Status:
COMPLETED
Anti-Inflammatory Effect of Statins in the Human Endotoxin Model
Lead Sponsor:
Medical University of Vienna
Conditions:
Endotoxemia
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the effects of HMG-CoA reductase inhibitor pretreatment on inflammation and coagulation activation in human endotoxemia.
Detailed Description
The beneficial effect of lipid lowering in cardiovascular disease is well established. Statin potently reduce elevated cholesterol levels but also exert pleiotropic other effects such as improvement o...
Eligibility Criteria
Inclusion
- Men aged between 18 and 45 years
- Nonsmokers or smokers \<5 cig/d
- Body mass index between 18 and 30; respectively weight ≤ 95 kilograms
- Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Exclusion
- Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
- Evidence of hypertension, pathologic hyperglycemia, hyperlipidemia
- Treatment in the previous 3 weeks with any drug
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
- Blood donation during the previous 3 weeks
- History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00309374
Start Date
March 1 2006
End Date
July 1 2006
Last Update
January 5 2007
Active Locations (1)
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1
Medical University of Vienna, Dept. of Clinical Pharmacology
Vienna, Vienna, Austria