Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 12:21 AM
NCT ID:
NCT01384058
Eligibility Criteria:
Inclusion Criteria:
* men \> 18 and ≤ 75 years
* post-menopausal women ≤ 75 years (follicle stimulating hormone (FSH) \>30 mIU/ml, women \> 60 years FSH \> 20 mIU/ml )
* well controlled diabetes mellitus type II (glycohaemoglobin ≤ 8,0 %)
* LDL-cholesterol ≤ 160 mg/dl
* LDL-subfractions: concentration of apoB-100 in dLDL (LDL-5 und LDL-6) \> 25 mg/dl
* written informed consent
Exclusion Criteria:
* participation in a clinical trial within the last 30 d before screening- visit
* patient is unable to give written informed consent
* Body mass index \<15 kg/m² and \> 35 kg/m²
* clinical atherosclerotic disease (coronary heart disease, peripheral artery disease, carotid artery disease)
* malignoma
* uncontrolled arterial hypertension (\>160/\>100 mmHg)
* clinically relevant disease of liver and/or kidneys
* clinically relevant endocrinally or hematologic problems
* allergy to study medication (Ezetimibe and/or Simvastatin)
* alcohol- or drug abuse
* laboratory: alanine aminotransferase, aspartate aminotransferase, total bilirubin \> 3 x ULN, creatine kinase \> 5 x ULN
* Concurrent treatment with potent CYP3A4-inhibitors (e.g. itraconazole, ketoconazole, HIV-protease-inhibitors, erythromycin, clarithromycin, telithromycin und nefazodone)
* other relevant diseases
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01384058
Study Brief:
Protocol Section:
NCT01384058