Heterozygous Familial Hypercholesterolemia Clinical Trial
— SPIRE-FHOfficial title:
A 52 Week, Phase 3 Double-blind, Randomized, Placebo-controlled, Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 In Subjects With Heterozygous Familial Hypercholesterolemia
| Verified date | June 2016 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 370 |
| Est. completion date | April 2016 |
| Est. primary completion date | April 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| 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. - Heterozygous familial hypercholesterolemia. 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Bulgaria | SHAT in Cardiology EAD, Department of Cardiology | Pleven | |
| Bulgaria | UMHAT "Sveti Georgi" EAD, Clinic of Cardiology | Plovdiv | |
| Bulgaria | MHAT "Sveta Anna", Clinic of Internal Diseases | Sofia | |
| Bulgaria | Second MHAT - Sofia | Sofia | |
| Canada | Ecogene-21 | Chicoutimi | Quebec |
| Canada | Institut de Recherches Cliniques de Montreal | Montreal | Quebec |
| Canada | Montreal Heart Institute | Montreal | Quebec |
| Canada | University of Ottawa Heart Institute | Ottawa | Ontario |
| Canada | Clinique des maladies lipidiques de Quebec | Quebec | |
| Canada | Health Sciences Centre | St. John's | Newfoundland and Labrador |
| Canada | St. Paul's Hospital, Healthy Heart | Vancouver | British Columbia |
| Canada | Discovery Clinical Services Ltd. | Victoria | British Columbia |
| Canada | Asper Clinical Research Institute | Winnipeg | Manitoba |
| Finland | Helsinki Central University Hospital | Helsinki | |
| Finland | Pohjois-Karjala Projekti Saatio | Joensuu | |
| Finland | Pohjois-Karjala Projekti Saatio/Ita-Suomen | Joensuu | |
| Finland | Laakarikeskus Aava Kerava/Aava Kerava Medical Center | Kerava | |
| Finland | Oulu University Hospital | Oulu | |
| Finland | Division of Medicine Turku University Hospital | Turku | |
| Italy | Azienda Ospedaliero Universitaria "Federico II" di Napoli | Napoli | |
| Italy | Policlinico "Paolo Giaccone" | Palermo | PA |
| Italy | Ospedale "Santa Maria della Misericordia" | Perugia | PG |
| Italy | Ospedale di Circolo e Fondazione Macchi | Varese | VA |
| Netherlands | Academic Medical Center | Amsterdam | |
| Netherlands | Academisch Medisch Centrum | Amsterdam | |
| Netherlands | Amphia Hospital | Breda | |
| Netherlands | Hagaziekenhuis | Den Haag | |
| Netherlands | Deventer Ziekenhuis | Deventer | |
| Netherlands | Admiraal de Ruyter ziekenhuis | Goes | Zeeland |
| Netherlands | Rotterdam Research Institute | Rotterdam | |
| Netherlands | St. Franciscus Gasthuis | Rotterdam | Zuid-holland |
| Netherlands | Albert Schweitzer Hospital | Sliedrecht | |
| Netherlands | UMC Utrecht | Utrecht | |
| Norway | Oslo Universitessykehus HF | Oslo | |
| Norway | Oslo Universitessykehus HF, Rikshospitalet Lipidklinikken | Oslo | |
| Norway | Oslo Universitetssykehus HF, Rikshospitalet Lipidklinikken | Oslo | |
| Norway | Oslo Universitetssykehus HF, Ulleval | Oslo | |
| Poland | 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 Slaska | |
| South Africa | Tiervlei Trial Centre, Karl Bremer Hospital | Bellville, Cape Town | Western Cape |
| South Africa | Iatros International | Bloemfontein | Free State |
| South Africa | Unitas hospital | Centurion | Gauteng |
| South Africa | Chelmsford Medical Centre 3 | Durban | Kwa-zulu Natal |
| South Africa | Midrand Medical Centre | Halfway House | Gauteng |
| South Africa | TREAD Research cc. | Parow, Cape Town | Western Cape |
| South Africa | Jongaie Research | Pretoria | Gauteng |
| South Africa | Medipark Centre for Clinical Research | Pretoria | Gauteng |
| South Africa | Synexus SA Watermeyer Clinical Research Centre | Pretoria | Gauteng |
| South Africa | Roodepoort Medicross Clinical Research Centre | Roodepoort | Gauteng |
| South Africa | Synexus Helderberg Clinical Research Centre | Somerset West | Western Cape |
| Spain | Hospital Clinic | Barcelona | |
| Spain | Hospital Universitario Reina Sofia | Cordoba | |
| Spain | Hospital Universitario de Bellvitge | L'Hospitalet de Llobregat | Barcelona |
| Spain | Fundacion Jimenez Diaz | Madrid | |
| Spain | Hospital Clinico San Carlos; U. de Lipidos; Medicina Interna III | Madrid | |
| Spain | Hospital General Universitario Gregorio Maranon | Madrid | |
| Spain | Hospital Universitario Sant Joan de Reus | Reus | Tarragona |
| Spain | Hospital Clinico Universitario, Santiago de Compostela | Santiago de Compostela | Galicia |
