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Hypercholesterolemia clinical trials

View clinical trials related to Hypercholesterolemia.

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NCT ID: NCT02434497 Completed - Clinical trials for Homozygous Familial Hypercholesterolemia (HoFH)

A Study to Evaluate the Safety of Rosuvastatin in Children and Adolescents With Homozygous Familial Hypercholesterolemia

Start date: June 6, 2015
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the safety of Rosuvastatin in Children and Adolescents with Homozygous Familial Hypercholesterolemia.

NCT ID: NCT02422927 Completed - Inflammation Clinical Trials

Nutraceutical Combination in Patients With Low-grade Systemic Inflammation

Start date: July 2014
Phase: Phase 4
Study type: Interventional

The investigators tested if a nutraceutical combination with red yeast rice, berberine and policosanol (NC) can significantly modify inflammation, lipid profile and markers of endothelial injury (endothelial microparticles) in subjects with elevated levels of high-sensitivity C-reactive protein (hsCRP).

NCT ID: NCT02409537 Completed - Healthy Clinical Trials

Effects of Dietary Antioxidants to Prevent Cardiovascular Disease

RWTAC
Start date: March 2013
Phase: Phase 2
Study type: Interventional

Background & Aims: The role of red wine in cardiovascular risk prevention has been documented by several epidemiological studies in patients and normocholesterolemic healthy individuals. However, it is unclear whether hypercholesterolemic individuals free of cardiovascular disease would equally benefit from moderate red wine consumption to prevent atherosclerosis and the development of cardiovascular disease. Methods: Forty (40) healthy volunteers males and females were recruited, divided into 2 age-adjusted groups according to their total cholesterol levels; in asymptomatic hypercholesterolemics (AHC ), and normocholesterolemics (NC ). Total Antioxidant Capacity (TAC ), Lipid profile, Vitamin E, and cardiovascular risk indexes ( LDL /HDL and Vitamin E/TC ) were evaluated in the blood serum of all subjects prior to and 1 month after once daily red wine consumption as well as prior to and after being given a placebo drink following a 1 month wash out period and resveratrol for 1 month after wash out period..

NCT ID: NCT02392559 Completed - Clinical trials for Heterozygous Familial Hypercholesterolemia

Trial Assessing Efficacy, Safety and Tolerability of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition in Paediatric Subjects With Genetic Low-Density Lipoprotein (LDL) Disorders

HAUSER-RCT
Start date: March 24, 2016
Phase: Phase 3
Study type: Interventional

A study to assess safety and efficacy of evolocumab (AMG-145) in paediatric subjects aged 10-17 years diagnosed with heterozygous familial hypercholesterolemia.

NCT ID: NCT02392416 Completed - Clinical trials for Hypercholesterolemia

Atorvastatin Study in Cardiovascular Disease Risk

ANTLER
Start date: April 2015
Phase: N/A
Study type: Observational

Treatment of hypercholesterolemia is based on the guidelines of ESC-EAS 2011 (European Heart Journal (2011) 32, 1769-1818, ESC / EAS Guidelines for the management of dyslipidaemias) These calculate the 10 year risk based on SCORE tables - Systematic COronary Risk Estimation and taking into account specific parameters in the patient's profile.

