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Evolocumab

ANITSCHKOW

ANITSCHKOW

Trial ANITSCHKOW: Effects of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition on Arterial Wall Inflamation Study in Patients With Elevated Lipoprotein(a) (Lp(a)). ClinicalTrials.gov Identifier: NCT02729025 Aim To assess the effects of PCSK9 inhibition on the arterial wall inflammation in patients with elevated Lp(a) Study design…

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BANTING

BANTING

Trial EvolocumaB efficAcy aNd safeTy IN type 2 diabetes mellitus on backGround statin therapy (BANTING) Type 2 diabetes with hypercholesterolaemia/mixed dyslipidaemia: NCT02739984 Aim To evaluate the effect of a 12-week regimen of monthly subcutaneous treatment with evolocumab 420 mg versus placebo, on low-density lipoprotein cholesterol…

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BEIJERINCK

BEIJERINCK

Trial BEIJERINCK: A Double Blind, Randomized, Placebo Controlled, Multicenter Study to Evaluate Safety, Tolerability, and Efficacy on LDL-C of Evolocumab (AMG 145) in Subjects With HIV and With Hyperlipidemia and/or Mixed Dyslipidemia. ClinicalTrials.gov Identifier: NCT02833844 Aim To investigate the efficacy and safety of evolocumab (420…

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BERSON

BERSON

Trial Type 2 diabetes with hyperlipidaemia/mixed dyslipidaemia: BERSON A double-blind, randomized study in diabetic subjects with hyperlipidaemia or mixed dyslipidaemia ClinicalTrials.gov Identifier: NCT02662569 Key results 986 patients (mean age 61.3 years, 43% male) were enrolled and randomized to placebo 2-weekly (n=166); placebo monthly (n=161); evolocumab…

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DE LAVAL

DE LAVAL

Trial DE LAVAL: A Randomized, Actively Controlled, Open-label, Multicenter Study of Efficacy and Safety of Evolocumab Compared With Low Density Lipoprotein Cholesterol (LDL-C) Apheresis, Followed by Single-Arm Evolocumab Administration in Subjects Receiving LDL-C Apheresis Prior to Study Enrollment. ClinicalTrials.gov Identifier: NCT02585895 Aim To evaluate the…

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DESCARTES

DESCARTES

Trial DESCARTES (Durable Effect of PCSK9 Antibody Compared with Placebo Study) Aim To evaluate the safety and efficacy of 52 weeks’ treatment with evolocumab 420 mg s.c. (every 4 weeks) versus placebo Study design Randomised, double-blind, placebo-controlled phase 3 trial Patient population Adults aged 18-75…

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EBBINGHAUS

EBBINGHAUS

  Trial EBBINGHAUS (Evaluating PCSK9 Binding antiBody Influence oN coGnitive HeAlth in High cardiovascUlar Risk Subjects); [Substudy of FOURIER] Aim To evaluate change over time in neurocognitive testing in subjects receiving statin therapy in combination with evolocumab versus statin plus placebo. Study design Double-Blind, Placebo…

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EVACS

EVACS

Trial Evolocumab in Acute Coronary Syndrome (EVACS) ClinicalTrials.gov Identifier: NCT03515304 Aim To evaluate 1) low-density lipoprotein cholesterol (LDL-C) reduction during hospitalization and at 30 days, (2) changes in vascular/plaque and myocardial inflammation at 30 days, (3) serum markers of endothelial function at hospital discharge and…

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EVOLVD

EVOLVD

Title EVOLVD:Cholesterol Lowering With EVOLocumab to Prevent Cardiac Allograft Vasculopathy in De-novo Heart Transplant Recipients ClinicalTrials.gov Identifier: NCT03734211 Aim To test whether treatment with evolocumab can ameliorate cardiac allograft vasculopathy in heart transplant recipients Study design Randomized, double-blind trial. Eligible patients were randomized 1:1 to…

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EVOPACS

EVOPACS

Trial EVOlocumab for Early Reduction of LDL-cholesterol Levels in Patients With Acute Coronary Syndromes (EVOPACS) ClinicalTrials.gov Identifier: NCT03287609 Aim To evaluate the safety and effectiveness of evolocumab versus placebo, administered in the acute phase of ACS, for reduction of low-density lipoprotein cholesterol (LDL-C levels) within…

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FLOREY

FLOREY

Trial FLOREY (Effects on Lipoprotein Metabolism From PCSK9 Inhibition Utilizing a Monoclonal Antibody) Aim To evaluate the effect of evolocumab, atorvastatin, and combination therapy on lipoprotein kinetics. Study design Double-blind, Randomized, Placebo-controlled, Single Site Study Patient population Primary hyperlipidaemia and mixed dyslipidaemia Primary efficacy endpoint…

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FOURIER

FOURIER

  Trial FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk ) (Ongoing trial) Aim To assess the effect of additional LDL-C lowering with evolocumab when used in addition to other treatment for dyslipidaemia on outcomes including cardiovascular death, myocardial infarction,…

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GAUSS-4

GAUSS-4

Trial GAUSS-4: Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-4 ClinicalTrials.gov Identifier: NCT02634580 Aim To evaluate the safety and efficacy of evolocumab, compared with ezetimibe, in hypercholesterolemic Japanese subjects unable to tolerate an effective dose of statin due to muscle related side…

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GAUSS-3

GAUSS-3

Trial GAUSS-3Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3 A Double-blind, Randomized, Multicenter Study to Evaluate the Safety and Efficacy of Evolocumab, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor Due to Muscle…

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GAUSS-2

GAUSS-2

Trial GAUSS-2 (The Goal Achievement after Utilizing an anti-PCSK9 antibody in Statin Intolerant Subjects trial) Aim To evaluate the efficacy and safety of subcutaneous (SC) evolocumab compared with oral ezetimibe in hypercholesterolaemic subjects unable to tolerate effective statin doses Study design Randomised, double-blind, placebo-controlled phase…

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GAUSS

GAUSS

Trial GAUSS (Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects) study Aim To assess the efficacy and tolerability of evolocumab in patients with statin intolerance due to muscle-related side effects. Study design A 12-week, randomised, double-blind, placebo- and ezetimibe-controlled, phase 2 dose-ranging…

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GLAGOV

GLAGOV

Trial GLAGOV (GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound (Ongoing study) Aim To evaluate whether LDL-C lowering with evolocumab results in greater change from baseline in percentage atheroma volume (PAV) at week 78 than placebo in subjects with…

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HAUSER-OLE

HAUSER-OLE

Evolocumab Study title: HAUSER-OLE Open Label Study to Evaluate Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Pediatric Subjects (10 to 17 Years of Age) With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH). ClinicalTrials.gov Identifier: NCT02624869 Aim To describe the safety and…

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HAUSER-RCT

HAUSER-RCT

Trial HAUSER-RCT: Trial Assessing Efficacy, Safety and Tolerability of PCSK9 Inhibition in Paediatric Subjects With Genetic LDL Disorders ClinicalTrials.gov Identifier: NCT02392559 Aim To assess the safety and efficacy of evolocumab in paediatric subjects aged 10-17 years diagnosed with heterozygous familial hypercholesterolemia (FH) Study design Multicentre,…

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LAPLACE-2

LAPLACE-2

Trial LAPLACE-2 (The Low-density Lipoprotein Cholesterol Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy – 2 Trial) Aim To evaluate evolocumab in statin-treated subjects with primary hypercholesterolaemia and mixed dyslipidaemia. Study design Phase 3, double-blind, randomised placebo and ezetimibe controlled multicentre study Patient…

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