endothelial dysfunction in cardiovascular diseases MedDRA version: 19.1 Level: PT Classification code 10048554 Term: Endothelial dysfunction System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Trade Name: Simvastatin Ranbaxy
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Simvastatin
Other descriptive name: SIMVASTATIN
Concentration unit: mg milligram(s)
Concentration type: equal
C
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Informed consent for participation - Men and women aged between 18 and 45 years, non-smokers - Body mass index between 15th and 85th percentile - Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant - Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant - Systolic blood pressure =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - History or presence of ocular disease - Ametropy = 6 dpt - Previous or current treatment with statins - Treatment with any drug in the 3 weeks preceding the first study day - Symptoms of a clinically relevant illness in the 3 weeks before the first study day - Participation in a clinical trial in the 3 weeks preceding the first study day - Blood donation during the 3 weeks preceding the first study day - History of family history of epilepsy - History or presence of myopathy, renal failure or elevation of creatine kinase (CK) - above normal levels - History or presence of hepatic dysfuncion, including increase of liver enzymes - Abuse of alcoholic beverages - Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the changes of flicker induced vasodilatation and retinal oxygen saturation before and during therapy with simvastatin as well as after simvastatin withdrawal.;Secondary Objective: not applicable;Primary end point(s): Difference in flicker induced vasodilatation after discontinuation of simvastatin;Timepoint(s) of evaluation of this end point: 3, 7 and 14 days after discontinuation of simvastatin | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Austria
Contacts
Public ContactDepartment of Clinical Pharmacology
Medical University of Vienna
Outcome results
None listed