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Sponsors and Collaborators: |
University of Erlangen-Nürnberg AstraZeneca |
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Information provided by: | University of Erlangen-Nürnberg |
ClinicalTrials.gov Identifier: | NCT00160745 |
The endothelium plays an important role in the regulation of vascular tone and regulation of blood flow. Nitric oxide (NO) is the most important known endothelium-derived vasodilating factor. Prospective studies have shown that hypercholesterolemia impairs endothelial function in different vascular beds. Lowering total cholesterol and particularly LDL-cholesterol with statins leads to an improvement in endothelium-dependent vasodilation in the forearm vasculature. There is strong evidence to suggest that the benefit is not merely related to the decrease in cholesterol-levels. A recent study in the forearm vasculature demonstrated that short-term lipid-lowering therapy improves endothelial function and NO availability already after 3 days of lipid lowering therapy. Whether endothelial function in the renal vasculature of hypercholesterolemic patients is similarly influenced has not yet been addressed adequately. In the present study we investigate whether lipid lowering therapy with rosuvastatin alters renal endothelial function, as assessed by systemic infusion of the NO synthase inhibitor L-NMMA, after 3 and 42 days of therapy.
Condition | Intervention | Phase |
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Hypercholesterolemia |
Drug: Rosuvastatin |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | A Randomised, Double-Blind, Placebo-Controlled, Mono-Centre, Explorative Phase II Trial to Study the Effects of Rosuvastatin on Basal Production and Release of Nitric Oxide From the Renal Vasculature in Patients With Hypercholesterolemia. |
Estimated Enrollment: | 46 |
Estimated Study Completion Date: | September 2006 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany, Krankenhausstrase 12 | |
CRC, Medizinische Klinik 4 - Nephrology and Hypertension, University of Erlangen-Nürnberg | |
Erlangen, Krankenhausstrase 12, Germany, 91054 |
Principal Investigator: | Roland E Schmieder, MD | CRC, Medizinsiche Klinik 4 - Nephrology and Hypertension, University of Erlangen-Nürnberg |
Study ID Numbers: | Rosuvastatin-study |
Study First Received: | September 6, 2005 |
Last Updated: | March 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00160745 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
endothelium, NO, renal, statins |
Nitric Oxide Rosuvastatin Metabolic Diseases Hyperlipidemias |
Metabolic disorder Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents |
Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |