CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 41 enrolled
Drug / intervention
ezetimibe +2 moredrug
Likely dose
ezetimibe 10 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/NCT01384058
NCT01384058Phase 4Completed
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The Effect of Ezetimibe 10 mg, Simvastatin 20 mg and the Combination of Simvastatin 20 mg Plus 10 mg Ezetimibe on Low Density Lipoprotein (LDL)-Subfractions in Patients With Type 2 Diabetes

University Hospital Freiburg·interventional·Posted Jun 28, 2011·Updated Jun 19, 2012

In Brief

A Phase 4 clinical trial evaluating ezetimibe, simvastatin, and 1 other intervention for Diabetes Mellitus Type 2 and Hypercholesterolemia. Completed, enrolled 41 participants across 2 sites.

Detailed Summary

It is of interest how ezetimibe alone or in combination with statin may influence atherogenic dense Low Density Lipoprotein (dLDL) in patients with type 2 diabetes mellitus. The primary objective of this study will be whether there is a change of the concentrations of Apolipoprotein B (ApoB) in dLDL from baseline in each of the 3 treatment groups.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus Type 2, Hypercholesterolemia
CountriesGermany
CollaboratorsEssex Pharma GmbH

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 28, 2011
Enrollment StartNov 1, 2007
Primary CompletionMay 1, 2010
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 15.0 years ago

Interventions

ezetimibedrug

ezetimibe 10 mg per day for six weeks

simvastatindrug

Simvastatin 20 mg per day for six weeks

Ezetimibe 10/Simvastatin 20drug

Ezetimibe 10mg/Simvastatin 20mg per day for six weeks