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Completed

NCT Number: NCT02256254

SIMOX - Induction of Oxidative Stress

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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Key information

Conditions

Oxidative Stress

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Department of Clinical Pharmacology

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

simvastatin

Drug

2 Simvastatin capsules of 20 mg every evening for 14 days

Placebo

Drug

2 placebo capsules every evening for 14 days

Primary outcomes

  1. Urinary excretion of 8-oxoguanosine (nmol/24h)

    Time frame: Change from Baseline after fourteen days of treatment

  2. Urinary excretion of 8-oxodeoxyguanosine (nmol/24h)

    Time frame: Change from Baseline after fourteen days of treatment

Secondary outcomes

  1. Malondialdehyde

    Time frame: Change from Baseline after fourteen days of treatment

  2. Vitamin C

    Time frame: Change from Baseline after fourteen days of treatment

  3. Vitamin E

    Time frame: Change from Baseline after fourteen days of treatment

  4. Biopterin

    Time frame: Change from Baseline after fourteen days of treatment

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Klinisk Biokemisk Afdeling
  • Klinisk farmakologisk Afdeling
  • Sektion for Biomedicin Institut for Veterinær Patobiologi

Registry information

Official study title

SIMOX - A Randomized, Double-blinded, Placebo Controlled Study of Simvastatins Possible Effect on Oxidative Stress on Healthy Volunteers

Acronym: SIMOX

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 3, 2014
Registry last updated
Mar 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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