SIMOX - Induction of Oxidative Stress

Phase 2

Completed

• Conditions: Oxidative Stress
• Interventions: Drug: Placebo; Drug: Simvastatin

• Registration Number: NCT02256254
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-22
• Study First Submitted QC: 2014-09-30
• Study First Posted: 2014-10-03
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-09
• Last Update Posted: 2015-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• Caucasian
• healthy men
• 18-50 years
• BMI: 18-30

Exclusion Criteria

• Total cholesterol less than 3 mmol/L
• Use of natural and herbal medicines that is affected/affects simvastatin:

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

• following diseases: a Coronary vascular disease b Renal insufficiency c Hepatic insufficiency d heart failure e Previous heart arrythmia f Hypokalaemia g Low blood pressure h hyperthyroidism i muscular toxicity j galactose intolerants k Lapp Lactase deficiency l Glucose/galactose-malabsorption m Psychiatric disorder
• allergies towards any of the tested medicine
• intake of narcotics within 2 months prior to trial
• intake of supplements within 2 months prior to trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	2 placebo capsules every evening for 14 days
Simvastatin	Simvastatin	2 Simvastatin capsules of 20 mg every evening for 14 days

Primary Outcome Measures

Name	Time	Method
Urinary excretion of 8-oxodeoxyguanosine (nmol/24h)	Change from Baseline after fourteen days of treatment
Urinary excretion of 8-oxoguanosine (nmol/24h)	Change from Baseline after fourteen days of treatment

Secondary Outcome Measures

Name	Time	Method
Malondialdehyde	Change from Baseline after fourteen days of treatment
Vitamin C	Change from Baseline after fourteen days of treatment
Vitamin E	Change from Baseline after fourteen days of treatment
Biopterin	Change from Baseline after fourteen days of treatment

Trial Locations

Locations (1)

Department of Clinical Pharmacology; 🇩🇰 Copenhagen, Denmark