drugset / Trial / NCT02256254
SIMOX - Induction of Oxidative Stress
Phase 2
Completed
40 enrolled
Rigshospitalet, Denmark
Klinisk Biokemisk Afdeling · collabKlinisk farmakologisk Afdeling · collabSektion for Biomedicin Institut for Veterinær Patobiologi · collab
RandomizedParallel-groupQuadruple-blindBasic science
Summary
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.
Timeline
- Start
- 2014-09
- Primary completion
- 2015-02
- Completion
- 2015-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Simvastatin | Small molecule | 40 mg | — |