E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
volunteers with Diabetes type I or II and volunteers with Glaucoma are included Glaucoma |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10012602 |
E.1.2 | Term | Diabetes mellitus (incl subtypes) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10018305 |
E.1.2 | Term | Glaucomas (excl congenital) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the effect of a 3 month treatment with rosuvastatin 10 mg on endothelial function in patients with diabetes and glaucoma |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 < 6 Dpt.
Cohort II -Men and women aged over 18 years - subjects with both hypercholesterolemia and normal lipid profile will be included - Open angle glaucoma defined as pathological optic disc appearance and characteristic visual field loss. Visual field loss is defined as having a glaucoma hemifield test outside normal limits and /or a CPSD with P < 0.05 (Keltner et al. 2003) - 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 < 6 Dpt - sufficiently controlled intraocular pressure
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Endothelial function will be assessed 12 weeks after treatment start. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |