Clinical trial NCT00487591: An Evaluation of Simvastatin Plus Omacor Compared to Simvastatin Plus Placebo in Subjects With Mixed Dyslipidemia
Official title: An Evaluation of Simvastatin 20 mg Plus Omacor 4 g Compared to Simvastatin 20 mg Plus Placebo in Subjects With Mixed Dyslipidemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mixed Dyslipidemia
Keywords: cholesterol
dyslipidemia
omega 3
Lead sponsor: Provident Clinical Research
Sponsor class: OTHER
Collaborators: name: Reliant Pharmaceuticals
First posted: 2007-06-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE

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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in non-high-density lipoprotein cholesterol (non-HDL-C)
timeFrame: Baseline to end of treatment
Secondary outcomes:
measure: Changes in other lipid and biomarker levels
timeFrame: Baseline through end of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Provident Clinical Research
name: Kevin C Maki, PhD
role: STUDY_DIRECTOR
References:
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
citation: 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.
citation: 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.