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The Effect of PXR Activation on Blood Pressure Regulation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01690104
First Posted: September 21, 2012
Last Update Posted: December 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Oulu University Hospital
Information provided by (Responsible Party):
University of Oulu
  Purpose
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.

Condition Intervention Phase
Blood Pressure Regulation Drug: Rifampicin Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of PXR Activation on Blood Pressure Regulation

Resource links provided by NLM:


Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • Systolic ambulatory blood pressure [ Time Frame: On day 8 of each arm ]
    Systolic blood pressure measured with ambulatory blood pressure monitor.

  • Diastolic ambulatory blood pressure [ Time Frame: On day 8 of each arm ]
    Diastolic blood pressure measured with ambulatory blood pressure monitor


Secondary Outcome Measures:
  • Systolic and diastolic blood pressure [ Time Frame: On day 9 of each arm ]
  • Pulse (ambulatory) [ Time Frame: On day 8 of each arm ]
  • Plasma renin activity [ Time Frame: On day 9 of each arm ]
  • Serum aldosterone [ Time Frame: On day 9 of each arm ]

Enrollment: 22
Study Start Date: August 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rifampicin
Rifampicin 600 mg daily
Drug: Rifampicin
Other Name: Rimapen
Placebo Comparator: Placebo
Placebo daily
Drug: Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers
  • BMI 19-30 kg/m2
  • Age 18-40 years
  • Systolic blood pressure 95 - 140 mmHg

Exclusion Criteria:

  • Any continuous medication
  • Any significant medical condition as judged by the study physician
  • Diastolic blood pressure over 90 mmHg
  • Sensitivity to rifampicin
  • Pregnancy and lactation
  • Difficult venipuncture
  • Abuse of alcohol or medications, or drug use.
  • Participation in other trial with medications in previous 30 days
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01690104


Locations
Finland
Oulu University Hospital
Oulu, Finland
Sponsors and Collaborators
University of Oulu
Oulu University Hospital
Investigators
Principal Investigator: Janne Hukkanen, MD, PhD Oulu University Hospital
  More Information

Responsible Party: University of Oulu
ClinicalTrials.gov Identifier: NCT01690104     History of Changes
Other Study ID Numbers: Rifa-BP
2011-005522-22 ( EudraCT Number )
First Submitted: September 7, 2012
First Posted: September 21, 2012
Last Update Posted: December 30, 2014
Last Verified: September 2012

Keywords provided by University of Oulu:
rifampicin
pregnane X receptor
blood pressure

Additional relevant MeSH terms:
Rifampin
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers