An Evaluation of Simvastatin Plus Omacor Compared to Simvastatin Plus Placebo in Subjects With Mixed Dyslipidemia
Information source: Provident Clinical Research
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mixed Dyslipidemia
Intervention: Omacor (omega-3-acid ethyl esters)plus simvastatin (Drug); simvastatin plus placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Provident Clinical Research Official(s) and/or principal investigator(s):
Kevin C Maki, PhD, Study Director, Affiliation: Provident Clinical Research
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.
Clinical Details
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 design: Cohort, Prospective
Primary outcome: Change in non-high-density lipoprotein cholesterol (non-HDL-C)
Secondary outcome: Changes in other lipid and biomarker levels
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
Minimum age: 18 Years.
Maximum age: 79 Years.
Gender(s): Both.
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)
Locations and Contacts
Additional Information
Starting date: November 2006
Ending date: August 2007
Last updated: April 28, 2008
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