Active clinical trials for "Hypercholesterolemia"

This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study in Japanese patients to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to stable statin therapy.

Hypercholesterolemia is considered one of the most important cardiovascular risk factors. Cardiovascular prevention include a class I indication to statins in addition to non-pharmacologic intervention and prevention strategies in patients deemed to be 'high risk'. Along with non-pharmacologic intervention and prevention strategies, newer approaches to reduce cholesterol blood levels currently include nutraceuticals, which are compounds derived from foods with cholesterol lowering actions. However, it remains unclear if nutraceuticals yield additive positive effects other than cholesterol lowering. In particular, there is evidence that Berberine has cardiovascular protective effects and that, in vitro, Morus Alba, mulberry fruit, modulates platelet function by inhibiting platelet activation, thromboxane formation, serotonin secretion, aggregation and thrombus formation. Furthermore, Morus Alba exerts an α-glucosidase inhibitory and antioxidant activity in vitro, which may reduce postprandial glucose peak, thus improving HbA1c concentration. Accordingly, we designated a study to evaluate the effects of two commercially available nutraceutical combined pills [LopiGLIK™, Akademy Pharma, 1 capsule/day containing red yeast rice 220 mg (at least 3,3 mg of Monacolin K) + Berberine 531,25 mg + Morus Alba 200 mg (at least 4 mg of Deoxynojirimycin) vs. Armolipid Plus®, Meda Pharma, 1 capsule/day containing Berberis aristata d.e. 588 mg (equivalent to Berberine chloride 500 mg) + Red yeast rice 200 mg (equivalent to Monacolin K 3 mg) + Policosanol 10 mg + Folic acid 0.2 mg + Coenzyme Q10 2.0 mg + Astaxanthin 0.5 mg] on lipid and metabolic profile, platelet aggregation, endothelial function and coronary flow reserve (CFR). For this purpose patients with hypercholesterolemia not requiring statins or statin intolerant at moderate cardiovascular risk will be subjected at day 0 and at day 28, after 4 weeks of therapy, to blood sampling to evaluate lipid and metabolic profile, peripheral arterial tonometry (EndoPAT), platelet aggregation tests with light transmission aggregometry (LTA), nitric oxide (NO) release, endothelial nitric oxide synthase (eNOS) phosphorylation on platelets. Only for CFR, patients will be further evaluated also after two hours from the administration of the first dose of nutraceutical combined pill. Patients will be randomly assigned to receive therapy with LopiGLIK™ or with Armolipid Plus®.

The purpose of this study is to assess the safety, tolerability, and efficacy of ALN-PCSSC in participants with homozygous familial hypercholesterolemia.

The main purpose of this study is to evaluate the effect on mental state (known as "neurocognitive function") with use of Praluent.

To investigate the effect of a supplement capsule containing LRC™ (L. reuteri NCIMB 30242), taken twice daily with lunch and dinner (NLT 2.5E9 CFU per dose), versus placebo capsule on serum low density lipoprotein (LDL)-cholesterol in otherwise healthy hypercholesterolemic adults after 9 weeks of product consumption.

The study will assess the safety and tolerability of Ezetimibe 10 mg+ Rosuvastatin 2.5 mg and Ezetimibe 10 mg+ Rosuvastatin 5.0 mg for up to 52 weeks in Japanese participants with hypercholesterolemia uncontrolled with monotherapy of Ezetimibe 10 mg or Rosuvastatin up to 5 mg.

The aim of the study is to demonstrate, whether the time of day of administration of the study drug (containing rosuvastatin and ezetimibe) has an impact on the effectiveness of lipid-lowering therapy.

The purpose of this study is to evaluate the effect of gemcabene on LDL-C and other lipid parameters in hypercholesterolemic patients on a stable dose of a statin.

This study will evaluate the efficacy and safety of MK-0653C (Ezetimibe [EZ] 10 mg/Atorvastatin [Atora] 10mg or 20 mg) compared to EZ 10 mg, Atora 10 mg, or Atora 20 mg alone when administered to Japanese participants with hypercholesterolemia. The primary hypothesis is that MK-0653C (EZ 10 mg/Atorva 10 mg) is superior to EZ 10 mg and is superior to Atorva 10 mg and that MK-0653C (EZ 10 mg/Atorva 20 mg) is superior to EZ 10 mg and is superior to Atorva 20 mg in percent change from baseline in low-density lipoprotein cholesterol (LDL-C) after 12 weeks of treatment.

Primary Objective: To evaluate the efficacy of alirocumab (75 or 150 milligrams [mg] depending on body weight [BW]), administered every 2 weeks (Q2W), on low-density lipoprotein cholesterol (LDL-C) levels at Week 12 of treatment in children and adolescents with homozygous familial hypercholesterolemia (hoFH) of 8 to 17 years of age on top of background treatments. Secondary Objectives: To evaluate the efficacy of alirocumab after 24 and 48 weeks of treatment on LDL-C levels. To evaluate the effects of alirocumab on other lipid parameters (eg, apolipoprotein B [Apo B], non-high density lipoprotein cholesterol [non-HDL-C], total cholesterol [Total-C], high density lipoprotein cholesterol [HDL-C], lipoprotein a [Lp (a)], triglycerides [TG], apolipoprotein A-1 [Apo A-1] levels) after 12, 24, and 48 weeks of treatment. To evaluate the safety and tolerability of alirocumab up to 48 weeks of treatment.