology Associates	Pittsburgh	Pennsylvania
United States	Advanced Clinical Research Associates	Plano	Texas
United States	St. Johns Center for Clinical Research	Ponte Vedra	Florida
United States	Arch Health Partners Clinical Research Department	Poway	California
United States	Rainier Clinical Research Center	Renton	Washington
United States	Zain Research LLC	Richland	Washington
United States	National Clinical Research-Richmond, Inc.	Richmond	Virginia
United States	Atlanta Center for Clinical Research / Internal Medicine	Roswell	Georgia
United States	Clinical Trials Research	Sacramento	California
United States	Northern California Research	Sacramento	California
United States	HealthEast Medical Research Institute	Saint Paul	Minnesota
United States	HealthEast St. Joseph's Hospital Pharmacy	Saint Paul	Minnesota
United States	PMG Research of Salisbury, LLC	Salisbury	North Carolina
United States	Bandera Family Health Care, LLC	San Antonio	Texas
United States	Sun Research Institute	San Antonio	Texas
United States	Guthrie Medical Group, PC	Sayre	Pennsylvania
United States	Alta California Medical Group	Simi Valley	California
United States	Cardio Metabolic Institute	Somerset	New Jersey
United States	South Miami Clinical Research Center, LLC	South Miami	Florida
United States	Palmetto Clinical Research	Summerville	South Carolina
United States	Northwest Heart Center	Tomball	Texas
United States	Premier Research	Trenton	New Jersey
United States	Oakland Medical Research Center	Troy	Michigan
United States	Advanced Arizona Clinical Research	Tucson	Arizona
United States	Desert Sun Clinical Research, LLC	Tucson	Arizona
United States	Orange County Research Center	Tustin	California
United States	Empire Clinical Research	Upland	California
United States	Buynak Clinical Research, P.C.	Valparaiso	Indiana
United States	Dolphin Medical Research	Virginia Gardens	Florida
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Warminster Medical Associates, P.C.	Warminster	Pennsylvania
United States	Mercy Health Research	Washington	Missouri
United States	Infosphere Clinical Research, INC	West Hills	California
United States	Metabolic Research Institute Incorporated	West Palm Beach	Florida
United States	PMG Research of Wilmington, LLC	Wilmington	North Carolina
United States	Amherst Family Practice, P.C.	Winchester	Virginia
United States	Selma Medical Associates	Winchester	Virginia
United States	PMG Research of Winston-Salem	Winston-Salem	North Carolina
United States	Clinical Research of Central Florida	Winter Haven	Florida
United States	North Georgia Clinical Research	Woodstock	Georgia
United States	North Georgia Internal Medicine	Woodstock	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Colombia,  France,  Hungary,  Lithuania,  Mexico,  Romania,  Russian Federation,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12		Baseline, Week 12
Secondary	Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52		Baseline, Week 12, 24, 52
Secondary	Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52		Baseline, Week 12, 24, 52
Secondary	Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52		Baseline, Week 12, 24, 52
Secondary	Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides (TG) Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52		Baseline, Week 12, 24, 52
Secondary	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		Baseline, Week 12, 24, 52
Secondary	Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Week 12, 24 and 52		Baseline, Week 12, 24, 52
Secondary	Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52		Baseline, Week 12, 24, 52
Secondary	Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24, 52: Treatment Period		Baseline, Week 24, 52
Secondary	Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52		Baseline, Week 12, 24, 52
Secondary	Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52		Baseline, Week 12, 24, 52
Secondary	Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52		Baseline, Week 12, 24, 52
Secondary	Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52		Baseline, Week 12, 24, 52
Secondary	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		Baseline, Week 12
Secondary	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		Baseline, Week 12
Secondary	Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12		Baseline, Week 12
Secondary	Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12		Baseline, Week 12
Secondary	Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (HDL-C) at Week 12		Baseline, Week 12
Secondary	Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12		Baseline, Week 12
Secondary	Absolute Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Week 12		Baseline, Week 12
Secondary	Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12		Baseline, Week 12
Secondary	Absolute Change From Baseline in Ratio of Fasting Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52		Baseline, Week 12, 24, 52
Secondary	Change From Baseline in Ratio of Fasting Apolipoprotein B (ApoB) to Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52		Baseline, Week 12, 24, 52
Secondary	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		Week 12, 24, 52
Secondary	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		Week 12, 24, 52
Secondary	Plasma Concentration of PF-04950615 at Week 12, 24 and 52	Plasma concentration of PF-04950615 at Week 12, 24 and 52 was reported.	Week 12, 24, 52
Secondary	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. 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.	Baseline up to Week 58
Secondary	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 (log2) unit was considered to be ADA positive and nAb titer >=1.58 (log2) unit was considered to be nAb positive.	Baseline up to Week 58
Secondary	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.	Week 58 follow-up visit to Week 110
Secondary	Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 Follow-up Visit, 71, 84, 97 and 110: Extension Period		Baseline, Week 58 follow-up visit, 71, 84, 97, 110
Secondary	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.	Week 58 follow-up visit, Week 71, Week 84, Week 97, Week 110

External Links

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