Status:
COMPLETED
Rosuvastatin and Renal Endothelial Function
Lead Sponsor:
University of Erlangen-Nürnberg Medical School
Collaborating Sponsors:
AstraZeneca
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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. Prospect...
Eligibility Criteria
Inclusion
- Female and male patients aged between 18 and 75 years
- fasting LDL C concentrations \>=160 and \< 250mg/dl
- fasting TG concentrations =\< 350mg/dl
Exclusion
- 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00160745
End Date
September 1 2006
Last Update
February 26 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CRC, Medizinische Klinik 4 - Nephrology and Hypertension, University of Erlangen-Nürnberg
Erlangen, Krankenhausstrase 12, Germany, 91054