Hyperlipidemia Clinical Trial
— SPIRE-HROfficial title:
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
| Verified date | February 2017 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 711 |
| Est. completion date | April 2016 |
| Est. primary completion date | April 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. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Australian Clinical Research Network | Maroubra | New South Wales |
| Australia | Core Research Group Pty Ltd | Milton | Queensland |
| Australia | The Avenue Cardiovascular Centre | St. Kilda East | Victoria |
| Canada | Ecogene-21 | Chicoutimi | Quebec |
| Canada | Diex Research Montreal Inc. | Montreal | Quebec |
| Canada | Montreal Heart Institute | Montreal | Quebec |
| Canada | ALPHA Recherche Clinique | Quebec City | Quebec |
| Canada | Centre Hospitalier Universitaire de Sherbrooke (CHUS) | Sherbrooke | Quebec |
| Canada | MEDEXA Recherche | Victoriaville | Quebec |
| Czech Republic | Fakultni nemocnice Hradec Kralove | Hradec Kralove | |
| Czech Republic | Kardiologie a interni lekarstvi | Praha 5 | |
| Czech Republic | Lekarsky dum Ormiga | Zlin | |
| Germany | Klinische Forschung Berlin-Mitte GmbH | Berlin | |
| Germany | Klinische Forschung Hannover - Mitte GmbH | Hannover | |
| Germany | Klinikum der Stadt Ludwigshafen am Rhein gGmbH | Ludwigshafen | |
| Germany | Klinische Forschung Schwerin GmbH | Schwerin | |
| Hong Kong | The Chinese University of Hong Kong | Shatin | |
| Hong Kong | Department of Medicine & Therapeutics-The Chinese University of Hong Kong | Shatin, NT | |
| Italy | IRCCS Centro Cardiologico Fondazione Monzino | Milano | MI |
| Italy | IRCCS Istituto Auxologico Italiano | Milano | MI |
| Italy | IRCCS Ospedale San Raffaele | Milano | MI |
| Italy | Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone" | Palermo | PA |
| Italy | Dipartimento di Medicina Interna e Specialita Mediche Policlinico Umberto I | Roma | RM |
| Korea, Republic of | Yonsei University Wonju Severance Christian Hospital | Gangwon-Do | |
| Korea, Republic of | Chonnam National University Hospital | Gwangju | |
| Korea, Republic of | Gangnam Sevrance Hospital, Yeonsei University Health System | Seoul | |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Korea, Republic of | Severance Hospital, Yonsei University Health System | Seoul | |
| Korea, Republic of | The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | |
| Korea, Republic of | Ajou University Hospital | Suwon | |
| Korea, Republic of | The Catholic University of Korea, Uijeongbu St. Mary's Hospital | Uijeongbu-si | Gyeonggi-do |
| Korea, Republic of | Ulsan University Hospital | Ulsan | |
| Poland | Synexus Polska Sp. z o.o. Oddzial w Gdyni | Gdynia | |
| Poland | NZOZ Terapia Optima | Katowice | Slaskie |
| Poland | Synexus Polska Sp. z o.o. Oddzial w Katowicach | Katowice | Mazowieckie |
| Poland | Niepubliczny Zaklad Opieki Zdrowotnej CEREO-MED Sp. z o.o. | Lodz | |
| Poland | Medicus w Opolu Sp z o.o. | Opole | |
| Poland | Medicome Sp. z o.o. | Oswiecim | |
| Poland | Synexus Polska Sp. z o.o Oddzial w Poznaniu | Poznan | |
| Poland | Centrum Medyczne Ogrodowa Sp. z o.o. | Skierniewice | |
| Poland | Centrum Medyczne "SOPMED" Sp. z o.o. | Sopot | Pomorskie |
| Poland | Centrum Medyczne AMED | Warszawa | |
| Poland | CSK MSW w Warszawie, Klinika Kardiologii Zachowawczej i Nadcisnienia Tetniczego | Warszawa | |
| Poland | Synexus Polska Sp. z o.o. Oddzial w Warszawie | Warszawa | |
| Poland | Synexus Polska Sp. z o.o. Oddzial we Wroclawiu | Wroclaw | |
| United States | Radiant Research, Inc | Akron | Ohio |
| United States | Comunity Clinical Research Center | Anderson | Indiana |
| United States | Integrated Medical Research, PC | Ashland | Oregon |
| United States | American Health Network of Indiana, LLC | Avon | Indiana |
| United States | Achieve Clinical Research, LLC | Birmingham | Alabama |
| United States | Cardiovascular Associates of the Southeast, LLC | Birmingham | Alabama |
| United States | Internal Medicine and Pediatric Associates of Bristol, PC | Bristol | Tennessee |
| United States | PMG Research of Raleigh, LLC d/b/a PMG Research of Cary | Cary | North Carolina |
| United States | Medical Research South,LLC | Charleston | South Carolina |
| United States | Rapid Medical Research, Inc. | Cleveland | Ohio |
| United States | ExpressCare Clinical Research | Colorado Springs | Colorado |
| United States | 3 rd Coast Research Associates | Corpus Christi | Texas |
| United States | Diagnamics, Inc. | Encinitas | California |
| United States | Encompass Clinical Research North Coast | Encinitas | California |
| United States | Horizon Research Group of Opelousas, LLC | Eunice | Louisiana |
| United States | Internal Medicine Associates | Eunice | Louisiana |
| United States | Evanston Premier Healthcare Research LLC | Evanston | Illinois |
| United States | MD Studies, Inc. | Fountain Valley | California |
| United States | Harleysville Medical Associates | Harleysville | Pennsylvania |
