<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02256254</url>
  </required_header>
  <id_info>
    <org_study_id>2014-647</org_study_id>
    <nct_id>NCT02256254</nct_id>
  </id_info>
  <brief_title>SIMOX - Induction of Oxidative Stress</brief_title>
  <acronym>SIMOX</acronym>
  <official_title>SIMOX - A Randomized, Double-blinded, Placebo Controlled Study of Simvastatins Possible Effect on Oxidative Stress on Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Klinisk Biokemisk Afdeling</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Klinisk farmakologisk Afdeling</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sektion for Biomedicin Institut for Veterinær Patobiologi</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to investigate if use of simvastatin is associated with the level&#xD;
      of oxidative stress in humans. The association is examined by comparing changes in oxidative&#xD;
      stress in a group treated with simvastatin with the change in a placebo group. The study is a&#xD;
      randomized-based, double-blinded placebo-controlled study. Each treatment group consists of&#xD;
      20 healthy male volunteers who consume simvastatin or placebo over 14 days. The induction of&#xD;
      oxidative stress is measured by 8-oxoguanosine and 8- oxodeoxyguanosine, isolated from urine.&#xD;
      A t-test will be performed to compare drug treatment with placebo. The results will be&#xD;
      published.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Urinary excretion of 8-oxoguanosine (nmol/24h)</measure>
    <time_frame>Change from Baseline after fourteen days of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Urinary excretion of 8-oxodeoxyguanosine (nmol/24h)</measure>
    <time_frame>Change from Baseline after fourteen days of treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Malondialdehyde</measure>
    <time_frame>Change from Baseline after fourteen days of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vitamin C</measure>
    <time_frame>Change from Baseline after fourteen days of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vitamin E</measure>
    <time_frame>Change from Baseline after fourteen days of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biopterin</measure>
    <time_frame>Change from Baseline after fourteen days of treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Oxidative Stress</condition>
  <arm_group>
    <arm_group_label>Simvastatin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2 Simvastatin capsules of 20 mg every evening for 14 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2 placebo capsules every evening for 14 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Simvastatin</intervention_name>
    <description>2 Simvastatin capsules of 20 mg every evening for 14 days</description>
    <arm_group_label>Simvastatin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>2 placebo capsules every evening for 14 days</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Caucasian&#xD;
&#xD;
          -  healthy men&#xD;
&#xD;
          -  18-50 years&#xD;
&#xD;
          -  BMI: 18-30&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Total cholesterol less than 3 mmol/L&#xD;
&#xD;
          -  Use of natural and herbal medicines that is affected/affects simvastatin:&#xD;
&#xD;
        anion exchangers, amiodarone, amlodipine, ciclosporin, clarithromycin, colchicine, danazol,&#xD;
        diltiazem, erythromycin, fibrates, fluconazole, fusidin acid, grape fruit juice, HIV&#xD;
        protease inhibitors, itraconazole, ketoconazole, nefazodone, niacin, posaconazole,&#xD;
        rifampicin, telithromycin, verapamil, vitamin K-antagonists, voriconazole&#xD;
&#xD;
          -  following diseases: a Coronary vascular disease b Renal insufficiency c Hepatic&#xD;
             insufficiency d heart failure e Previous heart arrythmia f Hypokalaemia g Low blood&#xD;
             pressure h hyperthyroidism i muscular toxicity j galactose intolerants k Lapp Lactase&#xD;
             deficiency l Glucose/galactose-malabsorption m Psychiatric disorder&#xD;
&#xD;
          -  allergies towards any of the tested medicine&#xD;
&#xD;
          -  intake of narcotics within 2 months prior to trial&#xD;
&#xD;
          -  intake of supplements within 2 months prior to trial&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Henrik Enghusen Poulsen, Professor MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department head</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Clinical Pharmacology</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>March 9, 2015</last_update_submitted>
  <last_update_submitted_qc>March 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 10, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Henrik Enghusen Poulsen</investigator_full_name>
    <investigator_title>Professor MD</investigator_title>
  </responsible_party>
  <keyword>Oxidative stress</keyword>
  <keyword>Simvastatin</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Simvastatin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02256254
org study id: 2014-647
nct id: NCT02256254
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Urinary excretion of 8-oxoguanosine (nmol/24h)
time frame: Change from Baseline after fourteen days of treatment
measure: Urinary excretion of 8-oxodeoxyguanosine (nmol/24h)
time frame: Change from Baseline after fourteen days of treatment
measure: Malondialdehyde
time frame: Change from Baseline after fourteen days of treatment
measure: Vitamin C
time frame: Change from Baseline after fourteen days of treatment
measure: Vitamin E
time frame: Change from Baseline after fourteen days of treatment
measure: Biopterin
time frame: Change from Baseline after fourteen days of treatment
arm group label: Simvastatin
arm group type: Active Comparator
description: 2 Simvastatin capsules of 20 mg every evening for 14 days
arm group label: Placebo
arm group type: Placebo Comparator
description: 2 placebo capsules every evening for 14 days
intervention type: Drug
intervention name: Simvastatin
description: 2 Simvastatin capsules of 20 mg every evening for 14 days
arm group label: Simvastatin
intervention type: Drug
intervention name: Placebo
description: 2 placebo capsules every evening for 14 days
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Henrik Enghusen Poulsen, Professor MD
role: Principal Investigator
affiliation: Department head
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Henrik Enghusen Poulsen
investigator title: Professor MD
mesh term: Simvastatin