| Trial ID: | L4101 |
| Source ID: | NCT01384058
|
| Associated Drug: |
Ezetimibe
|
| Title: |
Effect of Ezetimibe or Simvastatin or Both on Low Densitiy Lipoprotein -Subfractions in Patients With Type 2 Diabetes
|
| Acronym: |
EZE
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus Type 2|Hypercholesterolemia
|
| Interventions: |
DRUG: ezetimibe|DRUG: simvastatin|DRUG: Ezetimibe 10/Simvastatin 20
|
| Outcome Measures: |
Primary: Change of the concentration of apolipoprotein B (ApoB) in dense Low Densitiy Lipoprotein (dLDL) from baseline with ezetimibe, simvastatin or the combination of both drugs, multicentre, randomized, open-label study investigation in 6-week effect of ezetimibe (10mg/d), simvastatin (20mg/d) or combination of ezetimibe 10mg/simvastatin 20mg/d on concentrations of dLDL separated by preparative gradient ultracentrifugation in patients with type 2 diabetes., baseline and 6 weeks | Secondary: Change of the concentrations of Total Cholesterol, baseline and 6 weeks|Change of the concentrations of Low Densitiy Lipoprotein (LDL) -Cholesterol, baseline and 6 weeks|Change of the concentrations of High Density Lipoprotein (HDL) -Cholesterol, baseline and 6 weeks|Change of the concentrations of triglycerides, baseline and 6 weeks
|
| Sponsor/Collaborators: |
Sponsor: University Hospital Freiburg | Collaborators: Essex Pharma GmbH
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
41
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2007-11
|
| Completion Date: |
2010-06
|
| Results First Posted: |
|
| Last Update Posted: |
2012-06-19
|
| Locations: |
Institut für Stoffwechselforschung, Frankfurt, 60322, Germany|Stephan Jacob, MD, Villingen-.Schwenningen, 78048, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT01384058
|
