CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 100 enrolled
Drug / intervention
SIMVASTATIN 40 mg +1 moredrug
Likely dose
SIMVASTATIN 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00932620
NCT00932620Phase 4Completed
CompareCT.gov

THE EFFECT OF SIMVASTATIN VERSUS COMBINED SIMVASTATIN/EZETIMIBE TREATMENT ON THE CONCENTRATION OF SMALL DENSE LOW-DENSITY LIPOPROTEIN PARTICLES IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA

University of Ioannina·interventional·Posted Jul 3, 2009·Updated Aug 19, 2011

In Brief

A Phase 4 clinical trial evaluating SIMVASTATIN 40 mg and SIMVASTATIN/EZETIMIBE 10/10 mg for Hypercholesterolemia. Completed, enrolled 100 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia
CountriesGreece
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 3, 2009
Enrollment StartJun 1, 2009
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 17.0 years ago

Interventions

SIMVASTATIN 40 mgdrug

SIMVASTATIN 40 mg/day for 3 months

SIMVASTATIN/EZETIMIBE 10/10 mgdrug

SIMVASTATIN/EZETIMIBE 10/10 mg/day for 3 months