Effect of Rosuvastatin on Endothelial Function in Patients With Diabetes and Glaucoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Medical University of Vienna.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Medical University of Vienna
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00913562
First received: June 3, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
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Purpose
Endothelial dysfunction can be seen in a variety of vascular related ocular diseases such as glaucoma or diabetic retinopathy. There is accumulating evidence now that statins may at least partially improve endothelial function in several vascular beds, an effect that is probably independent of the lipid lowering effects of the statins.
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Glaucoma Diabetes |
Drug: Rosuvastatin Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Effect of Rosuvastatin on Endothelial Function in Patients With Diabetes and Glaucoma |
Resource links provided by NLM:
Further study details as provided by Medical University of Vienna:
Primary Outcome Measures:
- Flicker induced vasodilatation [ Time Frame: 10 minutes blood flow measurements on 3 study days - baseline, after 6 and 12 weeks of treatment with rosuvastatin ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Patients with diabetes
Rosuvastatin
|
Drug: Rosuvastatin
one tablet rosuvastatin 10 mg per day for 12 weeks
|
|
Active Comparator: Patients with glaucoma
Rosuvastatin
|
Drug: Rosuvastatin
one tablet rosuvastatin 10 mg per day for 12 weeks
|
|
Placebo Comparator: Control patients with diabetes
Placebo
|
Drug: Placebo
one tablet a day for 12 weeks
|
|
Placebo Comparator: Control patients with glaucoma
Placebo
|
Drug: Placebo
one tablet a day for 12 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Diabetes patients:
- 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:
- 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.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00913562
Locations
| Austria | |
| Department of Clinical Pharmacology, Medical University of Vienna | |
| Vienna, Austria, 1090 | |
Sponsors and Collaborators
Medical University of Vienna
Investigators
| Principal Investigator: | Gerhard Garhofer, MD | Medical University of Vienna |
More Information
No publications provided
| Responsible Party: | Gerhard Garhofer, Medical University of Vienna |
| ClinicalTrials.gov Identifier: | NCT00913562 History of Changes |
| Other Study ID Numbers: | OPHT-040908 |
| Study First Received: | June 3, 2009 |
| Last Updated: | June 3, 2009 |
| Health Authority: | Austria: Agency for Health and Food Safety |
Keywords provided by Medical University of Vienna:
|
Ocular Physiology Regional Blood Flow |
Additional relevant MeSH terms:
|
Diabetes Mellitus Glaucoma Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Ocular Hypertension Eye Diseases Rosuvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013