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Effect of Ezetimibe or Simvastatin or Both on Low Densitiy Lipoprotein -Subfractions in Patients With Type 2 Diabetes

NCT01384058 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2012-06-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

ezetimibe

ezetimibe 10 mg per day for six weeks

DRUG

simvastatin

Simvastatin 20 mg per day for six weeks

DRUG

Ezetimibe 10/Simvastatin 20

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

Sponsors & Collaborators

  • Essex Pharma GmbH

    collaborator INDUSTRY

  • University Hospital Freiburg

    lead OTHER

Principal Investigators

  • Karl Winkler, MD · University Hospital Freiburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2010-05-31
Completion
2010-06-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01384058 on ClinicalTrials.gov