<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/NCT01690104</url>
  </required_header>
  <id_info>
    <org_study_id>Rifa-BP</org_study_id>
    <secondary_id>2011-005522-22</secondary_id>
    <nct_id>NCT01690104</nct_id>
  </id_info>
  <brief_title>The Effect of PXR Activation on Blood Pressure Regulation</brief_title>
  <official_title>The Effect of PXR Activation on Blood Pressure Regulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oulu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Oulu University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oulu</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We are investigating the effects of pregnane X receptor (PXR) activation on the regulation of&#xD;
      blood pressure in healthy volunteers. Rifampicin (an antibiotic and also an efficient PXR&#xD;
      activator) and placebo will be given for a week to volunteers and blood pressure is measured&#xD;
      24 hours using an ambulatory blood pressure monitor. Blood pressure regulating hormones will&#xD;
      be measured in blood. Our hypothesis is that PXR is involved in the regulation of blood&#xD;
      pressure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Systolic ambulatory blood pressure</measure>
    <time_frame>On day 8 of each arm</time_frame>
    <description>Systolic blood pressure measured with ambulatory blood pressure monitor.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diastolic ambulatory blood pressure</measure>
    <time_frame>On day 8 of each arm</time_frame>
    <description>Diastolic blood pressure measured with ambulatory blood pressure monitor</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Systolic and diastolic blood pressure</measure>
    <time_frame>On day 9 of each arm</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulse (ambulatory)</measure>
    <time_frame>On day 8 of each arm</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma renin activity</measure>
    <time_frame>On day 9 of each arm</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum aldosterone</measure>
    <time_frame>On day 9 of each arm</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Blood Pressure Regulation</condition>
  <arm_group>
    <arm_group_label>Rifampicin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Rifampicin 600 mg daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rifampicin</intervention_name>
    <arm_group_label>Rifampicin</arm_group_label>
    <other_name>Rimapen</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers&#xD;
&#xD;
          -  BMI 19-30 kg/m2&#xD;
&#xD;
          -  Age 18-40 years&#xD;
&#xD;
          -  Systolic blood pressure 95 - 140 mmHg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any continuous medication&#xD;
&#xD;
          -  Any significant medical condition as judged by the study physician&#xD;
&#xD;
          -  Diastolic blood pressure over 90 mmHg&#xD;
&#xD;
          -  Sensitivity to rifampicin&#xD;
&#xD;
          -  Pregnancy and lactation&#xD;
&#xD;
          -  Difficult venipuncture&#xD;
&#xD;
          -  Abuse of alcohol or medications, or drug use.&#xD;
&#xD;
          -  Participation in other trial with medications in previous 30 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janne Hukkanen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oulu University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oulu University Hospital</name>
      <address>
        <city>Oulu</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>December 29, 2014</last_update_submitted>
  <last_update_submitted_qc>December 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 30, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>rifampicin</keyword>
  <keyword>pregnane X receptor</keyword>
  <keyword>blood pressure</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rifampin</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/NCT01690104
org study id: Rifa-BP
secondary id: 2011-005522-22
nct id: NCT01690104
lead sponsor: 
collaborator: 
has dmc: No
We are investigating the effects of pregnane X receptor (PXR) activation on the regulation of
      blood pressure in healthy volunteers. Rifampicin (an antibiotic and also an efficient PXR
      activator) and placebo will be given for a week to volunteers and blood pressure is measured
      24 hours using an ambulatory blood pressure monitor. Blood pressure regulating hormones will
      be measured in blood. Our hypothesis is that PXR is involved in the regulation of blood
      pressure.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Investigator)
measure: Systolic ambulatory blood pressure
time frame: On day 8 of each arm
description: Systolic blood pressure measured with ambulatory blood pressure monitor.
measure: Diastolic ambulatory blood pressure
time frame: On day 8 of each arm
description: Diastolic blood pressure measured with ambulatory blood pressure monitor
measure: Systolic and diastolic blood pressure
time frame: On day 9 of each arm
measure: Pulse (ambulatory)
time frame: On day 8 of each arm
measure: Plasma renin activity
time frame: On day 9 of each arm
measure: Serum aldosterone
time frame: On day 9 of each arm
arm group label: Rifampicin
arm group type: Active Comparator
description: Rifampicin 600 mg daily
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo daily
intervention type: Drug
intervention name: Rifampicin
arm group label: Rifampicin
other name: Rimapen
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Janne Hukkanen, MD, PhD
role: Principal Investigator
affiliation: Oulu University Hospital
facility: 
country: Finland
responsible party type: Sponsor
mesh term: Rifampin