Evolocumab
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-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-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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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
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
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…
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HUYGENS
Trial High-Resolution Assessment of Coronary Plaques in a Global Evolocumab Randomized Study (HUYGENS) (NCT03570697) Aim To evaluate the impact of PCSK9 inhibition with evolocumab on coronary atheroma phenotype. The primary objective is to evaluate the effect of evolocumab on changes in fibrous cap thickness (FCT)…
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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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LAPLACE-TIMI 57
Trial LAPLACE-TIMI 57 (LDL-C Assessment with Proprotein Convertase Subtilisin Kexin Type 9 Monoclonal Antibody Inhibition combined with statin therapy- Thrombolysis in Myocardial Infarction) trial. Aim To assess the efficacy, safety, and tolerability of evolocumab in stable patients with hypercholesterolaemia on a statin. Study design Multicentre,…
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MENDEL-2
Trial MENDEL-2 (Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently not Receiving Drug Therapy for Easing Lipid Levels) trial Aim To compare biweekly and monthly evolocumab with placebo and oral ezetimibe in patients with hypercholesterolaemia Study design Randomised controlled, placebo-controlled phase 3…
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MENDEL
Trial MENDEL (Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels) Aim To assess the effects of evolocumab in patients with hypercholesterolaemia in the absence of concurrent lipid-lowering treatment. Study design Phase 2 multicentre, double-blind…
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OSLER-2
Trial OSLER-2 (Open Label Study of Long Term Evaluation Against LDL-C Trial-2) Aim To evaluate the long-term safety, tolerability and efficacy of evolocumab (AMG 145) in subjects with hyperlipidaemia and subjects with mixed dyslipidaemia Study design Multicentre, controlled, open-label extension (OLE) study Evolocumab versus standard…
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OSLER
Trial OSLER (Open label study of long-term evaluation against LDL-C) study Aim To determine long-term efficacy and safety of evolocumab Study design Patients were randomised 2:1 to receive either open-label subcutaneous evolocumab 420 mg every 4 weeks with standard of care (SOC) (n=736) or SOC…
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PLEASe
Trial Evolocumab for PCSK9 Lowering in Early Acute Sepsis (The PLEASe Study) ClinicalTrials.gov Identifier: NCT03869073 Aim To evaluate evolocumab in patients with early acute sepsis Study design Randomized, double-blind, placebo-controlled study. Upon enrolling in the study patients will be randomized to treatment with evolocumab 420…
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POOLED ANALYSIS
Trial Pooled analysis of 4 trials Aim To assess the effect of evolocumab on lipoprotein (a) (Lp(a)) Study design Pooled analysis of 4 phase II trials Evolocumab given at 140 mg every 2 weeks and 420 mg every 4 weeks Patient population 1359 patients Primary…
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RUTHERFORD-2
Trial RUTHERFORD-2 (RedUction of LDL-C with PCSK9 InhibiTion in HEteRozygous Familial HyperchOlesteRolemia Disorder Study-2) Aim To investigate the safety, efficacy and tolerability of PCSK9 inhibition with evolocumab on LDL-C levels in patients with heterozygous familial hypercholesterolaemia (HeFH). Study design Phase 3, 12-week randomised, placebo-controlled, double-blind…
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RUTHERFORD
Trial RUTHERFORD (the Reduction of LDL-C with PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder randomised trial) Aim To evaluate the efficacy and safety of evolocumab in heterozygous familial hypercholesterolaemia patients. Study design Phase 2, multicenter, double-blind, randomised, placebo-controlled, dose-ranging study. Patient population Patients (≥ 18 to ≤…
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TAUSSIG
Trial TAUSSIG (Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects With Genetic LDL Disorders (Ongoing study) Aim To assess the long term safety and efficacy of evolocumab on LDL-C in subjects with homozygous familial hypercholesterolaemia or PCSK9 mutations. Study design Phase 2/3 multicentre…
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TESLA
Trial TESLA-Pilot (Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities) Aim To evaluate the efficacy and safety of evolocumab in patients with homozygous familial hypercholesterolaemia Study design Open-label, single-arm, multicentre, dose scheduling pilot studySubcutaneous evolocumab, 420 mg every 4 weeks for ≥12 weeks,…
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VESALIUS-CV
Trial VESALIUS-CV (Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke) ClinicalTrials.gov Identifier: NCT03872401 Aim To investigate the effect of lowering low-density lipoprotein cholesterol (LDL-C) with evolocumab on major cardiovascular events in adults without a prior myocardial infarction (MI)…
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