Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2
NCT ID: NCT01763918
Last Updated: 2019-06-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
331 participants
INTERVENTIONAL
2013-02-07
2013-12-19
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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Placebo Q2W
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
Placebo
Administered by subcutaneous injection
Placebo QM
Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
Placebo
Administered by subcutaneous injection
Evolocumab Q2W
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
Evolocumab
Administered by subcutaneous injection
Evolocumab QM
Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Evolocumab
Administered by subcutaneous injection
Interventions
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Evolocumab
Administered by subcutaneous injection
Placebo
Administered by subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of heterozygous familial hypercholesterolemia
* On a stable dose of an approved statin and lipid regulating medication
* Fasting LDL-C ≥ 100 mg/dL (2.6 mmol/L)
* Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)
Exclusion Criteria
* LDL or plasma apheresis
* New York Heart Association (NYHA) III or IV heart failure
* Uncontrolled cardiac arrhythmia
* Uncontrolled hypertension
* Type 1 diabetes, poorly controlled type 2 diabetes
* Uncontrolled hypothyroidism or hyperthyroidism
18 Years
80 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Scottsdale, Arizona, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Camperdown, New South Wales, Australia
Research Site
Perth, Western Australia, Australia
Research Site
Vancouver, British Columbia, Canada
Research Site
London, Ontario, Canada
Research Site
Chicoutimi, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Bron, , France
Research Site
Nantes, , France
Research Site
Paris, , France
Research Site
Cologne, , Germany
Research Site
New Territories, , Hong Kong
Research Site
Amersfoort, , Netherlands
Research Site
Amsterdam, , Netherlands
Research Site
Amsterdam, , Netherlands
Research Site
Gouda, , Netherlands
Research Site
Groningen, , Netherlands
Research Site
Hoorn, , Netherlands
Research Site
Tilburg, , Netherlands
Research Site
Utrecht, , Netherlands
Research Site
Christchurch, , New Zealand
Research Site
Oslo, , Norway
Research Site
Johannesburg, Gauteng, South Africa
Research Site
Midrand, Gauteng, South Africa
Research Site
Observatory, Western Cape, South Africa
Research Site
Parow, Western Cape, South Africa
Research Site
Córdoba, Andalusia, Spain
Research Site
Zaragoza, Aragon, Spain
Research Site
Reus, Catalonia, Spain
Research Site
Madrid, , Spain
Research Site
Stockholm, , Sweden
Research Site
Stockholm, , Sweden
Research Site
Reinach, , Switzerland
Research Site
Coventry, , United Kingdom
Research Site
London, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Manchester, , United Kingdom
Countries
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References
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Toth PP, Descamps O, Genest J, Sattar N, Preiss D, Dent R, Djedjos C, Wu Y, Geller M, Uhart M, Somaratne R, Wasserman SM; PROFICIO Investigators. Pooled Safety Analysis of Evolocumab in Over 6000 Patients From Double-Blind and Open-Label Extension Studies. Circulation. 2017 May 9;135(19):1819-1831. doi: 10.1161/CIRCULATIONAHA.116.025233. Epub 2017 Mar 1.
Kuchimanchi M, Grover A, Emery MG, Somaratne R, Wasserman SM, Gibbs JP, Doshi S. Population pharmacokinetics and exposure-response modeling and simulation for evolocumab in healthy volunteers and patients with hypercholesterolemia. J Pharmacokinet Pharmacodyn. 2018 Jun;45(3):505-522. doi: 10.1007/s10928-018-9592-y. Epub 2018 May 7.
Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7.
Wasserman SM, Sabatine MS, Koren MJ, Giugliano RP, Legg JC, Emery MG, Doshi S, Liu T, Somaratne R, Gibbs JP. Comparison of LDL-C Reduction Using Different Evolocumab Doses and Intervals: Biological Insights and Treatment Implications. J Cardiovasc Pharmacol Ther. 2018 Sep;23(5):423-432. doi: 10.1177/1074248418774043. Epub 2018 May 16.
Raal FJ, Stein EA, Dufour R, Turner T, Civeira F, Burgess L, Langslet G, Scott R, Olsson AG, Sullivan D, Hovingh GK, Cariou B, Gouni-Berthold I, Somaratne R, Bridges I, Scott R, Wasserman SM, Gaudet D; RUTHERFORD-2 Investigators. PCSK9 inhibition with evolocumab (AMG 145) in heterozygous familial hypercholesterolaemia (RUTHERFORD-2): a randomised, double-blind, placebo-controlled trial. Lancet. 2015 Jan 24;385(9965):331-40. doi: 10.1016/S0140-6736(14)61399-4. Epub 2014 Oct 1.
Shapiro MD, Minnier J, Tavori H, Kassahun H, Flower A, Somaratne R, Fazio S. Relationship Between Low-Density Lipoprotein Cholesterol and Lipoprotein(a) Lowering in Response to PCSK9 Inhibition With Evolocumab. J Am Heart Assoc. 2019 Feb 19;8(4):e010932. doi: 10.1161/JAHA.118.010932.
Stroes E, Robinson JG, Raal FJ, Dufour R, Sullivan D, Kassahun H, Ma Y, Wasserman SM, Koren MJ. Consistent LDL-C response with evolocumab among patient subgroups in PROFICIO: A pooled analysis of 3146 patients from phase 3 studies. Clin Cardiol. 2018 Oct;41(10):1328-1335. doi: 10.1002/clc.23049. Epub 2018 Oct 21.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2012-001365-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20110117
Identifier Type: -
Identifier Source: org_study_id
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