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Hypertriglyceridemia clinical trials

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NCT ID: NCT00435045 Completed - Clinical trials for Hypertriglyceridemia

Evaluation of Efficacy and Safety of Omacor, Co-Administered With Atorvastatin, in Subjects With Hypertriglyceridemia

Start date: February 2007
Phase: Phase 3
Study type: Interventional

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-HDL-C) in hypertriglyceridemic subjects.

NCT ID: NCT00422396 Completed - Clinical trials for Hypertriglyceridemia With the Metabolic Syndrome

Effects of Micronized Fenofibrate on Fasting and Postprandial Lipoproteins, Inflammatory Mediators and Thrombosis

Start date: January 2001
Phase: N/A
Study type: Interventional

This is a randomized placebo controlled clinical trial designed to investigate the effects of micronized fenofibrate on fasting and postprandial lipoproteins, oxidized fatty acids and lipoproteins, inflammatory mediators and thrombotic factors among hypertriglyceridemic individuals with two or more other characteristics of the metabolic syndrome.

NCT ID: NCT00397358 Withdrawn - Clinical trials for Hypertriglyceridemia

Effect of Extraneal (Icodextrin)on Triglyceride Levels in PD Patients

Start date: November 2006
Phase: Phase 4
Study type: Interventional

This is a Phase IV study evaluating triglyceride levels in peritoneal dialysis patients.

NCT ID: NCT00360217 Completed - Clinical trials for Coronary Artery Disease

The Triglyceride Lowering Effect of an Omega-3 Fat (DHA) in Addition to Statin Therapy for Patients With CAD or Diabetes

Start date: January 2006
Phase: N/A
Study type: Interventional

This study will explore the ability of an algae (ocean plant) omega-3 fat supplement (DHA) to reduce triglyceride levels in patients currently being treated with statin therapy (Zocor or simvastatin, Lipitor or atorvastatin, Pravachol or pravastatin, Crestor or rosuvastatin, etc.) for coronary artery disease(CAD)or risk equivalents (any of the following: heart attack, post angioplasty or stent, post coronary bypass surgery, angina, vascular disease, stroke or diabetes). The rationale for the study is based around the finding that patients with CAD have an approximately 20 % reduction in the risk of sudden death when treated with fish oil (DHA is one of the ingredients in fish oil). In studies of statin-based therapies, it has been observed that statins reduce the risk of coronary events 20-45%. There has not yet been research trials exploring the combination of the two ingredients (i.e., DHA plus statin) in patient treatment either to reduce recurrent cardiac events or to address another reported finding of fish oils to lower triglyceride levels (triglyceride is a form of "blood fat"). This research project will be a pilot project to assess the safety and effectiveness of DHA "add-on" therapy in patients currently being treated with statins for CAD. The study hypothesis is to test the effectiveness of DHA as compared to placebo to lower triglyceride levels in the blood. This is a double-blinded randomized clinical trial.

NCT ID: NCT00346697 Completed - HIV Infections Clinical Trials

Omega-3 Fatty Acids for High Triglycerides in HIV-infected Patients

Start date: October 2006
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of omega-3-fatty acids in HIV-infected patients with hypertriglyceridemia. In addition, we, the researchers, will evaluate the effect of omega-3 fatty acid administration of markers of bone turnover and inflammation.

NCT ID: NCT00329862 Terminated - Hypertension Clinical Trials

Laparoscopic Adjustable Gastric Banding With Truncal Vagotomy

Start date: May 2006
Phase: N/A
Study type: Interventional

Laparoscopic Adjustable Gastric Banding (LAGB) is a gold standard in the surgical treatment of morbid obesity. We hypothesize that the addition of truncal vagotomy (cutting of nerves to the stomach) will produce greater weight loss and better reduction of co-morbidities (diseases caused by or aggravated by morbid obesity) than LAGB alone. 25 patients will be enrolled and outcomes compared to LAGB historical controls over a post-operative period of 24 months.

