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| Name | Class |
|---|---|
| Klinisk Biokemisk Afdeling | UNKNOWN |
| Klinisk farmakologisk Afdeling | UNKNOWN |
| Sektion for Biomedicin Institut for Veterinær Patobiologi | UNKNOWN |
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The purpose of the study is to investigate if use of simvastatin is associated with the level of oxidative stress in humans. The association is examined by comparing changes in oxidative stress in a group treated with simvastatin with the change in a placebo group. The study is a randomized-based, double-blinded placebo-controlled study. Each treatment group consists of 20 healthy male volunteers who consume simvastatin or placebo over 14 days. The induction of oxidative stress is measured by 8-oxoguanosine and 8- oxodeoxyguanosine, isolated from urine. A t-test will be performed to compare drug treatment with placebo. The results will be published.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simvastatin | Active Comparator | 2 Simvastatin capsules of 20 mg every evening for 14 days |
|
| Placebo | Placebo Comparator | 2 placebo capsules every evening for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin | Drug | 2 Simvastatin capsules of 20 mg every evening for 14 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary excretion of 8-oxoguanosine (nmol/24h) | Change from Baseline after fourteen days of treatment | |
| Urinary excretion of 8-oxodeoxyguanosine (nmol/24h) | Change from Baseline after fourteen days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Malondialdehyde | Change from Baseline after fourteen days of treatment | |
| Vitamin C | Change from Baseline after fourteen days of treatment | |
| Vitamin E |
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Inclusion Criteria:
Exclusion Criteria:
anion exchangers, amiodarone, amlodipine, ciclosporin, clarithromycin, colchicine, danazol, diltiazem, erythromycin, fibrates, fluconazole, fusidin acid, grape fruit juice, HIV protease inhibitors, itraconazole, ketoconazole, nefazodone, niacin, posaconazole, rifampicin, telithromycin, verapamil, vitamin K-antagonists, voriconazole
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| Name | Affiliation | Role |
|---|---|---|
| Henrik Enghusen Poulsen, Professor MD | Department head | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Pharmacology | Copenhagen | 2100 | Denmark |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Placebo |
| Drug |
2 placebo capsules every evening for 14 days |
|
| Change from Baseline after fourteen days of treatment |
| Biopterin | Change from Baseline after fourteen days of treatment |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |