NCT00487591

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2006

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

May 7, 2008

Status Verified

April 1, 2008

Enrollment Period

9 months

First QC Date

June 14, 2007

Last Update Submit

April 28, 2008

Conditions

Mixed Dyslipidemia

Keywords

cholesteroldyslipidemiaomega 3

Outcome Measures

Primary Outcomes (1)

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

    Baseline to end of treatment

Secondary Outcomes (1)

  • Changes in other lipid and biomarker levels

    Baseline through end of treatment

Study Arms (2)

Simva+Omacor

Drug: Omacor (omega-3-acid ethyl esters)plus simvastatin

Simva + Placebo

Drug: simvastatin plus placebo

Interventions

Omacor (omega-3-acid ethyl esters)plus simvastatinDRUG

Omacor(omega-3-acid ethyl esters) - 4/g day (4 one gram capsules) simvastatin - 20 mg/day (1 tablet/20 mg)

Also known as: Lovaza
Simva+Omacor
simvastatin plus placeboDRUG

simvastatin 20mg/day (1 tablet 20 mg)plus 4 capsules matching placebo

Simva + Placebo

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnancy
  • Use of lipid-altering drugs which cannot be stopped
  • History of certain cardiovascular conditions or cardiac surgery within the 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Maki KC; McKenney JM; Lubin BC; Reeves MS. Lipid effects of prescription omega-3-acid ethyl esters plus simvastatin in subjects with hypertriglyceridemia. FASEB J 2008;22:147.8

    RESULT

  • Maki KC, McKenney JM, Reeves MS, Lubin BC, Dicklin MR. Effects of adding prescription omega-3 acid ethyl esters to simvastatin (20 mg/day) on lipids and lipoprotein particles in men and women with mixed dyslipidemia. Am J Cardiol. 2008 Aug 15;102(4):429-33. doi: 10.1016/j.amjcard.2008.03.078. Epub 2008 May 22.

    PMID: 18678300RESULT

  • Maki KC, Lubin BC, Reeves MS, Dicklin MR, Harris WS. Prescription omega-3 acid ethyl esters plus simvastatin 20 and 80 mg: effects in mixed dyslipidemia. J Clin Lipidol. 2009 Feb;3(1):33-8. doi: 10.1016/j.jacl.2008.12.007. Epub 2008 Dec 27.

    PMID: 21291786RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and plasma

MeSH Terms

Conditions

Dyslipidemias

Interventions

OmacorSimvastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Kevin C Maki, PhD

    Provident Clinical Research

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 14, 2007

First Posted

June 18, 2007

Study Start

November 1, 2006

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

May 7, 2008

Record last verified: 2008-04