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The objectives of this study are to assess the effects of 4 g/d prescription omega-3 acid ethyl esters (POM3), compared with a placebo, on indices of insulin sensitivity and secretion, as well as aspects of the fasting and postprandial lipid and lipoprotein profiles, in subjects with hypertriglyceridemia.
This trial will utilize a randomized, double-blind, two-period crossover design. At Visit 2 (Week 0), subjects meeting all entry criteria will be randomized to one of two treatment sequences: placebo or prescription omega-3 acid ethyl esters for the first 6 week phase followed by the study product they did not receive during the first phase (prescription omega-3 acid ethyl esters or placebo) for the second 6 weeks.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
prescription omega-3 acid ethyl esters, Placebo
Provident Clinical Research
Not yet recruiting
Provident Clinical Research
Published on BioPortfolio: 2014-08-27T03:17:12-0400
The trial was a double-blind, randomized, parallel-group study comparing Omega-3-Acid Ethyl Esters 90 Soft Capsules and placebo. The primary objective of the present study was to evaluate ...
The purpose of this study is to explore the effects of 8-week treatment with omega-3-acid ethyl esters on the lipid and lipoprotein profile in the blood in hyperlipidemic patients receivin...
The purpose of this study is to evaluate the efficacy and safety of Omacor (omega-3-acid ethyl esters) combined with atorvastatin for lowering non-high-density lipoprotein cholesterol (non...
The purpose of OM5/LOV111859 was to evaluate efficacy and safety of Omacor (omega-3-acid ethyl esters) as add-on therapy to Antara (fenofibrate) and diet for the treatment of patients with...
In a previous trial (LOV111858/OM6), subjects received in a double-blind fashion either 4 g/day of Lovaza® (omega-3-ethyl esters) [formerly known as Omacor] co-administered with simvastat...
Adult patients with severe hypertriglyceridemia (SHTG) are at increased risk of developing acute pancreatitis and cardiovascular disease. Omega-3 carboxylic acids (OM3-CA) are approved for treatment a...
The lack of systematic studies on the stability of ethanol's non-oxidative metabolites in postmortem specimens restricts their use in forensic cases. This study aimed to compare the stability of ethyl...
Efficacy and Safety of Adding Omega-3 Fatty Acids in Statin-Treated Patients with Residual Hypertriglyceridemia: ROMANTIC (Rosuvastatin-OMAcor iN residual hyperTrIglyCeridemia), a Randomized, Double-blind, and Placebo-controlled Trial.
The purpose of this study was to examine the efficacy and safety of adding ω-3 fatty acids to rosuvastatin in patients with residual hypertriglyceridemia despite statin treatment.
Animal models support dietary omega-3 fatty acids protection against abdominal aortic aneurysm (AAA), but clinical data are scarce. The sum of red blood cell proportions of the omega-3 eicosapentaenoi...
There is emerging evidence that Omega-3 polyunsaturated fatty acids (PUFA) supplements can decrease aggression. However, experimental studies with adults from non-specific populations are scarce. We h...
Salts or esters of carbamic acid, H2NC(=O)OH, or of N-substituted carbamic acids: R2NC(=O)OR', (R' = hydrocarbyl or a cation). The esters are often called URETHANE or urethan, a usage that is strictly correct only for the ethyl esters. (From IUPAC [Internet]. International Union Of Pure And Applied Chemistry; c1995 [updated 2004 Jan 9; cited 2004 May 3]. Available from http://www.chem.qmul.ac.uk/iupac/class/oneN.html#35/).
Methyl, propyl, butyl, and ethyl esters of p-hydroxybenzoic acid. They have been approved by the FDA as antimicrobial agents for foods and pharmaceuticals. (From Hawley's Condensed Chemical Dictionary, 11th ed, p872)
FATTY ACIDS which have the first unsaturated bond in the sixth position from the omega carbon. A typical American diet tends to contain substantially more omega-6 than OMEGA-3 FATTY ACIDS.
Salts or esters of acetic acid in which the terminal hydrogen atom is replaced by a metal, for instance copper acetate Cu(CH3COO)2, or where substitution is by a radical, for instance ethyl acetate CH3COOC2H5. (From Hawley's Condensed Chemical Dictionary, 12th ed)
Phosphoric acid esters of inositol. They include mono- and polyphosphoric acid esters, with the exception of inositol hexaphosphate which is PHYTIC ACID.
Hyperlipidemia - high cholesterol (hypercholesterolaemia)
Hyperlipidemia involves abnormally elevated levels of any or all lipids and/or lipoproteins in the blood. Lipids are transported in a protein capsule, the size of that capsule, or lipoprotein, determines its density. The lipoprotein density and type...
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase 'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...