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

This study has been completed.
Sponsor:
Collaborator:
Reliant Pharmaceuticals
Information provided by:
Provident Clinical Research
ClinicalTrials.gov Identifier:
NCT00487591
First received: June 14, 2007
Last updated: April 28, 2008
Last verified: April 2008
  Purpose

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.


Condition Intervention Phase
Mixed Dyslipidemia
Drug: Omacor (omega-3-acid ethyl esters)plus simvastatin
Drug: simvastatin plus placebo
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Evaluation of Simvastatin 20 mg Plus Omacor 4 g Compared to Simvastatin 20 mg Plus Placebo in Subjects With Mixed Dyslipidemia

Resource links provided by NLM:


Further study details as provided by Provident Clinical Research:

Primary Outcome Measures:
  • Change in non-high-density lipoprotein cholesterol (non-HDL-C) [ Time Frame: Baseline to end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in other lipid and biomarker levels [ Time Frame: Baseline through end of treatment ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

serum and plasma


Enrollment: 40
Study Start Date: November 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Simva+Omacor 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)
Other Name: Lovaza
Simva + Placebo Drug: simvastatin plus placebo
simvastatin 20mg/day (1 tablet 20 mg)plus 4 capsules matching placebo

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

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00487591

Sponsors and Collaborators
Provident Clinical Research
Reliant Pharmaceuticals
Investigators
Study Director: Kevin C Maki, PhD Provident Clinical Research
  More Information

Publications:
Responsible Party: Kevin C. Maki, PhD, Chief Science Officer, Provident Clinical Research
ClinicalTrials.gov Identifier: NCT00487591     History of Changes
Other Study ID Numbers: PRV-06009
Study First Received: June 14, 2007
Last Updated: April 28, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Provident Clinical Research:
cholesterol
dyslipidemia
omega 3

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 10, 2014