Hypercholesterolemia Clinical Trial
Official title:
A Stable-isotope Study in Healthy Normolipidemic Volunteers Comparing the Mechanisms of Action of Lifibrol and Pravastatin
Lifibrol is a new lipid-lowering drug which lowers cholesterol to an extent in the order of magnitude of the statins. The mechanism of action of this compound is different from the one of statins but remains unknown. The current study will investigate the mechanism of action using stable-isotope turnover methods. The study will be done in healthy male volunteers.
Status | Completed |
Enrollment | 18 |
Est. completion date | June 1998 |
Est. primary completion date | April 1996 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 35 Years |
Eligibility |
Inclusion Criteria: - male volunteers - 18 to 35 years old - good clinical condition - normal eating habits - mental abilities to be able to understand the study procedures - written informed consent Exclusion Criteria: - relevant pathological findings in the baseline examination - known allergic predisposition - concomitant drugs - alcohol or nicotine abuse - participation in other clinical trials in the last 30 days |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Germany | Dept. of Clinical Pharmacology, University of Bonn | Bonn |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bonn |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | LDL cholesterol lowering | 4 weeks | No | |
Secondary | Changes in other lipoprotein concentrations | 4 weeks | No |
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