View clinical trials related to Hypercholesterolaemia.
Filter by:The objective of this study is to evaluate the long-term safety of Leqvio in patients with familial hypercholesterolaemia or hypercholesterolaemia in post-marketing clinical practice
This is a phase 3, randomized, placebo-controlled study of the efficacy and safety of MK-0616, an oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in participants with high cardiovascular risk. The primary objective is to evaluate the efficacy of MK-0616 compared with placebo in increasing the time to the first occurrence of major adverse cardiovascular events (MACE) including coronary heart disease (CHD) death, ischemic stroke, myocardial infarction (MI), acute limb ischemia or major amputation, or urgent arterial revascularization.
The primary objective of the study is to compare the plasma pharmacokinetics (PK) of MK-0616 following a single 20 mg dose in participants on a background of statin therapy with varying degrees of renal impairment (moderate, severe, end stage renal disease [ESRD]) to those of healthy mean matched control participants on a background of statin therapy. There is no formal hypothesis.
This is a first-in-human,randomized, double-blind, placebo-controlled, single dose escalation, phase 1 study to evaluate the safety, tolerability, PK/PD and immunogenicity of AK102 administered subcutaneously in healthy subjects. Subjects will be randomized into 4 planned single dose escalation cohorts or placebo cohort.
In this study, there are two study medicines: NNC0385-0434 (the new medicine being tested) and placebo (a 'dummy' medicine). Participants will only get one of these medicines - which one is decided by chance. The study medicine for each person is chosen by a computer. A dummy medicine (placebo) looks like the study medicine but has no effect on the body. The dummy medicine needs to be used in the study to find out if the study medicine works as expected. The dose of the study medicines that participants receive will depend on which group they get into. The study has 4 groups of 8-15 participants in each. Each group will get a different dose of NNC0385-0434 or placebo. Participants and the study doctor will not know which of the study medicine/dose participants will get. However, if a participant's safety is at risk, the study doctor will be told in order to decide the future treatment. NNC0385-0434 may help to clear cholesterol from the blood. When there is less cholesterol circulating in the blood over a long period of time, then there is less risk of arteries (blood vessels) being clogged or developing diseases of the heart and blood vessels. Each participant will get one injection under the skin and will be in the study for about 4 months.
Primary Objective: To evaluate the efficacy of alirocumab administered every 2 weeks (Q2W) and every 4 weeks (Q4W) versus placebo after 24 weeks of double-blind (DB) treatment on low-density lipoprotein cholesterol (LDL-C) levels in participants with heterozygous familial hypercholesterolemia (heFH) 8 to 17 years of age on optimal stable daily dose of statin therapy ± other lipid modifying therapies (LMTs) or a stable dose of non-statin LMTs in case of intolerance to statins. Secondary Objectives: - To evaluate the efficacy of alirocumab versus placebo on LDL-C levels. - To evaluate the effects of alirocumab versus placebo on other lipid parameters. - To evaluate the safety and tolerability of alirocumab in comparison with placebo. - To evaluate the efficacy, safety, and tolerability of alirocumab after open label treatment. - To evaluate the development of anti-alirocumab antibodies.
Primary Objective: To collect real-use (usability) data assessing the robustness and user interaction of the new alirocumab auto-injector device (which is referred to as SYDNEY), in unsupervised settings. Secondary Objective: Device-related: - To collect real-use (usability) data assessing the robustness and user interaction of SYDNEY and the current alirocumab auto-injector device (which is referred to as AI) in supervised settings. Pharmacokinetics: - To compare alirocumab pharmacokinetics (PK) administered using SYDNEY and AI. - To evaluate alirocumab PK administered using SYDNEY. Anti-drug antibodies: - To evaluate the development of anti-drug (alirocumab) antibodies (ADA). Efficacy/pharmacodynamics: - To compare the percent and absolute change in low-density lipoprotein cholesterol (LDL-C) using SYDNEY and AI. - To evaluate the percent and absolute change in LDL-C using SYDNEY. Safety: - To evaluate the safety and tolerability of alirocumab using both SYDNEY and AI.
To evaluate pregnancy and infant outcomes among females diagnosed with familial hypercholesterolaemia (FH), exposed to Repatha® during pregnancy. This includes follow-up of their infants to the age of 12 months
Primary Objective: To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 8 weeks of treatment in heterozygous familial hypercholesterolemia (heFH) participants aged of 8 to 17 years, with LDL-C >=130 milligrams per deciliter (mg/dL) (3.37 millimoles per litre [mmol/L]) on optimal stable daily dose of statin therapy +/- other lipid modifying therapies (LMTs) or a stable dose of non-statin LMTs in case of intolerance to statins for at least 4 weeks prior to the screening period. Secondary Objective: - To evaluate the safety and tolerability of alirocumab. - To evaluate the pharmacokinetics profile of alirocumab. - To evaluate the effects of alirocumab on other lipid parameters.
Review of clinical characteristics of patients who are prescribed Repatha® and how their treatment is managed.