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Hypercholesterolemia clinical trials

View clinical trials related to Hypercholesterolemia.

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NCT ID: NCT01547585 Completed - Clinical trials for Cardiovascular Disease

A Human Trial to Assess the Low Density Lipoprotein Cholesterol (LDL-C) Lowering Effect of Soy

SOY-LDL
Start date: May 2012
Phase: N/A
Study type: Interventional

This study is being conducted to test the hypothesis that daily consumption of a baked food product containing whole soy for 6 weeks will significantly reduce plasma Low Density Lipoprotein Cholesterol (LDL-C) in individuals with hypercholesterolemia. As such the overall goals of this study are to determine whether daily consumption of muffins made from whole soy flour for 6 weeks can lower plasma LDL-Cholesterol, and if so, establish whether the effect is dose-dependent. To do this, study collaborators will: (1) conduct a detailed chemical and physical characterization of certified defatted whole soy flour that will be incorporated into a muffin; (2) formulate and produce a palatable whole soy flour muffin along with a control muffin containing wheat flour; (3) conduct a parallel controlled trial in which soy muffins will be fed randomly to persons with elevated LDL-cholesterol in a human clinical trial. All participants will be randomized into one of three groups and asked to eat two muffins daily for 6 weeks in the following combination: high dose soy; control group or low dose soy. Before, after, and mid-way during the feeding period, blood samples will be obtained for measurements of lipids, glucose, insulin, inflammation, and soy phytochemicals. The effect of soy consumption on waist circumference, body mass index (BMI) and blood pressure will also be examined.

NCT ID: NCT01544309 Completed - Clinical trials for Hypercholesterolemia With Concomitant Type 2 Diabetes

LIpid Lowering With Highly Potent Statins in Hyperlipidaemia With Type 2 Diabetes patiENts

LISTEN
Start date: March 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the effect of rosuvastatin and atorvastatin on lipid lowering effect and glucose metabolism in hypercholesterolemia patients with diabetes mellitus.

NCT ID: NCT01531569 Completed - Clinical trials for Diabetes Mellitus, Type 2

Single Oral Dose of BeneFlax to Healthy Young and Older Adults

SOD
Start date: December 2011
Phase: Phase 2
Study type: Interventional

This study is being done to look at age differences in the way the investigators bodies break down a compound found in flax seed (secoisolariciresinol diglucoside or SDG). It is administered to research subjects in a product called BeneFlax, which a concentrated version of flax seed containing 38% SDG. It is known that as people age, their bodies undergo physical changes both on the outside and the inside. The aging process may change the way that the investigators bodies deal with compounds the investigators eat. As an important measure of safety, the investigators want to check for evidence whether there is a difference in break down of SDG between different age groups.

NCT ID: NCT01524601 Completed - Clinical trials for Hypercholesterolemia

The Rosuvastatin In TrAnsplant Recipients Study

RITA
Start date: February 2012
Phase: Phase 4
Study type: Interventional

Renal transplant recipients need life long immunosuppression and one of the new drugs is everolimus. Everolimus is a potent immunosuppressive drug and one of the main side-effects are increased blood cholesterol levels. Many renal transplant recipients are treated with a cholesterol lowering agent, mainly fluvastatin. Rosuvastatin is a new cholesterol lowering drug on the market with a potential higher cholesterol lowering potency. In the present study the investigators will examine the hypothesis that rosuvastatin reduce cholesterol levels more than fluvastatin in renal transplant patients.

NCT ID: NCT01524289 Completed - Clinical trials for Hypercholesterolemia, Familial

Study to Assess the Tolerability and Efficacy of Anacetrapib (MK-0859) Co-Administered With Statin in Participants With Heterozygous Familial Hypercholesterolemia (MK-0859-020)

REALIZE
Start date: February 3, 2012
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the efficacy and tolerability of adding anacetrapib to ongoing statin therapy in participants with heterozygous familial hypercholesterolemia (HeFH).

NCT ID: NCT01516879 Completed - Clinical trials for Hypercholesterolemia

Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study

DESCARTES
Start date: January 5, 2012
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy, safety, and tolerability of 52 weeks of subcutaneous (SC) evolocumab (AMG 145) compared with placebo when added to assigned background lipid-lowering therapy.

