Rosuvastatin and Renal Endothelial Function
Hypercholesterolemia
About this trial
This is an interventional prevention trial for Hypercholesterolemia focused on measuring endothelium, NO, renal, statins
Eligibility Criteria
Inclusion Criteria: Female and male patients aged between 18 and 75 years fasting LDL C concentrations >=160 and < 250mg/dl fasting TG concentrations =< 350mg/dl Exclusion Criteria: History of statin induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitors (statins). History of hypersensitivity reaction to inulin. Lipid-lowering drugs (including lipid lowering dietary supplements of food additives) within the last 4 weeks. Diabetes mellitus, defined as glycosylated hemoglobin (HbA1C) above the upper limit of normal (ULN). Uncontrolled arterial hypertension (>160/100mm Hg). Subjects considered to be unstable (event within 12 weeks) by the investigator after the following events: a myocardial infarction, unstable angina, myocardial revascularisation (PTCA, CABG surgery or another revascularisation procedure) or a transient ischaemic attack (TIA) or stroke. Significant arrythmias or conduction disturbances. Congestive heart failure (NYHA classes III or IV). Pregnant women, women who are breast feeding, and women of childbearing potential who are not using chemical or mechanical contraception or have positive serum pregnancy test (a serum beta-human chorionic gonadotropin analysis). History of homozygous familial hypercholesterolaemia or known type III hyperlipoproteinemia (familial dysbetalipoproteinemia). Use of concomitant medications. Current active liver disease(SGPT > 2xULN) or severe hepatic impairment. Unexplained serum CK > 3 times ULN (e.g. not due to recent trauma, intramuscular injections, heavy exercise etc.). Serum creatinine > 2,0 mg/dl and creatinine clearance <80ml/min. History of nephrolithiasis with calcium oxalate aggregation. Uncontrolled hypothyroidism defined as a thyroid stimulating hormone (TSH) > 1,5 times the UL or subjects whose thyroid replacement therapy was initiated within the last 3 month. Severe disorders of the gastrointestinal tract or other diseases which interfere with the pharmacodynamics and pharmacokinetics of the study drug. History of malignancy(unless a documented disease-free period exceeding 10 years is present) with the exception of basal cell or squamous cell carcinoma of the skin. Women with a history of cervical dysplasia would be permitted to enter the study provided they have 3 consecutive clear Papanicolaou (Pap) smears. History of organ allografts. Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subjects´s safety or successful participation in the trial. Participation in a clinical study within 4 weeks preceding treatment start. Past or present alcohol or drug abuse. Suspected or confirmed poor compliance. Previous enrolment in this study.
Sites / Locations
- CRC, Medizinische Klinik 4 - Nephrology and Hypertension, University of Erlangen-Nürnberg