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
  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:


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
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: NCT00932620

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

Additional Information:
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
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 18, 2014