NCT ID: NCT01515241 Completed - Clinical trials for Heterozygous Familial Hypercholesterolemia

Exploratory Study of Plaque Regression

EXPRESS
Start date: January 2012
Phase: Phase 2
Study type: Interventional

Despite the availability of several classes of very effective drugs available to treat heterozygous Familial Hypercholesterolemia (HeFH), there remains a large unmet medical need for new, effective and well tolerated therapies. There are a number of therapies given on a chronic basis to reduce long term risk, such as statins, fibrates, niacin, omega 3 fatty acids, resins, cholesterol absorption inhibitors and antiplatelet or anticoagulant drugs, but subjects with heterozygous Familial Hypercholesterolemia remain at high risk for cardiovascular events. There is still a need for acute therapies that can lead to rapid pacification of unstable plaque in order to reduce the risk of these events. This study will assess the effects of CER-001 , a recombinant human Apo-A-1 based HDL mimetic, on indices of atherosclerotic plaque progression and regression as assessed by 3Tesla MRI (3TMRI)and intravascular ultrasound (IVUS) evaluations in patients with HeFH.

NCT ID: NCT01507831 Completed - Clinical trials for Hypercholesterolemia

Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)

Start date: January 2012
Phase: Phase 3
Study type: Interventional

Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9). Primary Objective of the study: To evaluate the long-term safety and tolerability of alirocumab in high cardiovascular risk participants with hypercholesterolemia not adequately controlled with their current lipid modifying therapy (LMT). Secondary Objectives: - To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo. - To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points. - To evaluate the effects of alirocumab on other lipid parameters.

NCT ID: NCT01493752 Completed - Clinical trials for Hypercholesterolemia

Investigation of the Effect of Dietary Nitrate Treatment on Endothelial Function and Platelet Reactivity in Hypercholesterolemics.

Start date: August 2011
Phase: Phase 1
Study type: Interventional

Diets rich in fruit and vegetables reduce the risk of strokes and heart attacks, however the exact cause of this beneficial effect is uncertain. Evidence suggests that certain vegetables, including beetroot and the green leafy vegetables, possess high inorganic nitrate concentrations. The investigators recent evidence suggests that inorganic nitrate provides a source of gas called nitric oxide in the body that exerts a number of beneficial effects upon the heart and blood vessels . The investigators have previously shown that beetroot juice ingestion improves blood vessel (vascular endothelial) and platelet function in healthy volunteers. Studies by the investigators show that these effects are due to conversion of nitrate to nitrite by symbiotic (helpful) bacteria (located on the tongue) and subsequent conversion of nitrite to nitric oxide in blood vessels. The investigators now wish to explore whether dietary nitrate, via its beneficial effects on platelets and blood vessels, might improve indices of atherosclerotic disease progression in high risk individuals (hypercholesterolemics). Recruits will have high cholesterol and no known atherosclerosis and will not yet be on any anti-cholesterol medications. Volunteers will consume a daily dose of beetroot juice or placebo nitrate-free juice for six weeks. Vascular function will be assessed using non-invasive techniques at the beginning and at the end of the study using ultrasound measurement of flow mediated dilatation (FMD) of the brachial artery in the arm and pulse wave analysis (PWA) and pulse wave velocity (PWV) to measure arterial compliance. To assess impact on platelet function, blood samples will also be taken at the start and at the end of the study.

NCT ID: NCT01483950 Completed - Clinical trials for Hypercholesterolaemia

Evaluation of Patients Treated With HMG-CoA Reductase Inhibitors to Reach Cholesterol Target Values

Start date: April 2012
Phase: N/A
Study type: Observational

This study is non-interventional study of patients who are treated with any HMGCoA reductase inhibitors (rosuvastatin, simvastatin,atorvastatin and fluvastatin) available in Bosnia and Herzegovina for at least 6 months. Data collection for each patient will take place at a single visit. The investigators will complete Case Report Form (CRF) with patient's demographic, the presence of the factors for high cardiovascular risk, current treatment, cholesterol value as well as with further treatment decision.