A Second Open-Label Extension of a Double-Blind, Parallel, Phase IV Study to Assess the Efficacy...
HypertriglyceridemiaThis was a 24-month, open-label extension study that followed an 8-week double-blind study (Study LOV111859/OM5) and an 8-week, open-label extension study (LOV111860/OM5X). Study LOV111859/OM5 was conducted to evaluate whether combination therapy with Lovaza (omega-3-acid ethyl esters) and Antara (fenofibrate) would result in a greater reduction in serum triglyceride levels in hypertriglyceridemic subjects than treatment with fenofibrate alone. This second extension of 24 months was to assess the continued efficacy of adjunctive Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] therapy in hypertriglyceridemic subjects treated with Antara (fenofibrate) in lowering serum triglyceride (TG) levels.
Interaction of Epanova on Warfarin Pharmacokinetic and Anticoagulant Activity and Comparison of...
HypertriglyceridemiaThe primary objective of this study is to determine the effect of Epanova® on the pharmacokinetic and anticoagulant activity of warfarin. The secondary objective of this study is to compare the systemic exposure of EPA and DHA following multiple-dose administration of Epanova®, a free fatty acid mixture, to Lovaza®, a mixture of fatty acid ethyl esters, under low-fat meal conditions since these products are likely to be administered to patients with cardiovascular disease who are recommended to consume low-fat meals.
A Study to Evaluate an Investigational Drug in Patients With Mixed Hyperlipidemia (0653A-071)(COMPLETED)...
HyperlipidemiaHypercholesterolemia1 moreThe purpose of this study is to assess the cholesterol lowering effects of an investigational drug in patients with mixed hyperlipidemia (high cholesterol and high triglycerides).
Niacin for Treatment of Elevated Cholesterol and Triglycerides in HIV-Infected Patients
HIV InfectionsHypercholesterolemia2 moreThe purpose of this study is to evaluate the safety, efficacy, and tolerability of extended-release niacin (Niaspan) in improving the level of fats in the blood of HIV-infected patients.
Study of Gemcabene in Adults With FPLD
Familial Partial LipodystrophyHypertriglyceridemia2 moreThe overall objective of this study is to assess the efficacy and safety of two dosing regimens of gemcabene (300 mg once daily for 24 weeks or 300 mg daily for 12 weeks followed by 600 mg daily for 12 weeks) in up to eight patients with Familial Partial Lipodystrophy with high triglycerides and Non-Alcoholic Fatty Liver Disease. The study will consist of a six week Wash Out Period, up to a 28 day Screening Period, a 24 week Treatment Period, and a follow-on safety assessment four weeks post final dose. Study participation will last approximately 4 months and includes at least 9 study visits, and can be as many as 11 study visits.
Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride...
Severe HypertriglyceridemiaThe purpose of this study is to evaluate the efficacy and safety of K-877 in adult patients With Fasting High Triglyceride Levels ≥500 mg/dL and <2000 mg/dL and Mild or Moderate Renal Impairment.
Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride...
Severe HypertriglyceridemiaThe purpose of this study is to evaluate the efficacy and safety of K-877 in adult patients with fasting high triglyceride levels ≥500 mg/dL and <2000 mg/dL and normal renal function.
Translation of Pritikin Program to the Community
Metabolic SyndromeObesity4 moreThe broad, long-term aims of this scope of work are to investigate the effects of the Pritikin Program to the general population. The study will test the effects on individuals from the community with dysfunctional lipids, blood pressure and glycemic control. To assess the effectiveness of the Pritikin Program in the community, the effects of Pritikin lifestyle intervention on overall health will be investigated.
Study of ARO-ANG3 in Healthy Volunteers and in Dyslipidemic Patients
DyslipidemiasFamilial Hypercholesterolemia1 moreThe purpose of this study is to evaluate the safety, tolerability, pharmacokinetcs and pharmacodynamics of single- and multiple doses of ARO-ANG3 in healthy adult volunteers and in dyslipidemic patients including familial hypercholesterolemia and severe hypertriglyceridemia.
Long-term Safety and Efficacy Study of MND-2119 in Patients With Hypertriglyceridemia
HypertriglyceridemiaThe purpose of this study is to evaluate the safety and efficacy of MND-2119 at a dose of 2g/day or 4g/day for 52 weeks in patients with hypertriglyceridemia.