View clinical trials related to Hypercholesterolemia.
Filter by:Familial hypercholesterolemia (FH) is an autosomal dominant genetic disorder characterized by elevated plasma levels of LDL-C cholesterol. This early and significant elevation of LDL-C triggers premature atherosclerosis, particularly coronary artery disease. The initiation and management of LDL-C therapies is based on cardiovascular risk assessment. Although this is undoubtedly higher than in normocholesterolemic patients, a significant heterogeneity in heFH patients still persists that is not completely explained. Moreover, the evaluation of cardiovascular risk in patients with heFH is difficult for many reasons: non-validity of risk scores, futility of a risk calculation limited to 10 years in a young patient, late positivity of stress tests . Therefore, there is a clear need for new cardiovascular risk assessment tools to identify higher risk heFH patients who could benefit from early and aggressive treatment. The Coronary Artery Calcium (CAC) Score has been widely studied in the US and validated in European recommendations, and has shown the best reclassification index for patients at intermediate cardiovascular risk. A CAC score of zero is associated with a very low risk of event irrespective of the number of risk factors. Non-calcified plaques are by definition not detected by ACC and patients with CAC = 0 may only have soft non-calcified plaques. The prevalence of these non-calcified plaques in very high-risk patients with acute coronary syndrome is 5%. The prevalence in FH patients is unknown. It has also been shown that the extent of the atherosclerotic burden is related to cardiovascular risk. CAC score has been poorly evaluated in heFH patients. However, hypercholesterolemia and calcifications have been shown to be correlated: supra-aortic calcified masses in homozygous FH patients, early calcifications associated with chronic exposure to high LDL-C (cholesterol burden, equivalent to cigarettes) and finally, the calcifying role of statins. The early increase of LDL-C in patients with genetic forms of FH causes premature cardiovascular damage. Investigators' hypothesis is that patients with FH have earlier coronary atheroma (and thus calcifications and non-calcified plaques) due to exposure early in life to high levels of LDL-cholesterol.
The effects of a nutraceutical combination (NC) containing low-dose monacolin K and berberine on lipid profile, proprotein convertase subtilisin/kexin type 9 (PCSK9), subclinical inflammation and arterial stiffness were investigated in human immunodeficiency virus (HIV)-infected patients receiving stable antiretroviral therapy (ART).
The objectives of this study are to examine fecal bacterial population(s) and plasma cholesterol levels elicited by 40g of Oats and Cream of Rice over 6 weeks.
To assess the efficacy and safety of rosuvastatin/ezetimibe combination therapy compared to rosuvastatin monotherapy in Korean patients with type 2 diabetes mellitus and hypercholesterolemia
To determine the efficacy of HS-25 (20mg) in reducing low density lipoprotein-cholesterol (LDL-C) levels after a 12-week period of treatment in combination with Atorvastatin in subjects with hypercholesterolemia and coronary heart diseases; To determine the safety of HS-25 (20mg) combination with Atorvastatin in subjects with hypercholesterolemia and coronary heart diseases
An open-label, prospective phase III study to compare the efficacy and safety of administering evolocumab versus treatment with LDLapheresis in patients with familial hypercholesterolemia and high cardiovascular risk.
The primary objective of the study is to assess pharmacokinetics, dynamics, safety and tolerability of CiVi007 following single and multiple subcutaneous doses in subjects, including those on statin therapy
The aim of this study was to assess the lipid-lowering activity and safety of a dietary supplement containing monacolin K, L-arginine, coenzyme Q10 and ascorbic acid (vitamin C). Twenty both gender caucasian outpatients aged 18-75 yrs with serum LDL-C between130-180 mg/dL, not significantly modified by an appropriate dietetic regimen assumed two different dietary supplements (Argicolina [trade mark]: A; Normolip 5 [trade mark]: N) both containing monacolin K 10 mg for 8 weeks each separated by a 4-week wash-out period in a single center, controlled, randomized, open-label, cross-over clinical study. Exclusion criteria were pregnancy or breast-feeding; known liver, renal or muscle diseases; serum triglycerides (TG) greater than 350 mg/dL; previous cardiovascular events; concomitant neoplastic or immunodepressive disease; use of lipid-lowering drugs or dietary supplements within the last three weeks; concurrent use of thiazide diuretics, oral contraceptives containing estrogen or progestogen, systemic corticosteroids; use of psycho-active substances, drug or alcohol abuse; neurological or psychiatric diseases that could affect consent validity or impair the patient's adherence to the study protocol. Evaluation criteria were Tot-C, LDL-C, HDL-cholesterol, TG, fasting blood glucose, aspartate aminotransferase, alanine aminotransferase, creatinkinase, gamma-glutamyl-transpeptidase, humeral blood pressure and heart rate measured at the start and a the end of each treatment period. Safety was monitored through the study.
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 determine the efficacy of HS-25 (20mg) in reducing low density lipoprotein-cholesterol (LDL-C) levels after a 12-week period of treatment in adults with primary hypercholesterolemia; To determine the safety of HS-25 (20mg) in subjects with LDL-C