Effect of Rosuvastatin on Endothelial Function in Patients With Diabetes and Glaucoma
NCT ID: NCT00913562
Last Updated: 2014-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2009-06-30
2014-11-30
Brief Summary
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Consequently, the current study seeks to investigate whether administration of 10 mg rosuvastatin by mouth (p.o.) for 12 weeks can improve the endothelial function in patients with glaucoma and diabetic retinopathy. For this purpose, flow mediated vasodilatation of the brachial artery and flicker induced vasodilatation of retinal vessels will be measured at baseline, after 6 and 12 weeks of treatment with rosuvastatin.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Patients with diabetes
Rosuvastatin
Rosuvastatin
one tablet rosuvastatin 10 mg per day for 12 weeks
Patients with glaucoma
Rosuvastatin
Rosuvastatin
one tablet rosuvastatin 10 mg per day for 12 weeks
Control patients with diabetes
Placebo
Placebo
one tablet a day for 12 weeks
Control patients with glaucoma
Placebo
Placebo
one tablet a day for 12 weeks
Interventions
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Rosuvastatin
one tablet rosuvastatin 10 mg per day for 12 weeks
Placebo
one tablet a day for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* 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, except diabetic retinopathy as described above, ametropia \< 6 Dpt.
Glaucoma patients:
* 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, except glaucoma as described above, ametropia \< 6 Dpt.
* sufficiently controlled intraocular pressure.
Exclusion Criteria
* 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.
* Ametropia of 6 or more than 6 dpt.
* Presence of intraocular pathology other than non proliferative diabetic retinopathy for cohort I and glaucoma for cohort II.
* Ophthalmological surgery (including argon laser trabeculoplasty (ALT), trabeculectomy, deep sclerectomy) within the last 6 months before the study.
* History or family history of epilepsy.
* Pregnancy.
18 Years
ALL
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Medical University of Vienna
Principal Investigators
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Gerhard Garhofer, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna
Locations
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Department of Clinical Pharmacology, Medical University of Vienna
Vienna, , Austria
Countries
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Other Identifiers
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OPHT-040908
Identifier Type: -
Identifier Source: org_study_id