Status:
COMPLETED
Recombinant Human Superoxide Dismutase (rhSOD) and Vascular Reactivity
Lead Sponsor:
Medical University of Vienna
Collaborating Sponsors:
Polymun Scientific, Vienna, Austria
Conditions:
Inflammation
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
Inflammation is characterised by an increased risk for cardiovascular events. Dysfunction of the vascular endothelium caused by oxidative stress might provide a mechanistic link. In acute and chronic ...
Eligibility Criteria
Inclusion
- Men aged between 18 and 45 years
- Nonsmokers
- Body mass index between 15th and 85th percentile
- 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, or participation in a clinical trial in the 3 weeks preceding the study
- Evidence of hypertension, pathologic hyperglycemia, or 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 :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00264186
Start Date
June 1 2005
Last Update
May 22 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical University of Vienna - General Hospital of the City of Vienna AKH
Vienna, Vienna, Austria, 1090