Trials
ODYSSEY High FH
Trial Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY High FH) Aim To evaluate the effect of alirocumab on LDL cholesterol levels after 24 weeks of treatment in comparison with placebo (on top…
read more »
ODYSSEY HoFH
Alirocumab Trial Study in Participants With Homozygous Familial Hypercholesterolemia (ODYSSEY HoFH) ClinicalTrials.gov Identifier: NCT03156621 Aim To assess low-density lipoprotein cholesterol (LDL-C) reduction with alirocumab in adult patients with HoFH. Study design Randomised, double-blind, placebo-controlled, parallel-group, phase 3 study. Eligible patients were randomly allocated (2:1)…
read more »
ODYSSEY JAPAN
Trial ODYSSEY JAPAN Efficacy and Safety Evaluation of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia on Lipid Modifying Therapy Aim To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable daily statin…
read more »
ODYSSEY KIDS
Alirocumab Trial An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia ClinicalTrials.gov Identifier: NCT02890992 Aim To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 8 weeks of treatment in heterozygous…
read more »
ODYSSEY LONG TERM
Trial Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular [CV] Risk Patients With Hypercholesterolemia (ODYSSEY Long Term) Aim To evaluate the long-term safety and tolerability of alirocumab in high cardiovascular risk patients with hypercholesterolemia not adequately…
read more »
ODYSSEY MONO
Trial Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Patients With Hypercholesterolemia (ODYSSEY MONO) ClinicalTrials.gov Identifier: NCT01644474 Primary aim To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab in comparison with ezetimibe after 24 weeks of treatment in participants with hypercholesterolemia. Study…
read more »
ODYSSEY-NIPPON
Trial ODYSSEY-NIPPON: Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin ClinicalTrials.gov Identifier: NCT02584504 Aim To evaluate the efficacy and safety of alirocumab in patients with hypercholesterolemia not adequately controlled with…
read more »
ODYSSEY OPTIONS I and II
Trial Efficacy and safety of combining alirocumab with atorvastatin or rosuvastatin versus adding ezetimibe, doubling statin dose or switching statin therapy in high cardiovascular risk patients (ODYSSEY OPTIONS I and II) Aim To evaluate the efficacy and safety of alirocumab as add-on therapy to either…
read more »
ODYSSEY OUTCOMES
Alirocumab Safety Alirocumab treatment was well tolerated; injection site reactions occurred in 3.8% of patients in the alirocumab group versus 2.1% on placebo. Trial ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab ClinicalTrials.gov Identifier: NCT01663402 Aim To test…
read more »
PACMAN-AMI
Trial PACMAN-AMI (Vascular Effects of Alirocumab in Acute MI-Patients) ClinicalTrials.gov Identifier: NCT03067844 Aim To investigate the effect of alirocumab in patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI) in the infarct-related artery and receiving guideline-recommended high-intensity statin therapy. Study design Multicentre, double-blind,…
read more »
PALMS
Trial Alirocumab in Patients With Sepsis (PALMS) ClinicalTrials.gov Identifier: NCT05469347 Aim To determine whether alirocumab can reduce the amount of inflammation caused by an infection that has caused either low blood pressure or difficulty breathing. Study design Phase 1b randomised, placebo-controlled, double-blind trial. Patients will…
read more »
PERI-DYS
Trial Prospective German Very High Cardiovascular Risk Patients Dyslipidemia Treatment Indication Registry (PERI-DYS) ClinicalTrials.gov Identifier: NCT03110432 Aim Registry study Study design Prospective observational registry. Patients will receive either standard lipid lowering therapy (statins, ezetimibe, nicotinic acid, fibrates, cholestagel, omega-3 fatty acids and any combinations of…
read more »
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…
read more »
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…
read more »
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…
read more »
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…
read more »
CARUSO
Trial CARUSO (CARotid plaqUe StabilizatiOn and Regression With Evolocumab) ClinicalTrials.gov Identifier: NCT04730973 Aim To investigate the efficacy of evolocumab in promoting carotid plaque morphological stabilization and regression versus traditional lipid lowering therapy. Study design Randomized, single-centre, investigator-initiated trial. Patients will be randomized to evolocumab 140…
read more »
CHORD
CHORD Trial CHOlesterol Lowering and Residual Risk in Type 2 Diabetes (CHORD) ClinicalTrials.gov Identifier: NCT04369664 Aim To investigate why individuals with type 2 diabetes are at increased risk for heart disease and stroke. This study will investigate risk factors for heart disease and stroke, including…
read more »
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…
read more »
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…
read more »
