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

Sponsor:	University of Ioannina
Information provided by:	University of Ioannina
ClinicalTrials.gov Identifier:	NCT00932620

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:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Simvastatin Ezetimibe

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:

Florentin M, Liberopoulos EN, Moutzouri E, Rizos CV, Tselepis AD, Elisaf MS. The effect of simvastatin alone versus simvastatin plus ezetimibe on the concentration of small dense low-density lipoprotein cholesterol in subjects with primary hypercholesterolemia. Curr Med Res Opin. 2011 Mar;27(3):685-92. Epub 2011 Jan 27.

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 24, 2012