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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00487591
• Other study ID #: PRV-06009
• 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

• Dyslipidemias
• Mixed Dyslipidemia

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