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54 active trials for Hypercholesterolemia

Evolocumab Plus Ezetimibe in High Risk Haemodialized Statin Intolerant Patients

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 reduction in LDL-C ? 20 mg/dL from baseline. 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; the number of patients achieving LDL-C <70 mg/dL. Every adverse event (serious and non-serious) correlated to drug infusion will be recorded (safety end-point).

Start: May 2020

Oil Consumption and Cholesterol

More than 31 million U.S. adults have high total cholesterol and over 73 million U.S. adults have high LDL cholesterol. Cottonseed oil (CSO) is found readily in our food supply, and recent research has shown improvements in blood lipids following CSO consumption in healthy adults with normal cholesterol profiles. To date, however, there are no published studies on the effects of CSO-enriched diets on blood lipids and markers of health in an older population with hypercholesterolemia. Therefore, the purpose of this study is to test the health effects of a diet rich in CSO against a diet rich in olive oil to determine if the CSO-enriched diet will show greater improvements in blood lipids and other health markers in adults with high cholesterol levels. If CSO in the diet is found to improve these markers, these study findings could lead to improvements in health.

Start: May 2018

Diets Enriched With Pecans

Background: Previous studies report that daily pecan consumption reduces cholesterol in healthy adults while promoting weight maintenance. Purpose: To examine the impact of daily pecan consumption with and without dietary substitution instructions for an 8-week period on markers of health in adults at risk for cardiovascular disease.

Start: August 2018

Vascular Lifestyle-Intervention and Screening in Pharmacy

The overall goal of the present project is to contribute to new knowledge about the effect of a low threshold population screening system for cardiovascular risk factors in Norway. Further, this project aim to study if identifying high cardiovascular risk itself may lead to beneficial changes in health behaviors such as physical activity, diet, tobacco and alcohol behavior together with reduced risk score of cardiovascular disease, across socioeconomic status. This fall, a nationwide, free screening of cardiovascular risk factors will be conducted in 150 pharmacies in Norway. All participants that consent to participate will measure full lipid-profile, blood pressure, HbA1c, body weight and height by health care providers in pharmacies. Based on their measurement levels, participants will be stratified into either a low or a high risk group. In the high risk group, participants will further be randomized to either the intervention group or one of the two control groups. Participants in the intervention group will be informed about all their measurement levels with comparison to the recommended levels. Contrary, participants randomized to the two control groups will have delayed information of their measured levels. Participants in the intervention group and the first control groups will receive general oral and written information about how to lower their measurement levels in 8 weeks. In the second control group, participants will not receive any information at the first visit. In this way the investigators may be able to isolate the effect of identifying high risk and high levels of the risk factors itself. All groups will be given a diet- and physical activity questionnaire at visit 1, and will be invited back after 8 weeks to once more perform the measurement screening and receive the same questionnaire. At visit 2, all participants will, after the measurement screening, be informed about their measured risk factors and receive information on how to lower their levels. 1 year after inclusion, all participants in the three groups will be invited back for a one-year follow up visit in pharmacy.

Start: September 2014

A Phase II Study of PCSK9 Inhibitor AK102 in Patients With Hypercholesterolemia

This is a double-blind, randomized, placebo-controlled, multicenter study to evaluate the safety and efficacy of AK102 in patients with Hypercholesterolemia Patients at Very High or High Risk of Cardiovascular Disease . The primary objective of this study is to evaluate the efficacy of AK102 in patients with Hypercholesterolemia Patients at Very High or High Risk of Cardiovascular Disease .

Start: May 2020

Effect of Atorvastatin on Carotid Intima Media Thickness

The investigators hypothesize that additive effects of combined antihypertensive medications and statin in a single pill combination may better reduce progression of vascular remodeling and inhibit atherosclerosis progression. The fixed association of atorvastatin, perindopril and amlodipine under the name of Lipertance is the first fixed combination of these three groups to control the risk factors that are hypertension and dyslipidemia which can be used both in primary and secondary cardiovascular prevention .

Start: April 2020

Alirocumab in Patients on a Stable Dialysis Regimen

12-week study of the efficacy and safety of alirocumab in patients maintained stably on hemodialysis or peritoneal dialysis. Measures of cholesterol levels, drug levels, PCSK9 levels, routine chemistry and cell counts, and biomarkers will be obtained at baseline and at weeks 4, 8, 10 and 12 weeks. Safety events will be obtained throughout the study.

Start: May 2018

Supplementation of Oil Palm Phenolics to Healthy Participants

Our previous study has found that oil palm phenolics (OPP) supplementation at 9 grams per day is safe for consumption. An interesting observation was reported where the consumption of OPP showed significantly lower total and LDL cholesterol compared to the control group. There is no clinical evidence as yet on the optimum dosage of OPP supplementation in improving fasting lipid profile. We hypothesize that in a clinical study, OPP supplemented participants will elicit a reduction in total and LDL cholesterol while maintaining safety and tolerability.

Start: December 2019

A Long-term Study of AK102 in Patients With Hypercholesterolemia

This is a phase II, open-label, non-controlled, extended study. The main objective of this study is to evaluate the long-term efficacy and safety of AK102 in combination with basic lipid-lowering therapy in patients with hypercholesterolemia. Subjects who have participated in the AK102 studies and have completed the last visit,and who, in the opinion of the investigator, are likely to benefit from continued treatment will be enrolled in this study.

Start: November 2019

The Effect of Viscous Dietary Fibers on LDL-cholesterol

This systematic review and meta-analysis is aimed to assess the effect of commonly consumed viscous fibers on blood lipids including LDL-C, non-HDL-C, and ApoB.

Start: September 2018

The Combined Portfolio Diet and Exercise Study

The purpose of this study is to determine whether a dietary portfolio of cholesterol-lowering foods (viscous fibres, soy protein, plant sterols and nuts) further enhanced by increased levels of monounsaturated fatty acids (MUFA) and low glycemic index foods; together with a structured exercise program reduce the progression of carotid and coronary atheromatous lesions, Low density lipoprotein-cholesterol (LDL-C), and blood pressure, while reducing the number of individuals requiring statins.

Start: November 2016

PET Imaging of Inflammation and Lipid Lowering Study

While 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) imaging has been used as an early marker of drug efficacy in numerous clinical cardiovascular drug trials, as a glucose analog, its signal in the vasculature lacks inflammatory cell-specificity. Moreover, high background 18F-FDG signals from the myocardium often preclude coronary artery imaging, despite attempts to suppress myocardial tracer uptake by dietary manipulation. These limitations of 18F-FDG for measuring changes in vascular inflammation arising from drug intervention highlight important unmet needs, which might be overcome by using a somatostatin receptor subtype-2 (SST2) PET tracer.

Start: October 2019

Lipid-lowering Therapies in Vietnamese Chronic Kidney Disease Population

This study aims to determine the mechanisms underlying dyslipidemia in chronic kidney disease (CKD) and effect of lipid-lowering therapies in patients with CKD via parameters of lipid, oxidative stress, tryptophan delegation as well as renal function and side effects. Thirty 3,4 CKD patients with low-density lipoprotein (LDL) > 100 mg/mL (2,59mmol/l), randomly receive three different LDL lipid-lowering therapies: Simvastatin (40 mg/day) or ezetimibe/simvastatin combination (10/20 mg/day or 10/40 mg/day).

Start: June 2018

Genetic Influence on Statin Pharmacokinetics

This study intends to investigate genetic influences on how individuals process statins.

Start: March 2012