NCT02256254

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 3, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

March 10, 2015

Status Verified

March 1, 2015

Enrollment Period

5 months

First QC Date

September 22, 2014

Last Update Submit

March 9, 2015

Conditions

Oxidative Stress

Keywords

Oxidative stressSimvastatin

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (4)

  • 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

Study Arms (2)

Simvastatin

ACTIVE COMPARATOR

2 Simvastatin capsules of 20 mg every evening for 14 days

Drug: Simvastatin

Placebo

PLACEBO COMPARATOR

2 placebo capsules every evening for 14 days

Drug: Placebo

Interventions

SimvastatinDRUG

2 Simvastatin capsules of 20 mg every evening for 14 days

Simvastatin
PlaceboDRUG

2 placebo capsules every evening for 14 days

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Pharmacology

Copenhagen, 2100, Denmark

Location

MeSH Terms

Interventions

Simvastatin

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Henrik Enghusen Poulsen, Professor MD

    Department head

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor MD

Study Record Dates

First Submitted

September 22, 2014

First Posted

October 3, 2014

Study Start

September 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 10, 2015

Record last verified: 2015-03

Locations

DK(1)