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

Sponsored by:	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 LDL-C reductions of approximately the same magnitude. However, the differential effects of these two treatment options on 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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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 LDL subfraction profile (i.e. mean LDL particle size, sdLDL-C levels) [ Time Frame: 3 months after treatment initiation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in • LDL-C, triglycerides and high-density lipoprotein cholesterol (HDL-C) levels • Lipoprotein-associated phospholipase A2 (Lp-PLA2) activity and mass [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	June 2009
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Simvastatin 40 mg: Active Comparator 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
Simvastatin 10 mg plus ezetimibe 10 mg: Active Comparator 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

Contacts

Contact: Moses S Elisaf, MD

+302651007509

egepi@cc.uoi.gr

Locations

Greece
University Hospital of Ioannina	Recruiting
Ioannina, Greece, 45 110
Contact: Moses S Elisaf, MD +302651007509 egepi@cc.uoi.gr
Sub-Investigator: Evangelos N Liberopoulos, MD

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

No publications provided

Responsible Party:	University of Ioannina ( Prof. M. Elisaf )
Study ID Numbers:	001
Study First Received:	July 2, 2009
Last Updated:	July 2, 2009
ClinicalTrials.gov Identifier:	NCT00932620 History of Changes
Health Authority:	Greece: Ministry of Health and Welfare

Keywords provided by University of Ioannina:

hypercholesterolemia
statins
simvastatin
ezetimibe
LDL particles

Study placed in the following topic categories:

Antimetabolites
Metabolic Diseases
Hyperlipidemias
Simvastatin
Antilipemic Agents
Ezetimibe

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Metabolic Disorder
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Enzyme Inhibitors
Ezetimibe

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Therapeutic Uses
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on September 10, 2009