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Lipid lowering effect, investigation of pharmacodynamics (inhibition of oxidosqualene cyclase, monoepoxysqualene (MES) as marker), safety / tolerability and preliminary pharmacokinetics
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIBB 1464 MS low dose | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| Pravastatin | Active Comparator |
| |
| BIBB 1464 MS medium dose | Experimental |
| |
| BIBB 1464 MS high dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBB 1464 MS low dose | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change of LDL plasma cholesterol | baseline, 2 weeks | |
| Percentage change of total plasma cholesterol | baseline, 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in lipid profile | baseline, 1 week | |
| Number of patients with adverse events | Up to day 42 | |
| Number of patients with clinical significant findings in eye lens opacification |
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Inclusion Criteria:
Exclusion Criteria:
Eye-lens
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|
| Pravastatin | Drug |
|
| BIBB 1464 MS medium dose | Drug |
|
| BIBB 1464 MS high dose | Drug |
|
| Up to day 42 |
| Number of patients with clinical significant findings in laboratory parameters | Up to day 28 |
| Number of patients with clinical significant findings in electrocardiogram (ECG) | Up to day 28 |
| Number of patients with clinical significant findings in physical examination | Up to day 28 |
| Number of patients with clinical significant findings in vital signs | Up to day 15 |
| Investigator assessed tolerability on a 4 point scale | day 42 |
| Amount of drug excreted in urine | Up to day 15 |
| Drug plasma concentration | Up to day 28 |
| Monoepoxysqualene (MES) plasma concentration | Up to day 28 |
| ID | Term |
|---|---|
| D017035 | Pravastatin |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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