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

Sponsors and Collaborators:	GlaxoSmithKline Reliant Pharmaceuticals
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00435045

Purpose

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.

Condition	Intervention	Phase
Hypertriglyceridemia	Drug: Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] plus atorvastatin Drug: atorvastatin	Phase III

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Triglycerides

Drug Information available for: Atorvastatin Atorvastatin calcium Omacor Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Forced Titration Study to Assess the Efficacy and Safety of Omacor, Co-Administered With Open-Label Atorvastatin Therapy, in Hypertriglyceridemic Subjects

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Change in non-high-density lipoprotein cholesterol (non-HDL-C)

Secondary Outcome Measures:

Changes in other lipid and biomarker levels

Enrollment:	245
Study Start Date:	February 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Detailed 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 Omacor 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 Omacor 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 Omacor or matching placebo corn oil doses remaining at 4 capsules per day)

Eligibility

Ages Eligible for Study:	18 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men and women, ages 18-79 years, inclusive
Fasting, untreated non-high-density lipoprotein cholesterol (non-HDL-C) level above NCEP ATPIII goals
Fasting, untreated triglyceride (TG) level in the high to very high range
Provide written informed consent and authorization for protected health information disclosure

Exclusion Criteria:

Pregnancy
Use of lipid-altering drugs which cannot be stopped
History of certain cardiovascular conditions or cardiac surgery within prior 6 months
Body mass index above 40 kg per square meter
Allergy or sensitivity to omega-3 fatty acids or to statin drugs
Poorly-controlled conditions including diabetes, hypertension, or thyroid disease
Certain muscle, liver, kidney, lung, or gastrointestinal conditions
Certain medications
Active cancers treated within prior 2 years (except non-melanoma skin cancer)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00435045

Show 37 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Reliant Pharmaceuticals

Investigators

Study Director:

Study Director

Reliant Pharmaceuticals

More Information

Responsible Party:	GlaxoSmithKline ( Study Director )
Study ID Numbers:	OM9L, LOV111819
Study First Received:	February 13, 2007
Last Updated:	May 21, 2008
ClinicalTrials.gov Identifier:	NCT00435045
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Hypertriglyceridemia
Triglycerides
Hyperlipidemias
Dyslipidemias
Lipids

Hypercholesterolemia
Omacor
omega-3-acid ethyl esters
omega-3 fatty acids
Lovaza

Study placed in the following topic categories:

Metabolic Diseases
Hypertriglyceridemia
Hyperlipidemias
Metabolic disorder

Hypercholesterolemia
Atorvastatin
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009