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

2014-08-27 03:40:10 | BioPortfolio

Summary

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.

Description

Randomized, double-blind, placebo-controlled, parallel-group study design with eleven clinic visits (one screening visit, three lead-in/baseline visits, and seven treatment visits) After a 4-week diet only lead-in period, subjects with a triglyceride (TG) level in the high to very high range and with non-HDL-C level above NCEP ATPIII goals will be randomized to receive either open-label atorvastatin 10 mg per day plus double-blinded Lovaza 4g (4 x 1g capsules) per day OR open-label atorvastatin 10 mg per day plus a double-blinded matching placebo (4 corn oil capsules per day) for 8 weeks After the initial 8-week treatment period, the dose of open-label atorvastatin will be titrated to 20 mg per day (with the Lovaza or matching placebo corn oil doses remaining at 4 capsules per day) for an additional 4 weeks At Week 12, a second open-label titration to 40 mg of open-label atorvastatin per day will be maintained for an additional 4 weeks (again with the Lovaza or matching placebo corn oil doses remaining at 4 capsules per day)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Hypertriglyceridemia

Intervention

atorvastatin, Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] plus atorvastatin

Status

Completed

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:40:10-0400

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Medical and Biotech [MESH] Definitions

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/).

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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.

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