NCT ID: NCT00286234 Completed - Metabolic Syndrome Clinical Trials

Niacin, N-3 Fatty Acids and Insulin Resistance

Start date: October 2007
Phase: Phase 4
Study type: Interventional

This research study is being conducted to test the effects of two drugs on blood lipids (cholesterol and triglycerides) and blood sugar (glucose) levels in patients with diabetes or "pre-diabetes" (both of which have a condition called "insulin-resistance"). These products are Niaspan (extended release nicotinic acid) and Omacor (omega-3 acid ethyl esters). We hypothesize that the combination of Niaspan and Omacor will reduce serum triglyceride levels, increase HDL-cholesterol levels and do so without altering glucose levels.

NCT ID: NCT00278928 Terminated - Clinical trials for Hypertriglyceridemia

Fat Tolerance From Lipid Emulsion Infusion Packaged in Glass or Plastic

Start date: January 2006
Phase: N/A
Study type: Interventional

This will be a prospective, randomized trial to determine if differences exist in the tolerance of lipid injectable emulsions in the neonatal intensive care unit (NICU). Lipid injectable emulsions are an essential nutrient for neonatal growth and development. Traditionally, lipid injectable emulsions have been commercially available in sterile glass bottles, but in April of 2004, a new container was introduced as a sterile plastic bag. In January, 2005, NICU personnel observed what appeared to be a higher than usual incidence of hypertriglyceridemia. Upon further laboratory investigation of the lipid injectable emulsions stored in glass bottles versus those in plastic, significant differences were noted in the population of large-diameter fat globules by globule size analysis, reflective of a less stable emulsion in plastic. The United States Pharmacopeia (USP) which sets the standards for drug purity and safety in the U.S., and whose drug monographs are enforceable by the FDA, has proposed to limit this large diameter fat globule population to a volume-weighted percent fat greater than five micrometers or PFAT5 to be less than 0.05% of the total lipid concentration. (At the present time, the USP monograph is not officially recognized, but is on track for adoption in 2006.) Our preliminary analyses of four lots of 20% lipid injectable emulsion packaged in glass to have a PFAT5 of 0.003±0.0008%, compared to an approximate 55-fold increase in the large-diameter fat globule population or 0.166±0.016% for an equal number of products packaged in plastic. We hypothesize this difference may explain the recent clinical observations. We will compare the incidence of hypertriglyceridemia in neonates between lipids packaged in glass versus those in plastic. The study will attempt to discern whether the differences in packaging influence the stability and subsequent tolerance of lipid injectable emulsions.

NCT ID: NCT00246701 Completed - Clinical trials for Hypertriglyceridemia

Evaluation of Efficacy and Safety of Combined Omacor (Omega-3-acid Ethyl Esters) and Simvastatin Therapy in Hypertriglyceridemic Subjects

COMBOS
Start date: November 1, 2005
Phase: Phase 3
Study type: Interventional

The purpose of OM6 is to evaluate efficacy and safety of Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] combined with simvastatin for lowering non-high-density lipoprotein cholesterol (non-HDL-C) in subjects with persistent high triglycerides despite statin therapy. Additionally, a two-year extension trial (LOV111818/OM6X) is posted on NCT00903409.

NCT ID: NCT00246636 Completed - Clinical trials for Hypertriglyceridemia

Evaluation of Efficacy and Safety of Omacor (Omega-3-acid Ethyl Esters) as Add-on Therapy in Hypertriglyceridemic Subjects Treated With Antara (Fenofibrate) Followed by an 8-week Extension

Start date: October 2005
Phase: Phase 4
Study type: Interventional

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 very high triglycerides. The purpose of both OM5X/LOV111860 was to assess the continued efficacy and safety of adjunctive Lovaza (omega-3-acid ethyl esters) therapy in hypertriglyceridemic subjects treated with fenofibrate in lowering serum triglyceride (TG) levels.