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An Evaluation of Simvastatin Plus Omacor Compared to Simvastatin Plus Placebo in Subjects With Mixed Dyslipidemia

NCT ID: NCT00487591

Last Updated: 2008-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-08-31

Brief Summary

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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.

Detailed Description

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This trial will utilize a randomized, double-blind, two-period crossover design. At Visit 4 (Week 0), after a 5-week diet lead-in/baseline period, subjects meeting all entry criteria will be randomized to one of two double-blind treatment sequences, simvastatin/Omacor first or simvastatin/placebo first. Each treatment period consists of 6 weeks. After randomization, subjects will self-administer the study drugs once a day in the evening.

Conditions

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Mixed Dyslipidemia

Keywords

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cholesterol dyslipidemia omega 3

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Simva+Omacor

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

Intervention Type DRUG

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

Simva + Placebo

simvastatin plus placebo

Intervention Type DRUG

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

Interventions

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

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

Intervention Type DRUG

simvastatin plus placebo

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

Intervention Type DRUG

Other Intervention Names

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Lovaza

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Reliant Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Provident Clinical Research

OTHER

Sponsor Role lead

Responsible Party

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Provident Clinical Research

Principal Investigators

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Kevin C Maki, PhD

Role: STUDY_DIRECTOR

Provident Clinical Research

References

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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

Reference Type 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.

Reference Type RESULT
PMID: 18678300 (View on PubMed)

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.

Reference Type RESULT
PMID: 21291786 (View on PubMed)

Other Identifiers

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PRV-06009

Identifier Type: -

Identifier Source: org_study_id