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Hyperlipoproteinemia Type II clinical trials

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NCT ID: NCT02048410 Completed - Dyslipidemia Clinical Trials

Efficacy of a New Symbiotic Formulation in Children With Familial Hypercholesterolemia

Start date: January 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Probiotics have been proposed for the treatment of dyslipidemia. the investigators aimed to evaluate efficacy, tolerability and safety of a new symbiotic formulation containing a combination of probiotic and prebiotics and amine in the treatment of children affected by familial hypercholesterolemia (FH).

NCT ID: NCT01995149 Completed - Obesity Clinical Trials

Effect of Weight Loss on Cholesterol Metabolism in Hereditary Hypercholesterolemias and Overweight or Obesity.

Start date: June 2010
Phase: N/A
Study type: Interventional

Background: Lipid lowering response to weight loss in subjects with genetic hyperlipidemias and overweight or obesity and its effect on cholesterol metabolism has not been studied. Objective: To explore the effects of weight loss on lipid values and cholesterol metabolism, by measuring circulating non-cholesterol sterols, in overweight or obese subjects with genetic hypercholesterolemias. Design: The investigators conducted a 6-months weight loss intervention in subjects with the diagnosis of familial hypercholesterolemia (FH) or familial combined hyperlipidemia (FCHL), body mass index >25 kg/m2, steady weight (±3 kg in the last 3 months) and absence of lipid lowering drugs in the previous 5 weeks. They were advised to follow a hypocaloric diet with a deficit of 600 kcal (30% fat, 15% protein, and 55% carbohydrates) per day as calculated from the person's resting energy expenditure and activity level. Anthropometric data, biochemical analysis including lipids, apolipoproteins and non-cholesterol sterols were evaluated at baseline, 3 months and 6 months.

NCT ID: NCT01968980 Completed - Clinical trials for Heterozygous Familial Hypercholesterolemia

A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia

SPIRE-FH
Start date: October 2013
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized study in subjects with heterozygous familial hypercholesterolemia receiving highly effective statins to assess the safety, efficacy and tolerability of Bococizumab (PF-04950615; RN316) to lower LDL-C.

NCT ID: NCT01878604 Completed - Clinical trials for Homozygous Familial Hypercholesterolemia

Gene Analysis and Treatment Optimization in Chinese Homozygous Familial Hypercholesterolemia

Start date: October 2001
Phase: N/A
Study type: Observational

Identify new or novel genes which may impact on cholesterol level, and establish the relationship between those gene mutations with atherosclerosis, as well as responses to lipid-lowering drugs.

NCT ID: NCT01824238 Completed - Clinical trials for Heterozygous Familial Hypercholesterolemia (HeFH)

A Study of the Safety and Efficacy of Anacetrapib (MK-0859) When Added to Ongoing Statin Therapy in Japanese Participants With Heterozygous Familial Hypercholesterolemia (MK-0859-050)

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

This study will evaluate the effects of anacetrapib (MK-0859) on low-density lipoprotein-cholesterol (LDL-C) when compared to placebo in Japanese participants with heterozygous familial hypercholesterolemia when added to an existing statin lipid-modifying therapy.

NCT ID: NCT01813006 Completed - Clinical trials for Familial Hypercholesterolemia

Effect of Omega-3 Fatty Acid on Endothelial Function

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

Background Familial hypercholesterolemia (FH) is an inherited disease in which the level of bad cholesterol (LDL-cholesterol) is increased, leading to an increase in coronary heart disease even if adequately treated with cholesterol lowering medication (statins). Polyunsaturated fatty acids (PUFA) including omega-3 is known to affect the risk for coronary disease, however its effect on patients with FH is not known. The purpose of the study is to assess the effect of PUFA on patients with FH, with regard to inflammation measured in the blood and the effect on the blood vessels`ability to relax (endothelial function) by means of tonometry. Hypothesis Treatment with 4 grams of PUFA a day for 4 months will lead to an improvement in the endothelial function, and the treatment will also lead to a decrease in in several markers of inflammation and in lipids in the blood.

NCT ID: NCT01763918 Completed - Hyperlipidemia Clinical Trials

Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2

RUTHERFORD-2
Start date: February 7, 2013
Phase: Phase 3
Study type: Interventional

The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneously once every 2 weeks (Q2W) and once monthly (QM), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial hypercholesterolemia (HeFH).

NCT ID: NCT01753232 Completed - Clinical trials for Hypercholesterolemia, Familial

Safety and Efficacy of the DALI LDL-adsorber and MONET Lipoprotein Filter

LINET
Start date: May 2012
Phase: N/A
Study type: Observational

Low Density Lipoprotein (LDL)-apheresis refers to a procedure in which blood taken from a patient's vein is cleaned from pathogenic substances, e.g. cholesterol, outside the body and then given back to the patient. In the DALI (Direct Adsorption of Lipoproteins)-system whole blood is pumped over an adsorber containing beads that selectively bind LDL-cholesterol. The MONET (Membrane filtration Optimized Novel Extracorporeal Treatment)-system works with plasma which is cleaned by filtration. This study comprises the recording of safety and efficacy data from patients treated either with the DALI or MONET-system over a period of 2 years.

NCT ID: NCT01709500 Completed - Clinical trials for Heterozygous Familial Hypercholesterolemia

Study of Alirocumab (REGN727/SAR236553) in Patients With heFH (Heterozygous Familial Hypercholesterolemia) Who Are Not Adequately Controlled With Their LMT (Lipid-Modifying Therapy)

ODYSSEY FH II
Start date: December 2012
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, parallel-group, multi-national study alirocumab (REGN727/SAR236553) in patients with Heterozygous Familial Hypercholesterolemia (heFH) who are not adequately controlled with their Lipid-Modifying Therapy (LMT).

NCT ID: NCT01624142 Completed - Clinical trials for Severe Familial Hypercholesterolemia

Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects With Genetic LDL Disorders

TAUSSIG
Start date: June 1, 2012
Phase: Phase 2/Phase 3
Study type: Interventional

A study to assess the long term safety and tolerability of evolocumab (AMG 145) in adolescents and adults with severe familial hypercholesterolemia.