A RANDOMIZED MULTICENTRE PHASE II STUDY TESTING TOLERABILITY AND EFFICACY ON SURROGATE ENDPOINTS (LIPID PROFILE, VASCULAR INFLAMMATORY MARKERS AND THROMBOGENESIS) OF SIMVAPUFA FORMULATION (ASSOCIATION OF SIMVASTATIN AND OMEGA-3 FATTY ACIDS) IN COMPARISON WITH THE ADMINISTRATION OF THE TWO SEPARATE COMPOUNDS, IN PATIENTS WITH ACUTE CORONARY SYNDROME AND POSITIVE BIOCHEMICAL MARKERS OF MYOCARDIAL NECROSIS. - Simva Pufa
An Evaluation of Simvastatin 20 mg Plus Omacor 4 g Compared to Simvastatin 20 mg Plus Placebo in Subjects With Mixed Dyslipidemia
The primary objective of this study is to compare the effect of simvastatin plus Omacor to simvastatin plus placebo for lowering non-high density lipoprotein cholesterol in subjects with mixed dyslipidemia.
OM6X: An Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Combined Lovaza (Previously Omacor®) and Simvastatin Therapy in Hypertriglyceridemic Subjects
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 simvastatin 40 mg/day or placebo co-administered with simvastatin 40 mg/day for 8 weeks. This extension trial, LOV111818/OM6X assessed the continued efficacy and safety of Lovaza® (omega-3-ethyl esters) co-administered with simvastatin 40 mg vs. switching from simvastatin plus placebo to simvastatin plus Lovaza® for lowering non-High Density Lipoprotein-Cholesterol (non-HDL-C) levels at 4 months (primary endpoint) and additionally at 12 and 24 months.
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