EUCTR2006-005906-30-DEActive, not recruitingNot Applicable
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 sites60 target enrollmentStarted: April 23, 2007Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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