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Hypercholesterolaemia clinical trials

View clinical trials related to Hypercholesterolaemia.

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NCT ID: NCT02585778 Completed - Clinical trials for Hypercholesterolaemia

Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM - Insulin)

Start date: October 23, 2015
Phase: Phase 3
Study type: Interventional

Primary Objectives: - To demonstrate the superiority of alirocumab in comparison with placebo in the reduction of calculated low-density lipoprotein cholesterol (LDL-C) in participants with diabetes treated with insulin and with hypercholesterolemia at high cardiovascular risk not adequately controlled on maximally tolerated LDL-C lowering therapy. - To evaluate the safety and tolerability of alirocumab in participants with diabetes treated with insulin. Secondary Objective: To demonstrate that alirocumab was superior in comparison to placebo in its effects on other lipid parameters (i.e., measured LDL-C, non-high-density lipoprotein cholesterol [non-HDL-C], apolipoprotein B [Apo B], total cholesterol [TC], lipoprotein a [Lp(a)], high density lipoprotein cholesterol [HDL-C], triglyceride [TG] levels, triglyceride rich lipoproteins [TGRL], apolipoprotein A-1 [Apo A-1], apolipoprotein C-III [Apo C-III], and LDL particle number and size).

NCT ID: NCT02065180 Completed - Clinical trials for Hypercholesterolaemia

The Effect of a Red Rice and Olive Extract Nutrition Supplement on Cholesterol Levels in Patients With Metabolic Syndrome

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

This randomised controlled trial studies the effect of a commercially available nutritional supplement on cholesterol levels in people with metabolic syndrome and elevated cholesterol levels.

NCT ID: NCT01935674 Completed - HIV Clinical Trials

Treatment With Rosuvastatin Versus Switching PI (Protease Inhibitor) in Patients HIV With High Cholesterol Levels

SOS
Start date: September 2013
Phase: Phase 4
Study type: Interventional

To compare the effect of rosuvastatin to protease inhibitor switching on fasting total cholesterol over 12 weeks.

NCT ID: NCT01779687 Completed - HIV Clinical Trials

Pharmacokinetic Drug Interaction Study Between Raltegravir and Atorvastatin.

AVIATOR
Start date: March 2013
Phase: Phase 1
Study type: Interventional

Dyslipidemia is highly prevalent among patients with HIV infection and contributes to the increased cardiovascular disease risk in this patient population. Atorvastatin lowers plasma low-density lipoprotein (LDL) cholesterol levels and is used for prevention of artherosclerotic disease. Raltegravir, an HIV integrase inhibitor, could be one of the preferred antiretroviral agents in HIV patients with dyslipidemia because it has a beneficial lipid profile. Theoretically, no clinically relevant drug interaction is expected between atorvastatin and raltegravir. However, atorvastatin and raltegravir share similar metabolic pathways which could be relevant in the occurrence of pharmacokinetic interactions. In order to be able to recommend raltegravir and atorvastatin concomitant use, a pharmacokinetic study in healthy volunteers is proposed.

NCT ID: NCT01711749 Completed - Clinical trials for Hypercholesterolaemia

Rosuvastatin Calcium Bioequivalence Study - Fast

Start date: February 25, 2013
Phase: Phase 1
Study type: Interventional

This is an open-label, randomized, two treatment, two sequences, two periods crossover study, using a crossover 2x2 design, where each subject will be randomly assigned to reference or test formulation, in order to evaluate if both formulations are bioequivalent.

NCT ID: NCT01617655 Completed - Clinical trials for Hypercholesterolaemia

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH)

Start date: June 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 effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo. Secondary Objectives: - 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 - To evaluate the safety and tolerability of alirocumab

NCT ID: NCT01597700 Completed - Clinical trials for Hypercholesterolaemia

Acotral® Versus Zetia® Ezetimibe Bioequivalance Study.

Start date: January 13, 2012
Phase: Phase 1
Study type: Interventional

Bioequivalence study comparing test Acotral® ezetimibe 10 mg tablet manufactured by Laboratorios Phoenix, with a reference comparator Zetia® ezetimibe 10 mg tablet of Merck/Schering-Plough Pharmaceuticals. The CRO Clinigene Bangalore, will conduct the study. Fifty two healthy adult subjects who have satisfied the inclusion and exclusion criteria and given their informed consent will be entered into the study. They will be fasted and receive one tablet by mouth in accordance with a randomisation list and blood samples will be taken at specified intervals over the ensuing 3 days. Between 14 and 21 days later, subjects will receive the opposite tablet and the clinical process repeated. Subjects will be continuously monitored while in the trial clinic and at ambulatory visits with regular measurements of vital signs and questioned for adverse events. Drug concentrations will be analysed and these results compared to ascertain bioequivalence by applying statistical methods to the pharmacokinetic data; this information and all safety data will be formally reported.

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.

NCT ID: NCT01354340 Completed - Clinical trials for Hypercholesterolaemia

Dose Effect of Limicol on (LDL)-Cholesterol Levels

Start date: April 2011
Phase: N/A
Study type: Interventional

The principal objective of this study is to investigate the dose-effect of the Limicol food supplement on LDL-cholesterol level in moderate hypercholesterolaemia subjects.

NCT ID: NCT01352897 Completed - Clinical trials for Hypercholesterolaemia

Registry On Efficacy and Safety Of Rosuvastatin, and Atorvastatin and Simvastatin In Hypercholesterolaemia

Start date: August 2010
Phase: N/A
Study type: Observational

The objective of this follow-up retrospective study is to evaluate the long term efficacy and safety of rosuvastatin in reducing lipid parameters in clinical practice.