| Spain | University Hospital "Virgen del Rocío" | Sevilla | Andalucia |
| Spain | Hospital Universitario Miguel Servet; Medicina Interna | Zaragoza | |
| United Kingdom | Birmingham Heartlands Hospital | Birmingham | West Midlands |
| United Kingdom | Queen's Hospital | Burton-on-Trent | Staffordshire |
| United Kingdom | Royal Free Hospital | London | |
| United Kingdom | Clinical Trials Pharmacy, 4th Floor Inpatient Pharmacy | Manchester | Greater Manchester |
| United Kingdom | Research Site: Central Manchester University Hospitals NHS Foundation Trust | Manchester | |
| United Kingdom | Royal Oldham Hospital | Oldham | Greater Manchester |
| United Kingdom | Peterborough and Stamford Hospitals NHS Foundation Trust | Peterborough | |
| United Kingdom | Lister Hospital - East and North Hertfordshire NHS Trust | Stevenage | Hertfordshire |
| United States | Burke Internal Medicine & Research | Burke | Virginia |
| 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 | Galenos Research | Dallas | Texas |
| United States | UT Southwestern Medical Center | Dallas | Texas |
| United States | Focus Clinical Research, LLC | Draper | Utah |
| United States | OnSite Clinical Solutions, LLC | Gaffney | South Carolina |
| United States | Hartford Hospital | Hartford | Connecticut |
| United States | Best Quality Research, Inc. | Hialeah | Florida |
| United States | Pioneer Research Solutions, Inc. | Houston | Texas |
| United States | Om Medical | Las Vegas | Nevada |
| United States | IMD Medical Group | Los Angeles | California |
| United States | Columbus Clinical Services, LLC | Miami | Florida |
| United States | Medical Research Center | Miami | Florida |
| United States | Premier Research Associate, Inc | Miami | Florida |
| United States | NewPhase Clinical Trials, Corp. | Miami Beach | Florida |
| United States | Oklahoma Heart Hospital | Oklahoma City | Oklahoma |
| United States | Oklahoma Heart Hospital Physicians | Oklahoma City | Oklahoma |
| United States | Oklahoma Heart Hospital Research Foundation | Oklahoma City | Oklahoma |
| United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
| United States | Pioneer Research Solutions, Inc. | Sugar Land | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Bulgaria, Canada, Finland, Italy, Netherlands, Norway, Poland, South Africa, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percent Change from Baseline in LDL-C at Week 12 | Low Density Lipoprotein (LDL) cholesterol blood concentrations | 12 weeks | No |
| Secondary | Change from Baseline in Lipid Parameters at Week 12 | Mean Total Cholesterol (TC), Apolipoprotein B (ApoB), non- HDL-C, lipoprotein (a), High Density Lipoprotein (HDL), Apolipoprotein A-I (ApoA-I), Apoliprotein A-II (ApoA-II), Very Low Density Lipoprotein (VLDL), Triglycerides, TC/HDL and ApoB/ApoA-I ratio. | 12 weeks | No |
| Secondary | Change from Baseline in Lipid Parameters at Week 24 | Low Density Lipoprotein (LDL), Mean Total Cholesterol (TC), Apolipoprotein B (ApoB), non- HDL-C, lipoprotein (a), High Density Lipoprotein (HDL), Apolipoprotein A-I (ApoA-I), Apoliprotein A-II (ApoA-II), Very Low Density Lipoprotein (VLDL), Triglycerides, TC/HDL and ApoB/ApoA-I ratio. | 24 weeks | No |
| Secondary | Change from Baseline in Lipid Parameters at Week 52 | Low Density Lipoprotein (LDL), Mean Total Cholesterol (TC), Apolipoprotein B (ApoB), non- HDL-C, lipoprotein (a), High Density Lipoprotein (HDL), Apolipoprotein A-I (ApoA-I), Apoliprotein A-II (ApoA-II), Very Low Density Lipoprotein (VLDL), Triglycerides, TC/HDL and ApoB/ApoA-I ratio. | 52 weeks | No |
| Secondary | Proportion of Subjects Achieving Fasting LDLC <= 100 mg/dL and <=70 mg/dL | Proportion of Subjects Achieving Fasting LDLC <= 100 mg/dL and <=70 mg/dL | 12 weeks | No |
| Secondary | Proportion of Subjects Achieving Fasting LDLC <= 100 mg/dL and <=70 mg/dL | Proportion of Subjects Achieving Fasting LDLC <= 100 mg/dL and <=70 mg/dL | 24 weeks | No |
| Secondary | Proportion of Subjects Achieving Fasting LDLC <= 100 mg/dL and <=70 mg/dL | Proportion of Subjects Achieving Fasting LDLC <= 100 mg/dL and <=70 mg/dL | 52 weeks | No |
| Secondary | Plasma PF-04950615 concentration | Plasma PF-04950615 concentration | 12 weeks | No |
| Secondary | Plasma PF-04950615 concentration | Plasma PF-04950615 concentration | 24 weeks | No |
| Secondary | Plasma PF-04950615 concentration | Plasma PF-04950615 concentration | 52 weeks | No |
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