Mixed Dyslipidemia Clinical Trial
Official title:
An Evaluation of Simvastatin 20 mg Plus Omacor 4 g Compared to Simvastatin 20 mg Plus Placebo in Subjects With Mixed Dyslipidemia
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 |
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.
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) |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Provident Clinical Research | Reliant Pharmaceuticals |
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
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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