A Phase 2 interventional study of Simvastatin and Placebo in Oxidative Stress, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-10.
Sponsored by Rigshospitalet, Denmark · Phase 2, Interventional, and Basic science
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.
Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
2 Simvastatin capsules of 20 mg every evening for 14 days
Drug: Simvastatin
2 placebo capsules every evening for 14 days
Drug: Placebo
2 Simvastatin capsules of 20 mg every evening for 14 days
2 placebo capsules every evening for 14 days
Urinary excretion of 8-oxoguanosine (nmol/24h)
Time frame: Change from Baseline after fourteen days of treatment
Urinary excretion of 8-oxodeoxyguanosine (nmol/24h)
Time frame: Change from Baseline after fourteen days of treatment
Malondialdehyde
Time frame: Change from Baseline after fourteen days of treatment
Vitamin C
Time frame: Change from Baseline after fourteen days of treatment
Vitamin E
Time frame: Change from Baseline after fourteen days of treatment
Biopterin
Time frame: Change from Baseline after fourteen days of treatment
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Rigshospitalet, Denmark