NCT ID: NCT02391701 Completed - Clinical trials for Cardiovascular Disease

Effect of an Atlantic Diet on Anthropometric Indices and Serum Lipid Profile

GALIAT
Start date: March 2014
Phase: N/A
Study type: Interventional

BACKGROUND: The Southern European Atlantic Diet (SEAD) is the traditional diet of Northern Portugal and Galicia, a region in northwest Spain. The SEAD has been associated with a lower risk of non-fatal acute myocardial infarction. Possible mechanisms of this association may be related with a lower concentration of markers of inflammation and with reduced triglycerides, insulin, insulin resistance, and systolic blood pressure. Aim: To evaluate the effect of an Atlantic Diet on i) lipid profile, ii) markers of inflammation, and iii) anthropometric indices in a population-based study METHODS: This is a non-pharmacological clinical trial study which is performed on a family-oriented basis. 250 families (~ 750 children and adults, older than 3 years) were selected to participate in the study and randomized into Atlantic Diet (AD) (n=125 families) and control (n=125 families) groups. The AD groups participate in a diet program 1 day a month for 3 months in 120-minute diet sessions and freely receive AD food, characterized by a high intake of vegetables, cheese, olive oil, mussels and by wine consumption during meals. Control group subjects do not participate in any regular diet activity during this period and did not receive additional food. Exclusion criteria are alcoholism, lipid treatment, dementia, and terminal disease. Weight, BMI, waist circumference (WC), skin folds, nutrient intake from 3-day recalls, food frequency questionnaire, physical activity, blood pressure, metabolic function (fasting blood glucose, HBA1c, insulin resistance and lipid profile), and inflammation markers (c-reactive protein, interleukin 6 and tumor necrosis factor-alpha) are measured at baseline, 3 and 6 months. Mixed effect models will be performed to assess the significance of changes in the cardiometabolic parameters. The primary end point is the change in lipid profile compared with baseline and the control group arm at the end of Month 6. The secondary exploratory end points were change in anthropometric indices and inflammation markers at Month 6.

NCT ID: NCT02390375 Completed - Clinical trials for Hypercholesterolemia

Phase 3 Study to Evaluate the Efficacy and Safety of the DW0929 in Patients With Primary Hypercholesterolemia

Start date: November 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of the DW0929 in patients with primary hypercholesterolemia

NCT ID: NCT02374047 Completed - Clinical trials for Hypercholesterolemia

A 2-Part, Phase 1, Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CAT-2054 in Healthy Subjects

Start date: January 2015
Phase: Phase 1
Study type: Interventional

This is a 2-part, Phase 1, placebo-controlled, double-blind, randomized, single and multiple ascending dose study. CAT-2054 will be administered either as an uncoated capsule (CAT-2054) or a coated capsule (CAT-2054-C). In Part A, CAT-2054 or placebo is administered as a single dose in a fasting state at 4 dose levels; at 3 dose levels, subjects will return for a second dose of the study drug after a high-fat meal. Additionally, at 1 dose level, CAT-2054-C or placebo will be administered as a single dose in a fasting state, and subjects will return for a second dose of the study drug after a high-fat meal. In Part B, CAT-2054 will be administered as multiple ascending doses at 4 dose levels for 14 consecutive days. In selected cohorts, CAT-2054, CAT-2054-C or CAT-2054 with atorvastatin will be dosed to assess safety in anticipation of future clinical trials.

NCT ID: NCT02342015 Completed - Osteoporosis Clinical Trials

Effect of Atorvastatin on Bone-vascular Axis

Start date: November 2012
Phase: Phase 4
Study type: Interventional

Background: Circulating osteoprogenitors and RANKL expression in immune cells have been implicated in the pathogenesis of osteoporosis and vascular calcification. The role played by statin therapy in the bone-vascular axis is unknown. Methods: Twenty naïve post-menopausal osteoporotic hypercholesterolemic women will be treated with Atorvastatin 40 mg/day for three months. Blood samples will be collected at baseline and at the end of the treatment. Gene expression analysis will be performed to assess modification in OPG/RANK/RANKL expression in isolated T-cells and monocytes. A flow cytometry analysis will be used to study changes in the levels of circulating osteoprogenitor cells.

NCT ID: NCT02341924 Completed - Clinical trials for Hypercholesterolemia

Validating the "Foods for Health" Portfolio of Functional Food Products

Start date: September 2015
Phase: N/A
Study type: Interventional

The objective of this research project is to investigate the ability to affect cardiovascular disease (CVD) risk factors through a novel, easily implemented functional food-based approach. The goal of the proposed project is to evaluate the effect of a range of proprietary products specifically formulated to deliver convenient pre-packaged condition-specific foods to positively impact blood cholesterol levels in statin intolerant and/or statin unwilling participants. The specific aim of this project is to evaluate the changes in serum low-density lipoprotein (LDL)-cholesterol, triglyceride (TG) glucose, insulin and high-sensitivity C-reactive protein (hsCRP) concentrations over a 4 week regimen using healthy tasty foods which are self-selected by a statin intolerant patient group.