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

NCT00435045 | Completed Phase 3 Results

• 1 other identifier: OM9L
• Study Type: interventional
• Target: 245
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hypertriglyceridemia

Keywords

Lovaza; Hyperlipidemias; Triglycerides; Lipids; omega-3 fatty acids; Hypercholesterolemia; Hypertriglyceridemia; omega-3-acid ethyl esters; Omacor; Dyslipidemias

Outcome Measures

Primary Outcomes (1)

• Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period

  Non-high density lipoprotein cholesterol is the Total Cholesterol minus the HDL(high density lipoproteins or the sum of the LDL, VLDL and IDL. That is, Low Density Lipoproteins, Very Low Density Lipoproteins and Intermediate Density Lipoproteins.

  Baseline and Week 8

Secondary Outcomes (23)

• Percent Change in Total Cholesterol (TC) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period

  Baseline and Week 8

• Percent Change in High Density Lipoprotein (HDL)Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period

  Baseline and Week 8

• Percent Change in Low Density Lipoprotein (LDL) Cholesterol (Beta-quantification) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period

  Baseline and Week 8

• Percent Change in Triglycerides From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period

  Baseline and Week 8

• Percent Change in Very Low Density Lipoproteins (VLDL) Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period

  Baseline and Week 8

Study Arms (2)

atorvastatin arm

ACTIVE COMPARATOR

atorvastatin + placebo

Drug: atorvastatin

Lovaza arm

EXPERIMENTAL

Lovaza + atorvastatin

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

Interventions

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

Lovaza + atorvastatin

Lovaza arm

atorvastatin DRUG

atorvastatin + placebo

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

atorvastatin arm

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Publications (2)

• Bays HE, McKenney J, Maki KC, Doyle RT, Carter RN, Stein E. Effects of prescription omega-3-acid ethyl esters on non--high-density lipoprotein cholesterol when coadministered with escalating doses of atorvastatin. Mayo Clin Proc. 2010 Feb;85(2):122-8. doi: 10.4065/mcp.2009.0397.

  PMID: 20118387 BACKGROUND

• Maki KC, Bays HE, Dicklin MR, Johnson SL, Shabbout M. Effects of prescription omega-3-acid ethyl esters, coadministered with atorvastatin, on circulating levels of lipoprotein particles, apolipoprotein CIII, and lipoprotein-associated phospholipase A2 mass in men and women with mixed dyslipidemia. J Clin Lipidol. 2011 Nov-Dec;5(6):483-92. doi: 10.1016/j.jacl.2011.09.001. Epub 2011 Sep 13.

  PMID: 22108152 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Hypertriglyceridemia; Hyperlipidemias; Hypercholesterolemia; Dyslipidemias

Interventions

Omacor; Atorvastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2007
• First Posted: February 14, 2007
• Study Start: February 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: February 2, 2017
• Results First Posted: May 12, 2009

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share