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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00487591
Other study ID # PRV-06009
Secondary ID
Status Completed
Phase Phase 4
First received June 14, 2007
Last updated April 28, 2008
Start date November 2006
Est. completion date August 2007

Study information

Verified date April 2008
Source Provident Clinical Research
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date August 2007
Est. primary completion date August 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 79 Years
Eligibility 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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Provident Clinical Research Reliant Pharmaceuticals

References & Publications (2)

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):429-3 — View Citation

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

Outcome

Type Measure Description Time frame Safety issue
Primary Change in non-high-density lipoprotein cholesterol (non-HDL-C) Baseline to end of treatment No
Secondary Changes in other lipid and biomarker levels Baseline through end of treatment No
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