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

This study has been completed.

Study NCT00932620 Information provided by University of Ioannina

First Received on July 2, 2009. Last Updated on August 17, 2011 History of Changes

Results First Received: June 13, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Hypercholesterolemia
Interventions:	Drug: SIMVASTATIN 40 mg Drug: SIMVASTATIN/EZETIMIBE 10/10 mg

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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 daily
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/ezetimibe 10/10 mg (n=50) daily

Participant Flow: Overall Study

	Simvastatin 40 mg	Simvastatin 10 mg Plus Ezetimibe 10 mg
STARTED	50	50
COMPLETED	50	50
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
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 daily
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/ezetimibe 10/10 mg (n=50) daily

Baseline Measures

	Simvastatin 40 mg	Simvastatin 10 mg Plus Ezetimibe 10 mg	Total
Number of Participants [units: participants]	50	50	100
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	45	44	89
>=65 years	5	6	11
Age [units: years] Mean ± Standard Deviation	57 ± 10	59 ± 9	58 ± 9
Gender [units: participants]
Female	16	17	33
Male	34	33	67
Region of Enrollment [units: participants]
Greece	50	50	100

Outcome Measures

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1. Primary:

Changes in Small Dense Low-density Lipoprotein Cholesterol (sdLDL-C) Levels [ Time Frame: Baseline and 3 months ]

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2. Secondary:

Changes in Low-density Lipoprotein Cholesterol (LDL-C) [ Time Frame: 3 months ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limitations of our study include its open-label design and the lack of clinical endpoints. However, all laboratory determinations were performed blindly with regard to treatment allocation.

Results Point of Contact:

Name/Title: Prof Moses Elisaf
Organization: University of Ioannina
phone: +302651007509
e-mail: egepi@cc.uoi.gr

Publications of Results:

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