The effect of Ezetimibe 10 mg, Simvastatin 20 mg and the Combination of Simvastatin 20 mg plus 10 mg Ezetimibe on LDL-Subfractions in patients with Type 2 Diabetes (Die Wirkung einer Monotherapie mit Ezetimib 10 mg vs. Monotherapie mit Simvastatin 20 mg vs. Kombinationsbehandlung mit Ezetimib 10 mg und Simvastatin 20 mg auf die LDL-Subfraktionen bei Patienten mit Typ II Diabetes)

niversitätsklinikum Freiburg, Abteilung klinische Chemie0 个研究点目标入组 60 人开始时间: 2007年4月23日最近更新: 2012年7月3日

适应症

试验速览

暂无简介。

•men > 18 and = 75 years
•post-menopausal women = 75 years (FSH >30 mIU/ml, women > 60 years FSH > 20 mIU/ml )
•well controlled diabetes mellitus type II (HbA1c = 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•participation in a clinical trial within the last 30 d before screening-visit
•patient is unable to give written informed consent
•BMI <15 kg/m² and > 35 kg/m²
•clinical atherosclerotic disease (coronary heart disease, peripheral artery disease, carotid artery disease)
•uncontrolled arterial hypertension(>160/>100 mmHg)
•clinically relevant disease od liver and/or kidneys
•clinically relevant endocrincally or hematologic problems
•allergy to study medication(Ezetimibe and/or Simvastatin)
•alcohol- or drug abuse
•laboratory: ALT, AST, total bilirubin > 3 x ULN, CK > 5 x ULN
•Concurrent treatment with potent CYP3A4-inhibitors (e.g. Itraconazol, Ketoconazol, HIV-protease-inhibitors, Erythromycin, Clarithromycin, Telithromycin und Nefazodon)
•other relevant diseases

发起方

niversitätsklinikum Freiburg, Abteilung klinische Chemie