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Dyslipidemias clinical trials

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NCT ID: NCT02651753 Completed - Dyslipidemia Clinical Trials

A Clinical Trial to Compare Safety and Pharmacokinetic Characteristics of CKD-337

Start date: January 2016
Phase: Phase 1
Study type: Interventional

This study is a randomized, open-label, single oral dose, 2-way crossover clinical trial to compare safety and pharmacokinetics of CKD-337 in healthy male volunteers.

NCT ID: NCT02642159 Completed - Dyslipidemia Clinical Trials

Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients With Type 2 Diabetes and Mixed Dyslipidemia (ODYSSEY DM-Dyslipidemia)

Start date: March 15, 2016
Phase: Phase 4
Study type: Interventional

Primary Objective: To demonstrate the superiority of alirocumab in comparison with usual care in the reduction of non-high-density lipoprotein cholesterol (non-HDL-C) in participants with type 2 diabetes and mixed dyslipidemia at high cardiovascular risk with non-HDL-C not adequately controlled with maximally tolerated statin therapy. Secondary Objectives: - To demonstrate whether alirocumab is superior in comparison with usual care in its effects on other lipid parameters (ie, low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), total cholesterol (Total -C), lipoprotein a (Lp[a]), high-density lipoprotein cholesterol (HDL-C), triglycerides (TGs), triglyceride rich lipoproteins (TGRLs), apolipoprotein A-1 (Apo A-1), apolipoprotein C-III (Apo C-III), lipid subfractions by nuclear magnetic resonance (NMR) spectroscopy (ie, LDL-C particle size and LDL, very low-density lipoprotein [VLDL], HDL, and intermediate-density lipoprotein [IDL] particle number). - To assess changes in glycemic parameters with alirocumab vs. usual care treatment. - To demonstrate the safety and tolerability of alirocumab. - To evaluate treatment acceptance of alirocumab. - To evaluate proprotein convertase subtilisin kexin type 9 (PCSK9) concentrations and antibody development. - To demonstrate the superiority of alirocumab vs. fenofibrate on non-HDL-C and other lipid parameters (subgroup analysis).

NCT ID: NCT02637115 Completed - Obesity Clinical Trials

Evaluation of the Effects Associated With the Administration of Akkermansia Muciniphila on Parameters of Metabolic Syndrome

Microbes4U
Start date: December 2015
Phase: N/A
Study type: Interventional

Overweight and obesity have reached worldwide epidemic level. Both overweight and obesity are characterized by comorbidities such as cardio-metabolic risk factors (i.e., insulin resistance, type 2 diabetes, hypertension, dyslipidemia, low-grade inflammation) representing a major public health problem. Therefore, it is urgent to find a therapeutic solution to target all these metabolic disorders. Among the environmental factors able to influence the individual susceptibility to gain weight and to develop metabolic disorders associated with obesity, more and more evidence show that the trillions of bacteria housed in our gastro-intestinal tract (i.e, gut microbiota) influence host metabolism. The investigators recently discovered a putative interesting microbial candidate, namely Akkermansia muciniphila (Akk). More exactly, we found that the administration of Akkermansia muciniphila reduced body weight gain, fat mass gain, glycemia and inflammatory markers in diet-induced obese mice. Moreover, in overweight/obese patients with cardiovascular risk factors subjected to a calorie restriction diet (calorie restriction diet for 6 weeks and an additional 6 weeks of weight maintenance), a higher abundance of Akkermansia muciniphila was associated with a better cardio-metabolic status in these patients. The investigators also discovered that patients having more Akkermansia muciniphila in their gut before the calorie restriction exhibited a greater improvement in glucose homoeostasis, blood lipids and body composition after calorie restriction. These observations suggested that the administration of Akkermansia muciniphila in overweight or obese people could be a very interesting therapeutic solution. Currently, no human study has investigated the beneficial effects of Akkermansia muciniphila administration on obesity and metabolic disorders. The overall objective of this study is to evaluate the effects associated with the administration of live or heat-killed Akkermansia muciniphila on the metabolic disorders (insulin-resistance, type-2 diabetes, dyslipidemia, inflammation) related to overweight and obesity in humans.

NCT ID: NCT02628990 Completed - Clinical trials for Hypercholesterolemia

Lipid-lowering Effect of Plant Stanol Ester Yoghurt Drinks

Start date: June 2005
Phase: N/A
Study type: Interventional

The aim is to investigate the effects of yoghurt drinks containing two doses of plant stanol ester either with or without added camelina oil on the serum cholesterol levels in moderately hypercholesterolemic subjects

NCT ID: NCT02623868 Completed - Dyslipidemia Clinical Trials

Study to Assess PK/PD Character, Safety/Tolerability of CKD-519 New Formulation in Healthy Male Subject.

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

Study to assess the pharmacokinetic/pharmacodynamic characteristics and safety/tolerability to CKD-519 new formulation in healthy male subjects.

NCT ID: NCT02586129 Completed - Dyslipidemia Clinical Trials

Clinical Trial of YH14755 in Subjects With Dyslipidemia and Type II Diabetes

Start date: November 4, 2015
Phase: Phase 3
Study type: Interventional

Randomized, double-blind, active-controlled, multicenter phase 3 trial to evaluate the safety and efficacy of YH14755 in subjects with dyslipidemia and Type II Diabetes.

NCT ID: NCT02548832 Completed - Mixed Dyslipidemia Clinical Trials

Bezafibrate Plus Berberine in Mixed Dyslipidemia

Start date: April 2013
Phase: Phase 3
Study type: Interventional

Dyslipidemia, is a cardiovascular risk factor of great importance whose prevalence has increased over the last decade. Part of the components of metabolic syndrome and consensus so far contemplated to increased triglycerides (TG) and reduced high-density lipoprotein cholesterol (HDL-C) as part of the elements for classification, which includes mixed dyslipidemia. Currently, fibrates, such as bezafibrate, are drugs used in treating hypertriglyceridemia, besides reducing the risk of coronary disease. However, although this treatment is safe, it is not without risks; with increased prevalence of adverse effects as the dose thereof is increased or joins combination with a statin drug for the treatment of mixed dyslipidemia long term. Among the alternative therapies is berberine, which to reduce cholesterol and triglycerides may be useful in combination with bezafibrate in the treatment of mixed dyslipidemia and as an option with lower cost and lower frequency of adverse events.

NCT ID: NCT02541201 Completed - Dyslipidemia Clinical Trials

The Effect of a Plant Sterols-Enriched Low-Fat Milk on Lipid Profile in Healthy Southern Chinese (COME-PASS)

COME-PASS
Start date: August 2015
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, single-center, two-arm, placebo-controlled clinical trial that examine the effect of the consumption of a plant sterols-enriched low-fat milk. Half of the participants will consume of 1.5g of plant sterols daily as provided by two servings of the plant sterols-enriched low-fat milk product for 3 consecutive weeks, while the other half will consume placebo low-fat milk.

NCT ID: NCT02537535 Completed - Dyslipidemia Clinical Trials

Guidelines Oriented Approach to Lipid Lowering (GOAL) in Canada

GOAL
Start date: January 2016
Phase:
Study type: Observational

Cross-sectional observational study designed to identify and describe the care gap in guideline-oriented low density lipoprotein cholesterol (LDL-C) management in Canadian patients at high cardiovascular risk.

NCT ID: NCT02529709 Completed - Dyslipidemia Clinical Trials

The Effect of Meal Composition on Blood Lipids

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

The purpose of this study is to see if a high-protein meal leads to a better postprandial (after a meal) blood lipid profile compared to a high-monounsaturated meal.