Active clinical trials for "Hypercholesterolemia"

Evolocumab is a monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9) and lowers low-density lipoprotein (LDL) cholesterol, reducing in turn the risk of cardiovascular events. Whether evolcumab is effective in haemodialized patients is uncertain. The investigators will conduct a randomized, double-blind, placebo-controlled trial to assess the feasibility, safety, and LDL-C-lowering efficacy of evolocumab in high cardiovascular risk haemodialized statin intolerant patients with hypercholesterolemia. Patients will be randomly assigned to receive evolocumab (140 mg subcutaneous every 2 weeks + ezetimibe 10 mg per os daily) or matching placebo (subcutaneous every 2 weeks + ezetimibe 10 mg per os daily) for 24 weeks. The primary efficacy end point will be the proportion of patients that will reduce LDL-C < 55 mg/dL in the evolocumab group compared to placebo at 24 weeks. The key secondary efficacy end points will be: the reduction of LDL-C from baseline at 4, 6 and 12 weeks; the reduction of HDL-C, non-HDL cholesterol and triglycerides from baseline at 24 weeks. Every adverse event (serious and non-serious) correlated to drug infusion will be recorded (safety end-point).

IBI306 is a bio-innovative drug against proprotein convertase subtilisin 9 (PCSK-9) monoclonal antibody. Currently, cholesterol-lowering drugs with multiple mechanisms of action are on the market or under development. Among them, anti-PCSK-9 monoclonal antibodies have received widespread attention due to their good safety and efficacy. The results of existing preclinical studies show that IBI306 has a clear structure, good stability, and is not inferior to other drugs of its kind in terms of drug activity, animal pharmacokinetics (PK)/pharmacodynamics (PD) and safety. This study is divided into two phases: the dose exploration phase (the first phase) and the confirmatory phase (the second phase). Each stage is divided into screening period, treatment period, and safety follow-up period. The first phase of this research is the randomized design of open labels. The second stage is an open, single-arm design. The main purpose of the first phase of the study: to evaluate the tolerability and safety of multiple-dose repeated administration of IBI306 in the Chinese population with hypercholesterolemia, and to recommend the dose for the second phase. The main purpose of the second phase of the study: to evaluate the effectiveness of IBI306 in the Chinese homozygous familial hypercholesterolemia population. Secondary research purpose: To evaluate the safety and immunogenicity of IBI306 in Chinese homozygous familial hypercholesterolemia population.

Reaching active aging makes it important to implement new methods affecting the biological age of a person. Biochemical parameters of a blood test are aging biomarkers that are ones of the most accessible for testing. We know that, with age, there is increase in levels of LDL, triglycerides, homocysteine and other biomarkers relating the body state. Methods of extracorporeal hemocorrection showed good results in this area. For instance, the use of plasmapheresis is very effective during prophylaxis, treatment and rehabilitation after various diseases/injuries. The main effects of plasmapheresis are related to removal of endo- and exotoxins, including products of lipid peroxidation, and to draining effect as a result of a heavy flow of interstitial fluid containing products of pathometabolism into the blood stream within concentration gradient (by "dynamic equilibrium" in concentration of different substances in intracellular, interstitial and intravascular compartments). These effects are also related to release of receptors, their sensitization to their own neurohumoral regulation mechanisms, to insulin, in particular (as consequences, lower glucose tolerance, lower substrate glycation).

The purpose of this study is to determine if CVI-LM001 is effective and safe versus placebo in drug-naive subjects with elevated LDL cholesterol. There will be 4 groups receiving 100mg, 200mg, 300 mg and placebo treatment for 12 weeks respectively.

The investigators planned to research the effect of vitamin D supplementation as an adjuvant therapy for patients with hypercholesterolemia.

The purpose of this study is to compare the effects of pravastatin and rosuvastatin on coronary plaque characteristics in patients with stable angina pectoris.

This study plans to enroll several patients with heterozygous familial hypercholesterolemia, randomly assigned to different dose groups, and randomly receiving subcutaneous injection of IBI306150 mg or placebo every two weeks: or subcutaneous injection of IBI306 450mg every four weeks (n=49) or placebo (n=25) treatment, treatment lasted for 12 weeks. During randomization, the LDL-C level (<4.8mmol/L or ≥4.8mmol/L) observed during the screening period visit (VI), and whether ezetimibe was used for stratification. After 12 weeks, each group entered the 12-week open-period treatment, in which subjects in the IBI306 group continued to receive IBI306 treatment, and subjects in the placebo group stopped using placebo and received IBI306 treatment. The exploratory endpoint is the population pharmacokinetic characteristics of IBI306 in Chinese heterozygous familial hypercholesterolemia population.

Background In subjects with hypercholesterolaemia, cholesterol values remain above guideline levels. One of the limiting factors to the achievement of goals in such patients is therapeutic non-adherence. The aim of this study is to assess the effectiveness of an intervention designed to improve control of hypercholesterolaemic patients, consisting of a combined strategy that would include the delivery of printed information, treatment-compliance check cards and the dispatch of text messages as complementary measures in support of the intervention at the general practitioner's practice. Methods/Design A randomised, parallel-group clinical trial will be conducted at the family medicine outpatient facilities of eight health centres in three of Spain's Autonomous Regions, covering a total of 358 subjects aged 18 years or over with diagnosis of hypercholesterolaemia. Patients in the intervention group will be supplied with printed material with information on the disease and its management, mobile-telephone text messages with guideline summaries, reminders of forthcoming appointments and/or arrangements for making new appointments in the event of non-attendance, and self-report cards to check compliance with recommendations. Both groups -intervention and control- will receive routine recommendations from their physicians in accordance with current European clinical practice guidelines for hypercholesterolaemia and cardiovascular risk management. As regards the measurements to be made, the main variable is the proportion of subjects who attain the low density lipoprotein cholesterol levels set as a target across a follow-up period of 24 months. The secondary variables are as follows: adherence to recommendations on lifestyle and adherence to drug treatment; variation in lipid profiles and cardiovascular risk levels; appearance of cardiovascular events; physical activity; food consumption; smoking habit; anthropometric measures; blood pressure; health problems; use of hypolipidaemic agents; socio-demographic data; beliefs and expectations about preventive recommendations; and degree of satisfaction with the combined strategy. Discussion Should this intervention prove effective, a recommendation could be issued on the application of this combined strategy to subjects with hypercholesterolaemia. It is a simple, relatively inexpensive intervention.

This is a Phase 1, open-label, single-dose, randomized, dose escalation study in healthy and hypercholesterolemic subjects. Each subject will receive 1 of 5 treatments as a single subcutaneous injection. Subjects will remain confined at the research clinic for approximately 2 days. After discharge, subjects will return to the research clinic 15 times during 12 weeks.

Osteoarthritis patients undergoing primary hip and knee replacement are followed-up and changes in their glucose metabolism and other metabolic parameters (obesity, cholesterol levels) are examined. Persistent postoperative pain is examined as secondary outcome.