| United States | Eastern Research, Inc. | Hialeah | Florida |
| United States | Pioneer Research Solutions, Inc. | Houston | Texas |
| United States | Texas Center For Drug Development, Inc. | Houston | Texas |
| United States | Protenium Clinical Research | Hurst | Texas |
| United States | Midwest Institute for Clinical Research | Indianapolis | Indiana |
| United States | Care Partners Clinical Research, LLC | Jacksonville | Florida |
| United States | East Coast Institute for Research, LLC at Northeast Florida Endocrine & Diabetes Associates | Jacksonville | Florida |
| United States | Alliance Research Centers | Laguna Hills | California |
| United States | Prime Care Clinical Research | Laguna Hills | California |
| United States | Utah Cardiology, P.C. | Layton | Utah |
| United States | Prestige Clinical Research Center Inc | Miami | Florida |
| United States | Allina Health System, dba Abbott Northwestern Hospital | Minneapolis | Minnesota |
| United States | Minneapolis Heart Institute Foundation | Minneapolis | Minnesota |
| United States | University of MN, Lillehei Clinical Trials Unit | Minneapolis | Minnesota |
| United States | Montana Medical Research Inc. | Missoula | Montana |
| United States | Berkeley Family Practice | Moncks Corner | South Carolina |
| United States | Edgewater Medical Research | New Smyrna Beach | Florida |
| United States | National Clinical Research - Norfolk, Inc. | Norfolk | Virginia |
| United States | Providence Clinical Research | North Hollywood | California |
| United States | Soundview Medical Associates | Norwalk | Connecticut |
| United States | South Oklahoma Heart Research LLC | Oklahoma City | Oklahoma |
| United States | The Office of Daniel G. Williams, MD | Perrysburg | Ohio |
| United States | Perelman Center for Advanced Medicine Heart & Vascular Center | Philadelphia | Pennsylvania |
| United States | Columbia Research Group, Inc. | Portland | Oregon |
| United States | Beacon Clinical Research, LLC | Quincy | Massachusetts |
| United States | San Diego Family Care | San Diego | California |
| United States | Fellows Research Alliance, Inc. | Savannah | Georgia |
| United States | SouthCoast Medical Group | Savannah | Georgia |
| United States | Premier Clinical Research | Spokane | Washington |
| United States | St. Joseph's Medical Associates | Stockton | California |
| United States | Gulfcoast Medical Research Center, LLC | Tampa | Florida |
| United States | ARA-Arizona Research Associates | Tucson | Arizona |
| United States | Southwest Heart Group | Tucson | Arizona |
| United States | Orange County Research Center | Tustin | California |
| United States | Clinical Research Advantage, Inc./Cassidy Medical Group - Vista | Vista | California |
| United States | Elite Clinical Trials | Wildomar | California |
| United States | Great Lakes Medical Research, LLC | Willoughby | Ohio |
| United States | Clinical Trials of America, Inc. | Winston Salem | North Carolina |
| United States | Berks Cardiologists, Ltd. | Wyomissing | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Australia, Canada, Czech Republic, Germany, Hong Kong, Italy, Korea, Republic of, Poland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percent Change from Baseline in LDL-C at Week 12 | Low Density Lipoprotein (LDL) blood concentrations. | 12 weeks | |
| Secondary | Change from Baseline in Lipid Parameters at Week 12 | Mean Total Cholesterol (TC), Apolipoprotein B, non-HDL-C, Low Density Lipoprotein (LDL) by TG level, High Density Lipoprotein (HDL), Triglycerides (TG), ApoA-I, ApoA-II blood concentrations. | 12 weeks | |
| Secondary | Change from Baseline in Lipid Parameters at Week 24 | Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL) and LDL by TG, lipoprotein (a), and High Density Lipoprotein (HDL), TG, ApoA-I, ApoA-II, blood concentrations. | 24 weeks | |
| Secondary | Change from Baseline in Lipid Parameters at Week 52 | Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL) and LDL by TG, lipoprotein (a), and High Density Lipoprotein (HDL), TG, ApoA-I, ApoA-II blood concentrations. | 52 weeks | |
| Secondary | Proportion of Subjects Achieving Fasting LDL-C <= 100 mg/dL and <=70 mg/dL | Proportion of Subjects Achieving Fasting LDL-C <= 100 mg/dL and <=70 mg/dL | 12 weeks | |
| Secondary | Proportion of Subjects Achieving Fasting LDL-C <= 100 mg/dL and <=70 mg/dL | Proportion of Subjects Achieving Fasting LDL-C <= 100 mg/dL and <=70 mg/dL | 24 weeks | |
| Secondary | Proportion of Subjects Achieving Fasting LDL-C <= 100 mg/dL and <=70 mg/dL | Proportion of Subjects Achieving Fasting LDL-C <= 100 mg/dL and <=70 mg/dL | 52 weeks | |
| Secondary | Plasma PF-04950615 concentration | Plasma PF-04950615 concentration | 12 weeks | |
| Secondary | Plasma PF-04950615 concentration | Plasma PF-04950615 concentration | 24 weeks | |
| Secondary | Plasma PF-04950615 concentration | Plasma PF-04950615 concentration | 52 weeks |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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