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Comparison of Simvastatin Versus Simvastatin/Ezetimibe on Small Dense Low -Density Lipoprotein (LDL)

This study has been completed.
Sponsor:
Information provided by:
University of Ioannina
ClinicalTrials.gov Identifier:
NCT00932620
First received: July 2, 2009
Last updated: August 17, 2011
Last verified: June 2011
History of Changes
  Purpose

Both simvastatin 40 mg and simvastatin/ezetimibe 10/10 mg result in low-density lipoprotein cholesterol (LDL-C) reductions of approximately the same magnitude. However, the differential effects of these two treatment options on small dense LDL-C (sdLDL-C) concentration have not been assessed.

The aim of the present study is to compare the effects of simvastatin 40 mg versus simvastatin/ezetimibe 10/10 mg on sdLDL-C concentration. The primary efficacy endpoint will be changes in LDL subfraction profile (i.e. mean LDL particle size, sdLDL-C levels) at 3 months after treatment initiation.


Condition Intervention Phase
Hypercholesterolemia
 Drug: SIMVASTATIN 40 mg
Drug: SIMVASTATIN/EZETIMIBE 10/10 mg
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: THE EFFECT OF SIMVASTATIN VERSUS COMBINED SIMVASTATIN/EZETIMIBE TREATMENT ON THE CONCENTRATION OF SMALL DENSE LOW-DENSITY LIPOPROTEIN PARTICLES IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

Further study details as provided by University of Ioannina:

Primary Outcome Measures:
  • Changes in Small Dense Low-density Lipoprotein Cholesterol (sdLDL-C) Levels [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in Low-density Lipoprotein Cholesterol (LDL-C) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: June 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Simvastatin 40 mg
All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin 40 mg (n=50) or simvastatin/ezetimibe 10/10 mg (n=50) daily
 Drug: SIMVASTATIN 40 mg
SIMVASTATIN 40 mg/day for 3 months
Active Comparator: Simvastatin 10 mg plus ezetimibe 10 mg
All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin 40 mg (n=50) or simvastatin/ezetimibe 10/10 mg (n=50) daily
 Drug: SIMVASTATIN/EZETIMIBE 10/10 mg
SIMVASTATIN/EZETIMIBE 10/10 mg/day for 3 months

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  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • LDL-C levels above those recommended by the National Cholesterol Education
  • Program Adult Treatment Panel III (NCEP-ATP III) based on each patient risk factors following a 3-month period of lifestyle changes.

Exclusion Criteria:

  • Triglycerides >500 mg/dL, renal disease (serum creatinine levels >1.6 mg/dL), hypothyroidism [thyroid stimulating hormone (TSH) >5 IU/mL] and liver disease (ALT and/or AST levels >3-fold upper limit of normal in 2 consecutive measurements).
  • Patients with hypertension will be included in the study if they are on stable medication for at least 3 months and their blood pressure is adequately controlled (no change in their treatment will be made during the study period).
  • Patients currently taking lipid lowering drugs or having stopped them less than 4 weeks before study entry will be excluded
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00932620

Locations
Greece
University Hospital of Ioannina
Ioannina, Greece, 45 110
Sponsors and Collaborators
University of Ioannina
  More Information

Additional Information:
2nd Department of Internal Medicine, University Hospital of Ioannina  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Prof. M. Elisaf, University of Ioannina
ClinicalTrials.gov Identifier: NCT00932620     History of Changes
Other Study ID Numbers: 001
Study First Received: July 2, 2009
Results First Received: June 13, 2011
Last Updated: August 17, 2011
Health Authority: Greece: Ministry of Health and Welfare

Keywords provided by University of Ioannina:
hypercholesterolemia
statins
simvastatin
ezetimibe
LDL particles

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
Ezetimibe
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 May 23, 2013