volunteers with Diabetes type I or II and volunteers with Glaucoma are included Glaucoma MedDRA version: 9.1 Level: HLT Classification code 10012602 Term: Diabetes mellitus (incl subtypes) MedDRA version: 9.1 Level: HLT Classification code 10018305 Term: Glaucomas (excl congenital)
Conditions
Interventions
Trade Name: Crestor
Product Name: Rosuvastatin
Pharmaceutical Form: Coated tablet
CAS Number: 287714414
Other descriptive name: ROSUVASTATIN
Concentration unit: mg milligram(s)
Concentration type: equ
Sponsors
Universitätsklinik für Klinische Pharmakologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cohort I - Men and women aged over 18 years - subjects with both hypercholesterolemia and normal lipid profile will be included - Diabetes type I or type II. Only patients with no signs of diabetic retinopathy (level 1) or patients with mild or moderate diabetic retinopathy will be included. Level of diabetic retinopathy will be assessed according to the modified Airlie House classification (1991) - Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant - Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant - Normal ophthalmic findings, ametropy =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study -Symptoms of a clinically relevant illness in the 3 weeks before the first study day -Previous or current treatment with statins -Current treatment with fibrates -History or presence of renal failure, creatine kinase (CK) and lactic dehydrogenase (LDH) above normal levels -History or presence of hepatic dysfunction, including increase of liver enzymes -Patients with known hypersensitivity to the study drug or any ingredients -Patients with or with a history of myopathy -Systemic treatment with oral anticoagulants except low dose aspirin -Blood donation during the previous 3 weeks -Ametropy more than 6 dpt -Presence of intraocular pathology other than non proliferative diabetic retinopathy for cohort I and glaucoma for cohort II -Ophthalmolgical surgery (including argon laser trabeculoplasty (ALT), trabeculectomy, deep sclerectomy) within the last 6 months before the study -History or family history of epilepsy -Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of a 3 month treatment with rosuvastatin 10 mg on endothelial function in patients with diabetes and glaucoma;Secondary Objective: none;Primary end point(s): Endothelial function will be assessed 12 weeks after treatment start. | — |
Countries
Austria
Outcome results
None listed